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The U.S. Food and Drug Administration said...that it had approved Otsuka Pharmaceutical Co Ltd’s Abilify MyCite, the first drug with a digital ingestion tracking system to be approved in the United States...The product, which uses digital tracking to record if the medication was taken, has been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults...The system sends a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application, so that patients can track the ingestion of the medication on their smartphone.

Gilead Sciences Inc….secured U.S. approval for its newly acquired CAR-T therapy, giving adult patients with a certain type of lymphoma and few other options a promising new treatment that offers the hope of remission for some...The regulatory OK...puts Gilead at the forefront of cancer cell therapy development and validates the biotech's decision to buy the drug's original developer, Kite Pharma Inc...Gilead will market the therapy under the brand name Yescarta (axicabatagene ciloleucel) at an annual cost of $373,000 — a price that underscores the affordability challenges presented by the personalized nature of CAR-T treatment…Throughout the development of Yescarta, Kite stayed neck and neck with the larger and well-resourced Novartis AG. While Novartis can claim the landmark of winning the first ever approval of a CAR-T therapy, Gilead's near $12 billion takeover of Kite is a worthy second prize.

The European Medicines Agency...warned that it could lose a majority of its staff based on which of the 19 cities vying to host the medicines regulator is selected by the European Council in November, threatening the pace of new drug approvals even in best-case scenarios for at least two years...Based on the results of a survey completed by 92% of EMA’s staff earlier this month, the agency says it could lose between 19% and 94% of its staff depending on which city is selected as its future host. Politico first reported that Amsterdam is the top choice among EMA staff...After Amsterdam, just three additional unnamed cities are projected to provide enough cover to maintain the regulator’s basic safety monitoring mission. “For certain locations staff retention rates could be significantly less than 30% [retention]. This would mean that the Agency is no longer able to function and, as there is no backup, this would have important consequences for public health in the EU,” the EMA says...In the worst cases, EMA says it would be “unable to operate” and the EU and member states would need to implement emergency measures to protect public health, such as relying on third countries for approval decisions.

The CEO of a herpes vaccine company at the center of a controversy over an offshore clinical trial,,,said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel...In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford's decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board, as is traditional...Fernandez...said that he now understands it is necessary from now on to conduct further trials following FDA oversight standards if Rational Vaccines hopes to market the vaccine in the United States...

Nineteen EU governments will slug it out in a series of secret ballots in 10 days’ time for the right to host the European Medicines Agency once it leaves London after Brexit...Confirming that none of the cities, from Porto to Helsinki, has dropped out of the running...those organizing it confessed they had no idea how long the voting would take...The EMA itself has warned that moving to some of the cities on the list -- sources have said notably those like Warsaw or Sofia in eastern Europe -- would see so many of its 900 London staff quit that it would harm Europe’s health. Top choices for employees are Amsterdam, Vienna and Barcelona...States agreed to a number of criteria, including that cities chosen should offer premises ready for a start in March 2019, when Britain leaves the EU, be accessible from across Europe and take account of “geographical spread” -- the fact newer members in the east host fewer agencies than richer neighbors.

China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices...It’s the latest in a string of regulatory initiatives implemented by Chinese authorities that could be a boost for international biopharma companies as well as Chinese patients, who sometimes have to wait six or seven years after launch in Western markets for drugs to be launched in China...The country’s huge and increasingly affluent population is facing an ever-growing burden of chronic diseases like cancer and diabetes, and the government has been under pressure to improve access to healthcare and new medicines...The latest wide-ranging set of proposals...recognizes that China is lagging behind other countries when it comes to approving new drugs. It’s approved 100 innovative new drugs in the last five years, around a third the number in developed markets...

In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market...A new analysis in the New England Journal of Medicine concludes that, in many cases, that’s not being done...among the 614 studies mandated in 2009 and 2010, 20 percent were never started and 9 percent have been delayed...When drugs are approved, the trials are usually small and short-term, and some side effects may not emerge until the post-marketing phase...The problem is, the faster you get them on the market, the more open questions there are about their safety or the best dose...In some cases, the FDA has simply dropped a requirement for a postapproval study without giving a reason...

The Food and Drug Administration is likely to take new actions on opioids that may be "disruptive" and "uncomfortable" to drugmakers, the agency's commissioner (Scott Gottlieb) said...In addition to seeking to treat opioid-addicted patients with alternative medications that don't produce a high, the FDA says it will look at ways to reduce exposure to the drug. That includes new ways of packaging and distribution..."For example, it's possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed,"..."We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," Gottlieb told "Squawk Box." "But we have to take more vigorous action to get ahead of this."...Gottlieb said the agency is having discussions with drug companies about the new packaging solutions..."Something like this could move potentially quickly," he said. "We're invested in taking a hard look at this and seeing what the opportunities are."...

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

FDA commissioner Scott Gottlieb has sounded a crystal clear warning over the high — and growing — cost of drug development. And in a speech to regulatory execs...Gottlieb committed the FDA to backing up more efficient drug development programs with new measures to clear the regulatory path for developers barreling ahead to relatively swift pivotal data in search of an accelerated OK...Gottlieb started by outlining a bleak picture in drug R&D, noting that the economic model for drug development is broken. It costs too much to develop a drug so it can be approved for marketing. And costs are swelling fast at the discovery end of the business, which will help swamp a system that already doesn’t work particularly well...Gottlieb held up some of the rapid-fire clinical trials we’ve been seeing in the cancer field as a model for what can work, paving the way to the accelerated approval pathway at the FDA. And he believes...that moving drug development into the fast lane can reduce R&D costs and thereby allow biopharma companies to pass on savings to patients through lower costs.