MenAfriVac, meningitis vaccine administered to 100 millionth person

WHO have announced meningitis vaccine will reach the 100 millionth person this week in a region of Africa that has been plagued by deadly epidemics for more than a century. The milestone will take place in northern Nigeria, part of Africa’s ‘meningitis belt’, where the country is conducting its second seasonal immunization campaign against the disease.

The historic achievement comes two years after the MenAfriVac® vaccine was first launched in Burkina Faso. Since then, nine other countries have held vaccination campaigns to protect people from ages 1 to 29 against meningitis A. Nigeria will vaccinate 16 million people over the next two weeks and Cameroon and Chad are also conducting immunization campaigns this week targeting 5.5 million and 2.3 million people respectively. By the end of this year, the vaccine will have reached more than 112 million people, providing widespread and long-awaited protection.

Source: WHO

Access to Medicine Index 2012

The Access to Medicine Index is an independent initiative that ranks the world’s 20 largest companies according to their efforts to improve access to medicine in developing countries, highlighting policy and practice that either facilitate or hinder access. It is published every two years by the Access to Medicine Foundation, which aims to encourage pharmaceutical companies to make their products more available, affordable and accessible for the millions of people worldwide who do not have reliable access to medicine

The Index uses a framework that evaluates company activities in seven areas of activity considered to be
key to enhancing access to medicine in developing countries. It analyses 101 indicators across these
areas, and within each, the indicators are distributed across four types of action to assess the level
of commitment the company demonstrates, how transparent it is about what it is doing, what specific
activities it is engaged in and how innovative its approach is.


The Index covers 20 companies, 103 countries, and a broad range of products such as drugs, vaccines,
diagnostic tests and other health-related technologies necessary for preventing, diagnosing and treating
disease. A total of 33 diseases are covered, and the disease scope this year includes maternal conditions
and neonatal infections.

Following is the ratings for the year 2012

Access to Medicine Index 2012

GlaxoSmithKline remains at the top of the Index, with a marginal improvement in performance since 2010, and this year, Johnson & Johnson and Sanofi follow closely in 2nd and 3rd positions. The top two companies have the most consistent approach to improving access to medicine, in terms of Index measurements – GlaxoSmithKline leads in four out of the seven key areas and is in the top three in others, and Johnson & Johnson is among the top five performers across all categories. Sanofi leads in public policy, and is second in three other areas; only its ninth position in patents and licencing and eighth position in pricing, manufacturing and distribution puts its overall score at third.

Source: Access to Medicine Index 2012

FDA agrees to review Merck's Suvorexant for sleeplessness

The US FDA have accepted the New Drug Application (NDA) for suvorexant, Merck's investigational insomnia medicine. Suvorexant will be evaluated by the Controlled Substance Staff of the FDA during NDA review. If approved by the FDA, suvorexant will become available after a schedule assessment and determination has been completed by the U.S. Drug Enforcement Administration, which routinely occurs after FDA approval.

The NDA for suvorexant was based on data from a broad clinical development program, including: two pivotal, three-month efficacy trials that evaluated the ability of suvorexant to help patients fall asleep and stay asleep; a 12-month study, followed by a two-month discontinuation phase, that was designed to assess the safety of suvorexant, while also evaluating its longer term efficacy and the impact of stopping treatment; and two next-day driving studies that provided an assessment of residual effects following evening use of suvorexant.

Merck researchers developed suvorexant to target and block orexins, chemical messengers that help to keep you awake. By temporarily blocking the actions of orexins, suvorexant helps to facilitate sleep. If approved, suvorexant would be the first in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep

Are Pharma Companies increasing the number of Voluntarily initiated Phase IV trials

The study, “Phase IV Clinical Trials: Best Practices in Post-Marketing Study Management,” conducted by Cutting Edge Information found that 82% of surveyed companies’ post-marketing trials are voluntarily initiated. That percentage is an increase from 61% of Phase IV trials that were voluntarily initiated by drug manufacturers in 2006.

I took a quick look at the number of phase IV trials at the ClinicalTrials.gov registry and surprised to see that the number of Phase IV trials disclosed by Pharmaceutical companies was on a decline. Is the disclosure limited to trials that are conducted as part of Life Cycle Managment of the drugs or are the companies conducting trials purely for commercial reasons and do not have an obligation to report those.

Here is what ClinicalTrials.gov reflects on the phase IV trials run by pharmaceutical companies.



Hyderabad holds the potential to become the medical tourism hub of India

With IMTCA (Indian Medical Tourism Conference and Alliance) 2012 kick starting its 1st edition in Hyderabad, the two day conference (2nd, 3rd) had unlocked the huge potentials that can be explored in the medical tourism sector in India. With advanced hospitals and well developed healthcare infrastructure, Hyderabad is set to become the medical tourism hub of India, revealed speakers at the conference.


With a potential of $35 billion global markets, the medical tourism sector holds a great growth potential if explored in the right direction. At present South Korea is leading in the medical tourism sector with a rapid growth of $6.9 millions in 2009 to 27.8 millions in 2011. In view of this India too can be explored to earn great revenues through promoting medical tourism in the country. With a well developed hospital infrastructure and well trained nurses and doctors Hyderabad stands in the forefront to grab the opportunity of become the India’s leading medical tourism hub.

Initiated as an objective to bring all stake holders (medical practitioners, doctors, hospitals, tourism and hospitality industry) at one place, the IMTCA event also gave an apt platform for networking with delegates and exchange ideas on research, academic and economic values
  About 200 medical practitioners, tourism professionals and specialists from across the country took part in the 1st edition of the IMTAC 2012. The two day event largely focused on global medical tourism and potential of Hyderabad as a medical tourism hub in India

DBT invites applications for “Innovative Young Biotechnologist Award”

The department of biotechnology (DBT) has invited applications for the “Innovative Young Biotechnologist Award” (IYBA) for the year 2012. The Award was instituted by the DBT in the year 2005, as an attractive, career-oriented scheme to identify and nurture outstanding young scientists with innovative ideas and desire to pursue research in frontier areas of biotechnology.


For the year 2012 awards, the department invites applications from the young investigators upto the age of 35 years. The award will consist of financial support for a project and cash award/fellowship for the awardees.

Awardees having a regular employment will receive a cash award of Rs.1 lakh every year during the course of the project in addition to grants-in-aid of Rs.50 lakhs for a project. The awardees, those are not in the regular employment will receive a fellowship of Rs.40,000 per month with grants-in-aid and shall be attached to a senior scientist (mentor) in a university, research institute, medical/agriculture/ veterinary college or any other institute of repute. The applications should reach the DBT by November 23, 2012.

The applicant should have an excellent academic career and also should have publications in high impact journals and/or should have invented technologies supported by Indian/ International patents. The proposed research project should clearly reflect the innovative thinking and execution capabilities of the applicant.

The minimum eligibility criteria for applicants include: the candidate should have secured First Class grades in examinations of all academic courses for award of a degree from the graduate level onwards; and cumulative publication impact factor of 10 of only either first author or corresponding author OR Cumulative publication impact factor of five of only either first author or corresponding author with two published Indian Patents or one International patent.

Minimum qualification for the applicant is Ph.D. in any branch of life sciences including medicine, veterinary sciences, pharmacy, agricultural sciences, and engineering sciences. Master degree in medicine, engineering/technology is also eligible to apply.
  Source: Pharmabiz

Novartis future growth prospects

Pharmaceuticals Division growth over the next 5 years expected to be driven by portfolio of recently launched products

 

• Division had 7 blockbusters in portfolio in 2011 and expects to achieve 14 or more blockbusters by 2017

Industry-leading Pharmaceuticals pipeline with 73 new compounds presented:

 

• 9 key regulatory milestones achieved so far in 2012
• Over the next 12 months, data read out of 13 late-stage pipeline projects, 9 filings and up to 7 regulatory decisions expected
• Oncology pipeline, AIN457 and heart failure (LCZ696 and RLX030) expected to provide significant newsflow; filing of RLX030 planned to commence in early 2013 in US and EU
• LAMA/LABAs, including QVA149 have potential to become new standard of care for COPD

 Oncology business aims to grow through Glivec patent expiry

 

• Robust late stage pipeline including 13 new chemical entities and 19 new indications
• Oncology late-stage pipeline products expected to contribute more than USD 1 billion in sales by 2017
• Afinitor now expected to contribute USD 2 billion sales in advanced breast cancer alone by 2017
• Start of broad scale clinical development program announced for leading PI3K inhibitor BKM120 across multiple indications (PRISM

Chimerix Presents Data Highlighting Burden Of Care Associated With Current Antiviral Therapies In Stem Cell Transplantation

RESEARCH TRIANGLE PARK, N.C.- Chimerix, Inc., a biotechnology company developing orally-available antiviral therapeutics, today announced data highlighting the significant morbidity and resource utilization associated with the current standard of care for the management of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients.  

This analysis, entitled "Preemptive Therapy (PrT) for Cytomegalovirus (CMV) Post-hematopoietic Cell Transplantation(HCT) is Associated with Significant Morbidity and Resource Utilization," was presented at the 52^nd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, September 9-12, San Francisco). 

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Discovery of New "Youth Pill" Revealed At International Scientific Conference

SAN ANTONIO -- What would you call a compound that can help reduce wrinkles, decrease body fat, increase lean muscle mass, strengthen bones, boost mood, improve sex drive, and make users look and feel decades – not years, but DECADES – younger? Well, a lot of people, including medical experts, are touting human growth hormone (HGH) as the proverbial "fountain of youth."

The problem has been that, until now, the rich and powerful of Hollywood had to resort to expensive injections of synthetic HGH to experience its numerous benefits. But at this week's 30^th annual international meeting of The Obesity Society in San Antonio, cutting-edge clinical results were presented detailing a new dietary supplement shown in a double-blind clinical trial to increase the body's own production of HGH by an average of 682%.

The Study

Dr. Amy Deaton, PhD. Director of Scientific Affairs for SanMedica International, LLC, presented the findings, which were compiled by a group of scientists at the Pennington Biomedical Research Center at Louisiana State University. The results demonstrate an oral compound called SeroVital, which is capable of supporting the pituitary gland's production of more youthful growth hormone levels in human subjects. In the randomized cross-over, placebo controlled, double-blind clinical trial, the specialized amino-acid blend was proven to actually increase bioactive, serum (blood) growth hormone levels by a mean of 682% at 120 minutes.

 The trial involved men and women between 18 and 70 years of age, who were scheduled for two testing sessions a week apart where, after an overnight fast, blood samples were drawn over a period of 120 minutes after consumption of either the proprietary SeroVital blend or placebo capsules. Neither the subjects nor the investigators knew at which session the subjects received the SeroVital blend and at which session they received the placebo. At the end of the study, the samples were tested for serum HGH levels, and the results were independently analyzed.

Independent Testing Confirms IBA Green's Revolutionary Molecular Process

NEWPORT BEACH, CA, - IBA Green, Inc., a wholly owned subsidiary of Pioneer Exploration Inc. (PIEX) is pleased to announce Advanced Technology Laboratories, Inc., an independent EPA certified lab confirmed IBA Green's test samples rendered "Non Detectable" of the toxins arsenic, barium, cadmium, chromium and lead.   The tested ash samples were derived from a Waste to Energy facility.

"This independent confirmation catapults IBA to the multi-billion dollar environmentally responsible construction materials market," said Angelo Scola, Chairman of the Board of IBA Green. "Not only does our one-of-kind process meet EPA standards it surpasses them and renders the coal ash toxins Non Detectable. 

Our best-in-breed nontoxic coal ash byproduct will be used to produce a concrete that is stronger and lasts twice as long as Portland  concrete used today in the building of highways and bridges", explains Mr. Scola. This is truly a milestone for the company and we fully expect today's announcement to have a major impact on how ash will be up-cycled to a higher and best use, and most importantly  adding value for our shareholders. 

Zafgen Announces Additional Weight Loss and Cardiometabolic Data from Phase 1b Studies of Beloranib in Obesity at Obesity 2012, the 30th Annual Scientific Meeting of The Obesity Society

SAN ANTONIO, -- Zafgen, Inc., a leading biopharmaceutical company dedicated to addressing the unmet needs of severely obese patients, today announced new data from two Phase 1b studies of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), which showed rapid weight loss, reductions in body fat, and improvements in cardiovascular disease risk markers in severely obese women.  These results were achieved with both the intravenous (IV) and subcutaneous administration of beloranib.

  The data were presented in a poster session at Obesity 2012, the 30^th Annual Scientific Meeting of The Obesity Society in San Antonio on September 22, 2012 at noon CDT.

With these latest findings, there are now three independent studies showing that treatment with beloranib resulted in identical weight loss and was well-tolerated.  Beloranib, a novel obesity therapy that utilizes a unique mechanism of action, is being studied for its ability to restore balance between the production and utilization of fat.

"Consistent results showing rapid and substantial weight loss in three independent placebo-controlled and double-blinded studies raise our confidence in beloranib as an obesity therapeutic," said Tom Hughes, PhD, president and CEO of Zafgen. "The latest findings also validate the transition from intravenous administration, which we employed to establish proof of concept, to a subcutaneous form that is more convenient for patients and paves the way to larger trials."  

Both Phase 1b trials presented at Obesity 2012 were randomized, double-blind, placebo-controlled studies to evaluate the safety, tolerability and metabolic effects of twice-weekly administered beloranib in severely obese women.  In one trial, beloranib was administered intravenously (IV); the second trial involved subcutaneous administration.  Patients in both studies were allowed to eat normally and were not counseled to change their exercise habits.   

The first poster presentation authored by Dr. Dennis Kim, Chief Medical Officer of Zafgen, showed that after four weeks of treatment, the fixed dosing regimen of IV beloranib was generally well-tolerated, resulted in rapid body weight (BW) loss, improved body composition and cardiometabolic risk markers and reduced hunger.  

Patients were obese women with mean (SEM) age 45.7 (2.6) yr, body weight (BW) 104.9 (4.0) kg, and BMI 39.5 (1.1) kg/m, who were enrolled into each of the 3 arms of the trials (N=6 in 3.0 mg, 5 in 6.0 mg, and 5 in placebo arm).  Results are based on the per-protocol population (n=6, 3, and 5 for 3.0 mg, 6.0 mg, and placebo, respectively) completing the trial.

After four weeks, subjects on 3.0 mg beloranib lost an average of 4.7 kg from baseline (P=0.0008), 6.0 mg beloranib lost 6.7 kg (p=0.0013) vs. a gain of 0.2 kg for placebo.  Body composition measurements were consistent with reduced adipose tissue mass.  Despite the fact that they lost weight, hunger tended to be reduced (-28% with 3.0 mg, -52% with 6.0 mg, vs. -2% with placebo).  

The cardiovascular disease risk markers LDLc (Low-Density Lipoprotein cholesterol) and CRP (C-Reactive Protein, an inflammatory marker), decreased significantly in the two beloranib groups vs. placebo.  Blood pressure (BP) and glucose did not change with treatment.  Doses less than 6.0 mg appear to have clinical utility in balancing effectiveness and tolerability.

The most frequent adverse events (AEs) were mild diarrhea, nausea, headache, dizziness, infusion site injury, and mild-to-moderate sleep disturbance (resulting in two drop-outs from the 6.0 mg group). There were no clinically significant abnormal laboratory or ECG findings.

The second poster (in the Late Breaking Abstract Poster Session) presented by Dr. Dennis Kim demonstrated that subcutaneously administered beloranib appeared safe and showed dose responsive weight loss over four weeks. 

Beloranib treatment was generally well-tolerated by subcutaneous administration, resulted in rapid BW loss, improved sense of hunger and cardiovascular disease risk markers.  Patients were white women (mean age 46.0 - 49.9 yr, BW 92.0 - 98.4 kg, and BMI 34.0 - 36.4 kg/m² across the treatment groups).

Regeneron Announces FDA Approval of EYLEA (aflibercept) Injection For Macular Edema Following Central Retinal Vein Occlusion

TARRYTOWN, N.Y.,-- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA (aflibercept) Injection for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO).  The recommended dose for EYLEA is 2 milligrams (mg) every 4 weeks (monthly).

"This second U.S. approval for EYLEA provides physicians and patients with a new treatment option for the treatment of macular edema following CRVO," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. 

"Based upon the pivotal Phase 3 study results, EYLEA has been shown to significantly improve visual outcomes in a disease characterized by high VEGF levels.  We thank the patients and clinical investigators who participated in our clinical studies, the FDA, and the Regeneron employees who helped make this day possible."  

The approval of EYLEA for Macular Edema following CRVO was based on data from the Phase 3 COPERNICUS and GALILEO studies.  In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS.  Results for the EYLEA 2 mg monthly group were superior to those for the sham control group for the primary endpoint.

EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.

Results from week 24 through 52 of the COPERNICUS and GALILEO studies have not yet been reviewed by the FDA.

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Computer Exercises May Offer New Hope for Alzheimer's Patients

YOKNEAM, Israel, September 21, 2012 --World Alzheimer's Day - As the planet turns its attention to World Alzheimer's Day, an emerging technology using focused computer brain exercises may offer new hope to Alzheimer's patients and their families.  

The NeuroAD system works like this: patients solve challenging computer exercises ranging from identifying colors, shapes, letters and animals to solving memory games. Simultaneously, the very same regions of the patient's brain responsible for memory and learning receive electromagnetic stimulation, which reactivates brain cell activity.

The combined treatment may work more effectively than either would alone. It has already shown promising interim results in a clinical trial at Harvard University, following significant statistical and clinical results from studies in Israel. The NeuroAD system not only stopped patients' symptoms from deteriorating, in some cases it actually improved patients' cognitive performance to a greater extent than what is currently available with approved medications.

"It is a completely new and different approach, safe, noninvasive, and painless," said Professor of Neurology Alvaro Pascual-Leone of Harvard Medical School, who directed the Harvardtrial. "Tests have shown significant improvement of cognitive functions. As a result, patients' daily activities such as taking care of themselves, speaking, and even recognizing their loved ones have improved dramatically."

"Wherever we go, physicians are eager to hear about this new technology because nothing else is available to help patients," said Eyal Baror, CEO of Israel-based Neuronix, the company behind the NeuroAD system. "NeuroAD is CE certified, which means centers in Europe and Asia are already using the device to great success.

 We are also aiming at FDA approval within the coming years. It may be a real game-changer for the management of Alzheimer's disease."

Developers are hoping that additional trials now set to take place at leading neuroscience centers in New York, Nevada and Arizona, in addition to continued work in Boston, will confirm these earlier findings.

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Cialis (tadalafil) Tablets Recommended for Approval for the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia in the European Union

INDIANAPOLIS, Sept. 21, 2012-- Eli Lilly and Company (NYSE: LLY) announced today it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU), recommending approval of Cialis 5 mg for once daily use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

The opinion is now referred for final action to the European Commission, which has the authority to approve medicines for the EU. The Commission usually decides on CHMP recommendations within one to two months.

Cialis was approved for erectile dysfunction (ED) in the EU in 2002. Cialis for once daily use was approved for the treatment of ED in the EU in 2007.

"If approved by the European Commission, Cialis will be the only medication in the EU to provide a single treatment option for men with both ED and BPH," said Anthony Beardsworth, senior medical director at Lilly. "The CHMP positive opinion for Cialis marks an important regulatory milestone for Eli Lilly and Company and our commitment to bringing new treatment options to the millions of men who experience ED and BPH."

Cialis 5 mg for once daily use was approved by the U.S. Food and Drug Administration (FDA) in October 2011 for the treatment of the signs and symptoms of BPH. The FDA also approved Cialis 5 mg for once daily use to treat men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH).

It is important to note that Cialis is not to be taken with medicines called "nitrates" such as isosorbide dinitrate or isosorbide mononitrate, which are often prescribed for chest pain, or with recreational drugs called "poppers" like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure.

 It also should not be taken by those who are allergic to Cialis or Adcirca(tadalafil), or any of its ingredients. Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing should call their healthcare provider or get help right away.

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CHMP Recommends Approval of Cialis for the Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia

INDIANAPOLIS, Sept. 21, 2012 -- Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Cialis (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

 The CHMP's opinion is now referred to the European Commission, which has the authority to approve medicines for the European Union (EU). The Commission usually issues a decision within one to two months following the CHMP opinion.

Tadalafil was approved for the treatment of erectile dysfunction in the EU in 2002. Tadalafil for once a day use was approved for the treatment of erectile dysfunction in the EU in 2007.

"If approved by the Commission, tadalafil will be the first and only medication approved in the EU to treat men with both erectile dysfunction and benign prostatic hyperplasia," said Kraig Kinchen, M.D., senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians."

The CHMP issued its opinion after reviewing safety and efficacy data from 1,500 patients in four clinical studies of BPH, including one study of BPH and ED. Additionally, safety data from the approved indication for erectile dysfunction were included in Lilly's submission. In the BPH and ED study, Cialis 5 mg for once a day use significantly improved scores on the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH, and the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function.

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Mylan Launches Generic Version of Antivert Tablets, 12.5 mg, 25 mg and 50 mg

PITTSBURGH, Sept. 21, 2012 -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Meclizine Hydrochloride Tablets USP, 12.5 mg, 25 mg and 50 mg. This product is the generic version of Pfizer's Antivert, which is indicated for the management of nausea and vomiting, and dizziness associated with motion sickness.

Antivert Tablets, 12.5 mg, 25 mg and 50 mg, had U.S. sales of approximately $53.5 million for the 12 months ending June 30, 2012, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 169 ANDAs pending FDA approval representing $79.4 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.

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FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture PR Newswire (http://s.tt/1nWJg)

THOUSAND OAKS, Calif., -- Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) approved a new indication for Prolia(denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture.  Prolia, the first FDA-approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months.

"While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Fractures can be a life-changing event, so we are pleased that we can offer a new treatment option for the growing number of men with osteoporosis at high risk for fracture."

According to the National Osteoporosis Foundation, two million men in the U.S. have osteoporosis and another 12 million are at risk. Osteoporosis and osteoporotic fractures in men remain under diagnosed and under treated.

The new indication for Prolia is based on results from the ADAMO trial (A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety ofDenosumAb 60 mg every six months versus placebo in Males with Osteoporosis), the pivotal Phase 3 study involving 242 men with low bone mineral density (BMD). 

In the study, treatment with Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo (5.7 percent vs. 0.9 percent). Effects of Prolia on BMD were independent of age, baseline testosterone levels, BMD status and estimated fracture risk.

Additional results showed that patients in the study who received treatment with Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip (2.4 percent vs. 0.3 percent) and at the femoral neck (2.1 percent vs. 0.0 percent). Safety findings were consistent with what have been observed in other studies of Prolia in postmenopausal women with osteoporosis. The most common adverse reactions reported (per patient incidence > 5 percent) were back pain, arthralgia and nasopharyngitis. 

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Intelomed Receives FDA 510(k) Clearance of CVInsight Medical Device

WEXFORD, Pa., -- Intelomed, Inc., a developer of non-invasive medical devices and technology for monitoring fluid adaptation for patients well or poorly perfused, announced today that it has received FDA 510(k) clearance on its CVInsight medical device.

CVInsight processes a pulse wave through proprietary algorithms to measure and display vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.     

Intelomed's CEO, Frank Amoruso, commented:  "We are very excited about the introduction of CVInsight.  We believe it will have a meaningful impact on the ability to monitor a patient's vital signs and cardiovascular health, thereby having an extremely positive effect on the quality of patient care."

CVInsight will provide clinicians and other caregivers with a utility for recording trends of pulse rate, SpO2, and the percentage of change in pulse rate and pulse strength derived from data recorded with a pulse oximeter.  A clinician may use this data as an indication of a clinical event based upon their experience and training. 

 Intelomed's Chief Researcher and inventor of CVInsight, Jan Berkow, said; "CVInsight will provide physicians with a non-invasive tool that gives a critical 'insight' into a patient's declining cardiovascular stability - much earlier than some current medical standards by trending of such values.

  With this early indication, the clinician may be able to determine what action to take well in advance, rather than reacting to recognition measures after the event has occurred.  One major challenge facing trauma surgeons and clinicians is the ability to non-invasively measure the circulatory system's blood volume adequacy in real-time.  I believe this could be a very significant step in patient care, especially in the areas of hemodialysis, cardiology, and trauma."

Intelomed is confident that CVInsight will have utility across many areas of healthcare, but the company will initially focus on specific applications where research shows that the greatest needs exist.  One of the first applications is hemodialysis, where clinicians seek tools to improve treatment and avoid acute events that put the patient at risk and often prevent a successful dialysis treatment. Mr. Amoruso adds, "Our Medical Advisory Board consists of very well respected and accomplished physicians that have given us excellent guidance relative to industry needs and market approach.  We are fortunate to have such consummate thought leaders on our team."      

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New Boehringer Ingelheim Oncology Data to be Presented at ESMO 2012 Congress

RIDGEFIELD, Conn., Sept. 20, 2012 -- Boehringer Ingelheim today announced that data from 13 abstracts assessing the efficacy and safety of two of its investigational oncology compounds – afatinib and nintedanib – were selected for presentation at the ESMO 2012 Congress (European Society for Medical Oncology) in Vienna, Austria, September 28– October 2, 2012.  These data represent Boehringer Ingelheim's commitment to further develop its oncology pipeline with the goal of bringing new treatment options to the oncology community.

Data will include results from Phase II and III studies of afatinib in various lung cancer treatment settings and patient groups as well as data on health-related quality of life and symptom control.  Data from Phase I studies of afatinib in advanced solid tumors will also be presented.  The nintedanib results are from Phase I studies in hepatocellular carcinoma and in combination with afatinib in advanced solid tumors.

"Boehringer Ingelheim is looking forward to sharing new results for our investigational oncology compounds with the global oncology community at ESMO," said Berthold Greifenberg, M.D., vice president, Clinical Development and Medical Affairs, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. "This is an exciting time for Boehringer Ingelheim as we continue to explore the potential of our growing oncology pipeline."

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Unigene To Present at the 2012 Obesity Society's 30th Annual Scientific Meeting

BOONTON, N.J., Sept. 20, 2012-- Unigene Laboratories, Inc. (OTCBB: UGNE), a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that its Chief Scientific Officer, Nozer Mehta, Ph.D., will present an update on UGP281, Unigene's novel anorexigenic peptide, at the 2012 Obesity Society's Annual Scientific Meeting in San Antonio.

Dr. Mehta's presentation, Recombinant Production, Oral Delivery and Preclinical Data on a Novel Anorexigenic Peptide UGP281, will be given on September 20, 2012 at 1:45 p.m. CT(2:45 p.m. ET) and will provide an overview of Unigene's peptide analog, UGP281, in development for the treatment of morbid obesity. The presentation will be part of a larger forum, entitled Pharmacologic and Device Session for Up and Coming Obesity Treatments. 

In addition to Dr. Mehta's oral lecture, Unigene will present a poster at the conference describing in greater detail its pre-clinical studies of UGP281.

"With the incidence of obesity and its associated co-morbidities such as type 2 diabetes quickly on the rise, there is a significant opportunity to leverage oral peptide technologies in helping address these issues," said Dr. Mehta.  "We are very encouraged by the promising preclinical data for UGP281 and believe it could offer a new, potentially high-value therapeutic for addressing morbid obesity."

UGP281, a potent anorexigenic peptide selectively targeting the amylin receptor, is under development by Unigene for the treatment of morbid obesity.  In multiple-dose pharmacology studies in animal models, UGP281, administered subcutaneously, produced an acute and dramatic reduction in food intake, and a sustained, dose-related decrease in body weight of 10-15%. These effects were achieved at relatively low doses, and were consistent with the targeted pharmacology. 

The efficacy of UGP281 was also demonstrated following oral delivery with Unigene's Peptelligence technology. UGP281 was well tolerated with no significant adverse findings in the studies conducted to date, and its therapeutic window appeared to be substantial.

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Van Andel Institute Research Symposium Showcases Latest Developments In Parkinson's Research

GRAND RAPIDS, Mich., Sept. 20, 2012 -- Van Andel Institute (VAI) hosts a scientific symposium September 19-20 that gathers some of the world's most noted experts in Parkinson's disease and reinforces the region's growing reputation in the field of Parkinson's research.

Grand Challenges in Parkinson's Disease features experts from a dozen nations including Australia, Malaysia and Sweden. The purpose of the event is to showcase the latest research in the field and to honor Andrew B. Singleton, Ph.D., of the National Institutes of Health (NIH) with the first Jay Van Andel Award for Outstanding Achievement in Parkinson's Disease Research.

"This is truly a gathering of some of the world's greatest minds in Parkinson's disease research," said chief event organizer Patrik Brundin, M.D., Ph.D., Chair of the Jay Van Andel Translational Parkinson's Disease Research Laboratory and Director of Van Andel Institute's Center for Neurodegenerative Science. "We will be sharing the results of recent and ongoing research that will become the building blocks for therapies that may be commonplace a decade from now."

The event features keynote addresses by noted Parkinson's experts Ted Dawson, M.D., Ph.D., of The Johns Hopkins University, who will speak on the topic of Looking Forward to Tomorrow's Therapies for Parkinson's Disease, and Roger Barker, Ph.D., of University of Cambridge, who will speak on Matching Therapies to Patients: The Complexities of Disease Heterogeneity in Parkinson's Disease.

Dr. Andrew Singleton is best known for his work aimed at understanding the genetic causes of Parkinson's disease – work that is opening entire new fields of research.

His first well-known work described the discovery of a duplication and triplication of the alpha-synuclein gene that causes a severe, early-onset form of Parkinson's disease. Scientists already knew that a few extremely rare mutant forms of the protein were bad, but Dr. Singleton showed that too much of the normal protein also has ramifications.

One year later he led the group that was the first to identify mutations in the LRRK2 gene as a cause of familial Parkinson's disease. Occasionally new mutations arise in this gene, which can explain some of the cases of the more common, sporadic Parkinson's disease.

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SPR Therapeutics Receives FDA Approval For Pivotal Study Of SMARTPATCH Peripheral Nerve Stimulation System

CLEVELAND, Sept. 20, 2012 -- SPR Therapeutics, an innovator in the application of electrical stimulation to peripheral nerves for the relief of pain, has earned Investigational Device Exemption (IDE) approval from the Food and Drug Administration to initiate a multi-center, pivotal study of the SMARTPATCH Peripheral Nerve Stimulation (PNS) System for the treatment of post-stroke shoulder pain.  SPR Therapeutics is one of the growing number of neurotechnology firms in Cleveland, one of the regions recognized by the Neurotechnology Industry Organization (NIO) for spurring neurotech innovation.

According to the Post-Stroke Rehabilitation Outcomes Project, shoulder pain has been found to affect one third of post-stroke survivors, most describing their pain as moderate to severe.  "The SMARTPATCH PNS System has provided significant pain relief and improvement in quality of life in earlier studies, and if similar results are achieved in this pivotal trial, it will offer a much needed treatment for patients who have very limited options at present.  

Perhaps most interesting is that unlike any other neurostimulation technology I'm aware of, SMARTPATCH is designed to offer pain relief that persists even after the short-term therapy has ended.  SMARTPATCH holds the potential to alleviate debilitating shoulder pain and to provide an alternative to pain medications," said Dr. John Chae, professor of Physical Medicine and Rehabilitation at Case Western Reserve University and MetroHealth Medical Center.  

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Glenmark Generics Receives Tentative Approval for Rizatriptan Benzoate

MUMBAI, September 20, 2012 --Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Limited, announced today that the United States Food and Drug Administration (U.S. FDA) has granted tentative approval for Rizatriptan Benzoate tablets, its generic version of Merck's Maxalt tablets.

According to IMS Health for the 12 month period ending June 2012, Rizatriptan Benzoate immediate release tablets achieved sales of USD 315 million.

Glenmark's current portfolio consists of 81 products authorized for distribution in the U.S. marketplace and 41 ANDA's pending approval with the U.S. FDA.

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InnoPharma, Inc., Announces U.S. FDA Approval of Acetylcysteine Solution, USP, 20% for Inhalation or Oral Administration

PISCATAWAY, N.J., -- InnoPharma, Inc. today announced U.S. FDA approval of their Abbreviated New Drug Application (ANDA) for Acetylcysteine Solution, USP, a bronchial mucolytic indicated as an adjuvant therapy for patients with certain lung diseases and also as an acetaminophen antidote when administered orally. Acetylcysteine Solution, USP will be available in the coming weeks in 20% concentration for inhalation or oral administration in 30 ml vials. Acetylcysteine Solution, USP is currently on FDA's and ASHP's drug shortage lists.

InnoPharma has an agreement with Fresenius Kabi USA, LLC for its APP division to sell, market and distribute Acetylcysteine Solution, USP in the United States.

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Acceliant Participates as Platinum Sponsor at the SCDM Annual Conference in Los Angeles

LOS ANGELES and HERNDON, Virginia, September 18, 2012--Acceliant is expanding the boundaries of eClinical trial technologies by delivering an end-to end clinical trial solution integrating Electronic Data Capture (EDC) and Patient Reported Outcomes (e-PRO) to support various clinical development activities in the life sciences industry. 

At the SCDM 2012 Annual Conference, held in Los Angeles Sep. 22-25, Acceliant, aPlatinum sponsor, will showcase "Integration of e-PRO through multi-modal data capture with the power of EDC."

A product demonstration is slated for September 24 at 7:15 a.m. in the Platinum Ballroom, Salons I-JW Marriott Live Hotel. Join us for hands-on experience on the technology in this session. Acceliant also invites all conference attendees to visit Booth #200 where Acceliant will showcase the integration of several new EDC and e-PRO modules.

Ven Thangaraj, CTO of Acceliant said, "Globally, Clinical Data Management Practice takes advantage of new data gathering technologies and processes to improve the speed and quality of data collection and rapidly merge it with EDC systems. Acceliant has developed a single EDC/e-PRO system that offers a superior solution by allowing study data to be readily available, eliminating integration costs. Acceliant will also showcase several of its proprietary solutions on the SCDM platform for pharmaceutical, biotech, and CROs who spend considerable time and money in the selection process."

Sri Manchala, CEO and President of Acceliant said, "The SCDM Annual Conference is an important event attended by clinical professionals and experts from the life sciences industry globally. It's like bringing the entire marketplace to one location. We strongly believe that SCDM, as a platform, brings us closer to our clients in understanding the challenges they face and developing innovative solutions that add value."

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Genomic Health Announces Positive Topline Results of Large Prostate Cancer Clinical Validation Study; Company to Proceed with 2013 Commercial Launch

REDWOOD CITY, Calif., Sept. 18, 2012 -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from a large clinical validation study of its biopsy-based prostate cancer test.  The study, performed in collaboration with leading prostate cancer researchers at the University of California, San Francisco (UCSF), met its primary endpoint by demonstrating that the multi-gene Oncotype DX Genomic Prostate Score (GPS), assessed in prostate needle biopsy tumor tissue, has been prospectively validated as a predictor of adverse pathology for patients with early-stage prostate cancer. 

 UCSF and Genomic Health plan to submit complete data from this study for presentation at the 2013 ASCO Genitourinary Cancers Symposium in February.  Based on these results, Genomic Health is completing the necessary work in its Clinical Reference Laboratory to make the OncotypeDX prostate cancer test available to physicians and patients in the first half of 2013.

"It is widely recognized that a very large percentage of men with low and intermediate risk prostate cancer are over-treated due in part to the lack of a standardized, validated biopsy-based test to more accurately distinguish between aggressive and clinically indolent disease," said Peter Carroll, M.D., M.P.H., Chair, Department of Urology, University of California, San Francisco. "These results have the potential to change medical practice significantly by providing physicians and their patients with a multi-gene prostate cancer test, designed specifically for biopsies, that will improve treatment decisions for early-stage prostate cancer at the time of diagnosis."

As was the case for the established Oncotype DX breast and colon cancer tests, Genomic Health and its collaborators used a rigorous clinical development strategy for development and validation of the Oncotype DX Genomic Prostate Score.  In a three year effort, Genomic Health optimized its proprietary RT-PCR methodology to be able to analyze the very small amounts of formalin-fixed paraffin-embedded prostate tissue obtained by diagnostic prostate needle biopsies.

"The over-treatment of prostate cancer represents one of the most significant issues in men's health today," said Howard Soule, Executive Vice President and Chief Science Officer of the Prostate Cancer Foundation. "With this study, Genomic Health has applied its groundbreaking technology and innovative clinical trial expertise to address a critical treatment decision facing hundreds of thousands of men each year."

Genomic Health conducted six feasibility and development studies in collaboration with the Cleveland Clinic evaluating more than 700 patients and 700 candidate genes to select the genes for this test.  The resulting pre-specified test was then evaluated in prostate needle biopsy specimens in the prospectively-designed UCSF clinical validation study.  It is expected that in conjunction with the Gleason grading system and conventional parameters such as PSA, age, and physical examination, the Oncotype DX Genomic Prostate Score will be utilized to personalize prostate cancer treatment based on the underlying biology of an individual patient's tumor.

"Each year in the U.S. alone, more than 240,000 men are diagnosed with prostate cancer, with the vast majority receiving aggressive treatments associated with serious, long-term side effects.  Based on the results of this study, we believe the Oncotype DX Genomic Prostate Score will increase the number of patients eligible for active surveillance, and identify those who should consider aggressive treatment," said Steven Shak, Executive Vice President of Research and Development and Chief Medical Officer at Genomic Health.  

"With our proven record of developing and validating multi-gene tests, combined with our established global infrastructure, we believe Genomic Health is well positioned to deliver this critical tool to physicians and prostate cancer patients around the world."

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Suneva Medical Completes Enrollment and Initial Treatment of Patients in Phase III Acne Scar Study

SAN DIEGO, Sept. 18, 2012 - Suneva Medical, Inc., a privately-held aesthetics company, today announced that it has completed the enrollment and initial treatment of patients in its Phase III acne scar study. Touch-up treatments are expected to be completed by the end of September. This multi-center, prospective study is being conducted at 10 prestigious aesthetic medical practices in the U.S. and is investigating the efficacy of Artefill for the treatment of moderate to severe atrophic acne scars. 

"We have reached yet another milestone in our pursuit of expanded indications for Artefill. If the study is successful and the FDA grants an approval for this indication, Artefill would be the only dermal filler approved and on the market for the treatment of acne scars. This represents a significant market opportunity for our growing aesthetics company and could expand the patient and physician audience for Artefill," commented Nick Teti, Chairman and CEO of Suneva Medical.  He continued, "Acne scars have a profoundly negative impact on the millions of people that have been living with this condition. If approved, Artefill could truly help these affected people."

According to the American Academy of Dermatology, acne is the most common skin condition in the United States, affecting 40 to 50 million Americans at any one time. By mid-teens, more than 40 percent of adolescents have acne or acne scarring requiring treatment by a dermatologist.

"Patients have been eager to enroll in the study as they are seeking a new and long-lasting option to treat their acne scars. We are excited about the prospects for this dermal filler with this growing patient population," commented study investigator Ava Shamban, M.D.

Artefill is a long-lasting, dermal filler approved by the FDA in 2006 for the correction of the nasolabial folds commonly known as "smile lines." To date, approximately 50,000 patients have been treated with the product.

This announcement follows several significant corporate developments for Suneva Medical in recent months. As previously announced, the company acquired Refissa and its generic equivalent, the only tretinoin cream currently available with a .05% strength, emollient base and broad indication for fine facial lines, hyperpigmentation and tactile roughness. Suneva Medical also previously announced the official roll-out of ReGenica Skincare, a next generation, growth factor skincare line clinically proven to reduce the signs of aging.

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