What were the biggest biopharma stories of 2019?
The biggest stories and trends of 2019 - mega-mergers, regulatory controversies, the national conversation about drug pricing and more - will likely have implications for 2020 as well.
The biggest stories and trends of 2019 - mega-mergers, regulatory controversies, the national conversation about drug pricing and more - will likely have implications for 2020 as well.
In data from several clinical trials released Friday and during the weekend, cell and other therapies for multiple myeloma targeting the antigen BCMA showed strong response rates.
Nine senators sent a letter to FTC Chairman Joseph Simons urging greater scrutiny over like the one between BMS and Celgene, expressing concern over antitrust issues, innovation and drug pricing.
Celgene will have opt-in rights to take responsibility for development, manufacturing and commercialization of T-cell receptor therapies that Immatics develops using its in-house technology.
Bristol-Myers Squibb said Celgene would sell the drug, Otezla (apremilast), to Amgen. The pharmaceutical company had said it would seek a divestment of the drug to satisfy competition concerns from the FTC.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The agency said Friday that it had approved Celgene's Inrebic (fedratinib), the first new drug approved for the disease - a type of rare blood cancer - since the approval of Incyte's Jakafi.
Celgene plans to file for approval of bb2121 (idecabtagene vicleucel) in myeloma in the first half of 2020, and lisocabtagene maraleucel in lymphoma in the fourth quarter of this year.
Celgene had been expected to hand the PD-1 checkpoint inhibitor tislelizumab back over to the Chinese company due to its $74 billion acquisition by Bristol-Myers Squibb, which already has its own well-established PD-1 inhibitor, Opdivo.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
In a statement, the agency said that a decision on whether to have Medicare cover the cell therapies would not be issued Friday, but would be forthcoming.
The agency also proposed increasing the maximum new technology add-on payment from 50 percent to 65 percent for fiscal year 2020.
The company has raised more than $100 million since 2017 and plans to use the current funding to build a pipeline of RNA-targeting small molecules.