HHS chief Alex Azar says the FDA will grant emergency use authorization for the Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) Covid-19 vaccine in the next couple of days. He expects Americans could begin getting the vaccine on Monday.
Both stocks are up modestly in premarket action.
The FDA also put out a press release saying it’s quickly working towards that EUA.
Speaking separately, assistant HHS chief Brett Giroir says he expects that by May or June, any American that desires so will be able to get a Covid vaccine shot.
Azar’s comments come after yesterday’s 17-4 adcom vote to recommend EUA.
Canadian antibody-drug discovery platform AbCellera Biologics (ABCL) has priced its IPO of 24.15M common shares at $20.00/share, for expected gross proceeds of $483M.
Underwriters’ over-allotment is an additional ~3.6M shares.
The company initially planned to offer 23M shares at a range of $17-18.
Trading kicks off December 11. Closing date is December 15.
The company’s artificial intelligence-, or AI, powered drug discovery platform searches and analyzes the database of natural immune systems to find antibodies that can be developed as drugs.
In a collaboration with Eli Lilly (NYSE:LLY), AbCellera applied its technology stack to co-develop LY-CoV555, a potential antibody therapy to treat and prevent COVID-19.
The U.S. has purchased 950,000 doses of Bamlanivimab, a COVID-19 antibody therapy co-developed by Lilly and AbCellera, which has been authorized for emergency use by the FDA.
A supply agreement has also been signed with the Canadian government for 26,000 doses.
With regard to acquisition of Trianni, AbCellera issued convertible promissory notes to certain investors in an aggregate amount of ~$90M.
Upon the closing of the offering, the Notes will convert into common shares at a price of $17.00/share.
Roche (OTCQX:RHHBY) is partnering with the French MedTech company Diabeloop to advance the management of insulin pump therapy, for people with diabetes and to improve therapy outcomes.
The partnership marks Roche’s first step in the field of automated insulin delivery (AID) representing a milestone in Roche’s strategy of integrated Personalised Diabetes Management (iPDM).
“The technology of Diabeloop, based on a self-learning algorithm, is unique. We are convinced that the potential of the hybrid closed-loop systems will contribute to a more efficient and personalised approach of diabetes management,” said Marcel Gmuender, Global Head of Roche Diabetes Care.
Hong Kong has reached agreements with two COVID-19 vaccine manufacturers, securing 15M shots, the first batch of vaccine to be available as early as January 2021 – Bloomberg.
The government will purchase 7.5M doses of the mRNA shot developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) and 7.5M shots from the Beijing-based Sinovac Biotech (NASDAQ:SVA), with one million shots available in Q1 2021 at the earliest.
Hong Kong is also in talks with AstraZeneca (NASDAQ:AZN) for a further 7.5M doses, though that agreement has not been signed.
The elderly and medical staff will get priority in a free mass vaccination government program, said Chief Executive Carrie Lam.
EMD Serono, the biopharma arm of Merck KGaA (OTCPK:MKGAY) and Pfizer Inc. (PFE) today announced that the European Medicines Agency has formed a positive opinion, recommending the approval of BAVENCIO® (avelumab), an antibody-based cancer therapy against urothelial carcinoma jointly developed and commercialized by the companies.
The positive opinion recommends the drug as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.
The endorsement, which was based on positive findings from the Phase III JAVELIN Bladder 100 trial, will be reviewed by the European Commission with a decision expected in early 2021, the companies said. The results of the trial appeared in The New England Journal of Medicine in September.
The treatment has already won FDA approval in June 2020 as a maintenance treatment for patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy.
“The overall survival results from JAVELIN Bladder 100 show the potential benefits of a first-line maintenance approach with BAVENCIO as a significant advancement for patients with locally advanced or metastatic urothelial carcinoma,” says Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development.
Bar-Zohar, M.D., Global Head of Development for the Biopharma business of Merck KGaA, Darmstadt, Germany, added: “Now with this positive opinion, we have come a big step closer to being able to offer a new option that may shift the treatment paradigm for patients in Europe.”
