BioCentury | Apr 6, 2021
Regulation

April 5 Quick Takes: FDA extends review of Rinvoq in atopic dermatitis; plus Acadia, Supernus

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review for an sNDA for Rinvoq upadacitinib to treat moderate to severe atopic dermatitis following the agency’s request for an updated assessment of the oral...
BioCentury | Mar 26, 2021
Regulation

CHMP backs GSK’s lupus drug for kidney complication, J&J’s oral MS therapy

GSK’s Benlysta and J&J’s Ponvory are two of the latest therapies to win support from EMA’s CHMP, which did not issue any negative recommendations in March. The agency recommended a label extension for Benlysta belimumab to treat active lupus...
BioCentury | Mar 20, 2021
Finance

Dallas TIL play leads Friday IPO trio: Data Byte

Less than three years after its launch, Dallas-based TIL specialist Instil led a trio of NASDAQ debuts late this week. Shares of Instil Bio Inc. (NASDAQ:TIL) rose 32% to $26.44 after raising $320 million in...
BioCentury | Mar 20, 2021
Product Development

March 19 Quick Takes: Ovarian readout for Rubraca lifts Clovis shares; plus Keytruda-Lenvima combo meets in endometrial, approvals for Kiniksa, J&J and more

Shares of Clovis Oncology Inc. (NASDAQ:CLVS) rose 48% to $7.86 to bring the company’s market cap back over the $800 million mark after the company said Rubraca rucaparib significantly improved progression-free survival vs. chemotherapy in...
BioCentury | Mar 17, 2021
Product Development

March 17 Quick Takes: FDA extends review of Rinvoq in psoriatic arthritis; plus Merck, PharmaEssentia, Lilly, Roche and more

AbbVie Inc. (NYSE:ABBV) said FDA extended by three months its review of an sNDA for Rinvoq upadacitinib to treat adult patients with active psoriatic arthritis after the agency had requested additional information on the oral...
BioCentury | Mar 12, 2021
Politics, Policy & Law

PDUFA VII to feature $4M fee, focus on cell, gene therapies

FDA and biopharma industry representatives have agreed on most elements of the next Prescription Drug User Fee Act deal, including an increase in the application fee to about $4 million by 2027 from the current...
BioCentury | Mar 11, 2021
Emerging Company Profile

Ventyx emerges with $114M to bring asset-centric immunology plays under one umbrella

Ventyx is the second start-up in the past month to bundle asset-centric companies under one umbrella with an eye towards advancing each program faster than the originator companies could have had they...
BioCentury | Feb 26, 2021
Distillery Therapeutics

Sphingosine receptor agonist identified for cervical cancer, sarcoma

DISEASE CATEGORY: Cancer INDICATION: Cervical cancer; sarcoma A decahydroisoquinoline-based agonist of S1PR3, a sphingosine phosphate receptor, could treat cervical cancer and rhabdomyosarcoma. A pancreatic cancer cell-based screen of 696 compounds for differential suppression of proliferation in...
BioCentury | Feb 6, 2021
Product Development

Genmab’s strategy for going commercial

Genmab is preparing to join the expanding ranks of biotechs taking on commercialization, and CEO Jan van de Winkel is approaching commercial strategy with the same innovative eye he’s applied to development. ...
BioCentury | Feb 6, 2021
Product Development

Incyte continues layering on new opportunities

The next stage of Incyte’s growth strategy is already well under way as the company continues to expand its cancer portfolio and prepares to bring its first dermatology program to market.  Much of the current...
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