The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems. Read More
Though Revolution Medicines Inc.’s SHP2 inhibitor, RMC-4630, fell short of internally set benchmarks in a pair of phase I combo trials, the prospect remains alive, as the company has been “very publicly moving towards combining the companion inhibitors that we have, which include RMC-4630 with RAS inhibitor therapies that we and others make,” said Steve Kelsey, president of R&D. Read More
Innocare Pharma Ltd. has signed a licensing agreement with Incyte Corp. for the exclusive rights to the monoclonal antibody Monjuvi (tafasitamab) for hematology and oncology indications in mainland China, Hong Kong, Macau and Taiwan. Under the terms of the deal, Innocare will pay Incyte an up-front fee of $35 million, as well as up to $82.5 million in potential development, regulatory and commercial milestones and tiered royalties. Read More
Aurinia Pharmaceuticals Inc. has added two potential drugs to its pipeline targeting autoimmune and kidney-related diseases through an acquisition and a licensing deal. Victoria, British Columbia-based Aurinia is building on its first ever FDA approval at the beginning of the year, for Lupkynis (voclosporin) for treating active lupus nephritis in adults. Read More
Abclon Inc. has filled the missing link in its development of antibody-drug conjugates (ADCs) by partnering with Abtis Co. Ltd. and gaining access to its ADC linker. Read More
As more therapies are approved to treat severe atopic dermatitis, U.S. payers should make available at least one biologic and one JAK1 inhibitor, given how different the drug classes are in their onset of action and their risk profile, a panel of experts recommended at a recent Institute for Clinical and Economic Review (ICER) roundtable. Read More
The U.S. Court of Appeals for the Federal Circuit didn’t change a thing in a trio of rulings stemming from Eli Lilly and Co.’s inter partes review challenges of several patents protecting Teva Pharmaceutical Industries Ltd.’s migraine drug, Ajovy (fremanezumab). Read More
The U.S. Supreme Court’s decision in the case of U.S. v. Arthrex might be seen as having fully resolved the interaction between the Appointments Clause and the inter partes review (IPR) process, but there are other controversies brewing, nonetheless. Patent attorney James Lovsin, of McDonnell Boehnen Hulbert & Berghoff LLP (MBHB), said on an Aug. 17 webinar that because the current commissioner of patents is only an acting commissioner, his review of IPRs may also be a violation of the Appointments Clause, thus invoking the possibility that some patent cases will be subject to additional administrative delays. Read More
Insider trading goes beyond the bounds of the companies at the center of nonpublic information, the U.S. SEC reminded biopharma industry insiders Aug. 17 when it charged Matthew Panuwat, former head of business development at Medivation Inc., with insider trading ahead of the California company’s Aug. 22, 2016, announcement that it was being acquired by Pfizer Inc. in a $14 billion deal. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amerimmune, Axcella, Biophytis, Biosight, Brickell, Eli Lilly, Enanta, Innocare, Innovent, Moderna, Oramed, Praxis, Sagimet, Senhwa, Tikomed, Travere, Turning Point. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aequus, Alzamend, Aobiome, Arthrosi, Azurrx, Cellular Engineering Technologies, Eli Lilly, Endocan Solutions, ERS Genomics, Glow Lifetech, HCW Biologics, Ico, Jaguar Health, Lixte, Nirvana Life Sciences, Revision, Satellos, Senhwa, Valeo. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carrick, Edgewise, Eli Lilly, Enlivex, Galmed, Inxmed, Jupiter, Merck & Co., Oncolys, Pfizer, Sesen, Therapeutic Solutions. Read More
