Recipharm says three more of its facilities are equipped and ready for US Drug Supply Chain Security Act (DSCSA) serialisation demands, the deadline for which passes today.
The US FDA has issued Establishment Inspection Reports (EIRs) closing out inspections at Biocon’s biomanufacturing plant in Bangalore and a Divi’s Lab facility in Visakhapatnam.
Pfizer has sold its share of a joint venture with Zhejiang Hisun Pharmaceuticals but will continue supporting the local production of generic drugs in China.
Evoke Pharma has selected Patheon to commercially manufacture its nasal delivery formulation of metoclopramide Gimoti ahead of a planned US FDA submission next year.
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.
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.
“Bring Your Own Device” (BYOD) in clinical trials will be a “critical component” of future research says Bracket CEO following the company’s acquisition of mProve Health.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
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.
Recipharm has installed serialization technology at its contract production facility in Lisbon, Portugal citing impending US and EU rules as a driver for the investment.
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.
The US FDA has finalised guidance supporting new technologies which look to modernise pharmaceutical manufacturing, such as 3D printing and continuous processing.
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.
Communication difficulties are hampering drug industry efforts to assess damage to manufacturing operations caused by the hurricane that struck Puerto Rico last week.
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).
CTTI has released new evidence-based recommendations to enable sponsors and investigators to better plan for and make decisions about pregnancy testing in clinical trials.
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
The US FDA has warned a Florida-based clinic and seized vials of a smallpox vaccine in California used to create an unapproved product in a crackdown against "unscrupulous" stem cell firms.
CordenPharma has implemented work to improve its quality and compliance systems after its Latina facility was issued a warning letter from the US FDA in May of last year.
The US FDA has issued a complaint against an outsourcing facility that purportedly manufactured and distributed sterile drug products in violation of the DQSA.
The US FDA has rejected Valeant Pharmaceuticals International’s eye drop candidate following a site inspection at its subsidiary’s facility in Tampa, Florida, US.
The laboratories will participate in oncology-focused clinical trials as the program’s preferred partners and will be among the first to access Thermo Fisher’s pipeline of novel platforms and assays.
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.