Shares in Ardelyx Inc. have crashed after its tenapanor, under FDA review for managing phosphate levels in chronic kidney disease (CKD), ran into trouble with the regulator. The company said that the FDA has identified “deficiencies” in the data package, which prevent discussions about labeling and postmarketing commitments. Read More
Amylyx Pharmaceuticals Inc.’s oversubscribed, $135 million series C financing led by Viking Global Investors will help lay the groundwork for commercializing in Canada and Europe, as well as for a second phase III study in the U.S. with lead candidate AMX-0035 for amyotrophic lateral sclerosis. Read More
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing. Read More
Rivus Pharmaceuticals Inc. has emerged from stealth and disclosed a $35 million series A round to fund development of its pipeline of “controlled metabolic accelerators,” or CMAs, for treating cardiometabolic diseases. Read More
Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.” Read More
Albireo Pharma Inc.’s Bylvay (odevixibat) becomes the first therapy to hit the commercial market for rare genetic liver disease progressive familial intrahepatic cholestasis (PFIC). A day after the European Commission approved the drug, the FDA gave the nod to the ileal bile acid transport inhibitor on its July 20 PDUFA date following a priority review. Read More
Junshi Biosciences Co. Ltd. entered an agreement with Immorna Biotechnology Co. Ltd. to establish a joint venture (JV) as part of its efforts to expand into the mRNA sector. Read More
New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.” Read More
In a deal worth up to $108 million, ophthalmic startup Eluminex Biosciences Ltd. has licensed the global rights to Fibrogen Inc.’s biosynthetic cornea derived from recombinant human collagen (RHC) type III intended to tackle corneal blindness. Read More
Cellares Corp. added Poseida Therapeutics Inc. to its expanding early access partnership program (EAPP) for the company's Cell Shuttle, a highly specialized "factory in a box" solution for development of cell therapies. San Diego-based Poseida brings two autologous CAR-T product candidates to the program and joins Pact Pharma Inc. and Fred Hutchinson Cancer Research Center in the EAPP. Read More
Three of the largest biopharma distributors in the U.S. agreed to a settlement of $1.179 billion with New York, bowing out of the state’s ongoing opioid lawsuit. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aronora, Bone, Celsion, Compugen, Cytodyn, Cytokinetics, Frontier, Gilead, Nanoscope, Navidea, Nrx, Prometheus, Receptor Life Sciences, Redhill, Roche, Samsung, Valneva, Vertex, Viiv. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinia, Ambiopharm, Creative Medical, CV Sciences, Creative Biolabs, Enzolytics, Everest Medicines, Eyepoint, Genfleet, Imeka, Inmune Bio, Insilico Medicine, Isa, Meditrust Health, Recce, Selva, Xeris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng. Read More
