Investors didn’t respond well to the U.S. FDA’s briefing document for the March 30 advisory committee meeting on Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) candidate. Shortly after the materials for the adcom were posted Monday, Amylyx (NASDAQ:AMLX) dropped from a morning high of $25.68 per share to an all-time low of $10.49 in the heaviest trading since the company went public in January. With share volume exceeding 15 million, Amylyx rebounded somewhat, ending the day at $16.01, down nearly 36% from its March 25 close of $25.
Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million. The pair last summer admitted to obtaining confidential, proprietary, and trade-secret information from Roche Holding AG’s Genentech Inc. unit and using what they stole to reduce expenses and hasten the timeline of JHL’s efforts to develop biosimilars.
Former JHL Biotech Inc. CEO Racho Jordanov and former Chief Operating Officer Rose Lin were sentenced for their respective roles in conspiring to commit trade secret theft and wire fraud exceeding $101 million.
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival in advanced breast cancer in a mid-stage trial.
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, including the launch of Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, and potential other interchangeables, will be determined in large part by three pharmacy benefit managers that together control the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance.
Partners Sanofi SA and Swedish Orphan Biovitrum AB (Sobi) said regulatory submissions are expected this year for once-weekly factor VIII therapy efanesoctocog alfa in hemophilia A following top-line success in a pivotal phase III study, which showed a clinically meaningful prevention of bleeds in people with severe disease receiving prophylaxis over 52 weeks. The drug, also known as BIVV-001, has fast track and orphan designations in the U.S., and the companies are banking on its extended half-life to go up against blockbuster bispecific antibody Hemlibra (emicizumab) from Roche Holding AG as well as a potential gene therapy from Biomarin Pharmaceutical Inc.
The potholes in the U.S. FDA’s accelerated approval path could be paved over by a bill introduced in Congress this week. Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Committee, introduced the Accelerated Approval Integrity Act March 8 to keep the path open to innovative drugs where there is unmet need while streamlining the process for taking drugs off the market when they don’t prove clinical benefit in a timely manner.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology.
Adagene Inc. has announced a research collaboration with Sanofi SA, to find “masked” monoclonal and bispecific antibodies that are safer than marketed drugs in oncology, in a deal worth up to $2.5 billion plus royalties. San Diego and Suzhou, China-based Adagene will generate masked versions of Sanofi antibodies, taking responsibility for early stage research activities using its Safebody technology. Sanofi will be responsible for later-stage research and all clinical, product development and marketing activities.
Dariohealth Corp. and Sanofi U.S., a subsidiary of Paris-based Sanofi SA, inked a strategic agreement that provides Dario with $30 million to speed commercial adoption of the company’s integrated digital therapeutics platform. The company simultaneously announced definitive agreements with institutional investors to purchase approximately 5,342,013 shares of its common stock at $7.49 per share, a deal that will generate about $40 million for the company.