Criminal and civil charges related to insider trading were filed Sept. 10 against Dishant Gupta based on his stock purchases of Epizyme Inc. in the months leading up to its acquisition by Ipsen SA.
Spectrawave Inc. surfed to a $50 million haul in its series B fundraising round for its Hypervue intravascular imaging system. The company appears to have captured the attention of at least one strategic investor, as Johnson & Johnson Innovation-JJDC Inc. led the round.
The FDA’s Sept. 5, 2024, draft guidance for the use of patient preference information (PPI) over the total product life cycle represents a new set of requirements for device makers when obtaining such information. Going forward, device makers may be required to provide more detail about patient heterogeneity, including when the benefit-risk calculation varies by subpopulation.
Another day, another insider trading deal involving biopharma stock. One of the latest U.S. SEC cases involves a retired dentist, Stephen Forlano Sr., who traded on a tip passed on through his son from a close friend who was an analyst at an investment firm handling a strategic financing collaboration with Harmony Biosciences Holdings Inc.
With an eye on shutting down national security threats and securing American innovation, the U.S. House overwhelmingly passed the Biosecure Act Sept. 9 with a vote of 306-81. The next stop on the bill’s path to enactment is a Senate vote and, if it gets that, then on to the president’s desk.
The third of three late-stage studies from Bayer AG in treating menopausal symptoms with elinzanetant has produced positive data for a nonhormonal treatment. Women looking for a nonhormonal option specifically for vasomotor symptoms, more often called hot flashes, will find few choices.
Implications for Amgen Inc.’s same-class Tepezza (teprotumumab) of positive phase III data from Viridian Therapeutics Inc. with veligrotug in thyroid eye disease became a topic of talk on Wall Street talk. “I’m not drawing any clinical trial comparisons, you’ll have to reach your own conclusions,” CEO Steve Mahoney said during a conference call on the results.
More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.
In a deal that brings $60 million in cash and equity up front, plus up to $575 million in milestone payments, Shanghai-based Epimab Biotherapeutics Inc. and San Diego-based Vignette Bio Inc. entered a licensing agreement for Epimab’s BCMA-targeting T-cell engager, EMB-06, for autoimmune disease.
The U.S. FDA on Sept. 6 granted fast track designation to MM-II – a novel, non-opioid injectable candidate for knee osteoarthritis (OA) co-developed by Sun Pharmaceutical Industries Ltd. and Moebius Medical Ltd. Mumbai, India-based Sun and Tel Aviv, Israel-based Moebius agreed, under undisclosed terms, to co-develop the novel liposomal non-opioid pain therapy in an exclusive global licensing deal in 2016.
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