As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).
Contract manufacturer Emergent BioSolutions and biosimilar developer Pfenex have both announced in recent days that they’ve won contract manufacturing and development grants with the US government.
The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) is offering a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help in the assessment of whether a new treatment is effective.
The huge former Ben Venue injectables manufacturing plant in Ohio that became the center of controversy over drug shortages a few years ago remains off line, and the company that now owns the site reiterated this week that it has no plans to resume making...
CRO (contract research organization) Accelovance has accepted a grant from the government of Wales and will open a new site in Swansea with 70 new employees.
The completion of the Phase II study of Isis Pharmaceuticals’ novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia included a collaborative effort between Isis and CTMG, which claims to be the world’s first Site...
After months of speculation, Charles River Laboratories has decided to move forward with the re-opening of its early-stage research site in Shrewsbury, Massachusetts sometime in the first quarter of 2016.
Taiwan’s pharmaceutical market is expected to grow to over $8bn by 2020, driven by chronic and non-infectious therapies, but uncertain relations with China, TPP entry, and price cuts will also influence the region.
Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.
With a flurry of recent deals tied to Sanofi and a string of other collaborations, Germany’s Evotec is seeing a steep rise in revenues from its contract research division and it expects that growth to continue.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on a pilot project investigating the feasibility of inspecting pharmacovigilance contract service providers as it’s becoming increasingly common for a MAH (marketing authorisation...
The Bill & Melinda Gates Foundation’s PATH Malaria Vaccine Initiative (MVI) has selected CMC Biologics for process development and manufacture of specific monoclonal antibodies (mAbs) to test for their capacity to protect humans from malaria infection.
Contract manufacturing will rise over the next five years as drugmakers feel the pressure to reduce supply chain time, and choose to focus on in-house R&D rather than conduct their own manufacturing.
Scientists in Japan have developed a technique for making crystal forms of active pharmaceutical ingredients (APIs) that until now have been hard to synthesise.
GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.
BioClinica is looking to target its new offering to the CROs and sponsors who have yet to adopt a cloud-based solution for the management and delivery of clinical trials.
The annual announcement of FDA user fees has brought scrutiny on the price tag for generic drug applications, as the approval backlog is almost a year longer than in 2012.
Indian contract testing company Sipra Labs has received a warning letter from the US FDA over issues with the company's validation of test methods and failure to investigate out of specification test results.
Service provider and contract manufacturer WuXi PharmaTech is vouching for TruTag Technologies’ edible microtags following a pilot project adding to evidence that they can help root out counterfeits.
CRO Medpace has tripled the size of its Stirling, Scotland office with a new office, also in Stirling, that will allow for growth in data management, biostatistics, quality assurance, regulatory affairs, clinical operations and safety services.
US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
A host of recent small deals, expansions, office openings and other news from CDMOs (contract development and manufacturing organizations) and CROs (contract research organizations) around the world.
Hamburg, Germany-based Evotec and Sanofi are launching a strategic collaboration in diabetes drug development that could be worth as much as $330m (€303m) for the German company, including €3m upfront.
The US House Energy and Commerce Committee is taking issue once again with the way the FDA manages its IT systems, according to a report released late last week.
Cardiac safety assessment service provider iCardiac Technologies has added respiratory and ePRO services to its offerings through the acquisition of the clinical trials division of nSpire Health.
Mid-size CROs (contract research organizations) are banding together once again, this time with Chiltern on Thursday signing a purchase agreement to acquire Theorem Clinical Research.
CRO Parexel’s staffing numbers took center stage during its earnings call Thursday as the company re-iterated plans to lay off as many as 850 employees – mostly in higher-cost countries -- to increase its margins.
New Jersey-based generics CMO (contract manufacturing organization) Amneal Pharmaceuticals has purchased a 200,000 square foot facility in Cashel, Ireland.
The Government of India will now defer EU trade negotiations as part of its effort to support local CRO GVK Biosciences, which was accused of data manipulation by the EMA (European Medicines Agency).
Eli Lilly on Tuesday cut ties with the University of California, San Diego (UCSD) as a legal battle between UCSD and the University of Southern California (USC) continues over the control of a major Alzheimer's disease study.
The US FDA has accepted for review Opko Health’s New Drug Application for a potential treatment for chronic kidney disease (CKD) and vitamin D insufficiency that uses Catalent’s proprietary softgel technology as its delivery platform.
With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio, two Aptuit facilities and a UK aseptic facility pay off.
Nine months since its IPO, a group of shareholders of CRO (contract research organization) INC Research common stock are looking to sell off 8m shares, according to an SEC filing.
API makers are looking for ways to slash costs and improve efficiencies to counter the impact currency fluctuations and other market challenges, earnings results from Lonza and BASF show.
French biotech TxCell is outsourcing manufacture of its T-cell therapy Ovasave to MaSTherCell, and says it expects to regain GMP certification of its own site later this year.
Baxter’s contract manufacturing business is expected to take a nearly 10% hit as one of its "major customers" has elected to self-manufacture products previously made by the CMO (contract manufacturing organization), Baxter CFO James Saccaro...
Australia’s National Health and Medical Research Council (NHMRC) is getting pragmatic with increasingly long clinical trial timelines and is now looking to streamline the research governance process in order to reduce delays in trial commencement.
Mereo BioPharma Group, a recently-formed specialty biopharma company, has selected CRO (contract research organization) Icon as its sole provider of clinical development services.
Late last month the China Food and Drug Administration (CFDA) began mandating that drug registration applicants self-inspect and verify clinical data to ensure that it’s authentic and reliable.
