Homerun success of Novo Nordisk A/S’ semaglutide, which recently became the U.S.’s biggest blockbuster drug, is serving as an “inflection point” for obesity therapeutics and fueling the drive for new and improved therapies, speakers said at Bio Korea 2024 on May 8. Read More
A boy participating in the phase II Daylight study of Duchenne muscular dystrophy (DMD) “has passed away suddenly,” according to Pfizer Inc. The participant had received fordadistrogene movaparvovec, a mini-dystrophin gene therapy, in early 2023. The fatal serious adverse event was reported May 3 as a cardiac arrest, Pfizer told BioWorld. Pfizer, together with the independent external data monitoring committee, is reviewing the data to understand the potential cause, the company added. Read More
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model. Read More
About a year ago, when Seres Therapeutics Inc. won U.S. FDA approval of oral microbiome therapy Vowst (live fecal microbiota spores), the drug – meant to prevent recurrent Clostridioides difficile infection – was hailed as first in the space, and launch plans sounded ambitious. In July 2021, Seres inked a deal with Nestlé Health Science SA, of Lutry, Switzerland, to jointly commercialize Vowst in the U.S. and potentially Canada. But shares of Cambridge, Mass.-based Seres (NASDAQ:MCRB) closed May 8 at 75 cents, down 36 cents, or 32%, after the firm provided an update on sales, roughly flat quarter over quarter. Read More
The EMA’s chief medical officer has expressed disquiet that Europe has fallen behind in the development of psychedelic drugs as approved therapies for mental disorders, saying they should be given “a second chance.” Read More
India’s first indigenous CAR T therapy is expected to cost around $50,000, nearly one-tenth of the price of top-selling CAR Ts in the U.S. India President Droupadi Murmu officially launched Immunoadoptive Cell Therapy’s (Immunoact) NexCAR19 (actalycabtagene autoleucel), a CD19-targeted CAR T, and dedicated it to the nation in April 2024. Read More
BioWorld Managing Editor Karen Carey joins the podcast to talk about the numbers from the first quarter of 2024, along with a look back at some 2023 deals and indicators that signal better times are on the way. Financings for the quarter were better than expected, sporting some of the best numbers of the past 13 years. It’s part of a larger trend, Carey says, of investors being a lot pickier about where they put their money and demanding better data. The result is a strengthened market and a better outlook. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
New hires and promotions in the biopharma industry, including: Advancell, Alcyone, DBV, Eterna, Hutchmed, Imunon, Kancera, Neurenati, Obsidian, Relief, Tolremo, Tyra. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Calliditas, Eledon, Eyedna, Inmagene, Mirum, Moleculin, Neurogene, Neurosense, Rion, Traws, Verve. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adcentrx, Biotheryx, Eli Lilly, FSD, Galderma, Iecure, Incannex, Innovent, Invivyd, Lykos, Merus, Pfizer, Precision. Read More
