As part of an effort to provide more certainty, India’s CDSCO (Central Drugs Standards Control Organization) has offered up a new compensation formula for trial participants who are killed or injured during a trial.
As the European Medicines Agency (EMA) has implemented the majority of elements of the new pharmacovigilance legislation, the agency is now reporting that the main objectives of the legislation are largely being achieved.
DrugDev, a network of active clinical trial doctors, has acquired TrialNetworks, a cloud-based suite of collaborative trial management apps and site-facing tools designed to improve processes, ensure transparency and streamline timelines for clinical...
Hospira says approval for its new manufacturing facility in India is still on track despite receiving a Form 483 form the US FDA with ten observations.
No shortage of an FDA approved scorpion anti-venom biopharmaceutical is envisioned after a manufacturing facility in Mexico received a Warning Letter, US distributor Rare Disease Therapeutics says.
AstraZeneca has chosen big data and analytics services provider Sinequa, to index millions of R&D documents for use in a search platform providing “sub-second” answers to research questions.
The European Medicines Agency (EMA) has published guidance for departing employees intended to ensure there is no conflict of interest in their new roles.
As regulators incentivise the development of orphan medicines and high price tags for the drugs continue to rise, logistics specialists are offering new ways to get the drugs to the increasingly small patient populations.
A stake in Brazil-based wholesaler Profarma will increase AmerisourceBergen’ global presence already strengthened by the World Courier acquisition, the firm says as it reports a robust Q2.
SAS, a provider of tools for data and health analysis, will supply the platform for a project sharing oncology data from studies by AstraZeneca, Janssen R&D, Pfizer and Sanofi.
Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.
Consultancy and drug developer Certara has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies, which offers regulatory writing and related services to biopharma and medical device companies worldwide.
US health insurer Independence Blue Cross (IBC) has selected LabCorp to be its preferred provider for outpatient and specialty lab services under a new eight year deal.
Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.
The Broad Institute in Massachusetts, US will provide computational modelling support for a joint research project between Pfizer and EMD Serono profiling the genomes of lupus patients.
Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.
Roche has clashed with the authors of a report slamming the efficacy of Tamiflu, each claiming the other’s analysis of patient data is seriously flawed.
Tamiflu shortens the duration of influenza symptoms by only half a day, does not stop person-to-person spread and increases the risk of nausea say the authors of a new review who want Governments to rethink stockpiling neuraminidase inhibitors.
CRO and sponsor payment service provider Clinverse announced a record first quarter to start 2014, with the addition of four significant new clients, as well as strong additional repeat business from existing clients.
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.
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.
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.
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.
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...
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.
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.
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.
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.
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.
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...
AmerisourceBergen (ABC) plans to buy a minority stake in a Brazilian drug wholesaler and outlined plans for a $100m distribution services joint-venture in the rapidly expanding market.
Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a scheme next month to allow doctors to prescribe medicines without a marketing authorisation to patients with life-threatening conditions.
US pharmaceutical firms ‘fear change’ and need guidance on assessing safe excipient supply to become more like their European counterparts, says a senior IPEC expert.
New EU laws safeguarding national ownership of ‘genetic resources’ may delay production of seasonal influenza vaccines according to EFPIA, which wants stakeholders to discuss the issue.
The Indian Supreme Court has been asked to cancel Ranbaxy’s manufacturing license in the wake of quality problems that earned the firm a US import ban.
CFS Clinical has selected C3i to provide global 24x365 multilingual technology support services for their site activation and investigator payment services.
