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According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Since July, several biotechs have been forced to pivot as previous agreements with the FDA around evidence required for approval were reversed, a phenomenon that, according to experts, could portend a more restrictive regulator.
The drugmaker’s dominance of the obesity market is fueling predictions that years of growth lie ahead.
Job Trends
Illumina, Inc. confirmed that it has received notice from Icahn Partners LP and certain of its affiliates of their intention to nominate three candidates—two current Icahn employees, Jesse Lynn and Andrew Teno, and one former Icahn employee, Vincent Intrieri—for election to the Board of Directors at Illumina’s 2023 Annual Meeting of Shareholders.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
The newly approved filling line will be able to provide both 50-mg and 100-mg doses of the respiratory syncytial virus antibody Beyfortus to help meet demand ahead of the 2024/2025 RSV season.
Bristol Myers Squibb presented the positive Phase III results on its already approved Opdivo-Yervoy combo at ESMO over the weekend, while separately announcing that it was returning Immatics’ bispecific T cell engager.
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.
Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
Oncternal Therapeutics will lay off about 10 workers as it explores “strategic alternatives” that could include asset sales or an M&A.