Regulatory pressure for risk-based supply chain management is increasing excipient suppliers’ audit burden according to the team preparing to launch the 'excipact' certification scheme as an independent association.
Dow says the acquisition of partner Bend Research is “good news” and will strengthen its developments in solving solubility and bioavailability issues in drug formulation.
Despite a strong Q3, Icon has outlined plans for further cuts at its UK clinical pharmacology unit (CPU) as it rejigs its ‘weak’ early phase services business.
Patheon brought in McKinsey consultants over the last three years to help overhaul its sagging business and institute a number of simple process changes that resulted in deep transformations.
Omega-3 supplier BASF will continue to produce the API for Amarin, as well as its competitor GlaxoSmithKline, despite an FDA panel saying that Amarin’s drug should not be approved for a broader population.
Indian manufacturing heavyweight Mylan Laboratories is looking to build off its major acquisition of Agila with a number of smaller acquisitions, while Natco is about to receive a cash infusion for manufacturing expansions.
Ben Venue’s closure is still being evaluated the troubled drugmaker says, in the week the European Medicines Agency (EMA) is meeting to discuss ongoing shortages.
Teva subsidiary Pliva has opened a new $100m (€73m) oral dosage manufacturing facility in Zagreb, Croatia to increase its export of tablets and capsules to the US and EU.
Sponsor network developer DrugDev on Monday announced it would acquire CFS Clinical, which specializes in managing the financing of clinical trials. Financial terms were not disclosed.
Azelis says its partnership with JH Nanhang (JHNH) will feed a large demand for polyvinylpyrolidones (PVP) excipients and bring the China-made ingredients to new markets.
Linking peptide and small molecule drugs to albumin will improve pharmacokinetics, says Almac as it partners its manufacturing capabilities with Novozymes’ half-life extension platform.
In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes...
Lab service provider LabCorp said Friday its third quarter net income was nearly the same as the identical quarter in 2012 because one-time restructuring and other costs offset a slight increase in revenue.
US contractor SAFC has joined the growing list of drugmakers and CMOs to invest in ADCs by announcing plans to add commercial-scale production capacity.
US and French regulators have given Oxford BioMedica the go ahead to restart studies of three eye drugs it is developing with Sanofi after an impurity found in trial materials was identified as a harmless culture media derivative.
Cirrus Pharmaceuticals has received a grant to investigate the effect of excipient concentration and API molecule size on metered dose inhaler (MDI) formulations.
Early stage drug developer Charles River Laboratories is pushing further into Asia with its purchase of the microbiology subcontractor BRASS Pte Ltd. Terms of the acquisition were not disclosed.
The US Food and Drug Administration (FDA) will soon run out of funding for the limited amount of medical product regulatory work it has carried out during the Government shutdown according to an agency spokesman.
CMC Biologics has received renewal of its GMP credentials from the Danish Medicines Agency (DKMA) after upgrading the manufacturing capacity at its Copenhagen site.
Yale University’s Cardiovascular Research Group (YCRG) and medical device CRO genae associates nv, have announced a collaboration and co-marketing agreement for cardiovascular devices.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has withdrawn its good manufacturing practice certificate for Wockhardt’s Chikalthana, India-based plant due to cGMP violations.
CRO Quintiles has decided to close its Phase I unit in Hyderabad, India, because of a “challenging external business environment,” a company spokesman told us.
Parexel has teamed up with Japanese trial management services firm Fuijitsu Systems West in an agreement that underlines the CROs eClinical growth ambitions in Asia.
Discovery CRO Crown Biosciences has partnered with X-ray drug research specialist Xstrahl Life Sciences in a deal designed to make preclinical models that more accurately reflect clinical use of radiotherapy.
CDMO Particle Sciences has completed the manufacture of an intravaginal delivery device for anti-retrovirals that is designed to prevent the transmission of HIV.
Roche will build an antibody-drug conjugate production facility to support production of its approved drug Kadcyla and others in its development pipeline.
The Ghanaian FDA has defended its decision to ban all imports from India' Bliss GVS amid growing industry concerns about the speed of the agency's decision making.
Furloughed US FDA staff will face a huge backlog of manufacturing plant inspections when the Government shutdown eventually ends, according to an influential healthcare advocacy group.
