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French authorities in December fined Merck US $21.5 million for attempting to stall market entry of generic versions of its opioid-dependence drug Subutex. Read More
Foreign pharma can continue to invest directly in existing Indian drug companies, provided there is no “noncompete” clause in the transaction, the government says. Read More
Transparency and bribery — ying and yang — all but dominated global pharmaceutical headlines in 2013. “Sunshine” was cast on regulatory authorities and drugmakers in the U.S. and European Union. A number of industry associations and some individual companies also took steps to operate more transparently. The moves came as a major bribery scandal made waves in China, bringing pressure for more punishing antibribery rules. Meanwhile, the EU and India pushed forward with new clinical trial controls, and U.S. track-and-trace efforts advanced. With 2014’s script still a work in progress, take a look back at 2013 and use its lessons to plan your business strategy for the coming year.Read More
Drugmakers that market products in Brazil have two years to present Anvisa with a full report of traceability of at least three batches, according to a resolution published in the Dec. 11 Official Journal. Read More
At least 75 percent of clinical trials are extended by six weeks or more because of failure to enroll enough patients, a new study finds, but help may be on the way in the form of “big data.” Read More
The FDA’s ban on the sale of prescription acetaminophen/opioid combination drugs that use more than 325 mg of acetaminophen per tablet went into effect Tuesday, and the agency will soon begin withdrawing approvals for products made by companies defying the ban. Read More
State governments are continuing their push to regulate compounding pharmacies, placing tighter restrictions on those compounders who stay out from under the voluntary regulations imposed by the Drug Quality and Security Act. Read More
Generic and brand drugmakers are urging the FDA to drop plans to require them to report manufacturing stoppages expected to result in shortages within five days of the stoppage occurring. Read More
With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. Read More
Dramatic spikes in the prices consumers and pharmacies are paying for generic drugs — as much as a 1,000-percent increase in some cases — have sparked a Senate investigation into generic drug pricing practices. Read More