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.

Royalty, credit setup worth as much as $1.25B for Blueprint

Blueprint Medicines Corp. disclosed financing collaborations with Sixth Street and Royalty Pharma for up to $1.25 billion. The arrangement with Sixth Street has three parts and includes $250 million cash up front in exchange for royalties on Ayvakit/Ayvakyt (avapritinib) and BLU-263, plus two credit facilities valued at up to $660 million in total. The Royalty pact monetizes royalties receivable from Gavreto (pralsetinib) sales by Roche Holding AG outside of the U.S., not including China, with $175 million cash paid to Blueprint up front and up to $165 million in potential milestone payments based on future sales. Shares of Blueprint (NASDAQ:BPMC) were trading midday at $49.71, down $2.50.

Talaris posts positive data for transplant therapy but stock slips

Despite positive data from the ongoing phase III study of Talaris Therapeutics Inc.’s lead asset, FCR-001, an allogeneic cell therapy product for treating living donor kidney transplant patients, investors are stepping away. The Boston and Louisville, Ky.-based company’s stock (NASDAQ:TALS) took a hit at midday as shares had dropped 15% to about $6 each. There are 22 donor-recipient pairs enrolled in the phase III study and three patients who are more than 12 months post-transplant have been successfully weaned from all their chronic anti-rejection drugs. All showed no signs of rejection and demonstrated stable kidney function. The first successfully weened participant is 24 months post-transplant.

South Korea approves first homegrown COVID vaccine

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.

Pfizer and Biontech land US order for up to 300M COVID vaccine doses

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.

Sunshine Guojian grants global rights for biosimilar to Xiling Lab in ¥1.03B deal

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. Sunshine Guojian will receive $153 million from Xiling Lab, including an up-front payment, research and development milestones, and sales milestone payments. Shanghai-based Sunshine Guojian is also eligible to receive royalties on sales of the therapy. It retained rights to the candidates’ use outside ADC projects.

Henlius secures China rights for two Palleon bifunctional sialidase programs

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.

Also in the news

89bio, 9 Meters, Adagene, ADC, Advaxis, Agenus, Aileron, Akeso, Alx, Alzecure, An2, Astellas, Avacta, Axalbion, Biolinerx, Bristol Myers Squibb, Can-Fite, Codiak, Eli Lilly, Elite, Endevica, Ermium, Freya, Galera, GBT, Generian, Genfleet, Icosavax, Inflarx, Ipsen, Jazz, Mitobridge, Mitsubishi Tanabe, Neurona, Nervgen, Novavax, Obseva, Oculis, Oyster Point, Palisade, Receptor, Regeneron, Sanofi, Santhera, Scisparc, Scorpion, Seres, Teraimmune, Trevi, Uni-Bio, Ventyx, Verrica, Xylocor