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.
Wednesday, March 11, 2020
Burke Therapeutics has signed an exclusive marketing and supply agreement with Coeptis for the U.S. market.
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Aldevron has hired Vijay Surapaneni as its Vice President of Biomanufacturing Operations. This is a new position and is a part of the senior management team.
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BioStem Life Sciences announced the buildout of a brand new R&D lab.
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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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WuXi AppTec announced the company's Wuhan site has resumed operations, in compliance with local regulations and global COVID-19 health and safety guidelines.
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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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Wednesday, March 18, 2020
The FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus tests developed by laboratories and commercial manufacturers during the public health emergency.
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Univercells has launched a contract development and manufacturing organization (CDMO), Exothera.
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The PBOA reports its member companies remain committed to serving patients by manufacturing effective, quality products for their customers, during this global health crisis, and report no material disruptions to their operations.
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FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19...
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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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CEL-SCI has signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop LEAPS COVID-19 immunotherapy.
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