BioCentury | Mar 5, 2020
Product Development

March 4 Quick Takes: Arcturus-Duke-NUS collaborate on COVID-19 vaccine; plus Gilead, Roche, Editas-Allergan, Alnylam, FDA

Arcturus, Duke-NUS partner on COVID-19 vaccine Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) and Duke-NUS Medical School are collaborating to use the company’s STARR technology and the university’s rapid vaccine screening platform to develop a vaccine against...
BioCentury | Jan 11, 2020

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Nov 21, 2019
Company News

Alnylam unveils pricing strategy for second FDA-approved RNAi drug

Alnylam unveiled a performance-based and prevalence-based pricing strategy to mitigate risks to participating payers covering RNAi therapy Givlaari givosiran, which FDA approved more than two months ahead of schedule for adults with acute hepatic porphyria....
BC Extra | Sep 3, 2019
Clinical News

RNAi therapy from Medicines Co., Alnylam cuts cholesterol by 54%, could compete with PCSK9 mAbs

The Medicines Co. announced data from a Phase III trial of inclisiran showing reductions in LDL-C that appear to be competitive with approved mAbs against PCSK9, but with a dosing advantage. Safety data from the...
BC Extra | Aug 5, 2019
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...
BC Extra | Jul 1, 2019
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...
BC Extra | Jun 5, 2019
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...
BioCentury | May 3, 2019
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...
BC Extra | Apr 12, 2019
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...
BC Extra | Mar 6, 2019
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...
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