Though it’s difficult to quantify, industry experts told investors at the BIO CEO conference in New York on Monday that the US FDA-industry interactions are improving though there’s still some inconsistency between FDA leadership, division directors and...
The anti-abortion group that blames Merck & Co for the recent US measles outbreak says it would not judge parents who have children vaccinated with MMR II for the good of society.
Most pharmaceutical companies are already behind on preparations for the EU Falsified Medicines Directive’s serialisation requirements for 2018, says one services firm.
Bangalore, India-based Apotex and Verna, India-based Micro Labs both received warning letters last month from the US FDA detailing data integrity questions linked to their quality systems.
The US Food and Drug Administration (FDA) is requesting a budget of $4.9bn for fiscal year (FY) 2016 – a 9% increase over the enacted budget for FY 2015.
The US CDC has recommended that doctors give people Tamiflu (oseltamivir) after detecting that this year's vaccines a less effective than in previous years.
Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as were included in the 2014 Cochrane Collaboration review.
Executives’ attitudes are shifting when it comes to supporting the idea that the FDA should evaluate drugs based on both clinical and economic effectiveness, a new PriceWaterhouseCoopers Health Research Institute survey found.
While Icon is adding 200 new jobs at a new innovation center in Ireland, PPD is looking to double its packaging warehousing capabilities and quadruple its distribution services on the island.
New hepatitis C drugs produced by Gilead, Janssen and AbbVie contributed to a first quarter spike in revenue for AmeriSourceBergen’s Pharmaceutical Distribution business.
US Pharma firms are prepared for delays in the supply chain caused by Winter Storm Juno thanks to advanced planning and backup generators, says a logistics expert.
Syriza's election victory may prompt drugmakers already burdened with unpaid Greek bills to rethink their presence in the country according to one analyst.
Biotec Services International, daughter company of clinical trial suppliers Packaging Coordinators Inc (PCI), has expanded its cold-chain storage and distribution capacity in response to client demand for a “one-stop shop”.
Drug industry execs at the World Economic Forum in Davos, Switzerland were told they are no longer best placed to develop antibiotics by a panel who said Governments should lead efforts to create these vital new drugs.
Draft guidance distinguishing wearable medical devices from ‘general wellness’ devices could slow pharma’s adoption of such data in the short-term, according to an analyst.
President Obama in his State of the Union address has called for the power to personally make stronger trade agreements – bringing divisive EU deal TTIP closer to adoption and angering campaigners for drugs access.
Rules governing when drugmakers should warn regulators about supply interruptions need to take mitigation plans into account according to European industry groups.
Following Wockhardt’s decision to cease supplying APIs to the EU market, the UK drug regulator MHRA (Medicines and Healthcare Products Regulatory Agency) has updated its statement of noncompliance to include all APIs made from the India-based manufacturer.
The value of the Swiss franc fluctuated today after the country’s central bank abandoned its minimum Euro exchange rate in a shock move that saw shares in Roche, Novartis, Actelion, SGS and Lonza fall.
Industry groups PhRMA, BIO and GPhA are petitioning the Supreme Court to overturn a local law that requires pharma companies to cough up payment for safe disposal of medicines which make their way to one county.
The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.
CROs, as well as sponsors, are receptive to, and plan to increase their use of ePRO (electronic patient reported outcomes), according to a survey published Monday from the Tufts Center for the Study of Drug Development.
Industry won’t see much of an initial impact from the US FDA’s newly formed Office of Pharmaceutical Quality, though in a couple of years the agency will have more benchmarks and new technology to find and single out the worst manufacturers.
The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra.
The record number of orphan drugs approved in Europe last year reflects the pharma industry’s need to refill pipelines and scientific advances says Genetic Alliance UK
Chinese service provider WuXi PharmaTech has acquired NextCODE Health, a US and Icelandic genomic analysis and bioinformatics company, for $65m in cash.
Regulatory enforcement saw fewer counterfeit drug websites in 2014 but sellers are turning to YouTube and social media sites to advertise their products, according to the MHRA.
India’s CDSCO (Central Drugs Standard Control Organization) has released a new draft bill that would amend the country’s landmark law governing pharmaceuticals from 1940.
Certara subsidiary and regulatory and medical consultancy Synchrogenix has acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Terms of deal were not disclosed.
The agency issued a warning letter and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.
