The new formula Indian regulators will use to calculate compensation for the families of patients who die in trials is confusing, imprecise and needs clarification, according to Outsourcing-pharma.com’s Zachary Brennan.
Efforts to address the current shortage of IV fluids in the US are a placing a strain on manufacturing capabilities according to Baxter, which is investing to try and increase production capacity.
Sigma-Aldrich has teamed with Biopredic to produce genetically-modified human liver cell lines and assays it says can cut costs by reducing animal toxicology studies in drug discovery.
European dependence on drugs and APIs made outside the EU is still ‘alarming’ despite recently introduced anti-falsified meds laws according to the European Fine Chemicals Group (EFCG).
CRO Harlan Laboratories announced that it will open its first oncology research model breeding facility in India, which has already sparked anger in the animal rights community.
AMRI says it intends to expand its fill/finish capability and progress its business into higher value technology following the recent all clear at its once troubled Burlington facility.
Aurobindo says it can make the loss making European generics operations it is buying from Actavis profitable by combining them with its production network in India.
The US FDA is positioned to increase drug plant inspections in China after US President Barack Obama signed a $1.1tr (€881bn) budget for fiscal 2014 into law on Saturday.
Complex generics will represent over 50% of Teva’s generic market by 2017, the firm says, but investments in delivery technology will have positive implications across the full business.
GMP auditors need a professional qualification similar to QP status according to a group whose new training scheme is designed to create a competency benchmark.
The six biggest CROs look set to see revenues grow in the next few years with both Parexel and Icon predicting the group will capture a larger share of research spend.
The combination cholesterol drug Liptruzet will be unavailable in the US for the foreseeable future, says Merck & Co., after packaging defect at CMO led to a total product recall.
Drugs containing APIs derived from cannabis plants are a far cry from the non-clinical approach of marijuana dispensaries, says GWPharma, as France approves Sativex.
The US Food and Drug Administration (FDA) has drafted social media guidelines for pharmaceutical companies, regulating the Facebook and Twitter posts of employees who mention drug products.
Whether McKesson will relaunch its bid to acquire German logistics firm Celsio has been questioned by analysts after the proposed $8.3bn (€6.1bn) takeover bid fell through.
Current economic problems may have hit Spanish drugmakers hard, but the downturn has not dampened demand for contract manufacturing services according to IDIFarma.
Alnylam has both acquired Merck & Co. subsidiary Sirna therapeutics and extended an alliance with Genzyme in order to advance its small interfering RNA (siRNA) delivery programme.
AMEC has announced its plan to buy US firm Foster Wheeler AG for $3.2bn (€2.3bn) in a deal that includes the latter’s pharmaceutical plant design services business.
Aurobindo has denied reports of a boiler blast at an Andhra Pradesh, India facility whilst Amgen is investigating an incident at its San Francisco R&D site.
All the obvious cancer targets have been found according to Horizon Discovery, which last week agreed to help AstraZeneca find some new ones using isogenic pairs of oncology relevant cells.
Davita Clinical Research (DCR) has said increasing client demand for adaptive trial designs in early Phase research prompted its partnership with Pacific Pharma Group study expert, Jon Ruckle.
Marine bacteria may yield the next generation of MRSA fighting drugs according to a team that used a peptide from a Pacific Ocean bug to render the hospital superbug less lethal.
Boehringer Ingelheim says it was well-prepared for the expiration of its blockbuster drug Micardis (telmisartan) with staff and capacity transfers as Actavis prepares to launch a generic version.
Roche has asked Tamiflu distributors to prioritize US regions hardest hit by flu as it works to address packaging delays expected to limit supplies of the oral suspension version of the antiviral for the rest of the month.
A drug delivery technology that ‘shuttles’ molecules across the blood-brain-barrier could have major implications in developing drugs for disorders such as Alzheimer's and Parkinson’s disease, Roche says.
The European Medicines Agency (EMA) has published for the first time details of manufacturers who have violated GMP as part of its transparency initiative.
Catalent has been contracted to make supplies of an extended-release drug for Parkinson’s disease (PD) patients set to enter Phase III trials by developer Adamas Pharmaceuticals.
Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers.
Patheon is the world’s largest pharmaceutical development services (PDS) provider and third largest contract manufacturer, according to a report released yesterday.
Gilde Healthcare Partners has bought a majority stake in specialist virology CRO Viroclinics Biosciences in a transaction prompted by growing global demand for virus research services and vaccines.
The higher demand for preclinical toxicity testing reported by public CROs last year may also be being seen by private firms if recent investments are any indication.
AstraZeneca says the small molecule cyclin-dependent kinase 9 (CDK9) inhibitor programme acquired from Probiodrug has the potential to target cancer cells.
