Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
The FDA finalized guidance for industry, “Competitive Generic Therapies,” which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.
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Emergent BioSolutions will collaborate with Novavax to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against coronavirus disease (COVID-19).
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Dr. Reddy’s announced the launch of Ziprasidone Mesylate for Injection, 20 mg (base)/mL Single-dose Vials, the generic equivalent of Geodon.
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Pfizer and BioNTech announced the companies have agreed to a letter of intent regarding the co-development and distribution of a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection.
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Catalent welcomed the announcement by Biohaven the FDA has approved its NURTEC™ ODT for acute migraine in adults.
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The Medical CBRN Defense Consortium has released a RFI seeking solutions to combat the novel Coronavirus pandemic.
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Novartis announced its commitment to donate up to 130 million doses of generic hydroxychloroquine to support the global COVID-19 pandemic response.
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Akers Biosciences has acquired a licensing agreement with Premas Biotech, under which Akers will in-license a novel coronavirus vaccine candidate under development by Premas.
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Mylan has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility.
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Wednesday, March 25, 2020
Hoth has reached an agreement with Voltron to form a joint venture entity to commence preclinical studies for the development of vaccine prospects to prevent, intercept or treat the COVID-19.
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Codexis has announced the signing of a collaboration and license agreement with Takeda for the research and development of novel gene therapies for certain disease indications.
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Wednesday, April 01, 2020
I-Mab announced a strategic partnership with Kalbe Genexine Biologics.
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Wednesday, April 01, 2020
Horizon Discovery and Pharmahungary Group announced positive early-stage results for a novel micro-RNA therapeutic for ischemic heart diseases.
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Hydroxychloroquine sulphate (Plaquenil) an analog of chloroquine has an established track record for treating malaria and has demonstrated in vitro activity against the SARS-CoV and therefore being considered as possible treatment for COVID-19.
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Zymewire announced the launch of CovidCollaborators.org, an online directory of expert, pro-bono, and discounted clinical development services being offered in the fight against COVID-19.
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