BioCentury | Feb 22, 2020
Product Development

FDA approves Lundbeck's Vyepti, the first CGRP inhibitor for migraine delivered IV

FDA's approval of Vyepti eptinezumab-jjmr from Lundbeck is the first for an IV-delivered CGRP inhibitor for migraine prevention, but the therapy will face competition from established subcutaneous drugs in its class. Already on the market...
BC Extra | Dec 24, 2019
Company News

Regulatory roundup: BioMarin poised to have first U.S., EU hemophilia gene therapy; plus Allergan, Eisai, FibroGen, ViiV and Vero

Monday's basket of regulatory news includes two landmark regulatory applications for BioMarin's hemophilia gene therapy in the U.S. and EU, and FDA approval of Allergan's migraine drug. BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) submitted a BLA to...
BC Extra | Oct 30, 2019
Company News

Amgen narrows neuro focus to inflammation

Despite early success for Amgen’s first marketed neurology product, the company will exit research and early development for neuroscience, narrowing its focus to neuroinflammation. “To compete effectively, we need to make investments in the areas...
BC Extra | Sep 24, 2019
Company News

Lundbeck, Alder negotiated ex-U.S. deal before opting for takeout

After soliciting offers from multiple parties to obtain ex-U.S. rights to its migraine treatment, Alder continued to negotiate such a deal with Lundbeck -- while also working out an outright acquisition offer the biotech would...
BC Extra | Sep 16, 2019
Company News

Lundbeck enters migraine race with $2B takeout of Alder

Lundbeck will add a CGRP inhibitor to its neurology pipeline by buying Alder for just shy of $2 billion, but the Scandinavian pharma will be playing catch-up as eptinezumab will likely be fourth among drugs...
BC Extra | Jul 31, 2019
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)...
BioCentury | Jun 29, 2019
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...
BC Extra | May 1, 2019
Company News

April 30 Company Quick Takes: Merck, G1, Pfizer, Amgen and more

Merck sales rise in China Merck & Co. Inc. (NYSE:MRK) said product sales in China were $725 million for 1Q19, up 67% on an ex-exchange basis from 1Q18 and driven by products in its vaccines...
BC Extra | Apr 24, 2019
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...
BC Extra | Apr 22, 2019
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...
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