The US FDA was flooded with comments on its draft guidance seeking to amend the informed consent process – with some saying the guidance will further confuse patients while others took issue with what the revisions didn’t include.
TransCelerate’s new RBM (risk-based monitoring) methodology focuses on the use of technology and centralized monitoring to shift away from Source Data Verification (SDV) to risk-driven monitoring, according to two papers in the Drug Information Association's Therapeutic...
Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.
Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.
Pharma service companies looking to access the growing Philippine and Indonesian markets have been invited to join a Public-Private trade mission by the US Department of Commerce.
After much discussion and some confusion, the ICH’s (International Conference on Harmonization) Q3D guideline, which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.
The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.
Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
Hospira has invested 15m AUD ($14m) in a Victoria injectables plant it says will continue to make drugs for export despite the economic downturn and strong Australian dollar.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
Charles River Labs (CRL) has singled out China as an area of “disproportionate growth” in biologics R&D and says it is on the hunt for preclinical acquisitions in the region.
Gilead has granted seven Indian drugmakers licenses to produce generic versions of its $1,000 a pill drug Sovaldi to increase access to hepatitis C medicines in 91 developing countries.
Almac has teamed up with Welsh Academics and industrial chemistry firm Hockley International to develop enzymes capable of making drug intermediates more quickly.
Almac’s subsidiary Galen has licensed UK sales and marketing rights to an emergency pain drug nicknamed the “green whistle” from Australian firm Medical Developments International (MVP).
In a venture with plasma products manufacturer Octapharma, DHL has opened a €3.4m ($4.4m) cold-chain logistics centre in Germany for the pharma and life sciences industries.
Mannkind says Sanofi could become a second API supplier for its recently approved inhalable insulin drug Afrezza following its commercialisation partnership last month.
CRO (contract research organization) Parexel International has allowed clinical technology companies CRF Health and Clinical Ink to join its Perceptive Partner Program.
As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved, the agency is still implementing a number of the individual modules that make up the over-arching law.
Half of drug discovery will eventually be outsourced as the service area goes the way of contract toxicology, according to the CEO of Charles River Laboratories (CRL).
Experts have predicted more CROs will go public as Private Equity looks to get a return on its investments, but such shifts are indicative of a booming market rather than waning interest.
The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.
Ireland once was a drug making nexus,Making meds sold from Cairo to Texas.But with key patents gone,Firms are keen to move on,And a new Limerick tech hub reflects this, says director.
Unilife has invested in manufacturing capacity for its drug delivery devices ahead of schedule to support the accelerated commercial launch date of its customers' products.
Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.
Researchers from the National University of Singapore (NUS) have developed a microneedle patch that can deliver lidocaine in what they say is a “faster, more effective and painless” way.
Recognizing the critical role of emerging biopharma companies and their recent influx of cash, Quintiles has launched a new ‘emerging biopharma solution’ that aims to capitalize on the unique development needs of the companies.
Drugmakers sponsoring trials in India will need to weigh the potential risks and benefits for the people who take part under new guidelines issued by the CDSCO.
High importation costs and country-to-country differences in national healthcare systems mean drugmakers will continue to vary the cost of products in Africa according to an industry analyst.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) says Twitter, Facebook and smartphone apps could soon be used to gather adverse drug reactions (ADRs).
Higher than normal cancellations for Covance’s clinical business have persisted now for a couple of quarters, though that downturn has since normalized and CEO Joe Herring believes the company was just in a short-lived rut.
Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.
Cloud-based solution provider Medidata and CRO Icon have launched a joint initiative to bring new efficiency to the administration of electronic patient-reported outcomes (ePROs) in clinical trials.
The Natoli Engineering Company has opened an pharmaceutical research institute to look for answers to enduring formulation problems in solid oral dosage.
WIRB-Copernicus Group (WCG), a provider of regulatory and ethical review services for clinical research, announced today it has acquired New England Independent Review Board (IRB).
A little more than a year after it was acquired by private equity company KKR (Kohlberg Kravis Roberts & Co.) for $1.4bn, newly rebranded PRA Health Sciences is looking to go public with an IPO.
Protalix shares rocketed 18% then reversed in one weekend after the Israeli protein manufacturer clarified it is not in talks to produce Ebola drug ZMapp.
US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012.
Hyperion says it is “shocked and disheartened” after discovering Phase III trial data for a type 1 diabetes candidate was manipulated by employees of recently acquired Andromeda Biotech.
Strategic partnerships - always a hot-topic for CROs – are becoming almost exclusively a big issue for mid-sized biopharma, though small biopharma and large pharma companies are interested as well, Quintiles CEO Tom Pike said Monday at the Morgan Stanley...
CDMO (contract development and manufacturing organization) Catalent saw Q4 revenue rise 3% and income rise 66% thanks in part to an increase in its oral technologies segment.
