Guangdong Zhanjiang Jimin Pharmaceutical Co. has received a warning letter from the US FDA citing cGMP violations as well as unapproved new drug and misbranding charges.
Oracle Health Sciences has launched its safety-reporting management software in China to monitor adverse events as the country’s clinical trials industry continues to grow.
Almac Group’s acquisition of BioClin Laboratories expands the company’s analytical services – a growing area of business due to increasing global client requirements, says CDMO.
Quintiles IMS’ Alan Shephard says manufacturing cost transparency will reduce criticism surrounding generics pricing, but one association believes this will lead to anti-competitive behaviour among drugmakers.
Parexel has augmented its active tracking service with in-pack wireless sensors to monitor temperature-sensitive medications from packaging to patient dispensation.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
A year after implementing its policy on the publication of clinical data, reports on 50 medicines have been published and more than 80,000 documents downloaded – outcomes achieved through industry collaboration, says EMA.
Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).
The US FDA has rejected the muscular dystrophy candidate Translarna (ataluren), telling PTC Therapeutics more trial data is needed to prove the drug works and asking for additional information about how it is made.
US FDA inspectors have raised concerns about Akorn Inc’s manufacturing facility on Grand Avenue in Decatur, Illinois in a Form 483 made public this month.
Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
Clinigen Group plc has acquired the Japanese unlicensed medicines supplier International Medical Management Corporation (IMMC) in order to further develop its market access, says CEO.
Mutual inspection report recognition is positive, but EU and US FDA alignment on product specs and compendia would help drug firms, says regulatory expert Ajaz Hussain.
Irish regulators say it is still not clear how Brexit will affect companies that make drugs in the UK, raising issues like MA status and mutual inspection agreements between the EMA and US FDA as areas of concern.
The global contract development and manufacturing organization (CDMO) has launched its Almac Pod service solution in the US after introducing it in Europe last year.
The European Medicines Agency (EMA) has announced it will launch an updated version of information system EudraVigilance to better monitor suspected adverse reactions to medicines.
The EDQM and Anvisa have signed an agreement that may allow drug firms seeking clearance to sell products in Brazil to file CEPs in approval applications.
The world’s largest single bioproduction plant has received its first US regulatory approval to make a monoclonal antibody, says CDMO Samsung Biologics.
Marken has acquired Touchdown International Ltd, a privately held specialty logistics company in Taiwan – a “key market” for pharma production and clinical trials.
The EMA has expanded the list of excipients that drug firms must declare on product labels in a bid to address safety concerns about undeclared components.
CMO PR agency ramarketing has secured investment to set up a US base in a bid to attract North American contractors interested in accessing the complex European market.
Police investigating thousands of adverse events linked to Levothyrox, a reformulated version of the hypothyroidism pill Euthyrox, have visited Merck KGaA's production facility in Lyon, France.
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.
The US FDA has warned that people with decreased liver function who taker higher than recommended doses of Intercept Pharma’s drug Ocaliva are at increased risk of liver injury and death.
Post-Brexit relocation will, at best, delay approvals and, at worst, limit drug availability and put European patients at greater risk of side effects and death according to the EMA.
Communication difficulties are hampering drug industry efforts to assess damage to manufacturing operations caused by the hurricane that struck Puerto Rico last week.
The EMA has asked the European Ombudsman for concrete details of its probe of pre-submission activities, warning that Brexit preparations have limited its capacity to respond.
According to industry delegates, smaller contract services firms struggling to meet track & trace implementation costs will look to consolidate with competitors in light of impending serialisation deadlines.
Pharma needs to include patient engagement solutions in marketing strategies as the patient’s role in decision-making continues to increase, says UDG COO, following MicroMass acquisition.
The US Food and Drug Administration (FDA) has issued warning letters to Korean company Firson Co. and Chinese firm Wuxi Medical Instrument Factory, citing sterilisation violations.
US regulators have approved Amgen Inc’s Mvasi (bevacizumab-awwb), a biosimilar version of Roche’s monoclonal antibody (mAb) cancer treatment Avastin (bevacizumab).
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
