Biopharmaceutical Manufacturing, Upstream, Downstream …
WEBThe San Diego-based biotech company Candid Therapeutics has launched with a huge $370 million with the aim to develop T-cell engager therapies for autoimmune diseases. Adaptin Bio has announced that the FDA has given the green light to start phase 1 clinical trials for its program APTN-101 targeting glioblastoma, the most common and aggressive ...
All news - biopharma-reporter.com
WEBAll news. News and analysis on the clinical development and manufacture of large molecule drugs. Women in Science - Emmanuelle Cameau on growing stronger from challenges. Emmanuelle Cameau is strategic technology partnership leader at Cytiva. Neuromuscular diseases in crosshairs in Forge Biologics gene therapy collaboration.
China approves Bio-Thera Solutions' biosimilar to Actemra
WEBJan 17, 2023 · The China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. BioThera claims a world first with BAT1806, saying it is the first tocilizumab biosimilar approved by the NMPA or any other regulatory agency around the world. BAT1806 has …
Biosimilar producer looking to get first to market advantage in …
WEBJun 23, 2021 · Bio-Thera is expected to file for regulatory approvals in China and the EU by Q1 2024, says the data provider. The Chinese company has not yet disclosed any plans related to the US trials. However, the company intends to file for regulatory approval with the US FDA, according to GlobalData’s report. Although Bio-Thera can attain first to ...
Speed, flexibility and innovation: Rethinking the way the …
WEBNov 29, 2021 · News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs. A new report reveals that “speed-to-market” has jumped up from a lower-ranking business driver before the pandemic to the top priority today for biopharma companies, overtaking cost-based considerations by a …
Process intensification in biopharma manufacturing can boost …
WEBAug 31, 2022 · Higher yielding processes, faster manufacturing and fewer consumables can all help drive significant reductions in environmental impact, highlight a group of authors including scientists from Genentech, GlaxoSmithKline and Merck & Co in a paper published in New Biotechnology. “The process intensification approach aligns perfectly with the direction of the biopharmaceutical industry striving ...
Pharma and biopharma outsourcing strategies need to use an …
WEBOct 26, 2022 · But a new CPhI report on 'The Future of Outsourcing' advises against this approach. “Traditionally, outsourcing strategies were designed to help secure next stage funding, but many biotechs and small pharma companies are now entering development with more robust cash flows and the ability to plan further downstream," "This opens the …
Novo Nordisk advancing hemophilia drug along regulatory pathway
WEBJul 12, 2022 · News and analysis on the clinical development and manufacture of large molecule drugs. Novo Nordisk has announced positive results from a Phase 3 study assessing the efficacy and safety of concizumab, its prophylactic treatment of hemophilia A or B with inhibitors. The pharma giant said it intends …
AstraZeneca starts new chapter as Alexion acquisition closes
WEBJul 21, 2021 · AstraZeneca heralds new chapter as Alexion acquisition completed. AstraZeneca has completed the acquisition of Alexion Pharmaceuticals, Inc., marking its entry into medicines for rare diseases. The $39bn deal, announced in December 2020, is AstraZeneca’s largest ever acquisition: allowing it to move further into immunology with an …
GlobalData identifies Top 20 global biopharmaceutical companies
WEBDec 22, 2022 · Expanding generic drug competition and a decline in the demand for COVID-19 vaccines and therapies have brought down the aggregate market capitalization of the global top 20 biopharmaceutical companies by 9.1%. The total value wsa $3.45 trillion in Q2 2022, with that dropping to $3.14 trillion in …
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