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.
Tuesday, December 08, 2020
Piramal Pharma Limited has announced plans to expand its facility in Michigan with additional capacity and new capabilities for the development and manufacturing of APIs.
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Monday, December 07, 2020
Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial.
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Thursday, December 03, 2020
Samsung Bioepis and Biogen announced the FDA has accepted for review the BLA for SB11, a proposed biosimilar referencing Lucentis.
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Wednesday, December 02, 2020
Pfizer and BioNTech announced the MHRA in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine against COVID-19.
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Wednesday, December 02, 2020
Lonza has announced additional investments in its oral drug product development and manufacturing capabilities at its Tampa, Florida site.
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Tuesday, December 01, 2020
Mustang Bio and Minaris have signed an agreement to enable technology transfer and GMP clinical manufacturing of Mustang’s MB-107 lentiviral gene therapy program for the treatment of XSCID in Europe.
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Monday, November 30, 2020
Allos Pharma has announced the exclusive license rights on arbaclofen in Fragile X Syndrome.
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Wednesday, November 25, 2020
Aeterna Zentaris has entered into an amendment of its existing License Agreement with NNBL related to the development and commercialization of macimorelin.
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Monday, November 23, 2020
Onyx Scientific announced it is investing in a new facility at its UK site in order to prepare for the approval of a commercial API license.
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Monday, November 23, 2020
Humanigen announced the company and the DoD have entered into a CRADA in collaboration with the BARDA in support of Operation Warp Speed to assist in the development of lenzilumab as a potential COVID-19 treatment.
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Wednesday, November 18, 2020
Pfizer and BioNTech have announced their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints.
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Tuesday, November 10, 2020
Novasep is investing €6.5 million to expand capacity & increase flexibility in an API manufacturing workshop at its Chasse-sur-Rhône site.
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Friday, November 06, 2020
Flamma has entered into an agreement with Gilead earlier this year to be part of the network of manufacturers contributing to the Veklury (remdesivir) supply chain.
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Tuesday, November 03, 2020
Protagonist Therapeutics announced two additional oral peptide IL-23 receptor antagonist candidates from its collaboration agreement with Janssen Biotech have been selected for advancement into clinical development.
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Monday, November 02, 2020
Quantum Genomics has entered into an exclusive licensing and collaboration agreement with Xediton to develop and commercialize firibastat in Canada.
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