BioCentury | Oct 17, 2020
Regulation

CHMP’s October recommendations

EMA’s CHMP has backed autologous cells therapies Tecartus, from Gilead, and Lebmeldy, from Orchard, in its October set of opinions. The agency recommended conditional marketing approval for Tecartus brexucabtagene autoleucel from the Kite Pharma Inc....
BioCentury | Aug 31, 2020
Deals

Takeout premium shows Nestlé’s faith in Aimmune peanut product, despite launch slowed by COVID

Nestlé Health Science’s premium-priced takeout of peanut allergy company Aimmune is its biggest move yet in biotech, giving it full control of a marketed program in which the nutrition company had already invested heavily. The...
BioCentury | Jun 16, 2020
Finance

June 15 Quick Takes: RA makes $200M investment in Novavax; plus venture rounds for Shattuck, ImmVira, Glyscend and Shukun

...company is developing therapies to treat cancer and autoimmune diseases using its Agonist Redirected Checkpoint (ARC...
BioCentury | May 28, 2020
Product Development

Daily Chart: TIGIT pipeline heats up

...“Arcus Keeps its Independence in Deal” ). Preliminary Phase II randomization data from the company’s ARC-7...
BioCentury | Oct 4, 2019
Emerging Company Profile

Arcellx debuts with $85M, tech for adapting CAR Ts

...Hilbert. Arcellx’s version of the platform involves CAR T cells dubbed Antigen Receptor Complex T (ARC-T...
...is exploring transplant and autoimmune disease indications with effector CAR T cells, but said the ARC-T...
...said Arcellx is following the allogeneic CAR T cell race and plans to position its ARC-T...
BioCentury | Sep 18, 2019
Company News

FDA panel backs Aimmune’s peanut allergy therapy, wants expanded REMS

Despite concerns over a new surrogate endpoint and increased risk of allergic reactions, the very thing the treatment is designed to diminish, an FDA advisory panel voted 7-2 in favor of the efficacy of Aimmune’s...
BioCentury | Jun 28, 2019
Company News

June 28 Company Quick Takes: FDA approves Pfizer's biosimilar of Avastin; plus Aimmune, PeptiDream, Novartis and Just/Teva

Pfizer gets second FDA-approved biosimilar with Zirabev approval FDA approved Zirabev bevacizumab-bvzr from Pfizer Inc. (NYSE:PFE) to treat metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell long cancer; recurrent glioblastoma; metastatic...
BioCentury | Jun 26, 2019
Company News

June 26 Company Quick Takes: Dupixent approved for nasal polyps; plus Ono/Rafael, Oxford/Santen and more

FDA approves Regeneron's Dupixent in nasal polyps FDA approved Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat chronic rhinosinusitis with nasal polyps. Dupixent is the first drug approved for the indication (see "Phase III...
BioCentury | Jun 11, 2019
Company News

June 11 Company Quick Takes: Genmab, Janssen together again on CD38; plus GT Apeiron’s launch; BiomX, Aimmune, Keytruda

Genmab, Janssen partner on next-gen CD38 mAb Genmab A/S (CSE:GEN; Pink:GMXAY) granted Janssen Biotech Inc. an option to HexaBody-CD38, building on the companies' collaboration on multiple myeloma CD38 mAb Darzalex daratumumab. Genmab will fund R&D...
BioCentury | May 16, 2019
Company News

May 16 Company Quick Takes: Iconic oncology deals; plus Zymeworks-GSK, Aimmune and more

Iconic in pair of deals to develop lead oncology program Iconic Therapeutics Inc. (South San Francisco, Calif.) granted Exelixis Inc. (NASDAQ:EXEL) an option to license ICON-2 for $7.5 million up front and funding for preclinical...
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