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Monday, January 4, 2021

Bharat Biotech aims to make 700 million doses of COVID-19 vaccine in 2021

 

India's Bharat Biotech is aiming to have a production capacity of about 700 million doses of its COVID-19 vaccine this year, according to a top executive of the biotechnology company.

The vaccine candidate, COVAXIN, received emergency use approval from India's drugs regulator on Sunday, a move that faced questions from industry experts and opposition lawmakers due to lack of efficacy data.

Efficacy data from the company's ongoing late-stage trial should be available by March, Krishna Ella, chairman and managing director of Hyderabad-based Bharat Biotech, said in an online address to the media on Monday.

"We have four facilities coming up and we are planning (to make) around 200 million doses in Hyderabad, 500 million doses in other cities," Ella said. The company has 20 million doses available so far, he added.

The approval for COVAXIN, jointly developed with a government institute, was hailed by Prime Minister Narendra Modi and his ministers as a success in India's self-reliance push.

Ella defended the approval, citing multiple examples of emergency authorisation approvals given in the past based only on immunogenicity data, and said he believes in COVAXIN's efficacy.

Health Minister Harsh Vardhan clarified on Twitter on Sunday that the emergency use approval for COVAXIN was "in clinical trial mode", wherein all recipients of the vaccine would be tracked and monitored as if they are in trial.

India has the second-highest number of coronavirus infections in the world, though cases have been steadily falling since a peak in September.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Bharat-Biotech-aims-to-make-700-million-doses-of-COVID-19-vaccine-in-2021-32116541/

EU drugs agency meeting to discuss Moderna COVID-19 vaccine

 The European Medicines Agency (EMA) was holding a meeting on Monday, two days ahead of schedule, that could decide to recommend approving Moderna's COVID-19 vaccine, a spokesperson said.

The EMA's human medicines committee (CHMP) had been scheduled to meet on Wednesday.

The agency has set a Jan. 12 deadline for whether to recommend Moderna's vaccine. It recommended a COVID-19 vaccine from Pfizer and its German partner BioNTech on Dec. 21.

"In the event that the CHMP reaches an opinion at today’s meeting, we would send out a press release as soon as possible after the meeting," it said in a statement.

A CHMP meeting scheduled for Wednesday was still planned "in case the committee does not reach a decision today," it added.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-EU-drugs-agency-meeting-to-discuss-Moderna-COVID-19-vaccine-32116784/

Moderna ups annual vaccine production forecast by 100M doses

 

Moderna Inc on Monday raised the lower end of its 2021 forecast for COVID-19 vaccine production by 100 million doses.

Moderna to Update at 2021 J.P. Morgan Healthcare Conference

 Moderna, Inc.  (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that CEO Stéphane Bancel will present an update on the Company and its pipeline of mRNA development programs at this year’s 39th annual J.P. Morgan Healthcare Conference.

Mr. Bancel’s presentation will take place virtually on Monday, January 11th, 2021 at 4:30 p.m. ET. A live webcast will be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for 90 days following the presentation.

https://www.biospace.com/article/releases/moderna-to-provide-business-and-pipeline-updates-at-the-2021-j-p-morgan-healthcare-conference/

Calithera Telaglenastat in Renal Cell Carcinoma Misses Primary Endpoint

  Calithera Biosciences, Inc.  (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small-molecule drugs for the treatment of cancer and other life-threatening diseases, today announced topline results from the CANTATA clinical study of the company’s glutaminase inhibitor telaglenastat in patients with advanced or metastatic renal cell carcinoma (RCC). As compared to treatment with cabozantinib, the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression free survival (PFS) in the study population.

The primary study endpoint is PFS by blinded independent review. The hazard ratio was 0.94 (p=0.65). Median PFS was 9.2 months among patients treated with telaglenastat and cabozantinib as compared to 9.3 months with cabozantinib and placebo. Sixty-two percent of patients were treated with prior PD(L)-1 containing therapy, and the arms were well balanced. The frequency and severity of adverse events in the telaglenastat-treated population were comparable to that of cabozantinib alone.

“We are disappointed that the CANTATA trial did not achieve its primary endpoint, particularly on behalf of the people living with advanced RCC, many of whom could benefit from additional treatment options with novel mechanisms of action to address this difficult-to-treat disease,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “Based on the strong scientific rationale for telaglenastat in KEAP1/NRF2 mutant non-small cell lung cancer patients, and the safety profile observed in CANTATA, we remain dedicated to advancing our randomized KEAPSAKE trial.”

Calithera will focus its financial resources on the ongoing KEAPSAKE trial, the ongoing trial of the arginase inhibitor CB-280 in cystic fibrosis patients and pipeline programs. As a result of the outcome of CANTATA, Calithera will reduce its workforce by approximately 35 percent to allow the company to focus on ongoing programs.

https://www.biospace.com/article/releases/calithera-biosciences-reports-cantata-study-of-telaglenastat-in-renal-cell-carcinoma-did-not-achieve-primary-endpoint/

ROCHE HOLDINGS AG Gets Buy rating from Bernstein

 Bernstein is positive on the stock with a Buy rating. The target price has been modified and is now set at CHF 360 compared to CHF 370.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/ROCHE-HOLDINGS-AG-Gets-a-Buy-rating-from-Bernstein-32115263/

Germany examines delaying second Pfizer COVID-19 vaccine shot

  The German health ministry is seeking advice on whether to delay administering a second dose of the COVID-19 vaccine from BioNTech and Pfizer to make scarce supplies go further, according to a document seen by Reuters on Monday.

The ministry is seeking the view of an independent vaccination commission on whether to delay a second shot beyond a 42-day maximum now foreseen, after a similar move by Britain, according to the one-page document.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-German-health-ministry-examines-delaying-second-COVID-19-vaccine-shot-document-32114462/