Cancer Genetics’ acquisition of vivoPharm expands its geographical footprint, customer base, and diversifies its business model beyond fee for service, says CEO.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Charles River Laboratories has acquired Brains On-Line in an ongoing effort to deepen its drug discovery capabilities and build out its portfolio through strategic acquisitions.
Corning has penned separate collaboration agreements with Italy-based Stevanato Group and Germany-headquartered Gerresheimer to supply glass packaging for injectable drugs.
Human tissue-focused products and services firm Reprocell Europe has opened headquarters in Glasgow, Scotland, which it says will boost business and create jobs.
Certara has added externalization technology to its D360 scientific informatics platform to expedite collaboration between sponsors and their research partners.
PRA Health Sciences has signed a definitive agreement to acquire Symphony Health Solutions Corporation for $530m as the industry increasingly looks to garner insight from real world data.
BioreclamationIVT has acquired the biospecimen and research services provider, Asterand Bioscience, following the purchase of TransCell Science earlier this year.
The US FDA has warned doctors not to use any liquid drugs made by PharmaTech LLC over renewed concerns they may be contaminated with the bacteria Burkholderia cepacia.
The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for a product this year.
The US FDA has issued a complaint against an outsourcing facility that purportedly manufactured and distributed sterile drug products in violation of the DQSA.
More drugs were recalled in the US in the three months to the end of June than in any period since Q4 2014 according to analysis by Stericycle ExpertSolutions.
Medpace stresses a continued investment in human resources as it anticipates growth and further opportunities from the small- and mid-sized biopharma market.
Evotec and Fraunhofer IME-SP have signed a strategic collaboration to advance Evotec’s patient-derived iPSC platform and subsequent drug discovery projects.
The US FDA has rejected Valeant Pharmaceuticals International’s eye drop candidate following a site inspection at its subsidiary’s facility in Tampa, Florida, US.
The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.
Cambrex Corporation says higher demand for APIs for controlled substances and branded drugs drove Q2 growth and confirms it is on the lookout for acquisitions.
Teva Pharmaceutical Industries Ltd has confirmed its API plant in Netanya, Israel will close as part of the cost reduction programme announced last week.
San Diego-based contract development and manufacturing organization (CDMO) has signed a drug product development, manufacture, and stability studies contract.
WIRB-Copernicus Group (WCG) has acquired eConsent technology to help clinical trial volunteers – and their families – make more informed decisions, says CEO.
The laboratories will participate in oncology-focused clinical trials as the program’s preferred partners and will be among the first to access Thermo Fisher’s pipeline of novel platforms and assays.
Başkent University’s hospital cluster has joined Clinerion’s Patient Recruitment System (PRS) Platform, expanding sponsor access to potential clinical trial participants.
BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.
Melinta Therapeutics has hired ScinoPharm to make the active pharmaceutical ingredient (API) for Baxdela, an antibiotic for skin infections that was recently approved by the US FDA.
CMC Biologics and Trellis Bioscience have entered into a manufacturing agreement for the process development and production of two of Trellis’ monoclonal antibodies (mAbs).
Dr Reddy's says efforts to fix plant problems flagged by US FDA impacted its active pharmaceutical ingredient (API) business in the first quarter of fiscal 2018.
