BioCentury | May 1, 2020
Product Development

April 30 Quick Takes: Pfizer to co-develop Valneva’s Lyme disease vaccine; plus Aravive-WuXi Biologics, Siga-BARDA, Pear, Capricor

Valneva gets $130M up front in Lyme disease vaccine deal  Pfizer Inc. (NYSE:PFE) will collaborate with Valneva SE (Euronext:VLA) to develop VLA15, the biotech’s vaccine candidate for Lyme disease. In a deal announced Thursday, Valneva...
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

BioMarin's hemophilia gene therapy gets Priority Review  BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) could become the first company to have a hemophilia gene therapy approved in the U.S. FDA accepted and granted Priority Review to a BLA...
BioCentury | Feb 11, 2020
Politics, Policy & Law

Senate bill introduced to close Orphan drug ‘loophole’

Legislation introduced Tuesday in the Senate seeks to tighten the little-used cost recovery pathway to obtaining Orphan Drug designation in the U.S. The Fairness in Orphan Drug Exclusivity Act is identical to a bill, H.R....
BC Extra | Jan 29, 2020
Politics & Policy

House bill seeks to tweak Orphan Drug Act, could pose threat to pathway

A new bill in the U.S. House of Representatives that seeks to limit abuse of the Orphan Drug Act could have the unintended effect of disincentivizing companies from developing therapies for rare diseases, if the...
BioCentury | Jan 3, 2020
Emerging Company Profile

Click: personalized digital therapeutics for cognitive, neurobehavioral disorders

Click is developing a pipeline of personalized prescription digital therapeutics that could be used alone or in combination with traditional therapeutics to treat cognitive and neurobehavioral disorders. Launched in 2012, Click Therapeutics Inc. markets a...
BC Extra | Nov 27, 2019
Company News

Nov. 27 Company Quick Takes: Orexo, GAIA in second deal for substance abuse digital therapy; plus PDUFA date for Verrica's skin infection candidate and $25M fol

Orexo gets U.S. rights to GAIA's alcohol abuse digital therapeutic  Orexo AB (SSE:ORX) licensed exclusive U.S. rights from GAIA AG to vorvida, a digital therapeutic to treat alcohol use disorder; financial terms are undisclosed. Orexo...
BC Extra | Nov 26, 2019
Politics & Policy

Pioneering FDA commissioner Frank Young dies at 88

Frank Young, who served as FDA Commissioner from 1984 to 1989, a pivotal and tumultuous era in drug regulation, died Nov. 24 at age 88. He was diagnosed last week with B Cell Lymphoma. Former...
BC Extra | Oct 29, 2019
Company News

Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

Galapagos, MorphoSys, Novartis discontinue atopic dermatitis program  With an interim analysis indicating futility of the Phase II IGUANA trial, MorphoSys AG (Xetra:MOR; NASDAQ:MOR), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) and Novartis AG (NYSE:NVS; SIX:NOVN) terminated development of...
BC Extra | Oct 16, 2019
Company News

Pear gearing up to sell products solo as Sandoz backs out of digital deal

While Sandoz has pulled out of its commercialization deal with Pear, the digital therapy pioneer believes it is well positioned to commercialize its flagship digital therapeutics independently. Pear Therapeutics Inc. will assume sole commercial responsibility...
BC Extra | Oct 4, 2019
Financial News

Oct. 4 Financial Quick Takes: Innovent raises $300M in Hong Kong's first biotech follow-on; plus Oyster Point, Heron, Molecular Assemblies and Geneoscopy

Innovent brings in first follow-on of HKEX's biotech chapter  A year after going public on the Hong Kong stock exchange, Innovent Biologics Inc. (HKEX:1801) raised HK$2.4 billion ($299.8 million) through the sale of 97 million...
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