Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2506, a Proposed Biosimilar to Simponi®, in the European Union
Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...
GlobalData on MSN1d
EMA establish advisory portal for high-risk medical devices
The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.
Fact Check: Moderna began clinical trials of COVID vaccine in 2020, not 2017
Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...
JD Supra1d
Regulatory and Commercial Updates on Bio-Thera’s BAT2506 (golimumab)
Bio-Thera had entered into an exclusive licensing agreement with STADA Arzneimittel AG to commercialize BAT2506 in the European Union (UK), the United Kingdom (UK), Switzerland, and selected other ...
RTÉ Ireland1d
USAID cut 'an absolute catastrophe', Dublin protest hears
Dozens of people have protested outside the US Embassy in Dublin against cuts to USAID which they say will cost thousands of ...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issuesFDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, ...
Regeneron Pharmaceuticals, Inc.: Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc.
Merck director Douglas Baker acquires $1.33 million in stock
Co., Inc. (NYSE:MRK), recently acquired 15,000 shares of the company's common stock. The transaction, which took place on ...
Center for Biosimilars6d
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...
The Manila Times1d
BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM
1 Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA ...
HIV activists urge Irish government to take action against Trump's foreign aid cuts
HIV and healthcare equity activists have called on the Irish government to take action against Donald Trump’s freeze on ...
Former U.K. Prime Minister Boris Johnson praises U.S entrepreneurial spirit
The tech billionaires who attended the inauguration of President Donald J. Trump are not the oligarchs seen in Russia or ...