Pharma firms developing inhalable drugs often fail to test that their formulations are compatible with their intended delivery devices early enough according to the Intertek team behind research stressing the benefits of early assessment.
The US Department of Agriculture (USDA) has filed a complaint against antibody supplier Santa Cruz Biotechnology for its allegedly poor treatment of animals.
The US Patent and Trademark Office (USPTO) has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.
Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications.
The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).
Hemispherx Biopharma has signed extended US distribution agreements as part of efforts to relaunch Alferon N Injection, a genital wart treatment it pulled in 2008 after production costs soared.
As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.
As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).
Taiwan’s pharmaceutical market is expected to grow to over $8bn by 2020, driven by chronic and non-infectious therapies, but uncertain relations with China, TPP entry, and price cuts will also influence the region.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is working on a pilot project investigating the feasibility of inspecting pharmacovigilance contract service providers as it’s becoming increasingly common for a MAH (marketing authorisation...
GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.
BioClinica is looking to target its new offering to the CROs and sponsors who have yet to adopt a cloud-based solution for the management and delivery of clinical trials.
The annual announcement of FDA user fees has brought scrutiny on the price tag for generic drug applications, as the approval backlog is almost a year longer than in 2012.
US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.
The US House Energy and Commerce Committee is taking issue once again with the way the FDA manages its IT systems, according to a report released late last week.
As the US regulator awards iclaprim expedited QIDP status, a former FDA antibiotics expert says the scheme boosts antibiotics without enough evidence for efficacy.
Industry headhunters have picked their top CEOs in European pharma, saying the most successful investors keep chief execs in place even through hard times.
A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.
A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...
New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.
DNA sequencing firm Source BioScience will bolster its stability testing and storage services through a proposed acquisition of Select Pharma Laboratories.
A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.
Increasing pharma R&D spending is helping grow revenues for Medidata, which has boosted its cloud-based clinical technology through a partnership with Validic.
Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.
Companies that recommission old single-use devices would have the same liability as the original device maker under draft guidelines proposed by the MHRA.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
As part of a push to bring more novel excipients to market, IPEC-Americas is calling on the FDA to create a new regulatory review process that could relieve some of the uncertainty around the use of new excipients.
Thermo Fisher Scientific has developed new software via a partnership with the Special Bacteriology Reference Laboratory at the CDC (Centers for Disease Control and Prevention) that helps public health labs to more quickly identify microbial pathogens...
Mylan has recalled 14 lots of calcium chloride intravenous infusion after customers found the prefilled syringes were not compatible with needless adaptors.
NASA has used a remote control plane and a fleet of drones to deliver drugs in an approach that could help pharma firms get medicines to patients in hard to reach locations.
The founder of a phony pharma company which made $12m importing fake chemo drugs to the US has been banned for life by the US FDA from working with any pharma businesses.
India’s Emcure Pharmaceuticals has been banned from shipping any of the drugs manufactured at its Maharashtra-based facility to the US, according to an import alert from the US FDA.
DNA-based diagnostics company Cancer Genetics has partnered with the lab services group of CRO Icon to provide clients with new offerings, including oncology-focused genomic testing, central lab analysis, project and data management, and sample logistics.
