Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says three-year analysis data from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter. Read More
In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration. Read More
On the eve of the June 17 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, which will discuss Moderna Inc.’s mRNA-1010, researchers at Washington University School of Medicine in St. Louis have reported that the vaccine conferred broader and more durable protection than a standard flu shot. Read More
Spyre Therapeutics Inc.’s striking “two for two” data on ulcerative colitis (UC) candidates, SPY-001 and SPY-002, drew applause from multiple analysts, putting eyes on the Boston biotech’s upcoming top-line data of anti-IL-23 antibody SPY-003 – the third biologic module in a six-strong inflammatory bowel disease (IBD) lineup. Read More
HMNC Brain Health GmbH has raised $50 million in the first close of a series B, enabling the company to prepare the way for phase III trials of its two lead programs. Read More
Shares of Abcellera Biologics Inc. got a modest boost on news of a preclinical research collaboration with Jazz Pharmaceuticals plc aimed at developing next-generation T-cell engaging multispecific antibodies targeting gastrointestinal cancers and other solid tumors. Read More
For the long-term impact of GLP-1 therapies in obesity to be realized, they must be paired with data and digital tools. While the drugs are effective, challenges are well known, such as loss of muscle mass loss, compliance and accessibility. With more treatments moving through the pipeline, innovation and technology will be key to supporting long-term use, delegates heard at the HLTH Europe conference in Amsterdam on June 17. Read More
Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies. Read More
New hires and promotions in the biopharma and med-tech industries, including: Adial, Broken String, Celltaxis, Genedx, Latus, Moderna, Nuwellis, Parallel, Syremis, Terray. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Alvotech, Aplagon, Coherent, Emmecell, Enliven, Forge, Multivalent, PTC, Racura, Rejoni, Skylark. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Alzecure, Biomarin, Edgewise, HCW, Minghui, Ncap, Nervonik, Pleopharma, Projenx, Rhythm, Soleno, Sumitomo, Takeda. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: 4E Therapeutics, Adaptive, Dr. Reddy’s, Eli Lilly, Innoviva, Neurocrine, Quoin, Stealth. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Gilead, Inhibrx, Novabridge, Outlook, Qihan, SK, Surgentec, Zai Lab. Read More
