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.
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.
The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
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.
CSSi LifeSciences and BioMARC have announced a strategic partnership to provide 'fully cohesive product development and support' for vaccine and biologic development.
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.
IntelGenx Corp has granted Chemo Group an exclusive worldwide license to commercialize several products – moving the company into the novel drug delivery market.
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.
A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.
The EMA has started reviewing drugs tested by Micro Therapeutic Research Labs after an inspection by Dutch and Austrian regulators identified potential data integrity problems.
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.
Almac Clinical Technologies, part of the Almac Group, has announced a collaboration with Exostar to help mitigate risk associated with intellectual property.
Through the collaboration, Purdue will leverage Exicure’s Spherical Nucleic Acid (SNA)™ technology to discover and develop a treatment for psoriasis, and other diseases.
The “Bring Your Own Device” (BYOD) continues to gain momentum with ERT’s acquisition of Exco InTouch, a provider of patient engagement, data capture, and digital health solutions.
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.
Swedish Orphan Biovitrum AB (Sobi) and Horizon Pharma plc have teamed up for a 5-year deal to distribute urea cycle disorder drugs Ravicti and Ammonaps in Europe and the Middle East.
Acticor Biotech has made a deal with Merck KGaA’s CMO MilliporeSigma to use its Provantage End-to-End services to make its anti-thrombotic antibody fragment ACT-017 for stroke.
Almac Clinical Technologies, part of the Almac Group, has announced a strategic partnership with the contract research organization (CRO) inVentiv Health.
Breckenridge Pharmaceutical has entered into a multi-product marketing agreement with development and manufacturing partner Gland Pharma Limited for seven injectable products.
Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).
The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19 target played a part.
