LONDON – The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use. The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27. Read More
Agios Pharmaceuticals Inc., a company that has until now revolved primarily around its FDA-approved acute myeloid leukemia drug, Tibsovo (ivosidenib), is selling that drug and the rest of its oncology business to Servier Pharmaceuticals LLC in a deal valued at up to $2 billion, plus royalties. The agreement includes $1.8 billion cash up front for the portfolio and as much as $200 million in regulatory milestone payments for the investigational glioma treatment vorasidenib. Read More
Amsterdam-based Uniqure NV’s regulatory hitch with its highly regarded hemophilia B program had analysts questioning during a conference call what the development might mean for the company’s deal with CSL Ltd. Read More
Shares in Chinese drug developer Jacobio Pharmaceuticals Group Co. Ltd. (HK:1167) rose 3% on their first day of trading in Hong Kong. The company, which develops small-molecule drug candidates to modulate enzymes by binding to their allosteric sites, raised HK$1.35 billion (US$174.1 million) in its IPO, pricing 96 million shares at HK$14. Shares closed at HK$14.42 on Dec. 21 after rising as high as HK$16.50. Read More
Money is flowing into gene therapy as investors have started looking favorably on the risk-reward prospects of the space. "I believe the risk has really substantially decreased as regulatory path has become clearer. There are more projects with lower risk," said Sarah Bhagat, a partner at Sofinnova Investments.
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LONDON – Sosei Heptares Ltd. has signed up Glaxosmithkline plc to take on the orphan G protein-coupled (GPCR) target GPR35, in a deal worth a potential $481 million. Read More
A day after the FDA’s Vaccines and Related Biological Products Advisory Committee lent its support to Moderna Inc.’s COVID-19 vaccine, the agency granted it emergency use authorization (EUA). About 20 million doses will be delivered by the end of December and the rest in the first quarter of 2021, according to Moderna. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: EMA updates on cyberattack; CDSCO extends import leniency; FDA’s obsolete human tissue rule on scrapheap. Read More
Biopharmas raising money in public or private financings, including: AB Science, Bioatla, Healthcare Capital, Hemostemix, Locust Walk, Qualigen, Scopus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aimmune, Aim Immunotech, Anixa, Aptorum, Bioinvent, Biontech, Janssen, Jazz, Legend, Lumosa, Merz, Moebius, Myovant, Pfizer, Sesen, Taysha, Transgene, Viiv, Zogenix. Read More
