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Home » Newsletters » BioWorld

BioWorld

Nov. 23, 2020

View Archived Issues
coronavirus-antibodies-immunity.png

FDA grants EUA to Regeneron's antibody treatment for COVID-19

An antibody cocktail developed by Regeneron Pharmaceuticals Inc. has received emergency use authorization (EUA) from the FDA for the treatment of mild to moderate COVID-19. Monoclonal antibodies (Mabs) such as Regeneron's, called casirivimab and imdevimab, "have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load," the company said. Read More

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. Read More
Progeria

Eiger counter’s needle jumps with key Zokinvy win in progeria; HDV next?

Although Eiger Biopharmaceuticals Inc. sees more would-be opportunities with ultra-rare disease-targeting Zokinvy (lonafarnib), the company’s vice president of clinical and development operations, Colin Hislop, said that “at the moment, we’re very clearly focused on the population identified in the label, because it fits most closely with the mechanism of action.” Read More

Merck’s COVID-19 coalition grows with Oncoimmune acquisition

With its acquisition of privately held Oncoimmune Ltd. 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 that is faring well in treating pandemic patients. Read More
T cells2

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.” Read More

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. Read More
FDA-icons

COVID-19 pandemic delays FDA approvals, causes CRL

Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected. Read More

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, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally. Read More

Pressure builds to undo latest Trump Rx pricing reforms

When U.S. President Donald Trump and Health and Human Services (HHS) Secretary Alex Azar announced last week the Jan. 1 launch of a Medicare Part B most-favored nation (MFN) drug pricing model and a final rule to end Medicare’s safe harbor for the rebates that create a black box around the pricing of Part D drugs, they called the reforms “historic.” Read More
US flag, Department of Health and Human Services flags

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 timeline comes up 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. Read More
Cells and DNA helix

Glycolysis inhibition via collateral lethality

BioWorld looks at translational medicine, including: Making exceptional responders unexceptional. Read More
ICYMI illustration

ICYMI: Week in review, Nov. 16-20, 2020

A quick look back at top stories. Read More

Appointments and advancements for Nov. 23, 2020

New hires and promotions in the biopharma industry, including: Adamas, Cytokinetics, Genenta, Legend, Mereo, Oxford, Penrose, Pharming, Summit. Read More

Financings for Nov. 23, 2020

Biopharmas raising money in public or private financings, including: Abcellera, Atai Baudax, Kodiak, Novalis, Verona, Virpax. Read More

In the clinic for Nov. 23, 2020

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 3Sbio, Algernon, Arcutis, Astrazeneca, Bellerophon, Bioshin, Cytodyn, Dnatrix, Eisai, Faron, Gemvax & Kael, Idorsia, IGC, Immunocore, Imugene, Innovent, Inovio, Karyopharm, Maplight, Molecular Partners, Neurana, Pfizer, PMV, Silicon Therapeutics, Saniona, Selecta, Syndevrx. Read More

Other news to note for Nov. 23, 2020

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Sbio, Actimed, Amgen, Aquestive, Argenx, Artelo, Bintai Kinden, Biogen, BMS, Connectyx, Curevac, Cytokinetics Selecta, Fairjourney, Generex, Halozyme, Hifibio, Horizon, Immunitybio, Iontas, Immunoprecise, Ligand, Minaris, Mustang, Nantkwest, Novellus, Pandion, Persephone, Pharmsynthez, Pierre Fabre, Poseida, SID Immunotech, Schrödinger, Sotira, Tempus, Teneobio, Tracon, Twist, Wacker, Y-biologics. Read More

Regulatory actions for Nov. 23, 2020

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anixa, Arca, Ascentage, Biontech, Brainever, Eiger, Genentech, Hillstream, Innovent, Kiniksa, Lilly, Merck, Neurelis, Onconova, Pfizer, Regeneron, Rigel, Sanofi, Theralase, VBI. Read More

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