Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.
Nine-year-old IFM Therapeutics LLC has notched yet another big deal as Novartis AG will acquire all the outstanding capital stock of IFM Due Inc., a subsidiary of privately held IFM in an agreement that began five years ago. The newest deal brings IFM $90 million up front and makes it eligible for up to $745 million in milestone payments for a deal value of $835 million.
It’s the end of the development line for Acadia Pharmaceuticals Inc.’s main asset, pimavanserin. The company said it won’t conduct any more clinical studies on the selective serotonin inverse agonist and antagonist targeting 5-HT2A receptors after a phase III fail in schizophrenia.
Wegovy (semaglutide) has racked up another indication. The U.S. FDA approved the injectable for reducing risk of major adverse cardiovascular events such as death, heart attack or stroke and for long-term weight management. The approval expands the drug’s potential. The mighty glucagon-like peptide 1 receptor agonist from Novo Nordisk A/S was already approved for those age 12 and older who are obese and for some overweight adults with weight-related problems.
The phase II Initium study of Ultimovacs ASA’s therapeutic cancer vaccine in treating unresectable or metastatic malignant melanoma did not meet the primary endpoint. The company framed the loss by saying the UV-1 vaccine still has other indications where it could succeed.
The biosimilars revolution continues with the U.S. FDA’s approval of the first denosumab biosimilars: Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz) from Sandoz Inc. for treating osteoporosis and to prevent bone problems in cancer. The approval puts up a strong challenge to Amgen Inc.’s Prolia, the first biologic for osteoporosis, and Xgeva, for bone cancer.
While preparing a follow-on phase III study of its Cardiamp cell therapy, Biocardia Inc. has mined positive interim data at a mean 20-month follow-up of all patients in the original Cardiamp HF Trial.
As Cardiff Oncology Inc. dosed the first patient in its phase II study of onvansertib (CRDF-004) in a first-line setting to treat RAS-mutated metastatic colorectal cancer (mCRC), the company also revealed positive efficacy data from its discontinued phase II of onvansertib as a second-line treatment of bevacizumab-naïve RAS-mutated mCRC.
In a panel discussion with executives at the 2024 BIO CEO conference this week in New York, the consensus emerged that artificial intelligence is here to stay, despite its occasional moments of hype, as its applications continually grow.
Drug pricing is playing an outsized role in the dynamics of the November U.S. election, creating turbulence for drug companies and for patients that will extend years after the votes are counted. During a Feb. 27 morning session on drug pricing trends during an election year at the BIO CEO & Investor Conference in New York, key opinion leaders spoke about their concerns, including the need to explain drug-pricing rationale to voters and patients in plain terms.