FDA Confirms Paragraph IV Patent Litigation for Idelalisib.
The follicular lymphoma market is thinning out fast. Days after Gilead Sciences pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies.
Gilead Sciences Inc., based in Foster City, CA, has announced they are pulling cancer drug Zydelig (idelalisib) off the market for certain types of cancer after failing to complete follow-up clinical trials to confirm efficacy and safety.
Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.
Jan 14 (Reuters) - Gilead Sciences Inc (GILD.O) on Friday notified the U.S. health regulator of its decision to voluntarily withdraw the use of its drug Zydelig for two types of cancer - follicular lymphoma and small lymphocytic leukemia.
The PI3K cancer drug family just got a new member, and it’s a potentially safer option than existing players, including Gilead Sciences’ Zydelig.
For Mei Pharma, the road to Morimoto — an upscale, dungeon-like sushi restaurant run by a celebrity chef, surrounded by wavy abstract walls and crowded with plexiglass booths where, last year, a micro-cap biotech could make their case to a large global partner between events at BIO’s Philadelphia convention — was long.
One class of proteins was at the heart of nearly $100 billion worth oncology M&A over the past decade, according to a new report.
Netherlands-based group Pharming has in-licensed for $20 million an experimental rare-disease drug from Novartis called leniolisib, which is part of a drug class more typically advanced for oncology indications.
ADC Therapeutics, headquartered in Lausanne, Switzerland, closed on a $103 million Series E financing expansion, bringing the total proceeds to $303 million. The final expansion round included a $25 million investment from a new U.S.-based institutional investor in addition to funds from existing investors.