BioCentury | Aug 12, 2020
Product Development

Aug. 11 Quick Takes: BMS hits, Genentech misses; plus JW-Lyell, CStone, Big Health

Opdivo clears Phase III hurdles in gastric, esophageal cancers Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) plus chemotherapy led to a survival benefit compared with chemotherapy alone in the Phase III CheckMate -649 trial as first-line...
BioCentury | Aug 1, 2020
Product Development

July 31 Quick Takes: FDA approves MorphoSys’ tafasitamab; Truvian, AbbVie, Boehringer, Lilly, Alector, Henlius-Accord, Ascletis, Roche, Merck

MorphoSys follows Kress’ first big deal with U.S. approval FDA granted accelerated approval to Monjuvi tafasitamab-cxix from MorphoSys AG (Xetra:MOR; NASDAQ:MOR) and Incyte Corp. (NASDAQ:INCY) in combination with lenalidomide to treat patients with relapsed or...
BioCentury | Jul 17, 2020
Emerging Company Profile

Acepodia: linking antitumor antibodies to immune cells

Acepodia is using its antibody-cell conjugation platform to link tumor-targeting antibodies to the surface of cell therapies while avoiding genetic engineering. The platform, which has the potential for cost savings compared with CAR T therapy,...
BioCentury | Jul 16, 2020
Regulation

July 15 Quick Takes: Early access in U.K. for Alnylam RNAi; plus Verrica, CytoDyn, J&J and Roche

U.K. clears early access to lumasiran The U.K.’s Medicines and Healthcare products Regulatory Agency is making lumasiran from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) available to patients with primary hyperoxaluria type I before its approval by the...
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 24, 2020
Product Development

Data Bytes: Phase I TIGIT data emphasize importance of patient selection

Phase I data from Genentech’s high-profile anti-TIGIT mAb tiragolumab suggest choosing the right indications and patient subsets will be key to success for next-generation checkpoint inhibitors. The data, presented at the American Association for Cancer...
BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | Jun 13, 2020
Product Development

Where companies see opportunity in the crowded PD-1 marketplace

Everyone wants a piece of the PD-1 pie, but as Merck continues to snap up new indications for Keytruda and the number of competitors grows, carving out niches in the competitive landscape is becoming increasingly...
BioCentury | Jun 10, 2020
Product Development

Keytruda’s frontline urothelial carcinoma miss creates opportunity for competitors in a tricky indication

Keytruda’s Phase III miss in first-line urothelial cancer opens the door to a spate of competitors hoping to beat Merck’s market-leading anti-PD-1 mAb to the indication. The combination of Keytruda pembrolizumab from Merck & Co....
BioCentury | Jun 2, 2020
Regulation

June 1 Quick Takes: CHMP recommendations, plus FDA action on AbbVie-Neurocrine, Shionogi, AZ, Lilly, Genentech

CHMP backs Ebola vaccine, targeted cancer therapies EMA’s CHMP recommended approval of a two-component Ebola vaccine -- Zabdeno and Mvabea -- from Johnson & Johnson (NYSE:JNJ) Friday. The agency also backed two targeted cancer therapies:...
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