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The FDA has released draft guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing draft labeling for ...
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SGS, a bio/pharmaceutical analytical and bioanalytical contract solutions provider, has entered into a collaboration with DiscoverX, a life science company that supplies cell-based assays and services for drug discovery and development.
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Brammer Biopharmaceuticals has announced its merger with Florida Biologix to create a cell and gene therapy biologics contract development and manufacturing organization (CDMO). The merged company, Brammer Bio, will combine deep technical expertise ...
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Eurofins Scientific, a biopharmaceutical products testing company, has signed an agreement to acquire Advantar Laboratories Inc., located in San Diego, California.
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Rich Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing innovative therapies in oncology, has extended its agreement with Theradex Systems, Inc., a global Contract Research Organization ("CRO"), to manage the ...
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Wednesday, March 30, 2016
Greater acceptance of biosimilar medicines in a growing number of therapy areas and an active pipeline of 56 new products in clinical development are expected to deliver total savings of as much as $110 billion to health systems across Europe and the...
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Wednesday, March 30, 2016
Ora, Inc. has announced the addition of Simon Chandler, PhD as Senior Director to lead regulatory and clinical operations for Europe. Simon will be based in the UK.
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Wednesday, March 30, 2016
X-Chem, a privately held biotechnology company applying its DNA-Encoded X-Chem (DEX™) drug discovery platform to generate novel therapeutics, has announced that a licensing option with Janssen Biotech, Inc., one of the Janssen Pharmaceutical ...
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Wednesday, March 30, 2016
Crown Bioscience Inc., a wholly owned subsidiary of Crown Bioscience International, a global drug discovery and development solutions company providing translational platforms to advance oncology and metabolic disease research, has announced the ...
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Wednesday, March 30, 2016
Envigo has been granted full accreditation for its Horst, Netherlands site from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International Council. AAALAC informed Envigo that that the criteria for achieving ...
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Wednesday, March 30, 2016
Biodextris Inc. has announced its suite of services and commitment to building a full service contract organization. The new contract research organization (CRO) provides analytical and process development services for vaccines and biologics ...
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Greenphire, a provider of global clinical payment solutions, has appointed Wayne Baker as Chief Commercial Officer to lead the commercial strategy of the rapidly growing organization worldwide.
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Aralez Pharmaceuticals has announced that the U.S. Food and Drug Administration ("FDA") has acknowledged acceptance of the New Drug Application ("NDA") for its investigational candidate, YOSPRALA™(PA32540/PA8140) for the secondary prevention of ...
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Eagle Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has denied Eagle’s request for seven years of orphan drug exclusivity in the U.S., for BENDEKA™ (bendamustine hydrochloride injection, or bendamustine HCI), a liquid...
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The Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet label was recently updated to expand the indication to include pediatric patients weighing at least 12 kilograms and the addition of the following strength tablets (100/150 mg, 133/200 ...
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