As WuXi STA expands its facility footprint in China, a VP of the company explains how global regulatory approvals fit with strategic plans for services to be concentrated geographically.
Novartis initiates a recall of Promacta after its contract manufacturer introduced peanut flour into the same facility as the treatment, potentially causing cross-contamination.
eClinical technology company, Axiom Real-Time Metrics, will be recapitalized by Great Point Partners to provide eClinical solutions to increase service offerings for Phase I-III clinical trials.
As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.
Immunologix bolsters its scientific expertise with two new hires to build on its bioanalytical biomarker programs created from the launch of its Translational Sciences division.
Mispro is expanding its vivarium service network with the opening of its fifth facility, an 18,000 square foot facility in Broad Hollow Bioscience Park, NY.
Recipharm is launching inhalation product solutions following its acquisition of Sanofi’s inhalation manufacturing business and increased use of inhaled drug products.
Par Pharmaceutical initiates a recall of mycophenolate mofetil injection, after a vial containing a glass fragment was discovered during reconstitution.
Biopharmaceutical manufacturers in 2017 invested approximately $15.2bn at clinical trial sites around the country – resulting in a total economic impact of more than $42bn, says PhRMA director of public affairs.
Lonza will provide manufacturing for Alector’s Phase I drug candidates for neurodegenerative diseases from its Switzerland site, which is expected to be operational by mid-2020.
Samsung Biologics is providing contract development services for GI Innovation’s pipeline, with the first among five molecules to initiate development immediately, says company representative.
LabCorp participated in a $3m Series B2 financing round for Kiyatec, which is developing ex vivo 3D cell culture technology to help model and predict cancer patients’ response to drug therapies.
Elligo Health Research raises $20m in Series C funding to expand into more states, as part of the company’s goal to connect more physicians and their patients to clinical trials.
Increasingly concerned with the potential for cyber attacks at third-party vendors, pharma looks to gain visibility into supplier performance, says industry expert after the recent breach at Charles River.
The industrialized process the industry has developed over the years is not ready for the non-blockbuster environment its entering but AI can help, says Numerate executive.
Bioanalytical Systems acquires Smithers Avanza Toxicology Services business unit in response to a strong demand for its toxicology and drug disposition services.
Lundbeck announces the acquisition of Abide, which provides the former with access to an R&D platform, a Phase II drug candidate, and drug discovery site in California.
The Indian company announced that the US FDA issued observations for both its Indrad and Dahej facilities, as well as being required to expand its losartan recall.
Synteract adds to its therapeutic centers of development, Sterling Pharma continues growth in the US, and WCG’s site division sees the addition of several executives, among other people on the move this month.
Debbie Profit, vice president of applied innovation and process improvement at Otsuka Pharmaceuticals addressed ACRP in April and discussed the various technologies that could ‘transform’ the pharmaceutical industry.
Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...
The USTR stated that 20% of medicines on the Indian market were counterfeit, a claim that the country’s health secretary labelled as an ‘opposition to low-cost generics.’
The US FDA has issued draft guidance on the process of voluntary recalls, after a series of recalls involving sartan contamination with carcinogenic impurities.
Clinical trials are less safe today as researchers are inundated with increasing amounts of data and new processes developed in part by CROs, which have created “tier upon tier of bureaucracy,” argues industry expert, who warns that things are getting...
