The US FDA announced a task force has been formed to prevent the shortage of drugs, by addressing the ‘underlying structural concerns’ that allow this to happen.
Pfizer has announced a major shakeup of its business by splitting into three units: Innovative Medicines, Established Medicines and Consumer Healthcare.
An EMA survey has found that 42% of businesses, with an important step in their regulatory processes occurring in the UK, are not adequately prepared to retain marketing authorisation post-Brexit.
Cross-industry discussion is expanding from early discovery to post-licensing challenges – as the nexus of innovation and policy improvements is rapidly changing, says DIA executive.
The US FDA has sent a warning letter to Chinese contract manufacturing organisation Foshan Jinxiong Technology, which makes over-the-counter products for children.
President Trump has condemned pharmaceutical companies, including Pfizer Inc., on social media, tweeting that they have increased list prices of prescription drugs without cause.
Novartis has instigated a voluntary recall of 470,000 packages of drugs, after a child managed to open and swallow a pill from a child-resistant product.
Recipharm has revealed that it will be offering a standalone serialization service to companies that have not yet prepared for the upcoming FMD deadline.
UDG Healthcare has acquired two healthcare-focused firms, expanding its global footprint and service offerings – including those in health economics and outcomes research – in a deal worth up to $82.4m.
Dr. Reddy’s Laboratories has announced receipt of a US FDA establishment inspection report regarding two active pharmaceutical ingredient plants in Hyderabad, India.
The US FDA has announced that over 236,000 bottles of statins will be voluntarily recalled by Dr. Reddy’s Laboratories, after issues were found with impurities.
Shared manufacturing equipment and utensils used between non-potent and potent drugs were among the cleaning concerns observed by the US FDA in West Virginia, US.
The US FDA has issued Henan Lihua Pharmaceutical Co. Ltd. a warning letter and imposed an Import Alert 66-40 following inspections at two manufacturing facilities in Henan, China.
Indivior has requested a temporary restraining order against Dr. Reddy’s Laboratories to prevent further sales of its generic buprenorphine and naloxone sublingual film product in the US.
Mylan says ‘minor deficiencies’ in its abbreviated new drug application for its proposed generic version of GSK’s Advair Diskus have prompted the US FDA to issue a complete response letter.
Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.
Providing a coherent and persuasive risk assessment and a “well-messaged outline of key communication points” are key to winning US FDA Advisory Committee approval, say industry consultants.
A lack of ‘basic documentation’ and ‘dubious’ environmental control system reports at Taiwan Biotech’s manufacturing plant were cited in the US FDA warning letter.
The Republic of Ireland’s competitive corporate tax rate represents a ‘stability’ that may not be found in other economies, says IDA Ireland executive.
Medidata is acquiring Shyft Analytics for $195m, creating a new platform that will combine clinical development with commercial and real-world data analytics in a first for the industry, says a company executive.
Marken this week has announced the relocation of its Chicago logistics hub into a new, larger facility equipped with cold chain technology for clinical trial materials shipments.
Alcami began work on Flexion Therapeutics's ZILRETTA in the fall of 2014 and today announced that it will further support commercial supply of the product, which is approved for the treatment of OA-related knee pain.
Covance has acquired Sciformix in a deal that augments the CRO’s pharmacovigilance capabilities for post-approval safety solutions and expands its global footprint.
Following on from the success of last year's survey, Outsourcing-Pharma is running another 'state of the industry' survey to gauge views about the current state of the pharmaceutical contract services industry.
SIGA is slated to receive FDA approval for the world’s first antiviral drug to treat smallpox – a milestone not reached in isolation, but in collaboration with several CROs, government agencies, and others.
The Centre for Process Innovation (CPI) has confirmed its role in a UK initiative to accelerate vaccine production and eliminate the need for cold-chain shipping.
Analytical testing concerns and ‘inadequate’ investigations into failed results were among the GMP deviations observed by the US FDA at IDT Australia Limited’s facility.
The US FDA has agreed to recognise GMP inspections of API and drug product facilities carried out by Ireland's and Lithuania’s respective regulatory authorities.
The US FDA has issued a warning letter to Chinese API maker Jilin Shulan Synthetic Pharmaceutical Co., citing lax electronic data security and inadequate batch records.
The European Commission has angered the biopharma industry by proposing to relax the rules detailing when companies can manufacture biosimilars and generics in the region.
Recipharm has established a Brexit taskforce and plans to hire additional staff to navigate any potential effects of the UK’s departure from the EU in less than a year.
The US FDA has approved US WorldMeds LLC’s non-opioid treatment Lucemyra, adding another “tool to the toolbox” for withdrawal management, says American Society of Addiction Medicine.
Dr Reddy’s expects to have addressed all GMP violations at its Duvvada drug formulation plant and Srikakulam API facility within the next six weeks, says CEO.
GDP growth and low-priced generics in pharmerging countries have contributed to the growth of Asia Pacific's pharmaceutical market, which has surpassed Western Europe as the second largest globally, says report.
Motif Bio plc has secured £10m ($14m) to support the potential commercialization of its lead candidate – iclaprim – which was granted FDA fast-track status in 2015.
