The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events. In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make  final preparations  to ensure that their processes and IT infrastructures can work with the new...

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...

Rep. Gus Bilirakis (R-FL) on Monday reintroduced a bill that would grant drugmakers an additional six months exclusivity for repurposing already-approved drugs to treat rare diseases. The bill, known as the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act , was initially included in the 21st Century Cures Act , but was removed before it was signed into law last year. The additional exclusivity for new orphan indications under the OPEN Act w...

Ten years after the development of the conditional marketing authorization (CMA) pathway, European Medicines Agency (EMA) on Monday said the program is working as intended, and has led to earlier patient access to 30 drugs, nearly half of which were for orphan indications, and 80% of which target seriously debilitating or life-threatening conditions. Additionally, EMA says that the majority of products granted conditional marketing authorization were either for indicatio...

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public be considered in violation of the law or US Food and Drug Administration (FDA) regulations? FDA on Wednesday attempted to answer these questions and more with the release of two new draft guidance documents and a 63-page memorandum on public health interests and First Amendment considerations related to off-label communica...

The US Food and Drug Administration (FDA) on Monday raised some eyebrows with its approval of another long-acting opioid, Egalet’s Arymo ER (morphine sulfate extended-release tablets), with abuse-deterrent properties. What makes this approval unique is not only the oddly-worded FDA explanation of an another opioid's marketing exclusivity in relation to this approval, but the agency overriding a nearly unanimous advisory panel of outside medical experts. Back in August,...

Galena Biopharma on Monday disclosed in an SEC filing that the US Attorney’s Office for the District of New Jersey and the US Department of Justice (DOJ) are pursuing a criminal investigation, in addition to a previously announced civil investigation, related to the marketing and promotion of its deadly opioid Abstral (fentanyl), which the company sold for $8 million upfront in 2015. The details of the criminal investigation have not been disclosed. “There also have b...

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. The policy was informed by an FTC workshop held last year to examine how such drugs are marketed to consumers. The FTC also released its  staff report on the workshop , which summarizes the panel presentations and related public comments in addition to describing...

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics. As for the new medicines, CHMP recommended granting a marketing authorization to CSL Behring’s Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with hemophilia A, Novo Nodisk’s Fiasp (...

The majority of ongoing postmarketing requirements (PMRs) and postmarketing commitments (PMCs) from Fiscal Years 2013 and 2014 were on schedule, but a large number of companies are still struggling to meet some of these regulatory requirements on time, the US Food and Drug Administration (FDA) said in a new report issued Friday. The slew of data released by FDA offer a murky look at how drugmakers meet such postmarket requirements once a new drug or biologic is ...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Government Plans Significant Increase in Regulatory Oversight of Antibiotics The United Kingdom government expects regulatory oversight of veterinary antibiotics to increase significantly in the future. Ministers singled out the enactment of legislation that restricts or bans the veterinary use of antibiotics that are of critical importance to people as one of the ...

Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain. Madigan alleges that Insys illegally marketed its painkiller to doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists...