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The European Medicines Agency is encouraging drugmakers looking to apply novel drug development tools to seek the EMA’s blessing first and get qualification or prospective advice. Read More
Forest Laboratories is acquiring N.J.-based drugmaker Aptalis from global investment firm TPG in a deal worth $2.9 billion, the companies said Wednesday. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
FDA Commissioner Margaret Hamburg has named Howard Sklamberg as the agency’s new deputy commissioner of global regulatory operations and policy. Read More
The Centers for Medicare & Medicaid Services (CMS) plans to force makers of antidepressants and immunosuppressants to compete for inclusion on Medicare Part D formularies, which it hopes will compel drugmakers to lower prices. Read More
The FDA has set a deadline of November 2014 to revise its current good manufacturing practice (cGMP) regulations to strengthen its oversight of pharma supplier quality. Read More
A champion in the global fight against counterfeit drugs is adding an unusual voice to growing calls for relaxing the U.S. ban on the personal importation of prescription drugs. Read More
The drug industry wants the FDA to drop plans to require drugmakers to report manufacturing stoppages that will result in shortages within five days of the stoppage occurring. If any timeline is imposed, 15 days is adequate, industry says. Read More