BioCentury | May 1, 2020
Regulation

CHMP backs new therapy for 1L AML, triple combos for asthma

EMA’s CHMP this month recommended four new medicines for approval, including a new front-line therapy for AML and triple combination therapies for asthma. The agency recommended approval for Daurismo glasdegib from Pfizer Inc. (NYSE:PFE) to...
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 | Apr 10, 2020
Product Development

April 9 Quick Takes: BMS tops off CAR T patent win; plus approval for Braftovi plus Erbitux, Merck, BMS, Liquidia, Circassia-AZ, Bridge

Award swells to $1.2B, plus royalties, in Kite CAR T suit  Bristol Myers Squibb Co. (NYSE:BMY) and Memorial Sloan Kettering Cancer Center will receive at least $1.2 billion from Gilead Sciences Inc. (NASDAQ:GILD) after a...
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 | Mar 19, 2020
Product Development

Trials, in-hospital treatments and guidances hit snags in the wake of COVID-19

As vaccine and therapeutic companies ramp up clinical trials for COVID-19, other biotechs are halting trials to protect patients and to preserve hospital resources. The ripple effects of the pandemic are also beginning to play...
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 19, 2019
Company News

Alkermes expands CNS pipeline with Rodin acquisition

A mix of preclinical and clinical data spurred Alkermes' takeout of Rodin, which adds HDAC-targeting programs to the biotech's CNS arsenal. The deal comes less than a month after Alkermes plc (NASDAQ:ALKS) restructured to maintain...
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 | Nov 1, 2019
Product Development

Novartis, Merck KGaA see opportunity in select pockets of MS patients

As companies continue to pile into the multiple sclerosis market with new therapies, Novartis and Merck KGaA are dissecting the landscape to define populations for their newly launched drugs. While the former is staking out...
BC Extra | Oct 30, 2019
Company News

Oct. 30 Company Quick Takes: Clinical hold for Zolgensma; plus Biogen-Alkermes, Roche’s satralizumab, Pear-Ironwood

Partial hold for Novartis’ SMA gene therapy  FDA placed a partial clinical hold on studies of intrathecally delivered Zolgensma onasemnogene abeparvovec-xioi from Novartis AG (NYSE:NVS; SIX:NOVN) to treat spinal muscular atrophy after observing dorsal root...
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