Sunday, November 28, 2021

Eurofins Technologies Announces Launch of RT PCR kIts for Rapid Detection of SARS-CoV-2 Variant B.1.1529 (OMICRON)

 Eurofins Technologies (Paris:ERF) continues to innovate and develop a wide range of diagnostic solutions for COVID-19, particularly in response to the threat of emerging mutations.

Researchers have identified a new SARS-CoV-2 variant with a concerningly high number of mutations in the spike protein. The variant, first identified in Botswana in November 2021, is spreading rapidly across South Africa.

The variant contains more than 30 mutations to the spike protein — the SARS-CoV-2 protein that recognises host cells and is the main target of the body’s natural or vaccine induced immune responses. Similar mutations found in variants such as Delta and Alpha have been linked to heightened infection rates and potential resistance to infection-blocking antibodies. However, the combination of these mutations seems to be unique to this variant. No related variants have so far been identified.

It is critical to quickly identify clusters to limit spread of this variant. Eurofins, through Gold Standard Diagnostics Europe, provides the toolset to rapidly identify the variant B.1.1.529. GSD NovaType Select is a set of RT-PCR assays to specifically detect mutations in the genome of SARS-CoV-2 in around 1 hour, much faster than genome sequencing methods.

GSD NovaType Select P681H can differentiate variant B.1.1.529 from the currently dominant Delta variant and can be used as a large-scale screening test for PCR positive samples. Additionally, all samples positive for the mutation P681H should be tested using GSD NovaType Select T478K and K417N to further differentiate B.1.1.529 from other circulating SARS-CoV-2 variants of concern

Moderna Announces Strategy to Address Omicron (B.1.1.529) SARS-CoV-2 Variant

Moderna, Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, have announced updates to its strategy to address SARS-CoV-2 variants of concern, given the emergence of the B.1.1.529 (Omicron) variant.

The recently described Omicron variant includes mutations seen in the Delta variant that are believed to increase transmissibility and mutations seen in the Beta and Delta variants that are believed to promote immune escape. The combination of mutations represents a significant potential risk to accelerate the waning of natural and vaccine-induced immunity. A booster dose of an authorized vaccine represents the only currently available strategy for boosting waning immunity. The Moderna COVID-19 vaccine (mRNA-1273) is authorized as a booster for many populations at the 50 µg dose level. The Company is working rapidly to test the ability of the current vaccine dose to neutralize the Omicron variant and data is expected in the coming weeks.

Since early 2021, Moderna has advanced a comprehensive strategy to anticipate new variants of concern. This strategy includes three levels of response should the currently authorized 50 µg booster dose of mRNA-1273 prove insufficient to boost waning immunity against the Omicron variant.

First, Moderna has already tested a higher dose booster of mRNA-1273 (100 µg) in healthy adults. Moderna has completed dosing of 306 participants in a safety and immunogenicity study of this high dose (100 µg) booster. The 100 µg dose of mRNA-1273 has also recently been studied by the National Institutes of Health (NIH) in the U.S. and has generally resulted in the highest neutralizing titers against prior SARS-CoV-2 strains. Moderna is working to rapidly test sera from its high dose booster recipients in neutralizing assays to determine if the 100 µg dose provides superior neutralizing protection against Omicron.

Second, Moderna is already studying two multi-valent booster candidates in the clinic that were designed to anticipate mutations such as those that have emerged in the Omicron variant. The first candidate (mRNA-1273.211) includes several mutations present in the Omicron variant that were also present in the Beta variant of concern1. The Company has completed dosing in a potentially pivotal safety and immunogenicity study of mRNA-1273.211 at the 50 µg (N=300) and 100 µg (N=584) dose levels. A second multi-valent candidate (mRNA-1273.213) includes many of the mutations present in the Omicron variant that were also present in the Beta and Delta variants2. The Company has completed dosing at the 100 µg (N=584) dose level and also plans to explore the 50 µg dose level in approximately 584 participants. Moderna will rapidly expand testing of sera from completed and ongoing multi-valent booster studies to determine if these multi-valent candidates are able to provide superior neutralizing protection against Omicron.

Third, Moderna will rapidly advance an Omicron-specific booster candidate (mRNA-1273.529). This candidate is part of the Company’s strategy to advance variant-specific candidates for a subset of variants of significant concern. During 2021 this has already included Beta- and Delta-specific boosters. The Company has repeatedly demonstrated the ability to advance new candidates to clinical testing in 60-90 days.

Dr. B Suresh resigns as PCI president

 The president of the Pharmacy Council of India (PCI), Dr Suresh Bhojraj, has resigned from the post on November 24 on health grounds. His term was to end in August 2023. Dr Suresh has been the president of the Council for the last 18 years.   


He has tendered his resignation letter to the Registrar-cum-Secretary advising her to carry out office proceedings as per the Pharmacy Act 1948. Later, he sent one letter to the recently elected vice-president of the Council urging him to coordinate with the secretary for Council’s activities in the absence of the president.

When contacted, registrar-cum-secretary of the Council Archana Mudugal said she was informed of his decision to step down from the position on November 24 itself. She said the vice-president is now looking after the responsibilities of the Council president.

Sources close to Dr Suresh said he announced his decision to quit the post of president on November 24 midnight just to avoid discouraging requests from his fraternity and he disseminated the information about his stepping down from PCI to all whatsapp groups of PCI members and pharmacists. He assured in his message to all that he would remain as a ‘passionate pharmacist’ and continue as a dedicated pharmacy teacher. Currently, he is Pro-Chancellor of the JSS Academy of Higher Education and Research in Mysuru.
 
Dr Suresh was first elected president of the PCI in 2003. He was the first academician elected to the post of Council president when he was acting as the president of the Tamil Nadu State Pharmacy Council in 2003. Later, in 2008 and in 2013 he was unanimously elected to the top post. In 2018 he was elected through ballot. The present vice-president was the opposite candidate.

During his 18 years period as PCI president, Dr Suresh brought out many education regulations and modifications that have fundamentally altered the pharmacy education in the country. Through publication of uniform pharmacy education policies integrating regulations for the graduate and post-graduate courses, B Pharm and M Pharm, he brought a common pattern for teaching and learning system for all institutions and universities in the country with a view to increase the standard of the education.

His major achievements include the various education regulations he introduced to streamline the pharmacy education and pharmacy practice in the country. In 2008, he introduced the Pharm D Education Regulations 2008 for the six-year and the three year (post Baccalaureate) Pharm D programmes. Followed by it, the doctoral pharmacy programme was launched in India. In 2015, the PCI introduced the Pharmacy Practice Regulations 2015 which empowers the professional pharmacists in healthcare delivery. Bachelor of Pharmacy (B Pharm) Course Regulations 2014, Minimum Qualification for Teachers in Pharmacy Institutions Regulations 2014 and M Pharmacy (M Pharm) Course Regulations 2014 were introduced in the year 2014. Before the introduction of these regulations, B Pharm and M Pharm courses were regulated by regulations introduced by various universities. In September 2020 the council notified the Education Regulations for Diploma Course in Pharmacy 2020 after withdrawing the ER 1991. Finally in 2021, the PCI has notified the D Pharm Ext Exam Regulations, 2018. The new office building at Noida near Delhi was constructed two years ago was a landmark achievement for the PCI.

Responding to the news of his resignation, the president of the Tamil Nadu Pharmacy Council, J Jayaseelan said in addition to his health issues the interventionism of certain Central council members have also prompted him to resign.

Enzychem to Partner with Zydus Cadila to Manufacture COVID-19 Plasmid DNA Vaccine in Korea

Enzychem Lifesciences and Cadila Healthcare Ltd, a part of the Zydus Group, have announced that they have entered a Manufacturing License and Technology Transfer Agreement for the world’s first plasmid DNA vaccine (ZyCoV-D®). Following the results of a large clinical trial involving nearly 30,000 subjects

Under the terms of this agreement, Zydus shall transfer its manufacturing technology and provide technical assistance to Enzychem. Both CHL and Enzychem believe that this partnership will lead to estimated manufacturing of 80 million or more doses of the plasmid DNA vaccine in 2022. Accordingly, Enzychem shall pay Zydus license fees and royalties for the commercialization of the Plasmid DNA-based COVID-19 vaccine made in Korea and exported to a number of countries, including low-medium income countries (LMICs) in Latin America and Asian New Southern Policy member countries.

GE Healthcare and Optellum Collborate to Advance Lung Cancer Diagnosis with Artificial Intelligence

GE Healthcare and Optellum have announced that they have signed a letter of intent to collaborate to advance precision diagnosis and treatment of lung cancer.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules — enabling pulmonologists and radiologists to make optimal clinical decisions.

The clinician’s AI-assisted diagnosis of malignancy may enable patients whose nodules are not malignant to avoid unnecessary and aggressive procedures such as biopsy and surgical resection, while expediting the diagnostic process, and enabling the right treatment to start earlier. This has the potential to provide patients with personalized diagnosis and treatment plans, enabling lung cancer patients to be treated at the earliest possible stage when survival rates are the highest.

GE plans to collaborate with Optellum’s sales team on the distribution of the Virtual Nodule Clinic and work with Optellum to integrate the platform with AI solutions powered by GE Healthcare’s Edison platform. In addition the companies intend to bring results from Optellum’s Lung Cancer Prediction AI into the existing workflow of various GE Healthcare technological pathways, including CT and PACS.

Tuesday, November 16, 2021

GE Healthcare announces FDA Clearance for First X-ray AI to Help Assess Endotracheal Tube Placement

 GE Healthcare have announced that they have received Food and Drug Administration (FDA) 510(k) clearance for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

GE have distributed this solution under the FDA COVID-19 imaging guidance since November 2020, citing its potential to impact clinicians who were experiencing an influx of critically ill COVID-19 patients who required ventilation. Research shows that up to 25 percent of patients intubated outside of the operating room have misplaced ETTs on chest x-rays, which can lead to severe complications for patients, including hyperinflation, pneumothorax, cardiac arrest and death. Moreover, as COVID-19 cases climb, with more than 250 million confirmed worldwide, anywhere from 5-15 percent require intensive care surveillance and intubation for ventilatory support. Over the past year, 200 hospitals have deployed the technology to assist with ETT placements. 

The FDA have now granted 510(k) clearance for this solution allowing its continued sale outside of the public health emergency.

Competency mapping - course in new D.Pharm syllabus

 Competency mapping - course in new D.Pharm syllabus



Competencies for the Indian D.Pharm Holders Explained

In the earlier post, we shared the Competencies for the Indian D. Pharm holders. 

Competencies for the Indian D.Pharm Holders

In this post, we dvelve in the details of the competencies

1. Review Prescriptions: The student should receive and handle prescriptions in a professional manner and be able to check for their completeness and correctness. Also, the prescribers should be contacted for any clarifications and corrections in the prescriptions with suggestions if any.

2. Dispense Prescription / Non-Prescription Medicines: The student should be able to dispense the various scheduled drugs / medicines as per the implications of the Drug & Cosmetics Act and Rules thereunder. Also, the non-prescription medicines (over-the-counter drugs) should be dispensed judicially to the patients as required.

3. Provide Patient Counselling / Education: The student should be able to effectively counsel / educate the patients / caretakers about the prescription / nonprescription medicines and other health related issues. Effective communication includes using both oral and written communication skills and various communication techniques

4. Hospital and Community Pharmacy Management: The student should be able to manage the drug distribution system as per the policies and guidelines of the hospital pharmacy, good community pharmacy practice and the recommendations of regulatory agencies. Also, be able to manage the procurement, inventory, and distribution of medicines in hospital / community pharmacy settings. 

5. Expertise on Medications: The student should be able to provide an expert opinion on medications to health care professionals on safe and effective medication-use, relevant policies and procedures based on available evidences

6. Proficiency on Pharmaceutical Formulations: The student should be able to describe the chemistry, characteristics, types, merits and demerits of both drugs and excipients used in pharmaceutical formulations based on her/his knowledge and scientific resources.

7. Entrepreneurship and Leadership: The student should be able to acquire the entrepreneurial skills in the dynamic professional environments. Also, be able to achieve leadership skills through teamwork and sound decision- making skills

8. Deliver Primary and Preventive Healthcare: The student should be able to contribute to various healthcare programs of the nation including disease prevention initiatives to improve public health. Also contribute to the promotion of national health policies. 

9. Professional, Ethical and Legal Practice: The student should be able to deliver professional services in accordance with legal, ethical, and professional guidelines with integrity. 

10. Continuing Professional Development: The student should be able to recognize the gaps in the knowledge and skills in the effective delivery of professional services from time to time and be self-motivated to bridge such gaps by attending continuing professional development programs. 

 Related post:

Competencies for the Indian D.Pharm Holders

Competency mapping - course in new D.Pharm syllabus

Competencies for the Indian D.Pharm Holders

The Pharmacy Council of India, under the approval from Ministry of Health and Family Welfare, published revised syllabus for Diploma in Pharmacy (D.Pharm) course. 

Competencies for the Indian D.Pharm Holders’ based on the knowledge, skill, attitude and value that are essential for the successful practice of the profession have been derived. These competencies have  been mapped with the individual courses of the curriculum based on the expected outcomes of the individual course

Competency is defined as “A distinct composite of knowledge, skill, attitude and value that is essential to the practice of the profession in real life contexts”. 

The candidates who successfully complete the Diploma in Pharmacy (D. Pharm) program of Education Regulations 2020 (ER-2020), from the institutions approved by the Pharmacy Council of India are expected to attain the following professional competencies.

1. Review Prescriptions

2. Dispense Prescription / Non-Prescription Medicines

3. Provide Patient Counselling / Education

4. Hospital and Community Pharmacy Management

5. Expertise on Medications

6. Proficiency on drugs / pharmaceuticals

7. Entrepreneurship and Leadership

8. Deliver Primary and Preventive Healthcare

9. Professional, Ethical and Legal Practice

10. Continuing Professional Development


Related post:

Competencies for the Indian D.Pharm Holders explained

Indian Pharmacopoeia Commission launches 7 New Indian Pharmacopoeial Reference standards

 


Indian Pharmacopoeia Commission launches 7 New Indian Pharmacopoeial Reference standards

  • Amphotericin B
  • L - Histidine
  • L - Isoleucin
  • L - Phenylalanine
  • L - Leucine
  • Citicoline Sodium
  • Luliconazole



Saturday, November 6, 2021

Veracyte's Immunoscore Colon Cancer Test Included in ESMO Clinical Practice Guidelines Adapted for Pan-Asia

 Veracyte. (Nasdaq: VCYT) have announced that their Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer. The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021

Veracyte acquired the Immunoscore Colon Cancer test through its acquisition of HalioDx in August 2021. The test measures patient immune response at the tumor site and is used to inform chemotherapy decision-making for patients with Stage II and III colon cancer.

The Immunoscore Colon Cancer test was included in the 2020 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients. They comprise the consensus opinions reached by 14 experts representing the oncological societies of Japan, China, India, Korea, Malaysia, Singapore and Taiwan.

The 2020 ESMO guidelines and the new Pan-Asian adapted version both emphasize that tumor recurrence risk-assessment and expected benefit from chemotherapy are key to the evaluation of adjuvant therapy options. In this context, the Immunoscore Colon Cancer test is recommended for its ability to refine the prognosis of stage II and stage III colon cancer patients, in conjunction with standard cancer staging known as TNM (Tumor, Node, Metastasis).

Wednesday, November 3, 2021

Syllabus for the post of Administrative Assistant at Indian Pharmacopoeia Commission

On Oct 25, 2021, Indian Pharmacopoeia Commission have published the exam patter and syllabus for the written examination being conducted for the appointment of Administrative Assistant.

Pay Matrix Level 5 with a salary range Rs. 29,200 to 92,300.

The interesting part of the syllabus is the quantitative aptitude that covers topics 




I could not stop but wonder, for what would the Administrative Assistant use Trigonometry and Algebra in his job at the Indian Pharmacopeia commission!

In case, anyone interested in checking out the full syllabus, it is available here (or was here at least until 1 Nov at the time of writing this post)

Tuesday, October 19, 2021

New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer

EMA’s human medicines committee (CHMP) has approved two additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer.

One site, located in Monza, Italy, is operated by Patheon Italia S.p.A. The other in Anagni, also in Italy, is operated by Catalent Anagni S.R.L. Both sites will manufacture finished product.

These sites will produce up to 85 million additional doses to supply the EU in 2021.

These recommendations do not require a European Commission decision and the sites can become operational immediately.

EMA is in continuous dialogue with all marketing authorisation holders of COVID-19 vaccines as they seek to expand their production capacity for the supply of vaccines. The Agency provides guidance and advice on the evidence required to support and expedite applications to add new sites or increase the capacity of existing sites for the manufacture of high-quality COVID-19 vaccines.

Ready-to-use formulation approved

The CHMP has approved a ready-to-use formulation of Comirnaty. This formulation does not require dilution prior to administration, will be available in a 10-vial (60 dose) pack size and can be stored at 2-8°C for up to 10 weeks. The current concentrated formulation requires dilution prior to administration, is available in a 195-vial (1,170 dose) pack size and can be stored at 2-8°C for up to one month).

These differences will provide improved storage, transport and logistic options for vaccine distribution and administration. The new formulation will be available in a phased rollout starting in early 2022.

European Medicines Agency starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11

European Medicines Agency has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to children aged 5 to 11.

Comirnaty is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.

EMA’s human medicines committee (CHMP) will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, in order to decide whether to recommend extending its use. The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final decision.

EMA will communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.

Comirnaty was first authorised in the EU in December 2020. More information about the vaccine is available on the EMA website.

Monday, October 18, 2021

Roche partners with Ibex Medical Analytics to develop artificial intelligence-based cancer diagnostics

Roche have announced that they have entered into an agreement with Ibex Medical Analytics, a global leader in artificial intelligence (AI)-based cancer diagnostics. 

Under the agreement, the companies will jointly develop an embedded image analysis workflow for pathologists to seamlessly access Ibex's AI algorithms, insights, and decision support tools using NAVIFY Digital Pathology, the cloud version of Roche's uPath enterprise software. Collaborations with leading AI companies like Ibex are made possible through Roche's Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche's growing menu of AI-based image analysis tools.

Ibex's Galen platform recently received Breakthrough Device Designation by the U.S. Food and Drug Administration (US FDA) and CE mark in Europe for breast and prostate cancer detection in multiple workflows. Through this alliance, customers using Roche Digital Pathology will gain access to Ibex's innovative tools, such as algorithms that analyse prostate and breast biopsies, in addition to the AI tools already provided by Roche.

The clinical-grade AI algorithms and digital workflows included in this expanded menu of tools is expected to enable pathologists to provide accurate, efficient and timely diagnoses for their patients and support them in the detection and grading of cancer, identification of important non-cancerous features, case reporting and more.

Sunday, October 17, 2021

60th National Pharmacy Week (NPW) - 2021

The Indian Pharmaceutical Association has been celebrating the National Pharmacy Week every year during the 3rd week of November. 

The major focus of National Pharmacy Week celebrations is to create awareness amongst the public, other healthcare providers and the authorities, about the National Pharmacy Week theme in particular and about the pharmacy profession and the role of the pharmacist in general.

The 60th National Pharmacy Week (NPW) will be celebrated from 15 to 21 November, 2021.

The theme selected for this year is: "Pharmacist: An integral part of healthcare"

IPA is looking for innovative ideas about how the NPW should be celebrated this year as well as about the educational material to be developed to make it most effective and meaningful. 

If you have a suggestion, mail it to ipacentre@ipapharma.org / ipacpdetimes@gmail.com

NIPER organizes free webinar on "Validation Process Usage and Documentation"




Registration link: https://forms.gle/DSsCXe5ikZwmkLaz8

Joining link: https://niper.webex.com/niper/j.php?MTID=m682377ece9a59c29dd9f7ad8ff1db790

Meeting ID: 2642 398 5148 Password: AFbx525

Saturday, October 16, 2021

FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

 US Food and Drug Administration has announced an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

On Nov. 30, the advisory committee will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who have tested positive for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

The FDA intends to make background materials for the AMDAC meeting available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.

The FDA intends to live stream the AMDAC meeting on the agency’s YouTube pageExternal Link Disclaimer; the meeting will also be webcast from the FDA website.

Dr. Reddy's Laboratories announces launch of Carmustine for Injection, USP in the US market

Dr. Reddy’s Laboratories Ltd. have announced the launch of Carmustine for Injection, USP, a therapeutic equivalent generic version of BiCNU (carmustine for injection) approved by the .US Food and Drug Administration (USFDA).

The BiCNU brand and generic market had US sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health.

Dr. Reddy’s Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.

Full prescribing information including boxed warning available at:

https://www.drreddys.com/media/1019198/carmustine-for-inj-leaflet.pdf

Friday, October 15, 2021

Genentech’s Tecentriq gains US FDA approval as Adjuvant Treatment for PD-L1 positive Stage I-IIIA Non-Small Cell Lung Cancer

Genentech, a member of the Roche Group have announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%, as determined by an FDA-approved test.

Tecentriq is now the first and only cancer immunotherapy available for adjuvant treatment of NSCLC.

Approval is based on results from an interim analysis of the Phase III IMpower010 study.

IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either Tecentriq for 1 year (16 cycles), unless disease recurrence or unacceptable toxicity occurred, or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and intent-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival (OS) in the overall study population, ITT Stage IB-IIIA NSCLC.

Results showed that treatment with Tecentriq following surgery and platinum-based chemotherapy reduced the risk of disease recurrence or death by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA (UICC/AJCC 7th edition) NSCLC whose tumors express PD-L1≥1%, compared with best supportive care (BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. Fatal and serious adverse reactions occurred in 1.8% and 18%, respectively, of patients receiving Tecentriq. The most frequent serious adverse reactions (>1%) were pneumonia (1.8%), pneumonitis (1.6%), and pyrexia (1.2%).



Saturday, September 18, 2021

PINK Better Mammo Service - World’s First FDA Cleared Artificial Intelligence Solution for 3D Mammography

ImageCare Centers is unveiling their new “PINK Better Mammo” service with the addition of ProFound AI for Digital Breast Tomosynthesis (DBT). ProFound AI was the first artificial intelligence (AI) software for DBT, or 3D mammography, to be FDA cleared; the software is clinically proven to improve accuracy and efficiency for radiologists reading mammography. 

The technology will be rolled out to all of ImageCare’s mammography centers this October.

ProFound AI for DBT was clinically proven in a large reader study to increase radiologists’ sensitivity by 8 percent, minimize the rate of false positives and unnecessary recalls by 7 percent and reduce reading time by 52.7 percent. ProFound AI was also clinically proven to slash reading time by up to 57.4 percent for radiologists reading cases of women with dense breasts.



FDA Ad Comm Votes Unanimously in Favor Of COMIRNATY Booster for Emergency Use in People 65+ and Certain High-risk Populations

 Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. 

The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.

VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY.

Real-world surveillance data also were presented to the VRBPAC by the Israel Ministry of Health, providing further support for the public health impact of boosters. The data presented from Israel included an analysis published this week in The New England Journal of Medicine. The analysis comprised approximately 1.1 million individuals ages 60 years and older who were eligible for a booster dose of the vaccine between July 30 through August 31, 2021. No new safety signals were observed, and reported adverse events were lower than those observed after dose two. The analysis showed that a booster dose restored very high levels of protection against COVID-19 infections and severe disease in this period when Delta was the dominant strain. Individuals who received the booster dose were less likely by a factor of 11.3 (95% CI: 10.4, 12.3) to develop a confirmed infection and less likely by a factor of 19.5 (95% CI: 12.9, 29.5) to develop severe illness compared to those who were previously fully vaccinated but did not receive a booster dose.

Monday, September 6, 2021

Dr. Reddy’s Laboratories and Citius Pharmaceuticals enter into agreement for denileukin diftitox

 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) have announced that they have entered into a definitive agreement with Citius Pharmaceuticals pursuant to which they sold all of their rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets.

Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

Recall, in Mar 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Click here to know more about the clinical trials of denileukin diftitox.