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Regulators in the U.S. and EU have paved the way for a new treatment approach to treat chronic hepatitis C, clearing highly anticipated new drugs from Gilead Sciences and Janssen/Medivir. Read More
Amgen’s first long-term trial for its next-generation heart drug evolocumab has shown positive results, heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More
The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
Finalized guidance on preclinical considerations for gene and cellular therapies, posted Monday, reiterates the agency’s position that sponsors should focus on five objectives in preclinical trials. Read More
Orphan drug incentives, new technology and anxiety over expiring patents have dramatically spurred investment into biotech products, with the number of large molecule, biologic drugs in development tripling over the past decade. Read More
GlaxoSmithKline said Nov. 6 that several new chemical entities identified through its novel drug discovery program, Discovery Partnerships with Academia, are close to being ready for clinical studies. Read More
The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More
To improve compliance in clinical trials, investigators need to find ways to accommodate individual patient needs and help trial participants understand the rationale behind protocols, an industry report says. Read More
Swiss drugmaker Roche plans to partner with Swiss-owned Polyphor to develop a drug that targets a leading cause of hospital-borne infections. Read More
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
AbbVie on Monday released the first of six SAPPHIRE Phase III trial results for its hepatitis C candidate, M11-646. The rosy results set the drugmaker up for regulatory filings in early 2014. Read More