AXIM Biotechnologies, Inc. will start 40-person clinical trial in the Netherlands for a mint-flavoured medical marijuana chewing gum to treat Irritable bowel syndrome (IBS).
Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA.
The distribution giant, McKesson Corporation, has agreed to pay the DEA's record fine of $150m after allegedly failing to report “suspicious orders” for controlled substances.
The Chapel Hill, NC-based contract research organization (CRO) has implemented PhlexEview4 as its preferred eTMF solution to support commercial and government clients.
Technology is catapulting clinical trials into a 'new era' as scientific breakthroughs bring new opportunities to an industry that has traditionally lacked innovation.
Poor communication between healthcare providers and clinical research professionals is contributing to low recruitment rates, according to a recent study by Tufts.
Helomics has signed a deal with the diagnostics firm MDNA Life Sciences Inc., to help further develop MDNA’s liquid biopsy platform and commercialize its tests for prostate cancer.
MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.
Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
Welcome to in-PharmaTechnologist's monthly round up of who's been moving where in the small-molecule manufacturing world. The CEO of BMS is moving internally, Axim Biotechnologies and Pharmalink have new board members, whilst Vium and Dova Pharmaceuticals...
Catalent will assess Jupiter Orphan Therapeutics’ resveratrol across its softgel technologies in an effort to improve the bioavailability of the rare disease candidate.
Parexel’s restructuring plan to ‘simplify the organization’ will include eliminating an undisclosed amount of positions as the CRO looks to save on costs.
Pharmaron’s acquisition of Xceleron further supports early discovery, preclinical and clinical development with expanded radiolabeled sciences capabilities.
After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.
Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.
High frequency radiation can be used to test tablet quality and structural characteristics on the production line according to scientists planning to develop low cost THz sensors.
CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development.
Following an €8M Series A fundraising round by Eternygen GmBh, the German CRO Evotec AG will help get the virtual biotech’s metabolic disease inhibitor programme to preclinical trials.
From a new administration under president-elect Donald Trump, to continued consolidation, the CRO and CMO industry can expect accelerated change – good or bad – says PCI Synthesis.
In an exclusive licensing agreement with Merck & Co Inc (MSD), Cerveau will take on development of the firm’s investigative PET imaging agent up to Phase III trials for Alzheimer’s Disease.
Sharp Edge Labs will use its propriety biosensor platform to identify lead compounds for Sumitomo Dainippon Pharma – technology that the company says will help focus discussions on outcomes rather than cost.
Worldwide Clinical Trials will support the full scope of Renova Therapeutics Phase III trial for its lead gene therapy product candidate, says the CRO.
Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.
Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.
Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.
Absorption Systems has announced a technology licensing agreement with Pfizer Inc., in which the pharma company will use the preclinical CRO’s cell lines to test potential drug candidates.
IntelGenx Corp has granted Chemo Group an exclusive worldwide license to commercialize several products – moving the company into the novel drug delivery market.
Teewinot’s Irish subsidiary has been granted a fourth patent for a pharmaceutical cannabinoid manufacturing technique which it says saves both time and money.
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.
Cryoport’s network of cold chain logistics will support the delivery of Gradalis Inc’s autologous cell therapy to various cancer trial sites across the US.
Bruker has bolstered its molecular biologics and mass spectrometric offering through the acquisition of contract manufacturing organisation (CMO) InVivo Biotech.
