BioCentury | Jun 19, 2020
Product Development

June 18 Quick Takes: Approvals for Ultragenyx, Epizyme, Merck; plus Tecfidera tussle, Tecentriq in TNBC, Sarepta-Selecta, and Gelesis goes to China

A first from Ultragenyx in a rare disease  FDA approved Crysvita burosumab-twza from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat tumor-induced osteomalacia in patients age two and older. The anti-FGF23 mAb is the first to be...
BioCentury | Apr 23, 2020
Finance

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

Biogen’s aducanumab roller-coaster ride continued Wednesday as investors reassessed the risk for the Alzheimer’s therapy following a roughly six-month delay for the company’s BLA submission. Biogen Inc. (NASDAQ:BIIB) disclosed Wednesday plans to push back an...
BioCentury | Mar 26, 2020
Regulation

FDA finally approves ozanimod for MS, satisfying first criterion for Bristol-Celgene CVR; launch delayed due to COVID-19

FDA’s approval of Celgene’s multiple sclerosis drug Zeposia ozanimod represents the first domino to fall among three that could lead to a big payout for Celgene’s former shareholders, who would be owed a contingent value...
BioCentury | Feb 5, 2020
Product Development

Biogen investors look ahead to Alzheimer’s after Tecfidera IP win

The U.S. Patent Trial and Appeal Board removed a major overhang for Biogen investors on Wednesday after ruling to uphold the validity of a patent covering blockbuster MS therapy Tecfidera dimethyl fumarate. The news sent...
BC Extra | Nov 14, 2019
Company News

MS Society calls out Biogen, Alkermes on Vumerity price

The National Multiple Sclerosis Society is once again standing up to companies for their pricing of new drugs. This time, the group has called out the price of Biogen and Alkermes’ newly launched Vumerity and...
BioCentury | Oct 25, 2019
Product Development

Deciding factors in the shifting MS treatment landscape

The efficacy and convenience advantages that established oral medicines as the go-to therapy in multiple sclerosis are the same factors now squeezing them out. Two years post-launch, the success of injectable Ocrevus ocrelizumab from Roche...
BC Extra | Oct 23, 2019
Company News

With MS approval looming, Alkermes restructures to seek sustainable profits

Alkermes expects cost savings from a newly announced restructuring, combined with payments due to the company upon the anticipated approval of a new MS therapy, will allow it to maintain profitability in the coming years....
BC Extra | Oct 23, 2019
Company News

Oct. 22 Company Quick Takes: Zealand acquires Encycle; plus Novartis, Vitalis, Roche-Spark

Zealand expands peptide platform with Encycle acquisition  Zealand Pharma A/S (CSE:ZEAL; NASDAQ:ZEAL) said it will expand its peptide therapeutics platform through the acquisition of Encycle Therapeutics Inc. In return for all its outstanding shares, access...
BC Extra | Oct 18, 2019
Company News

Pending patent expiration, Alkermes-Biogen MS therapy nears final FDA approval

Alkermes disclosed that FDA has granted tentative approval of Vumerity diroximel fumarate (BIIB098) to treat multiple sclerosis, signaling that full approval could come following the expiration of a patent on Oct. 20. The company’s partner...
BioCentury | Oct 9, 2019
Politics, Policy & Law

Long-term data help two drugs sway ICER in drug price report

An analysis by the Institute for Clinical and Economic Review of price increases for some of the costliest drugs in the U.S. has found that seven of nine were not supported by new clinical evidence,...
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