Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation
The US FDA has revealed its work plan for implementing aspects of the 21st Century Cures Act, including an investment in in silico tools for use in clinical trials.
Researchers developing a method to determine drug bioavailability say the approach could become a ‘shortcut’ for scientists in drug discovery and development.
Pfizer Inc. has awarded Catalent Pharma Solutions the long-term manufacturing contract for a smaller version of its over-the-counter (OTC) painkiller Advil (ibuprofen).
UDG Healthcare has acquired Cambridge BioMarketing LLC in a deal worth up to $35m as the healthcare service provider looks to continue expansion in the United States.
Adents has become an official Certified Gateway Provider following a series of tests with the European Medicines Verification Organization (EMVO) ahead of the EU Falsified Medicines Directive (FMD).
Gelatin firm Rousselot BV has joined IPEC Europe describing the move as an opportunity to contribute to the development of regulatory standards for pharmaceutical excipients.
India-based Alembic Pharmaceuticals has inaugurated its manufacturing facility in Panelav, Gujarat, where the firm will make generic oncology products for international markets.
UK patients face drug shortages unless Tory Government Ministers negotiate an orderly withdrawal from the EU – Brexit – that safeguards existing approvals and continued regulatory cooperation according to pharmaceutical industry groups.
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.
The US FDA has rejected Ocular Therapeutix’s eye pain treatment Dextenza for a second time, again citing concerns about how the drug is made and tested.
Merck KGaA has announced a plan to close some EU production sites and invest in others, citing the centralization strategy employed by Sigma-Aldrich as inspiration.
Worldwide Clinical Trials has planned its rollout and risk mitigation strategy as it implements Medidata’s Payments Cloud to automate site payments, says CFO.
UDG Healthcare plc has acquired the US-based healthcare industry management consulting firm Vynamic LLC as it looks to augment its commercialization services division.
The US has told Mallinckrodt LLC to pay $35m (€30m) to settle allegations it broke record keeping rules at its oxycodone plant in New York and failed to notify the DEA of suspicious orders.
AstraZeneca has committed A$100m ($76.4m) to expand its manufacturing facility in Sydney Australia, citing growing demand for asthma medications in China.
EQT's acquisition of Certara is a bet on the continued convergence of healthcare and technology as the industry further adopts biosimulation to advance drug development.
A directive granting Belgium, Greece and Italy a six-year reprieve in serialisation adoption has raised concerns delayed implementation could be an opportunity for drug counterfeiters.
Gilead Sciences Inc. faces renewed allegations it bought an API used in three of its HIV drugs from an unapproved Chinese supplier after a US Court of Appeals ruling.
The data-focused clinical research organization (CRO) Quanticate has upgraded its pharmacovigilance safety database ahead of EudraVigilance’s go-live in November.
The preclinical CRO Pharmatest has developed an animal model to clarify the role of human immune cells in bone metastases using Taconic Biosciences’ huNOG model.
Newlink Genetics Corporation has expended its indoximod IP portfolio weeks after data suggested the cancer drug may make Provenge and Keytruda more effective.
IndieBio has teamed up with Science Exchange’s network of more than 2,500 qualified scientific service providers in a strategic partnership that “levels the playing field” for startups.
Elite Pharmaceuticals has halted trials of its reformulated opioid painkiller SequestOx (naltrexone and oxycodone hydrochloride) after disappointing bioequivalence data from a study testing the drug in combination with a high fat meal.
Researchers at London, UK-based Imperial College are developing a technology to transport drugs directly to the lungs of pulmonary arterial hypertension (PAH) patients.
Spheryx, Inc. has been awarded a $1.5m grant over two years to support modifications to the company’s propriety protein aggregation detection and monitoring technology.
German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission
