FDA Approves New Treatment for Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

“The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness,” said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).

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Apollo pharmacy chain gets DCGI nod for selling the Swine flu drug "oseltamivir"

Apollo Pharmacy, India's leading pharmacy network with over 1000 outlets across the country, has received license from the Drug Controller General of India for the retail sale of oseltamivir, a drug for the treatment of H1N1 Influenza.

The drug is listed under Schedule-X of the Drug and Cosmetic Act 2008. Apollo Pharmacy has launched 24X7 helplines across the country to assist Swine Flu medicine procurement and better disease management. Patient can avail home delivery of the drug by calling the helpline numbers, a release said.

CDSCO in Hyderabad issuing CoPP despite stay orders by HCs of TN, Karanataka

Although High Courts of Madras and Bangalore already stayed the order of Drug Control General of India asking the CDSCO offices to issue the Certificate of Pharmaceutical Products (CoPP) from October 1, some zonal and sub-zonal offices of CDSCO are going ahead with the process of issuing the same without considering the judgements of these regional courts.

The sub-zonal office in Hyderabad has issued 10 Certificates of Pharmaceutical Products within twenty days of the issuance of the order. Whereas, Bangalore and Chennai offices have stopped the 'speedy movement' of the process after the court order. When contacted the officials of these offices said they have not been conveyed any court order staying the DCGI's circular, so far.

A Chandrasekhara Rao, CDSCO- sub-zonal officer, Hyderabad said, "We are getting applications and the office is issuing the certificates. We are following the instructions of DCGI. We have not been informed of any court order. After all, the manufacturers are happy in receiving certificates from our office. I have called a meeting of all the manufacturers with the help of Pharmaexcil and briefed them about the new order and they are happy. So I am not expecting a stay from Andhra high court against the order."

When asked how they conduct the inspections, he said that they have three drug inspectors and the process is going on as usual, but issuance of certificates is depending on factors.

CoPP centralised to uphold India's image at global level: DCGI

Drug Controller General of India (DCGI) Dr Surinder Singh has said that the centralisation of issuing of Certificate of Pharmaceutical Products (CoPP) was introduced in the country by his office recently to uphold the image of the country on the regulatory frameworks, especially in the wake of steady increase in export of pharma products from the country.

Dr Singh said that his decision to centralize the CoPP was based on a letter from the World Health Organisation (WHO) on April 29 this year in which the world health body had taken objection to the use of its name or logo in the title of such certificate. In the letter, the WHO had also found fault with the way the CoPP was issued in India. WHO said that the CoPP is issued by the National Regulatory Authority (NRA) of the producing country based on certain guidelines and formats as laid down by WHO. Referring to some cases, the WHO complained that such guidelines or formats are not followed in India while issuing CoPP by some state authorities.

Source: Pharmabiz

Record Number of Medicines In Development to Treat Diseases Affecting Women

America’s pharmaceutical research and biotechnology companies are working on nearly 1,000 life–changing medicines for diseases affecting women, according to a new report released by the Pharmaceutical Research and Manufacturers of America (PhRMA). The medicines are awaiting approval by the U.S. Food and Drug Administration or are in human clinical trials.

In the U.S., diseases that disproportionately affect women include diabetes, which has reached epidemic proportions and affects 11 million women nationwide. Autoimmune diseases strike women three times more and anxiety and depression two times more women than men. The number one killer of American women is heart disease.

The report lists 969 new medicines in development. They include 112 new treatments for breast cancer, 86 new treatments for obstetric/gynecologic conditions, 76 for asthma, 114 for autoimmune diseases, 155 for diabetes, 131 for arthritis, and 80 for Alzheimer’s disease.

One medicine in the report is a potential cutting–edge treatment that attacks the cause of Alzheimer’s disease rather than merely treating its symptoms. Currently, treatment options for Alzheimer’s disease are limited. This groundbreaking medicine holds the potential to slow the progression of the disease and could vastly improve quality of life for Alzheimer’s patients. Women account for 70 percent of Alzheimer’s deaths.

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Madras High Court issues another injunction staying DCGI order on CoPP

In a big blow to the Central Drug Control Administration, the Madras High Court on last Thursday issued for the second time an injunction staying the order of the Drugs Controller General of India (DCGI) by centralizing the issuance of CoPP (Certificate of Pharmaceutical Products).

The court has issued the interim order acting on a petition filed by B Sethuraman, chairman of the Federation of South Indian Pharmaceutical Manufacturers Association. The injunction will be in force until further orders.

The injunction of the court restricts all the CDSCO offices in south India in implementing the order of the Central Drug Regulator. The DCGI issued the order in last month directing all the zonal and sub-zonal offices of CDSCO to issue CoPP through their offices from October 1.

source: Pharmabiz

list of medicines recommended for disposal by flushing

Medicine	Active Ingredient
Actiq, oral transmucosal lozenge	Fentanyl Citrate
Avinza, capsules (extended release)	Morphine Sulfate
Daytrana, transdermal patch system	Methylphenidate
Demerol, tablets *	Meperidine Hydrochloride
Demerol, oral solution *	Meperidine Hydrochloride
Diastat/Diastat AcuDial, rectal gel	Diazepam
Dilaudid, tablets *	Hydromorphone Hydrochloride
Dilaudid, oral liquid *	Hydromorphone Hydrochloride
Dolophine Hydrochloride, tablets *	Methadone Hydrochloride
Duragesic, patch (extended release) *	Fentanyl
Embeda, capsules (extended release)	Morphine Sulfate; Naltrexone Hydrochloride
Fentora, tablets (buccal)	Fentanyl Citrate
Kadian, capsules (extended release)	Morphine Sulfate
Methadone Hydrochloride, oral solution *	Methadone Hydrochloride
Methadose, tablets *	Methadone Hydrochloride
Morphine Sulfate, tablets (immediate release) *	Morphine Sulfate
Morphine Sulfate, oral solution *	Morphine Sulfate
MS Contin, tablets (extended release) *	Morphine Sulfate
Onsolis, soluble film (buccal)	Fentanyl Citrate
Opana, tablets (immediate release)	Oxymorphone Hydrochloride
Opana ER, tablets (extended release)	Oxymorphone Hydrochloride
Oramorph SR, tablets (sustained release)	Morphine Sulfate
Oxycontin, tablets (extended release) *	Oxycodone Hydrochloride
Percocet, tablets *	Acetaminophen; Oxycodone Hydrochloride
Percodan, tablets *	Aspirin; Oxycodone Hydrochloride
Xyrem, oral solution	Sodium Oxybate

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Gardasil’s effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, N.J.

Gardasil product information:
www.fda.gov/cber/products/gardasil.htm

Better monitoring of clinical research an imperative

Todd Clark, president, Value of Insight Consulting Inc, recently came up with an outstanding report on behalf of the Association of Clinical Research Organisations titled "The Case for Globalisation: Ethical and Business Considerations for Clinical Research."

The report, prepared for the Pharmaceutical Research and Manufacturers of America (PhRMA) members, brings out a number of perspectives about the need of global clinical trials, the progress made in enriching pipelines due to multi-centric trials and the further need to involve emerging markets for quicker patient enrolments and cutting time-to-market products.

One of the important reference points in the report is about India.

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