The U.S. FDA has put five phase III studies of Sanofi SA’s potential multiple sclerosis and myasthenia gravis blockbuster tolebrutinib on partial clinical hold after several cases of liver injury were identified after exposure to the drug. Sanofi said new recruitment in the U.S. is paused and participants who have been part of the trial for fewer than 60 days should stop taking tolebrutinib, although those taking the drug for longer can continue. Read More

Blueprint Medicines Corp. CFO Mike Landsittel called his firm’s potential $1.25 billion financing deals with Sixth Street and Royalty Pharma “once in a lifetime” arrangements that came at the end of a competitive process in a formidable cash environment.

Read More

Despite mostly positive data from the ongoing phase III study of Talaris Therapeutics Inc.’s lead asset, FCR-001, an allogeneic cell therapy for treating living donor kidney transplant patients, investors are stepping away. The Boston and Louisville, Ky.-based company’s stock took a hit June 20 as shares (NASDAQ:TALS) fell 36.7% to $4.51 each. Read More

South Korea’s Ministry of Food and Drug Safety has granted marketing authorization to SK Bioscience Ltd.’s COVID-19 vaccine, Skycovione (GB-510), marking the country’s first homegrown COVID-19 vaccine to be approved. The company has already signed an advanced purchase agreement with the Korea Centers for Disease Control for 10 million doses of the vaccine. Read More

Pfizer Inc. and Biontech SE have signed a deal with the U.S. government to supply up to 300 million doses of COVID-19 vaccines in a deal worth more than $3.2 billion. Depending on the U.S. FDA, the vaccine doses fulfilling the order may include the companies’ omicron-adapted candidate, which they reported June 25 demonstrated a high immune response against the omicron BA.1 subvariant of SARS-CoV-2, when given as a fourth booster. Read More

Sunshine Guojian Pharmaceutical Co. Ltd. has granted Xiling Lab Pharmaceutical Co. Ltd. global rights to develop and commercialize the trastuzumab biosimilar Cipterbin (inetetamab) for antibody-drug conjugates (ADC) in a ¥1.03 billion (US$153 million) deal. Read More

Shanghai Henlius Biotech Inc. has inked a deal to acquire greater China rights for two cancer-focused bifunctional sialidase programs from Palleon Pharmaceuticals Inc. In return, Palleon will receive an unspecified up-front payment and is eligible for up to $196.5 million in milestone payments. Read More

New hires and promotions in the biopharma industry, including: Apexigen, Kures, Enterobiotix, Oyster Point. Read More

Biopharmas raising money in public or private financings, including: 9 Meters, Adagene, Ermium, Nervgen, Seres, Verrica. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, ADC, Advaxis, Agenus, Aileron, ALX, Alzecure, An2, Avacta, Axalbion, Can-Fite, Codiak, Endevica, Galera, GBT, Icosavax, Jazz, Mitsubishi Tanabe, Neurona, Oculis, Palisade, Receptor, Scisparc, Trevi, Ventyx, Xylocor. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Biolinerx, Eli Lilly, Generian, Genfleet, Mitobridge, Novavax, Oyster Point, Scorpion. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Alx, Bristol Myers Squibb, Endevica, Freya, Inflarx, Ipsen, Obseva, Regeneron, Sanofi, Santhera, Teraimmune, Unibio. Read More