Moderna (NASDAQ:MRNA) announces that Israel’s Ministry of Health (MOH) has given authorization to import the company’s COVID-19 vaccine in Israel.
The MOH has secured 6M doses and first deliveries are expected to begin shortly.
This is the third regulatory authorization for Moderna’s COVID-19 vaccine, following the U.S. on December 18, 2020 and Canada on December 23, 2020.
Additional authorizations are currently under review in Singapore, Switzerland, U.K. European Union is yet to make final decision on the vaccine approval.
Moderna and NIH to study the effects of halving the COVID-19 shot – NYT
Amid concerns over plans to halve the COVID-19 vaccine doses, scientists at the National Institute of Health and the vaccine maker Moderna (MRNA -3.2%) have initiated a research to see if it’s possible to double the vaccine supply by halving the vaccine dose.
Citing Dr. John Mascola, the director of the Vaccine Research Center at the N.I.H, the New York Times reports that the analysis of vaccine research data, involving scientists from Operation Warp Speed is likely to take about two months.
Earlier, Dr. Stephen Hahn, FDA Commissioner, and Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, expressed their displeasure over any changes to the dosing regimen.
Any suggested changes to FDA-authorized dosing or schedules of the vaccines are, ‘premature and not rooted solidly in the available evidence.’, they said in a joint statement.
Trinity Biotech’s COVID-19 antibody test OK’d in Europe
Trinity Biotech (NASDAQ:TRIB) gains 10% in premarket after receiving CE Mark approval and registration for its Covid-19 IgG ELISA antibody test, the Captia SARS-CoV-2 IgG ELISA.
The test uses a recombinant form of coronavirus spike protein to detect IgG antibodies, the detection of which indicate either past exposure to the virus or the desired immune response following vaccination.
The company says that this is in addition to the launch of the product in the US following submission under the FDA Emergency Use Authorization pathway.
Biogen inks deal for ophthalmic gene therapy development
ViGeneron GmbH, a gene therapy company, announces a global collaboration and licensing agreement with Biogen (NASDAQ:BIIB) to develop and commercialize gene therapy products based on adeno-associated virus (AAV) vectors for an undisclosed target to treat inherited eye diseases.
The companies will use ViGeneron’s vgAAV technology to efficiently transduce retinal cells via intravitreal injections.
ViGeneron will receive an upfront payment and R&D funding for the mutually agreed workplan, and will be eligible to receive milestone payments and tiered royalties.
Biogen has the right to add an additional reserved target within two years after the effective date. The companies will work together on the in vivoproof of concept and Biogen will be responsible for all further development and commercialization of the selected therapeutic candidates.
Abbvie returns global rights to muscarinic agonist programs to Sosei
AbbVie (NYSE:ABBV) has notified Sosei Group Corporation (OTCPK:SOLTF) that it will return the worldwide rights to its muscarinic agonist programs. In 2016, the program was licensed by Sosei to Allergan, which was later acquired by Abbvie.
As part of the process, Sosei will regain all assets in development under the program and all associated intellectual property licensed and all clinical and preclinical data generated under the partnership.
Noting that the return of rights was based on business decisions regarding AbbVie’s pipeline strategy, Sosei rules out any efficacy, safety, or other data related to the collaboration programs as a reason for the handover.
The outcome of a review to determine a strategy for the further development and re-partnering of the program will be disclosed at the time of full-year results presentation in February 2021, an announcement from the company said.
The event has no immediate impact on the consolidated financial results for the accounting period ending December 2021. As part of the initial agreement with Allergan, Heptares Therapeutics, which was acquired by Sosei, was eligible for an up-front payment of $125M in addition to milestone payments of up to $665M.