23:52 , Aug 5, 2019 |  BC Extra  |  Company News

Aug. 5 Company Quick Takes: Briefing docs for Descovy cast doubt on full PrEP approval; plus Alnylam, Provention and more

FDA questions Descovy as PrEP in cis women Briefing documents released ahead of the Aug. 7 Antimicrobial Drugs Advisory Committee meeting for Descovy emtricitabine/tenofovir alafenamide from Gilead Sciences Inc. (NASDAQ:GILD) indicate that FDA is uncertain...
23:27 , Jul 1, 2019 |  BC Extra  |  Company News

July 1 Company Quick Takes: Alnylam submits MAA for hepatic porphyria therapy; plus Sage, Amicus and PTC

Alnylam submits hepatic porphyria therapy MAA  Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) submitted an MAA to EMA for givosiran to treat acute hepatic porphyria. Last month, the biotech completed a rolling NDA for the subcutaneous RNAi therapeutic...
21:55 , Jun 5, 2019 |  BC Extra  |  Company News

June 5 Company Quick Takes: Enzyvant's athymia candidate gets Priority review; plus Alnylam, Corbin and Institute Pasteur

Priority Review for Enzyvant's RVT-802  Enzyvant Sciences GmbH (Basel, Switzerland) said FDA accepted and granted Priority Review to a BLA for RVT-802 to treat pediatric congenital athymia. A decision is expected in December for the...
23:29 , May 3, 2019 |  BioCentury  |  Product Development

Independents’ day: after their first solo launch, biotechs look to new partnering strategies

Having taken their first products to market alone, the new class of independent biotechs face decisions for what to keep and what to change as they seek to build sustainable value as end-to-end companies. One...
23:08 , Apr 12, 2019 |  BC Extra  |  Clinical News

Alnylam's givosiran reduces mean porphyria attacks by 74% in Phase III

Alnylam reported detailed data Friday showing that givosiran reduced the mean attack rate in acute hepatic porphyria patients by 74% in the Phase III ENVISION trial. The company reaffirmed its plans to complete submission of...
20:51 , Mar 6, 2019 |  BC Extra  |  Clinical News

Alnylam's rare liver disease RNAi meets in Phase III

Alnylam’s givosiran met the primary endpoint in the Phase III ENVISION trial to treat acute hepatic porphyria, setting the company up to complete submission of a rolling NDA to FDA and submit an MAA to...
18:06 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

Alnylam to seek accelerated approval for RNAi therapy in rare liver disease

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said it will seek accelerated approval of givosiran (ALN-AS1) to treat acute hepatic porphyria after interim data showed that the compound significantly reduced urinary aminolevulinic acid (ALA) levels in the Phase...
20:19 , Sep 27, 2018 |  BC Extra  |  Clinical News

Alnylam to seek accelerated approval for RNAi therapy in rare liver disease

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said it will seek accelerated approval of givosiran to treat acute hepatic porphyria after interim data showed that the compound significantly reduced urinary aminolevulinic acid (ALA) levels in the Phase III...
01:27 , Jan 13, 2018 |  BioCentury  |  Strategy

Remapping growth

As patisiran and fitusiran get closer to market, Alnylam Pharmaceuticals Inc. and Sanofi Genzyme concluded that the territorial complexity of their partnership for the products would limit their commercial value. Amendments announced on Jan. 7...
18:25 , Jan 12, 2018 |  BC Week In Review  |  Company News

Sanofi, Alnylam restructure RNAi therapeutics deal

Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) gained global development and commercialization rights to transthyretin (TTR)-mediated amyloidosis candidates patisiran (ALN-TTR02) and ALN-TTRsc02 after it and Sanofi (Euronext:SAN; NYSE:SNY) amended their 2012 deal. The pharma and its Sanofi Genzyme...