Shares in Forma Therapeutics Holdings Inc. gained as much as 50% as Novo Nordisk A/S made a $20-per-share offer that values the firm’s equity at $1.1 billion. The stock (NASDAQ:FMTX) had closed at $13.40 prior to the disclosure of the bid on Sept. 1. It quickly reached a high of $20.05 during initial trading, suggesting some investors may believe the final price could go higher. Assuming it does close, the transaction would enlarge Novo Nordisk’s presence in a once dormant but now rapidly evolving market. Watertown, Mass.-based Forma has majored in small-molecule discovery and development for rare disease and cancer. The main driver for the present deal is etavopivat, an oral activator of pyruvate kinase-R, which is currently recruiting 344 sickle cell disease patients onto a phase II/III trial.

Sinocelltech receives first NMPA approval for a homegrown anti-CD20 MAb 

Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab, has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.

Biocytogen IPO raises HK$471.1 to back cancer candidates

Biocytogen Pharmaceuticals Co. Ltd. has raised HK$471.1 million (US$60 million) in net proceeds through an IPO on the Hong Kong Stock Exchange Sept. 1. It plans to use about three-quarters of the proceeds to advance clinical trials of two of its core cancer candidates, YH-003 and YH-001. Company shares (HKEX:2315), initially offered at HK$25.22 each, closed at HK$26 on their first trading day.

More nods for COVID-19 bivalent boosters

Bivalent COVID-19 mRNA vaccines are picking up steam globally, at least on the regulatory front. On the heels of yesterday’s U.S. FDA authorization of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants, the EMA’s human medicines committee recommended authorization of the companies’ first bivalent boosters, which target omicron BA.1 instead of BA.4/5. EU Commissioner Stella Kyriakides said she expects the European Commission to proceed “with an accelerated authorization of these vaccines to ensure that they can be rolled out quickly across the EU.” She noted that the EMA also is assessing the bivalent boosters targeting BA.4/5, adding that she expects an opinion on those vaccines in the coming weeks. Speaking at today’s meeting of the U.S. CDC’s Advisory Committee of Immunization Practices, the CDC’s Natalie Thornburg characterized the BA.5 subvariant as the most antigenically distant of all the variants to date from the ancestral virus.

COVID-19 retreats, endemic phase nears; targeted boosters on the front lines

As cases and deaths begin to level out, not showing the up and down spikes indicative of the first two COVID-19 pandemic years, the world may finally breathe a sigh of relief. But behind the scenes, the biopharma industry and global governments are not underestimating the evolving SARS-CoV-2 virus. Preparing for the next battle, the U.S. FDA authorized new bivalent boosters in August, while regulatory agencies across the globe expanded vaccines into younger populations. The month also included disappointing news for therapeutics, such as sotrovimab and Paxlovid; a filed lawsuit over mRNA patents; and a retirement announcement by U.S. NIH NIAID director Anthony Fauci. A total of 1,085 therapeutics and vaccines have entered development for COVID-19 since the virus first emerged, including seven new candidates in the last month. Meanwhile, there are 599.8 million confirmed cases globally, according to the World Health Organization, and 6.47 million deaths.

Regulators play catch-up as advanced therapy research races forward

Regulation of advanced therapies has come under scrutiny at a conference in London, as activity in the sector heats up amid Europe’s root and branch review of pharmaceutical legislation. There are more than a dozen advanced therapy medicinal products (ATMPs) approved in Europe and thousands more in the pharma and biotech pipeline – and regulators are working with manufacturers to expand use of already approved products into new indications. Manufacturing processes are also being tweaked and improved as manufacturers scale up production of cell therapies and other complex products that have made it to market over the last few years. With more than a thousand such therapies in the pharma and biotech pipeline in cancer alone, activity is likely to increase over the next decade and regulators are already struggling to keep up, attendees of the Advanced Therapies Europe conference heard in London.

University of Sydney to invest AU$478M into Sydney Biomedical Accelerator to translate research 

The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies. A large focus for the Sydney Biomedical Accelerator (SBA) will be on cell and gene therapies, precision medicine and products that include artificial intelligence (AI), Robyn Ward, executive dean and pro vice-chancellor, Medicine and Health, at the University of Sydney, told BioWorld. Part of that vision is to keep promising startups in New South Wales, she said.

Also in the news

Amgen, Aquestive, Arcturus, Ascendis, Biocardia, Biocryst, Biodol, Biokangtai, Bright Minds, Castle Creek, Codiak, Cybin, Epiendo, Finch, Futura, Geneuro, Hepion, Hibiscus, Hightide, Hillevax, Immunogen, Innocare, Lannett, Laverock, Liquidia, Longeveron, Madrigal, Maze, Mindset, Mymetics, Nanomerics, Novartis, PCI, Provention, Quince, Recordati, Regenxbio, Sanofi, Scilex, Sensei, Sernova, Synox, Tikomed, Trethera, United