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.

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.

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

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

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%).