A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA." Read More
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29. Read More
Prevail Therapeutics Inc. won't be prevailing on its own. Eli Lilly and Co. is acquiring the gene therapy company for $880 million up front plus an earn-out of up to $160 million if Lilly can gain regulatory approval for at least one of Prevail's drugs. Read More
PERTH, Australia – Stem cell therapy company Mesoblast Ltd. saw its stock drop 15% on the news that its allogeneic mesenchymal cell therapy, rexlemestrocel-L (Revascor), failed to meet the primary endpoint of a reduction in hospitalizations in its phase III advanced chronic heart failure trial. Read More
DUBLIN – Minervax Aps raised €47.4 million (US$57.6 million) in a series B funding round to take a recombinant-protein-based vaccine for group B streptococcus (GBS) through a phase II program as well as parallel surveillance studies to enable it to define correlates of protection against GBS in newly born infants. Read More
Christmas arrived early for Athenex Inc. as the FDA approved Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp nearly two weeks before the treatment’s PDUFA date. Read More
HONG KONG – Overland Pharmaceuticals Inc., a company created to bring innovative medicines to China, this week revealed the formation of two joint ventures intended to deliver on that mission, one with ADC Therapeutics SA and another with Allogene Therapeutics Inc. Read More
As the year draws to a close, there is no doubt that investors have been keeping a close watch on emerging companies developing cancer therapies as well as those with new vaccines and treatments aimed at defeating COVID-19. Read More
With a $39 billion offer in hand, Alexion Pharmaceuticals Inc. is the target of what could be the third largest takeover to date of a pure play biotech company. At a 45% premium, the proposed transaction, which is expected to close in the third quarter of 2021, is largely applauded by analysts who point to three years of languishing stock prices despite the promise of the Boston-based company’s C5 complement franchise and a sturdy pipeline. Read More
Several hospital and pharmacy groups, including the American Hospital Association, filed suit last week in the U.S. District Court for the Northern District of California in an effort to force the Department of Health and Human Services to stop drug companies from “undermining” the 340B prescription drug discount program. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Athenex, Astrazeneca, Can-Fite, Cyxone, Fortress, Genentech, IO Biotech, Nascent, Prometheus, Rafael, Takeda, Xentria. Read More
