Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety update reports. Read More
“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. Read More
Researchers have reported that the predictive abilities of a machine learning algorithm trained using best practices on a large clinical dataset did not generalize beyond the data that was used to train it. Read More
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. Read More
U.S. biopharma Sermonix Pharmaceuticals Inc. handed off China rights of lasofoxifene, an oral endocrine therapy in development for breast cancer, to Shanghai’s Henlius Biotech Inc., for an undisclosed up-front payment and up to $58 million in milestone fees. Read More
Shanghai-based Ji Xing Pharmaceuticals has signed a number of licensing deals over the last week for China rights to cardiovascular drugs to advance its pipeline and its global ambitions, partnering most recently with Tokyo-based TMS Co. Ltd. after the Chinese company acquired global rights for TMS-007 (also known as BIIB-131) from Biogen Inc. Read More
In December, biopharma deals reached $23.56 billion, the second-highest monthly total for the year. This reflects an uptick of 25.04% compared to November’s $18.84 billion in deal value. The full year 2023’s deal value of $217.69 billion marked the highest level ever recorded by BioWorld. This was an increase of 5.58% from $206.18 billion recorded in 2022 and surpassed the previous peak, 2021’s $213.57 billion. Read More
A landmark, real-world study in the U.K. has demonstrated that combining whole genome sequencing with clinical data enabled tailored cancer treatment and improved outcomes. At one health care center, having DNA sequence data led to changes from usual standard of care in 25% of cases. “Mostly, [patients] got into clinical trials; some got medicines they wouldn’t have got. Others avoided medicines because their genetic make-up suggested that if they were exposed to the medicines, they would be at risk of harm,” said Mark Caulfield, professor of clinical pharmacology at Queen Mary University of London, who is co-author of a paper outlining the findings in Nature Medicine, Jan 11, 2024. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bridgebio, Chiesi, Dermavant, Elicio, Indapta, Zai Lab. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ampio, Arena Bioworks, Biontech, Debiopharm, Elevatebio, Emergent, Enamine, Henlius, Immunitybio, Ladrx, Sermonix, Syntheticgestalt, Thinkingnode, Wuxi Bio, Xcell, Xoma, Zevra. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioartic, Bond, Sellas, Pharmather. Read More
