Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8.
Xenon Pharmaceuticals Inc. took to the stage this week at the J.P. Morgan Healthcare Conference to talk up its pipeline, including the phase III program testing XEN-1101 in focal-onset seizures (FOS), due to complete enrollment in the second half of this year. It’s an indication where such other players as Biohaven Ltd. are busy, too. Several million adults are afflicted with FOS in the U.S., with close to a half-million pediatric patients.
Tough times can create great companies if they can navigate the turbulence, a panel of biopharma executives and academics told attendees at the Wuxi Global Forum 2024. Companies must learn how to endure bad periods and thrive during the good times, said Mathai Mammen, CEO of Fogpharma Inc., because those disparate financial and scientific cycles will never go away. Right now, the money part is tough, but the science is thriving
Among the firms updating progress at the J.P. Morgan Healthcare Conference (JPM) in San Francisco this week was Relay Therapeutics Inc., coming off a $30 million financing to boost its Dynamo platform and candidates.
Gene therapy has finally become the “new normal” with serial breakthroughs unlocking “tremendous value” for patients and society, while at the same time the U.S. health care system is shaping up to enable access to these costly treatments, according to Tim Hunt, CEO of the Alliance for Regenerative Medicine.
Major contract research development and manufacturing organizations (CDMO) out of Asia are announcing plans to ramp up production and antibody-drug conjugate (ADC) capabilities worldwide.
Cell and gene therapy companies continue moving away from traditional treatment modalities into a future that’s often unclear. A panel of CEOs said at the Biotech Showcase in San Francisco that, instead of aiming for developing silver bullet therapies that knock out indications in a single blow, they tend to only be able to take incremental steps in development.
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