Novasep has announced it is expanding API synthesis its facility in Boothwyn, Pennsylvania and confirmed that US growth is important after the sale of Pharmachem.
Incoming Indonesian government measures to attract foreign manufacturing joint ventures (JVs) could include a regulation to reduce API imports, Vincent Harijanto, committee head GP Farmasia said.
PRA Health Sciences will launch a recruitment and education drive for trials in the UK this spring in collaboration with advertising agency DJM Pan Unlimited.
Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
The pharma industry has traditionally been slow to adopt mobile technology, but as new innovations emerge the process for conducting clinical trials could transform.
Plans to centralise its manufacturing operations will optimise use of new technologies across Novartis’s divisions without resulting in any additional facility closures, the firm says.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
The US NIAID is supporting development of several experimental Zika vaccines but none will be ready before Brazil, the country at the centre of the current outbreak, hosts the Olympic Games this summer.
CROs have been experiencing increased pressure to implement risk-based monitoring (RBM), and while adoption has been slow, it is gaining speed, say speakers at CROWN Congress.
The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
Recipharm has raised SEK276m ($32m) to part finance the acquisition of a majority stake in Indian CMO Nitin Life Sciences that it announced in October.
Hermes Pharma has added hot melt coating capabilities to its offering and hopes the food industry technique will win it pharma customers with unpleasant tasting APIs.
Yan Mei, a defendant charged with stealing GlaxoSmithKline (GSK) trade secrets including biopharmaceutical manufacturing processes, remains at large, a spokesperson for the US Attourney's office told us yesterday.
ICON has announced Flex Advantage, its next-generation Interactive Response Technology (IRT) platform, as sponsors and investigators continue to embrace adaptive trial designs.
Catalent will pursue strategic acquisitions and licensing in 2016, said VP Marketing & Strategy Elliott Berger, noting growth areas include complex delivery technologies and specialised logistics.
A Zika vaccine is a long way off according to a UK academic who suggested vaccines for related viruses could be used as delivery vectors to accelerate development.
Certara’s new consulting firm will rely on modeling and simulation expertise to expedite the drug development process, as China commits to increasing innovation.
Clinical trial participants willingly put themselves at risk, so a committee is proposing that data sharing be mandated before manuscript publication is considered.
Government purchasing commitments would discourage industry antibiotic marketing and help developers overcome reluctance to invest in new antimicrobials say drugmakers in Davos.
Mucosis has been awarded a Wellcome Trust grant of €3.7m ($4m) to help develop a Respiratory Syncytial Virus (RSV) vaccine using its intranasal delivery platform.
India has 16% of the world’s population, 20% of the disease burden, and has contributed to less than 1.4% of global clinical trials, but the country is looking to fix this imbalance.
Currently, more than 85% of trial sites are paid using manual or in-house process, but as the need for CROs increases, so does the need for automated payments, says Clinverse's CEO.
Mylan has stopped production at a sterile injectables plant after Polish regulators observed 29 major violations of GMP, an EU statement of non-compliance reveals.
FAAH inhibitors will be looked at closely after a volunteer died in a trial of BIA 10-2474 last week, but it is too early to say drugs of this class are unsafe according to a leading expert.
Drug manufacturers, regulators, and consumers are increasing pressure on pharma companies to make the Rx-to-OTC switch, as non-prescription medications are cheaper and easier to access.
While CMOs are currently engaged mainly through tactical outsourcing, this paradigm will shift as more companies begin outsourcing to preferred providers, says ISR report.
Pfizer has invested $46m in separate collaborations with four R&D companies specialising in developing ADCs, immuno-oncology candidates and gene-therapies.
A study halted in France after one volunteer died and others were injured differs markedly from the disastrous “elephant man” trial that hospitalized six in the UK in 2006 according to the MHRA.
On Friday, the French Minister of Health addressed the public pledging to provide answers after one man was declared clinically dead as the result of a clinical trial gone wrong.
As it becomes increasingly expensive to develop drugs, analysts predict that deal-making will become more important for pharmaceutical companies seeking to offset R&D costs.
