An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization from the FDA for the treatment of mild to moderate COVID-19 in adults and some children at high risk for progressing to severe disease. Formerly known as REGN-COV, it includes casirivimab and imdevimab. It was not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy. Separately, Bellerophon Therapeutics Inc. put a clinical hold on a phase III test of its inhaled nitric oxide technology, Inopulse, sending company shares down (NASDAQ:BLPH) 18.6% by midday.

Astrazeneca’s COVID-19 vaccine shows 70% efficacy on average, 90% with prime-boost regimen

LONDON – A third COVID-19 vaccine has turned in positive results in the phase III interim analysis, with Astrazeneca plc/Oxford University reporting an average of 70.4% efficacy across two dose regimens for AZD-1222. Significantly, efficacy increased to 90% in the prime-boost arm of the trial, in which volunteers received half a dose, followed by a full dose. In addition to greater protection, that will make supplies go further. Adding to the positive findings, there were no cases of severe disease or need for hospitalization in vaccinated people who did contract COVID-19, and there are early indications that AZD-1222 reduces transmission of the virus, as seen in the fact that there were fewer asymptomatic infections in the vaccinated arm.

Launch of just-approved Zokinvy in progeria and PL slated for January: Eiger

Eiger Biopharmaceuticals Inc. said it will begin shipping Zokinvy (lonafarnib) in January of next year, having won approval of the compound as the first and only therapy for Hutchinson-Gilford progeria syndrome, also known as progeria, and processing-deficient progeroid laminopathies (PL). Progeria and PL are fatal, ultra-rare, genetic, premature aging diseases that accelerate mortality in young patients. Zokinvy, also in the works for hepatitis D, blocks the farnesylation of progerin.

Merck’s COVID-19 coalition grows with Oncoimmune acquisition

With its acquisition of privately held Oncoimmune Ltd., of Rockville, Md., for an up-front $425 million in cash, Merck & Co. Inc. ups its COVID-19 game with CD24Fc, a recombinant fusion protein targeting the innate immune system. The immunomodulator is in a phase III trial, with recently revealed top-line results showing a 60% better chance over placebo in achieving clinical recovery (p=0.005), with median time to recovery of six days vs. 10 days for placebo. Merck is also developing COVID-19 therapies with Ridgeback Biotherapeutics LP and with nonprofit scientific research organization IAVI.

Anchors aweigh: Catamaran Bio sets sail with $42M to develop allogeneic CAR-NK cell therapies

When the first chimeric antigen receptor T-cell (CAR T) therapy, Kymriah (tisagenlecleucel), was approved in 2016 for treating B-cell acute lymphoblastic leukemia, its developer, Novartis AG, confined the initial rollout to just 20 treating centers. Its label carried a black box warning, because of the risk of life-threatening cytokine release syndrome, and Basel, Switzerland-based Novartis put in place a comprehensive risk evaluation and mitigation system to ensure its safe use. Catamaran Bio Inc., a Boston-based startup that has raised $42 million in seed and Series A financing, is considering the administration of similarly engineered natural killer cells in walk-in clinics. “If the product is safe, it can be given as an out-patient treatment,” Chief Scientific Officer Vipin Suri told BioWorld. “As a field, this absolutely has to be our ambition.”

Australia’s Imugene shows positive overall survival in ongoing phase II gastric cancer trial

PERTH, Australia – Sydney-based Imugene Ltd.’s stock shot up 15% on news that an interim analysis of phase II data in its B-cell peptide vaccine, HER-Vaxx, in advanced gastric cancer showed positive survival data, and the data monitoring committee said it could lower the number of patients required for study completion.

COVID-19 pandemic delays FDA approvals

Multiple companies, including Spectrum Pharmaceuticals Inc. and Bristol Myers Squibb Co., have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA have kept their manufacturing plants from being inspected. One saving grace: Remote inspections are possible in some instances.

Chi-Med receives $100M equity investment from Canada Pension Plan Investment Board

HONG KONG – Hutchison China Meditech Ltd. (also known as Chi-Med) has received a $100 million equity investment from the Canada Pension Plan Investment Board (CPP Investments), which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally. The firm signed a definitive agreement for the sale of $100 million of shares at a price equivalent to $30 per American depositary share (ADS) via a private placement to CPP Investments. Chi-Med will receive all proceeds from the equivalent of about 3.3 million ADSs.

Pressure builds to undo Trump Rx pricing reforms

When U.S. President Donald Trump and Health and Human Services Secretary Alex Azar announced the Jan. 1 launch of a most-favored nation drug pricing model and a final rule to end the safe harbor for the rebates that create a black box around U.S. drug prices, they called the reforms “historic.” They would be historic, if they’re allowed to stand. But that’s a big if. The biopharma industry and pharmacy benefit managers already are lining up to challenge the changes in court. And other groups, including the American Hospital Association, are adding their weight to the pressure that will be applied to Congress and the incoming Biden administration to undo what Trump has done.

Twin HHS final rules may not find favor under Biden administration

Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This is a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.

Also in the news

3Sbio, Abcellera, Actimed, Algernon, Amgen, Anixa, Aquestive, Arca, Arcutis, Argenx, Artelo, Ascentage, Astrazeneca, Baudax, Bellerophon, Bioshin, Brainever, Bristol Myers Squibb, Connectyx, Curevac, Cytodyn, Cytokinetics, Dnatrix, Eiger, Eisai, Fairjourney, Faron, Gemvax, Generex, Halozyme, Hifibio, Hillstream, Horizon, IGC, Immunitybio, Immunocore, Innovent, Inovio, IPA, ISD Immunotech, Karyopharm, Kiniksa, Kodiak, Ligand, Lilly, Maplight, Medison, Merck, Minaris, Molecular Partners, Mustang, Neurelis, Novalis, Novellus, Nugenerex, Ology, Onconova, Persephone, Pfizer, Pharmadrug, Pharmsynthez, Pierre Fabre, PMV, Regeneron, Rigel, Saniona, Sanofi, Schrödinger, Silicon, Sotira, Syndevrx, Teneobio, Theralase, Todos, Tracon, Twist, VBI Vaccines, Verona, Virpax, Y-Biologics