23:40 , Aug 14, 2019 |  BC Extra  |  Clinical News

Regeneron data could set up first-in-class approval in lipid-lowering indication

Regeneron's evinacumab could give certain hypercholesterolemia patients a new treatment option, with an FDA submission looming based on new results from a Phase III trial evaluating the first-in-class therapy as an add-on to existing treatments....
23:32 , Aug 7, 2019 |  BC Extra  |  Clinical News

Aug. 7 Clinical Quick Takes: Waylivra cuts triglycerides in Phase III; plus Lynparza, Moderna, Athenex and Opthea

Waylivra hits Phase II/III endpoint in FPL  Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said Waylivra volanesorsen cut serum triglyceride levels by 88% vs. 22% for placebo (p<0.001) in patients with familial partial...
01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
00:47 , Jun 29, 2019 |  BioCentury  |  Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
22:06 , May 7, 2019 |  BC Extra  |  Company News

May 7 Company Quick Takes: Akcea, Bicycle/DDF, Arbutus, Celgene/Sutro, MDGH, Pfizer, Sanofi/Regeneron

Akcea's Waylivra approved in EU  The European Commission granted conditional approval to Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) as an adjunct to diet in adult patients with familial chylomicronemia...
22:46 , May 6, 2019 |  BC Extra  |  Company News

Pfizer's small molecule tafamidis approved for TTR amyloid cardiomyopathy

FDA approved two forms of Pfizer's tafamidis Monday well ahead of their PDUFA dates, making the therapies the first small molecules approved for the cardiomyopathy dominant form of transthyretin (TTR) amyloidosis in the U.S. The...
18:21 , May 3, 2019 |  BC Week In Review  |  Company News

Express Scripts excludes rare disease drugs Onpattro, Ingrezza

Express Scripts excluded from its 2019 preferred formulary two rare disease therapy, Alnylam's amyloidosis drug Onpattro patisiran and Neurocrine's tardive dyskinesia drug Ingrezza valbenazine. Each are one of two approved drugs in their respective indications....
00:21 , May 3, 2019 |  BC Innovations  |  Product Development

With a deal and a debut, targeted oligo delivery gets a boost from ADCs

The marriage of antibody-drug conjugates and oligonucleotides won two votes of confidence last month with a deal between Lilly and Avidity, and the debut of Atlas-backed Dyne Therapeutics. The approach promises delivery of oligos to...
17:36 , Mar 8, 2019 |  BC Week In Review  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions on March 1, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first...
22:10 , Mar 1, 2019 |  BC Extra  |  Company News

CHMP recommendations include Ondexxya, Waylivra

EMA's CHMP recommended a basket of approvals and label extensions Friday, including Ondexxya andexanet alfa and Waylivra volanesorsen. The agency recommended conditional approval of Ondexxya from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) as the first approved antidote...