MADRID (Reuters)—The likely relocation of the European Medicines Agency (EMA) from London threatens to disrupt the approval of new drugs and is a medium and long-term worry for top Spanish drugmaker Almirall, its chief executive says on Monday. The EMA, Europe’s equivalent the U.S. Food and Drug Administration, approves medicines for all European Union countries…
French Prosecutors Open Probe into Fatal Drug Trial
PARIS (Reuters)—Paris prosecutors said on Tuesday they have begun an involuntary manslaughter investigation into a failed drug trial that left one dead and five hospitalized in January. The prosecutors’ office said the investigation had been opened to determine whether there was a criminal element in any mistakes made or whether it was simply the result…
The ACR’s Collaboration with International Rheumatology Associations Promotes Progress
More than 10 years ago, New York Times journalist Thomas Friedman opined an old-world perspective that the world is, in fact, flat. In an article published on April 3, 2005, Mr. Friedman contended that “Individuals must, and can, now ask: Where do I fit into the global competition and opportunities of the day, and how…
FDA Seeks Suspension of 4,402 Illegal Prescription Drug Websites
(Reuters)—The U.S. Food and Drug Administration said on Thursday it, along with international authorities, has formally sought to suspend 4,402 websites that illegally sell potentially dangerous, counterfeit or unapproved prescription drugs to U.S. consumers. The move is part of a global effort being led by the INTERPOL, the world’s largest police organization, to identify the…
Sun Pharma Gets U.S. Subpoena over Generic Drugs Pricing
MUMBAI (Reuters)—The U.S. Department of Justice (DOJ) has subpoenaed India’s largest drugmaker Sun Pharmaceutical Industries Ltd. seeking information about the pricing and marketing of the generic drugs it sells in the U.S., the company said on Saturday. The DOJ’s antitrust division has also asked Sun Pharma’s U.S. unit for documents related to employee and corporate records…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…
U.K. Cost Body Finally Approves Limited Use of GSK’s Lupus Drug
LONDON (Reuters)—Britain’s healthcare cost watchdog has finally approved GlaxoSmithKline’s lupus drug Benlysta (belimumab) for limited use, after rejecting it since 2011 on the grounds that it failed to offer good value for money. The National Institute for Health and Care Excellence (NICE) said on Tuesday that the drug would be made available under a managed…
France Gets G7 to Discuss Global Regulation of Medicine Prices
PARIS (Reuters)—France will press its G7 partners this month to launch an “irreversible” process to control the prices of new medicines, part of a global drive to make life-saving drugs more affordable, three sources told Reuters. President Francois Hollande said in March he would push for the international regulation of drugs prices when he meets…
Europe Launches New Fast Approval Scheme for Promising Drugs
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
U.S. & EU Regulators Urge Indian Drug Companies to Step Up Standards
MUMBAI (Reuters)—U.S. and EU drug regulators called upon India’s pharmaceutical sector on Tuesday to step up efforts to improve manufacturing standards and ensure the reliability of data if it is to maintain its dominance in the generic drugs industry. India’s $15 billion pharmaceutical industry, an increasingly important global supplier of cheaper generic medicines, has been…
- « Previous Page
- 1
- 2
- 3
- 4
- 5
- …
- 8
- Next Page »