Enzyme experts trying to make the anticancer APIs vincristine and vinblastine with engineered cell lines say the technology could be used to produce a wide range of plant-derived drug actives including alkaloids like morphine.
Molecular Profiles has invested in hot melt extrusion (HME) and nano milling capabilities citing client demand for improving the bioavailablity of drugs.
The EMA and TGA have agreed to share full assessment reports related to marketing authorisations of orphan drug in the latest regulatory collaboration intended to save time and resources.
A consortium developing treatments for children infected by parasitic worms has signed up Brazilian drugmaker Fiocruz as a formulation and manufacturing partner to support upcoming clinical trials.
CRO Evotec AG will help Debiopharm identify and develop novel compounds with the potential to treat multiple forms of solid tumours and leukaemias with defined genetic alterations under a collabortation announced today.
Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.
The EMA (European Medicines Agency) has cut what it charges small and medium-sized enterprises (SMEs) and micro businesses to help them comply with regulations once their drugs are approved.
Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.
Almost two-thirds of supply chain executives plan to increase their expenditure in clinical trial logistics over the next two years, according to an industry survey conducted by Marken.
As smaller biotech, pharma and medical device companies seem keen to expand R&D, they also seem to be consistently turning to mid-size CROs to run their trials.
Cell transportation technology firm Austrianova has licensed a low-cost, disposable microfluidics platform from SIMTech to improve how it dispenses cells used in biomanufacturing and therapeutic applications.
Big Pharma's split opinion on the best way to work with a CRO was in evidence in Las Vegas this week with Pfizer underlining its commitment to strategic deals and Merck KGaA backing a multi-vendor model.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
Pernix Therapeutics will no longer be a CMO as it has signed a definitive agreement to divest its Houston, Texas-based manufacturing operations to Woodfield Pharmaceutical to cut costs.
A US FDA review panel has recommended that Afrezza be approved and concluded that the technology used to deliver MannKind's inhalable insulin does not damage airways or lung cells.
With generic drugs covering 80% of all dispensed drugs in the US, Democrats and Republicans seem split over a proposed FDA rule that would allow generic manufacturers to submit labelling changes within 30 days after discovering a new adverse event or...
CRO BioClinica has signed two multi-year contract extensions worth $30m for cloud-based technologies and professional services and training across its e-clinical product suite.
Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.
French mAb developers that hire Cobra Biologics stand to benefit from tax breaks after the French Ministry of Higher Education and Research (MESR) named the CMO as a preferred provider.
GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.
The pharmaceutical industry lacks the regulatory models to govern sweeping changes in the near future surrounding combination products and large molecule drugs, said an expert at DIA Euromeeting in Vienna last week.
Quality and IP issues are driving firms back to the US and Europe for their contract manufacturing according to experts, but Kemwell says there are still opportunities for Indian CMOs.
US-based BioDelivery Sciences International (BDSI) has selected Quintiles to provide a range of services to support the expected launch of Bunavail (buprenorphine and naloxone buccal film), a maintenance treatment for opioid dependence.
Ireland-based CRO Icon has agreed, subject to certain closing conditions, to acquire Aptiv Solutions for $143.5m in cash to further expand its adaptive trial offerings.
Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.
Hospira has agreed to pay $60m (€44m) to settle a lawsuit related to manufacturing and quality control deficiencies at its Rocky Mount facility, which is already subject to a $200m remediation programme.
CRO inVentiv Health subsidiary Campbell Alliance has launched its consulting business in Japan and will open an office in Tokyo nearly a year after inVentiv made its initial push into the country.
As biopharma companies look to develop cancer therapies more quickly, some are turning to CROs with the hopes of using surrogate endpoints to expedite US FDA approval.
In light of the implementation of the Drug Quality and Security Act of 2013 in the US, which calls for the phased implementation of electronic tracking down to the package level, companies are looking at options to catch up and reduce counterfeiting at...
CMO Cytovance Biologics is extending its manufacturing agreement with Precision Biologics to advance clinical trials with its leading monoclonal antibody candidate, which is being developed as a therapeutic candidate for pancreatic and colorectal cancers....
ADC-makers could avoid using costly cytotoxics in antibody-drug conjugates (ADCs) by using near‐infrared (NIR) light to activate targeted cell-killing payloads, says Goodwin who has team up with Aspyrian Therapeutics.
Demand from biotech firms and Big Pharma’s need to refill its pipeline is driving the preclinical services industry, say analysts at this year’s Society of Toxicology (SOT) meeting.
BioReliance has updated its big blue assay for the second time in six months by creating a version of the drug genotoxicity test that can be used in rats.
Aenova says the acquisition of Haupt Pharma and Patheon’s merger with DSM are evidence of consolidation in the CMO industry, as it looks to further increase its global footprint.
GSK has asked Formula One team Mclaren to help it discover drugs, arguing that Big Data expertise from outside the contract research sector can accelerate its efforts to develop new blockbuster meds.
GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow developed in Formula One pit lanes by partner, McLaren.
Covance has announced that its recently expanded large molecule bioanalytical space at its laboratory facility in Indianapolis will come online in late 2014.
