Sanofi says it will demolish a pilot plant in Montpellier that has been left idle since its completion in 2011, citing its evolving biologics-focused portfolio.
Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
ATLAS Global Compliance is a Software-as-a-Service (SaaS) solution that helps clinical trial sponsors to “disclose locally and comply globally,” says TrialScope CEO.
Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
Celerion has implemented Verified Clinical Trials’ (VCT) biometric fingerprint technology to address “significant amount” of participants dual enrolling at Ph I units.
The CRO market in Asia has “massive implications” as it continues to emerge as a preferred destination for clinical trials – a global market expected to reach $57bn by 2020.
The Trump administration is looking to massively reduce regulations – which could have major implications for pending guidelines that look to increase clinical trial patient safety.
Bioclinica has expanded its eHealth App xChange to make a greater range of technologies available to the increasing number of industry stakeholders – many with differing priorities.
GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Enteris to work on Sanofi oral type 2 diabetes candidate & metabolic peptide for Nordic Bioscience
The HHS issued a final rule updating outdated regulations to provide enhanced protection for clinical research participants – and the FDA may follow suit.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
Technology is catapulting clinical trials into a 'new era' as scientific breakthroughs bring new opportunities to an industry that has traditionally lacked innovation.
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Pharmaron’s acquisition of Xceleron further supports early discovery, preclinical and clinical development with expanded radiolabeled sciences capabilities.
Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.
As holidays shoppers wrap up their presents with ribbons and bows, Outsourcing-Pharma.com reviews how contract pharmaceutical packaging companies help ensure successful patient outcomes with iterative design.
Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.
As part of its collaboration with the National Institutes of Health (NIH) in the DNA vaccine clinical trial for the Zika virus, PharmaJet is providing its Stratis Needle-Free device and training to the NIH.
Wearable technology has been making inroads in the clinical trial industry, however several challenges and concerns surrounding lack of experience still stand in the way of increased adoption.
Despite requiring more API, the price of inhaled insulin Afrezza has dropped below that of injected rapid-acting rivals says MannKind's CEO, reporting a resilient Q3.
Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
Saneca Pharma will invest in its manufacturing site in Slovakia to service a five-year agreement supplying the Menarini Group with controlled release pellets.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
Premier Research has become the most recent contract research organization (CRO) to receive funding from private equity as the industry looks for "like-minded" partners for the long run.
The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.
UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.
