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A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Read More
India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing practice (cGMP) violations. Read More
The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Read More
The International Council on Harmonisation (ICH) has released a draft guideline on good clinical practice (GCP), designed to facilitate acceptance of clinical trial data by ICH member countries and regions. Read More
Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
An FDA advisory committee turned down Intercept Pharmaceuticals’ push for an Accelerated Approval for its fatty liver drug Ocaliva (obeticholic acid) by a 15-1 vote, but did leave the door open for full approval if data from an ongoing phase 3 trial show Ocaliva’s benefits outweigh its risks. Read More
Center for Biologics Evaluation and Research (CBER) Director Peter Marks and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni laid out their centers’ current priorities and how they’re tackling ongoing challenges in separate sessions at the FDLI Annual Conference, May 17-18. Read More
Marketing authorization holders, wholesalers, distributors and manufacturers should have a shortage prevention plan specific to their role and strengthen the reliability and resilience of their supply chains to help prevent a drug shortage, according to a new guidance from the European Medicines Agency. Read More
The U.S. Supreme Court (SCOTUS) on Thursday struck down Amgen’s attempt to revive patents on its cholesterol medicine Repatha (evolocumab), effectively preventing the company from monopolizing an entire class of drug antibodies. Read More
The FTC and Congress were on the same drug pricing track this week as the trade commission extended an inquiry into pharmacy benefit managers’ (PBM) impact on the cost of prescription drugs and a House subcommittee unanimously voted in favor of a bill requiring hospitals to identify standard charges, including drugs. Read More