It’s been a rough year at Macrogenics Inc., but times may be changing. Having terminated a phase II study due to fatalities, dropped 15% of its workforce and closed research and manufacturing sites in the past year, the company has taken the helping hand of Gilead Sciences Inc. The pair have agreed to develop the bispecific MGD-024, which has a CD3 component for minimizing cytokine release syndrome, as an oncology candidate along with two additional bispecific research programs, a potential treatment for certain blood cancers, including acute myeloid leukemia and myelodysplastic syndromes. Read More
Over the next two weeks, the team at NGM Biopharmaceuticals Inc. will be digging through the data from its phase II trial of complement 3 inhibitor NGM-621 in patients with geographic atrophy (GA) secondary to age-related macular degeneration, following reports of a top-line miss Oct. 17 and a severe reaction from investors, who sent shares (NASDAQ:NGM) plummeting 70.5% to close at $3.41. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) came out punching Oct. 17 at the start of a three-day hearing before the Obstetrics, Reproductive and Urologic Drugs Advisory Committee on whether Covis Pharma BV’s Makena (17-hydroxyprogesterone caproate), a branded version of a drug that’s been used since 1956 to prevent preterm births, should be withdrawn from the market. Read More
Nearly one year after CSL Ltd. announced its $11.7 billion acquisition of Vifor Pharma Ltd., the company outlined for the first time the synergies of the two companies and its long-term growth strategy aimed at the nephrology market. Read More
Milestone Pharmaceuticals Inc. saw a premarket surge in its share price value after a phase III trial of the company’s self-administered, heart rhythm-restoring nasal spray, etripamil, hit its target in a phase III trial, setting up a potential filing with the U.S. FDA in mid-2023. Read More
Differences in individual responses to COVID-19 vaccines have been linked directly to different human leukocyte antigen (HLA) alleles and it has been shown that people carrying one specific variant, HLA-DQB1*06, generate higher antibody responses and are better protected from SARS-CoV-2 infection. Read More
“Epilepsy is really a classical neurological disorder,” Lars Pinborg told the audience at the European College of Neuropsychopharmacology (ECNP) annual conference on Sunday. “Or is it?” Pinborg, of Rigshospitalet's The Neuroscience Center in Denmark, was chairing a session dedicated to an alternative hypothesis, summed up in the session title: “Is epilepsy a psychiatric disorder?” Read More
New hires and promotions in the biopharma industry, including: Ankyra, Avalyn, Aviceda, Immuneid, Immunos, Kalvista, Revance, Verge Genomics, Zentalis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Alterity, Bio-Thera, Bridgebio, Immune-Onc, Moleculin, Nuance, Verona, Xbiotech.. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acorda, Alkermes, Amgen, Day One, Evotec, Kineta, Merck & Co., Moderna, Qu. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atara, Beigene, Biomea, Mirum, Novartis, Phanes, Prestige, Reata, Regeneron, Takeda, Travere. Read More
