The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Cancer Genetics’ acquisition of vivoPharm expands its geographical footprint, customer base, and diversifies its business model beyond fee for service, says CEO.
Charles River Laboratories has acquired Brains On-Line in an ongoing effort to deepen its drug discovery capabilities and build out its portfolio through strategic acquisitions.
Corning has penned separate collaboration agreements with Italy-based Stevanato Group and Germany-headquartered Gerresheimer to supply glass packaging for injectable drugs.
The US FDA has rejected Vernalis’ new drug application for its investigative cough and cold treatment CCP-08, which is the second time the firm has failed to win approval for a product this year.
Certara has added externalization technology to its D360 scientific informatics platform to expedite collaboration between sponsors and their research partners.
The MHLW has ordered Pfizer, Bayer, Daichi Sankyo and firms selling generic warfarin and azithromycin in Japan to expand their products’ adverse event warnings.
BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.
Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July.
API operations hit by the Petya cyberattack have not been restored according to Merck & Co Inc, which expects difficulties fulfilling some product orders and lower 2017 profits partly due to the hack.
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.
Lonza Group AG has predicted it will generate annual revenue of CHF7.5bn ($7.9bn) by 2022, citing recent acquisition Capsugel and its new Visp-based Ibex manufacturing service as drivers.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
French regulators says Chongquing Succeway Pharmaceutical Co Ltd should recall APIs made at its plant in Chongquing after inspectors found evidence of record manipulation and an undeclared manufacturing area.
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
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).
Researchers developing a method to determine drug bioavailability say the approach could become a ‘shortcut’ for scientists in drug discovery and development.
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.
PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.
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.
The US Food and Drug Administration (FDA) has released draft guidelines offering a reprieve for manufacturers which have not integrated product identifier requirements by the November 26 serialisation deadline.
Industry delegates say the US Food and Drug Administration (FDA) is showing increased support for continuous manufacturing, a stance C-SOPS told us is quality control-driven.
BASF has said it will build an ibuprofen plant in Ludwigshafen, Germany and increase production capacity for the API at a facility in Bishop, Texas in the US.
Baxter International has announced an agreement with India-based Dorizoe Lifesciences to develop over 20 generic injectables, a sector it says is growing annually.
Corning says it is on the brink of capturing an increased share of the $12bn glass quality and packaging markets through material advancements in the space.
The EMA says aligning antibiotic trial requirements with the US FDA and Japan’s PMDA should allow drug firms to conduct single global development programmes.
Researchers define action profile of Bial compound
Experts are calling for an increased focus on human cellular model development after animal tests failed to detect the toxicity of an experimental drug before the first-in-human clinical trial that left one dead.
Cure Pharmaceutical has entered into a strategic collaboration to test and develop potential cancer therapeutics utilising a blend of the cannabis plant-derived terpenes.
Bristol Myers Squibb (B-MS) has recalled one lot of the oral anti-clotting drug Eliquis in the US after a customer found 2.5mg strength tablets in a bottle labelled as containing 5mg tablets.
