01:02 , Aug 8, 2019 |  BC Extra  |  Company News

Aug. 7 Company Quick Takes: Panel backs narrower PrEP label for Descovy; plus Teva, Blueprint, DBV and more

FDA panel backs narrower PrEP label for Descovy FDA’s Antimicrobial Drugs Advisory Committee voted 16 to 2 that Gilead Sciences Inc. (NASDAQ:GILD) has provided sufficient evidence that Descovy emtricitabine/tenofovir alafenamide is safe and effective for...
22:47 , Aug 5, 2019 |  BC Extra  |  Clinical News

Aug. 5 Clinical Quick Takes: Emgality meets for migraine with treatment failures; plus Verona, Alkahest-Grifols, Squarex and Denali-Sanofi

Emgality meets in Phase III in pretreated migraine patients  Eli Lilly and Co. (NYSE:LLY) reported that anti-CGRP mAb Emgality galcanezumab-gnlm met the primary endpoint in the Phase III CONQUER trial, reducing migraine headache days by...
00:44 , Jul 31, 2019 |  BC Extra  |  Company News

Amgen still head of class in CGRP-migraine

As Amgen and Lilly continue to expand their presence in the migraine prevention market, the former's first-in-class CGRP inhibitor is maintaining its lead in the space. Amgen Inc. (NASDAQ:AMGN) and Eli Lilly and Co. (NYSE:LLY)...
00:19 , Jul 31, 2019 |  BC Extra  |  Clinical News

July 30 Clinical Quick Takes: Biogen, Alkermes MS candidate superior to Tecfidera; plus Amgen, Lilly and more

Biogen, Alkermes Phase III MS candidate beats Tecfidera  Biogen Inc. (NASDAQ:BIIB) and Alkermes plc (NASDAQ:ALKS) said diroximel fumarate (BIIB098) met the primary endpoint in the Phase III EVOLVE-MS-2 trial: superiority to Biogen’s Tecfidera dimethyl fumarate...
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...
20:37 , Jun 7, 2019 |  BC Extra  |  Company News

June 7 Company Quick Takes: Expanded label for PTC’s DMD drug; plus Achaogen, ICER on migraine and Nucala

PTC’s DMD drug approved in patients ages 2-5  FDA approved an sNDA for Emflaza deflazacort from PTC Therapeutics Inc. (NASDAQ:PTCT) to treat Duchenne muscular dystrophy in patients ages 2-5. The drug was first approved in...
23:46 , Jun 4, 2019 |  BC Extra  |  Company News

June 4 Company Quick Takes: Lilly's Emgality gets expanded indication; plus Vimizim, Zerbaxa and more

Emgality gets U.S. approval for episodic cluster headaches  FDA approved Emgality galcanezumab-gnlm from Eli Lilly and Co. (NYSE:LLY) to treat episodic cluster headache in adults. The anti-CGRP mAb is already approved as a prophylaxis for...
21:31 , May 28, 2019 |  BC Extra  |  Company News

Months after scuttling IPO bid, Centrexion adds to balance sheet with Lilly deal for pain therapy

A licensing deal with Lilly for an analgesic will bolster Centrexion's balance sheet six months after it canceled plans for an IPO. Centrexion will receive $47.5 million up front and is eligible for $950 million...
20:06 , Apr 24, 2019 |  BC Extra  |  Financial News

Why Satsuma investors see room for another migraine therapy

While a new class of drugs has captured most of the attention around migraine treatments, Satsuma's investors believe there's room in the marketplace for a new formulation of an old drug. Satsuma Pharmaceuticals Inc. (South...
21:59 , Apr 22, 2019 |  BC Extra  |  Company News

FDA accepts BLA for Alder's migraine therapy for infusion

Alder said FDA accepted a BLA for eptinezumab to prevent migraine. The company, which submitted the BLA on Feb. 21, said it expects to receive a PDUFA date within 74 days following the submission. If...