Japan’s Astellas Pharma Inc. is continuing its investment in gene therapies, following up its $3 billion acquisition of Audentes Therapeutics Inc. with a technology licensing deal with Dyno Therapeutics Inc. potentially worth more than $1.6 billion. Central to the deal is Cambridge, Mass.-based Dyno’s adeno-associated virus (AAV) vector technology, which can be used to direct gene therapies to skeletal and cardiac muscle. Read More
Pricing of VBI Vaccines Inc.’s just-approved hepatitis B virus (HBV) vaccine, Prehevbrio, won’t be known before launch in the first quarter of next year, but CEO Jeff Baxter said the company will take into account that the sector is “one of the most price-intensive and price-competitive. A lot of the market-access research says that the wholesale acquisition cost is one of the key determinants” in avoiding sluggish adoption, he said, so that by staying moderate the firm can “supply [its] product on a much quicker basis than you might do, say, if you went with a 30% or 40% premium to standard of care.” Read More
Abogen Biosciences Co. Ltd. has raised $300 million in a series C+ round to support the development of its mRNA products, specifically to support the development of its COVID-19 mRNA vaccine and expand to the global market. Read More
Apollo Health Ventures raised $180 million for a new venture capital fund focused on biotechnology companies developing therapies for age-related diseases. It may also invest in healthtech and digital health opportunities, but the latter constitute a minority pursuit for an investment team that is building up capabilities and expertise in disease biology. Read More
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency. Read More
One of the biggest concerns at the Nov. 30 meeting of the FDA’s Antimicrobial Drugs Advisory Committee is that, if Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s antiviral drug, molnupiravir, is authorized for use in treating mild to moderate COVID-19 in patients at high risk of progressing to severe disease, it might be used too broadly, given its potential risks. Read More
Whether it’s the highly mutated Omicron variant emerging in South Africa as biopharma researchers scramble to create custom-made vaccines in record time or the institutional mandates juxtaposed with waning vaccine immunity and the ongoing ups and downs of cases and deaths, the SARS-CoV-2 virus continues to dig its ugly spikes into an uncertain and anxious world. Read More
Stimulating the innate immune system with defective viral genomes (DVG)-based strategy provided broad-spectrum protection against RNA viral infections, including SARS-CoV-2 and other respiratory diseases in animal models, according to a U.S.-led international collaborative study reported in the Nov. 17, 2021, edition of Cell. Read More
New hires and promotions in the biopharma industry, including: Adcendo, Aveo, Federation, Gelesis, Ironwood, Neurocrine, Parthenon, Point, Tranquis, Zyus. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Allakos, Anji, Astrazeneca, Axial, Blade, Daiichi, Ensysce, First Wave, Hoth, Immunogen, IMV, Isarna, Jazz, Kintara, Kyowa, Mei, Mereo, Nicox, Olema, Ose, Seres, Synact, Visus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ABM, Adagene, Astrazeneca, Atara, Codiak, Cumberland, Cybin, Evofem, Hepion, Junshi, Kymera, Merck & Co., Pharmadrug, RDIF, SERB, TG, Treadwell. Read More
