BioCentury | Nov 5, 2020
Product Development

FDA signals relatively clear path ahead for Alzheimer’s therapy aducanumab

...atrophy (SMA) therapy Spinraza nusinersen and multiple sclerosis drug Tecfidera dimethyl fumarate...
BioCentury | Oct 21, 2020
Product Development

Aducanumab looms larger after Biogen cuts guidance, shelves programs in MS and SMA

...weighing on Biogen’s top line was the shortfall in sales of multiple sclerosis drug Tecfidera dimethyl fumarate...
...district court’s decision invalidating one of its key patents.With its assumption that further erosion of Tecfidera’s...
...BIIB037) Spinraza (Brand), IONIS-SMNRx (Compound #), ISIS-SMNRx (Former compound #), nusinersen (Generic), Spinraza (Informal) Tecfidera, dimethyl fumarate (bg-12, BG00012) Anti-LINGO1...
BioCentury | Sep 18, 2020
Product Development

Sept. 17 Quick Takes: Another Tecfidera setback for Biogen; plus ChemoCentryx PDUFA date and Amytrx’s debut

...By BC Staff Tecfidera patent ruling another setback for BiogenThe U.S. District Court for the District...
...the District of Delaware concluded that another court’s prior ruling invalidating a patent for Tecfidera dimethyl fumarate...
...and has raised $11 million in series A funding. TARGETSC5a – Complement 5a BC Staff Tecfidera, dimethyl fumarate (bg-12, BG00012) Avacopan...
BioCentury | Aug 19, 2020
Product Development

Launch of generic Tecfidera puts more pressure on Biogen’s pipeline

...Virginia Li, Associate Editor The introduction of generic competition in the U.S. for MS blockbuster Tecfidera...
...8,399,514 would remove an overhang for Tecfidera dimethyl fumarate  (see “Biogen Investors Look Ahead to Alzheimer’s After Tecfidera...
...slipped $8.90 to $279.98 on Wednesday, while Mylan gained $0.32 to $16.51. Virginia Li Biogen Inc. Mylan N.V. Tecfidera dimethyl fumarate MS...
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

...rare disease. It is also approved to treat X-linked hypophosphatemia. Court win for Mylan in Tecfidera...
...case While investors had hoped a February IP decision had removed an overhang for Tecfidera dimethyl fumarate...
...the U.S. District Court for the Northern District of West Virginia invalidated a patent for Tecfidera...
BioCentury | Apr 23, 2020
Finance

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

...got hurt a lot, and suddenly a 50/50 chance makes the stock look undervalued.” Earnings, Tecfidera...
...EPS of $9.14 on revenues of $3.5 billion for the quarter. Multiple sclerosis drug Tecfidera dimethyl fumarate...
...$1.1 billion. While the U.S. Patent Trial and Appeal Board had in February upheld a Tecfidera...
BioCentury | Mar 26, 2020
Regulation

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

...Gilenya fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN), Aubagio teriflunomide from Sanofi (Euronext:SAN; NASDAQ:SNY) and Tecfidera dimethyl fumarate...
BioCentury | Feb 5, 2020
Product Development

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

...Wednesday after ruling to uphold the validity of a patent covering blockbuster MS therapy Tecfidera dimethyl fumarate...
...U.S. Patent No. 8,399,514 covers the method of use of a 480 mg dose of dimethyl fumarate...
...the ANDA cases, which also focus on the ‘514 patent. Stephen Hansen, Associate Editor Tecfidera, dimethyl fumarate (bg-12, BG00012) Biogen...
BioCentury | Nov 14, 2019
Company News

MS Society calls out Biogen, Alkermes on Vumerity price

...on real-world patient outcomes.” The patient group also called out Biogen’s price increases for Tecfidera dimethyl fumarate...
...to treat RRMS at an annual WAC of $54,750. The annual WAC is now $94,991. “Tecfidera...
...Talente said at the time. Erin McCallister, Senior Editor Vumerity, diroximel fumarate (ALKS 8700, BIIB098) Tecfidera, dimethyl fumarate (bg-12, BG00012) Biogen Alkermes...
BioCentury | Oct 25, 2019
Product Development

Deciding factors in the shifting MS treatment landscape

...has established itself as a competitor to front-runner small molecules: Gilenya fingolimod from Novartis, Tecfidera dimethyl fumarate...
...1H19 sales of $1.6 billion, and just below Biogen’s $2.1 billion in 1H19 sales for Tecfidera...
...NASDAQ:ALKS) are planning to launch Vumerity diroximel fumarate this year, a more tolerable version of Tecfidera...
Items per page:
1 - 10 of 340