BioCentury | Dec 10, 2020
Deals

Late in a year of cancer deals, Gilead spends $1B+ to add an antiviral for HDV

...There are no FDA-approved drugs for HDV.Gilead markets Viread tenofovir disoproxil fumarate and Vemlidy tenofovir alafenamide fumarate...
BioCentury | Nov 5, 2020
Product Development

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

...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

...on Biogen’s top line was the shortfall in sales of multiple sclerosis drug Tecfidera dimethyl fumarate...
...Bonanos aducanumab (BIIB037) Spinraza (Brand), IONIS-SMNRx (Compound #), ISIS-SMNRx (Former compound #), nusinersen (Generic), Spinraza (Informal) Tecfidera, dimethyl fumarate...
BioCentury | Sep 18, 2020
Product Development

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

...District of Delaware concluded that another court’s prior ruling invalidating a patent for Tecfidera dimethyl fumarate...
...University and has raised $11 million in series A funding. TARGETSC5a – Complement 5a BC Staff Tecfidera, dimethyl fumarate...
BioCentury | Aug 19, 2020
Product Development

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

...biotech’s pipeline. On Wednesday, Mylan N.V. (NASDAQ:MYL) launched at risk 120 mg and 240 mg dimethyl fumarate...
...uphold the validity of U.S. Patent No. 8,399,514 would remove an overhang for Tecfidera dimethyl fumarate  (see...
...is appealing the decision. Tecfidera sales were $2.3 billion in 1H20.Late last year, Biogen launched Vumerity diroximel fumarate...
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

...While investors had hoped a February IP decision had removed an overhang for Tecfidera dimethyl fumarate...
...lack of written description, opening the door for Mylan N.V. (NASDAQ:MYL) to launch its dimethyl fumarate...
BioCentury | May 1, 2020
Regulation

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

...for asthma, while AstraZeneca plc (LSE:AZN; NYSE:AZN) has its own triple combination, Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate...
BioCentury | Apr 23, 2020
Finance

Market recalibrates Biogen’s valuation as aducanumab filing is delayed

...of $9.14 on revenues of $3.5 billion for the quarter. Multiple sclerosis drug Tecfidera dimethyl fumarate...
...Court of Appeals for the Federal Circuit upheld a district court’s ruling that Bafiertam monomethyl fumarate...
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

...with AstraZeneca plc (LSE:AZN; NYSE:AZN) for Tudorza Pressair aclidinium bromide and Duaklir Pressair aclidinium bromide/formoterol fumarate...
BioCentury | Mar 26, 2020
Regulation

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

...fingolimod from Novartis AG (NYSE:NVS; SIX:NOVN), Aubagio teriflunomide from Sanofi (Euronext:SAN; NASDAQ:SNY) and Tecfidera dimethyl fumarate...
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