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BioWorld, Regulatory
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Multiple sclerosis-damaged myelin

Biogen, Alkermes win FDA approval for oral multiple sclerosis drug Vumerity

Oct. 31, 2019
By Michael Fitzhugh
FDA approval of Vumerity (diroximel fumarate), a new therapy for people with multiple sclerosis (MS) offering improved gastrointestinal tolerability over Tecfidera (dimethyl fumarate), marks a win for its co-developers, Biogen Inc. and Alkermes plc, while triggering a $150 million payment from Biogen to its partner to mark the milestone. Biogen will also pay Alkermes a royalty on worldwide sales of the product.
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Regulatory front for Oct. 30, 2019

Oct. 30, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Australia's Senate passes new IP bill, introduces more uncertainty into Patents Act

Oct. 28, 2019
By Tamra Sami
PERTH, Australia – Australia's Senate has passed new intellectual property laws that substantially weaken IP in Australia.
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Regulatory front Oct. 25, 2019

Oct. 25, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front Oct. 24, 2019

Oct. 24, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front Oct. 23, 2019

Oct. 23, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front Oct. 22, 2019

Oct. 22, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Assertio stock continues downward slide after CRL

Oct. 22, 2019
By Lee Landenberger
The complete response letter (CRL) received by Assertio Therapeutics Inc.'s development partner, West Therapeutic Development LLC, regarding its NDA for cosyntropin (synthetic adrenocorticotropic hormone, ACTH) knocked Assertio's stock back 28% on Monday.
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Ebola vaccination in Democratic Republic of Congo

CHMP backs EU approval for Merck's Ebola vaccine at October meeting

Oct. 21, 2019
By Cormac Sheridan
DUBLIN – Merck & Co. Inc. is in line to obtain conditional marketing authorization from the European Union for its live attenuated vaccine for preventing Ebola virus infection, V920 Ebola Zaire vaccine (rVSVDG-ZEBOV-GP live), following a positive recommendation for approval from the EMA's Committee for Human Medicinal Products (CHMP) at its October meeting last week. Formal approval should follow within 67 days, after which the Kenilworth, N.J.-based pharma would market the vaccine as Ervebo.
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Regulatory submissions, approvals and other actions: September 2019

Oct. 21, 2019
Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways, in September 2019.
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