Now that Apellis Pharmaceuticals Inc.’s Empaveli pegcetacoplan has won FDA approval as the first targeted C3 therapy for treating paroxysmal nocturnal hemoglobinuria (PNH), the cost of treating the rare blood disorder is hefty. Read More
Soteria Biotherapeutics Inc., a company developing switchable bispecific T-cell engagers to treat patients with solid tumors, has raised $42 million in series A financing to fund early development of a pipeline of candidates with potential in validated cancer targets, it said. Roche Venture Fund and 5AM Ventures led the round, with further investments from M Ventures, Novartis Venture Fund and Alexandria Venture Investments. Read More
Shanghai and New Jersey-based Lianbio Co. Ltd. has made its second in-licensing deal in a week. This time, it obtained rights for omilancor and NX-13, both under development by Landos Biopharma Inc. for the potential treatment of ulcerative colitis (UC) and Crohn’s disease (CD) – plus eosinophilic esophagitis, for omilancor – in greater China, South Korea and seven ASEAN countries as part of a $218 million deal. Read More
Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation. Read More
It looks like the two biosimilars referencing Amgen Inc.’s Enbrel (etanercept) will have to wait out the rest of the decade before launching in the U.S. The U.S. Supreme Court declined May 17 to hear Sandoz Inc.’s appeal of last year’s split Federal Circuit ruling affirming the validity of two patents protecting etanercept and its manufacturing methods Read More
As investors await interim data this quarter from Arcus Biosciences Inc.’s ARC-7 phase II effort with domvanalimab (AB-154) in non-small-cell lung cancer, the anti-TIGIT space continues to bubble, with Wall Street busy trying to sort out the odds of various players. Read More
As part of its ongoing investigation into what it considers excessive price increases for some prescription drugs, the U.S. House Oversight Committee plans to put Abbvie Inc. CEO and Chairman Richard Gonzalez on the hot seat May 18 for a grilling on the company’s pricing of Humira and Imbruvica. Read More
The U.S. Health Resources and Services Administration (HRSA) ordered six drug companies May 17 to immediately resume providing 340B discounts to contract pharmacies without restrictions and to credit or refund overcharges stemming from those restrictions. Read More
To accelerate drug development targeting the pandemic, the FDA issued final guidance May 17 on master protocols for drugs intended to prevent or treat COVID-19 infections. Although the guidance is geared toward developing COVID-19 drugs, the FDA said it expects master protocols to continue to play an important role in addressing the public health needs in future pandemics. Read More
For almost two months, Brazil’s health care surveillance agency Anvisa, the European Medicines Agency, and the Directorate-General for Health and Food Safety have been sharing regulatory and confidential information as part of an effort to improve the safety and efficacy of drugs and medical devices. Read More
Song Guo Zheng, a rheumatology professor and researcher at Ohio State University (OSU), was sentenced May 14 to 37 months in prison for lying on U.S. NIH grant applications about his ties to at least five Chinese research institutes. Read More
New hires and promotions in the biopharma industry, including: Aavantibio, Affamed, Aulos, Blueprint, Caribou, Escient, Genenta, Inovio, Makana, Mymd, Oncosec, Oxurion, Turning Point. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American College of Cardiology annual meeting, including: Amarin, Attralus, BMS, Esperion, Imbria, Janssen, Milestone, Stealth. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: AC Immune, Amo, Antengene, Appili, Athenex, Baudax, Foghorn, Galera, GSK, Incyte, Knopp, Regeneron, Sanofi, Seelos. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Adamis, Algernon, Apellis, Diamedica, Everest, Icanomab, Immunitybio, Ix, Kiromic, Mindmed, Pharmather, RDIF. Read More
