U.S. Bans Import of Ranbaxy Drugs From Indian Plant

Citing concerns about drug quality, the Food and Drug Administration on Monday announced a ban on imports of any products made at the generic drug maker Ranbaxy’s newest factory in India.

The move is the third time Ranbaxy imports have been blocked in the United States since 2008.

The factory in Mohali, in the Punjab region of India, is not currently producing any products sold in the United States, according to the Food and Drug Administration.

But the recently renovated facility was to be the centerpiece of Ranbaxy’s comeback from years of major manufacturing lapses, so the news that it, too, would now be prohibited from making drugs destined for the United States sent investors fleeing on Monday.

Ranbaxy’s stock fell by 30 percent, to 318.5 rupees ($4.99), in Mumbai on Monday and financial analysts predicted the development could slow the introduction of several products, including the generic version of the best-selling blood pressure drug Diovan, which has already been delayed for a year. Ranbaxy is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo.

The F.D.A. said it decided to issue the ban after agency inspectors uncovered significant manufacturing violations at the Mohali facility in September and December of last year. It said the company would be required to hire an outside expert to inspect the Mohali factory and certify that it met the agency’s standards before the restrictions were lifted.

A spokesman for Ranbaxy declined to comment on Monday. Ranbaxy officials have said they are awaiting further details from the F.D.A.

Ranbaxy has been operating under a federal consent decree with the F.D.A. since last year. In May, the company pleaded guilty to federal drug safety violations as part of a $500 million settlement that was the largest in history involving a generic manufacturer and drug safety. As part of the settlement, Ranbaxy admitted that it had failed to conduct proper safety and quality tests of drugs made at its Indian plants. Two other Ranbaxy plants have been operating under an import ban since 2008.

In spring 2012, Ranbaxy began exporting generic Lipitor to the United States that was manufactured at Mohali, a facility the company said in a news release at the time was “equipped with the latest state-of-the-art technology.” But late last year, the company halted all production of generic Lipitor after tiny pieces of glass were found in the tablets. When sales resumed in March, the drug was being manufactured at the company’s Ohm Laboratories facility in New Jersey.

Despite the Lipitor setback, some investors had held out hope that the company would make a comeback by selling exclusive copies of best-selling drugs, many of them manufactured at the Mohali facility.

Several analysts speculated that the F.D.A’s action could further delay the debut of generic Diovan, a hypertension drug by Novartis that lost its patent protection one year ago. Ranbaxy has the exclusive right to sell the generic version of the drug for six months, but the F.D.A. has not given final approval. A competing generic company, Mylan, unsuccessfully sued the F.D.A. last year to force the agency to revoke Ranbaxy’s exclusive rights.

Ranbaxy and the F.D.A. have not said where generic Diovan would be manufactured, but the analysts Nitin Agarwal and Param Desai of IDFC Securities in India said in a note Monday that the ban on the Mohali plant was likely to put further pressure on Ohm Laboratories, which they said was now Ranbaxy’s only manufacturing plant selling products to the United States market. “The facility is already running at full capacity,” they wrote in the note, in which they also downgraded the stock to underperform. “The alert on Mohali facility will hurt future approvals.”

Drugs at Music Festivals Are Threat to Investors as Well as Fans

Since March, at least seven young people attending dance events around the country have died after exhibiting symptoms consistent with overdoses from MDMA and other so-called party drugs, often called ecstasy or molly. This month, the Electric Zoo festival on Randalls Island was shut down at the request of New York City officials after two patrons died, apparently from MDMA overdoses, officials said.

Executives say that deaths like these have the potential to scare off investors and the corporate sponsors that are eager to reach the genre’s young, affluent and technologically connected fans.

The ecstasy-related deaths come just weeks before an expected initial public offering by SFX Entertainment, a new company whose fortunes are predicated on sponsorship and media deals for electronic dance music, or E.D.M. According to its prospectus, SFX wants to raise as much as $300 million through its I.P.O., much of it to acquire promoters like Made Event, the company behind Electric Zoo.

Festivals draw tens of thousands or even hundreds of thousands of fans to see well-known D.J.’s like David Guetta, Tiesto and Deadmau5, with top festivals charging up to $300 for two or three days of music. Defenders of the dance world say they are being singled out by the news media. Drugs and overdoses, they say, have long been associated with popular music. For example, 10 people have died since 2002 at the Bonnaroo festival in Tennessee, many from drug-related causes.

“The scrutiny that this is going to come under because of the stock market deal with SFX, it’s like a magnifying glass that’s unfair,” said Amy Thomson, the manager behind Swedish House Mafia, one of the genre’s most successful acts.

Robert F. X. Sillerman, the chief executive of SFX, said in an interview that his company was committed to providing a safe environment, and that as dance music “has grown from uncontrollable rave parties to professionally run festivals and events, it in fact provides the opportunity to provide health and safety guidance.”

He declined to discuss business details, citing the mandatory “quiet period” before the I.P.O. But TomorrowWorld, a festival near Atlanta this month in which SFX is a majority partner, is working with DanceSafe, a nonprofit group, to provide educational information about the dangers of drug use, said Shawn Kent, one of the executives behind the event.

SFX seemed to anticipate the need for greater medical care when it appointed to its board Dr. Andrew N. Bazos, an orthopedic surgeon with experience in “comprehensive medical coverage for large-capacity venues,” according to its prospectus.

Drugs have been linked to the mythology and slang of dance culture for decades, and the current ecstasy scare reflects an earlier wave in the 1990s when cities around the country cracked down on illegal raves. Today, stars like Miley Cyrus and Kanye West allude to molly in songs, and the term turns up repeatedly at festivals, on T-shirts, banners or body paint.

Among the deaths in recent months is that of Matthew Rybarczyk, a 20-year-old from Staten Island, who collapsed with a 107-degree temperature at a Governors Island rave on July 14.

When Mr. Rybarczyk’s grandmother saw him in the hospital the next morning, he was contorted unrecognizably and was bleeding from his nose and mouth; he died 14 hours later. The medical examiner found methylone in his system, an ecstasylike drug sometimes sold as molly.

“It was the saddest thing of all to watch him die,” his grandmother, Peggy Rybarczyk, said. “He went to have a good time and he never came home.”

A growing history of drug-related deaths has not slowed the genre’s popularity. In 2010, a 15-year-old girl died from an overdose of ecstasy at Electric Daisy Carnival in Los Angeles, but the festival has since spread around the country and even to London. This year, Live Nation Entertainment, the world’s biggest concert company, bought half of Insomniac, the company behind the festival, for a reported $50 million.

In an interview, Pasquale Rotella, Insomniac’s founder, defended his company’s security measures, and said that dance promoters, to some degree, “inherit societal problems.”

But he and others in the industry admitted that the negative perceptions had kept away sponsorship money.

“If you look at dance festivals in general, you don’t typically see a ton of branding yet,” said Edward H. Shapiro, a lawyer who works with dance acts. “Part of that has been this notion that it isn’t an environment that is ripe for really big brands to participate in.”

Many of the most prominent branding deals in the electronic dance music world have been tied to artists, including Absolut Vodka with Swedish House Mafia, and Pepsi with the D.J. Calvin Harris. But for even the most popular dance festivals, the sponsor rosters are dwarfed by those of comparable rock and pop events, like Lollapalooza or Coachella.

The sponsors of Electric Zoo this year included Coors Light and Blue Moon beers, owned by Molson Coors; Vita Coco, a coconut water drink; and Hi-Chew, a fruit-flavored snack. Constellation Brands, whose Pacifico beer was also a supporter, said in a statement that its sponsorships “are focused on providing a peaceful, safe and responsible environment for fans 21-and-older to enjoy our product, and are made on a case-by-case basis.” Other sponsors have not commented.

Most major festival promoters have zero-tolerance drug policies, and their sites have security checks, free water stations, first-aid tents and ambulances on call. Such measures are essential for insurance purposes and are often required by state law for any large gathering.

No promoter can prevent all drugs from entering a festival site, nor can do they do anything about drugs consumed before an attendee walks through the gate. Yet many in the dance world think promoters and stars need to do more to discourage it.

“I don’t think we should be scared of saying ‘don’t do drugs,’ ” said A-Trak, a top D.J. “There is this sort of elephant in the room, where people are scared to say, ‘That stuff is dangerous and don’t mess around.’ ”

But Armin van Buuren, another popular D.J., said that Electric Zoo was one of the better-run festivals he had attended, with plenty of security and medical personnel.

“For some reason we have the stamp of drug misuse and I think that it’s unfair,” he said. “It ruins the party for a lot of other people.”

European Regulator Finds Little Risk in Diabetes Drugs

Regulators in Europe have concluded that there was little evidence that widely used drugs to treat Type 2 diabetes could cause pancreatic inflammation or pancreatic cancer, a finding that might reassure patients while also removing a potential sales threat for Merck and some other drug companies.

“Presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines,” the European Medicines Agency said in a news release on Friday.

Both the European agency and its American counterpart, the Food and Drug Administration, have been reviewing the safety of a big class of drugs that includes Merck’s Januvia and the drugs Byetta, Bydureon and Onglyza, which are sold by Bristol-Myers Squibb and AstraZeneca.

The F.D.A. has not yet released its conclusions.

The concerns have been raised over the last few years mainly by Dr. Peter Butler, the chief of endocrinology at the University of California at Los Angeles. Dr. Butler has been hailed by some drug safety watchdogs as a hero for standing up to the drug companies but criticized by many diabetes experts as a zealot.

In his latest study, the one that triggered the reviews, Dr. Butler and colleagues examined the pancreases from 34 organ donors, some with diabetes and some without, who had died from causes other than diabetes. They found that the pancreases of the people who had used Januvia or Byetta tended to have more signs of inflammation and precancerous cellular changes than the pancreases from diabetics who had not taken those drugs and those from nondiabetics.

But the European Medicines Agency said Friday that the study had “a number of methodological limitations and potential sources of bias.” The donors who had taken Januvia or Byetta were older and had diabetes for far longer than the diabetics who had not taken the drugs, making it difficult to draw conclusions on the possible effects of the drugs.

The agency said the prescribing information for the drugs already contained warnings about pancreatic inflammation, known as pancreatitis. It said clinical trials had shown no increased risk of pancreatic cancer, though that the trials were too small to draw firm conclusions. It said “some uncertainties remain’’ regarding the long-term effects of the drugs, but much larger trials are under way to answer those questions.

The drugs involved, which the F.D.A. calls incretin mimetics and the European agency calls GLP-1-based therapies, effectively increase the body’s levels of a hormone called glucagon-, like peptide-1, which helps control blood sugar levels. Some of the drugs, known as GLP-1 agonists, mimic the effect of the hormone, while others, known as DPP-4 inhibitors, slow the breakdown of the body’s own hormone.

Collectively, the drugs had more than $9 billion in global sales last year, led by Merck’s Januvia and a related drug, Janumet, which together had sales of $5.7 billion. Other drugs include Victoza from Novo Nordisk and Tradjenta from Eli Lilly and Boehringer Ingelheim.

Public-Private Effort Seeks to Expedite Discovery of Autism Drugs

Under a contract with the institute, U.C.L.A. will form a network of researchers at other academic centers that will try to identify promising new and older drug compounds quickly, and conduct early tests to see if they merit additional investment.

The program, part of the “Fast Fail” initiative at the institute, aims to determine within weeks whether a drug works, rather than the years it traditionally takes to evaluate a new drug.

“The whole idea is just getting much better in these early phases at identifying drugs that are going to be efficacious and safe, and thereby greatly speeding the development of effective new therapies and reducing the overall cost,” said Dr. James McCracken, who is leading the effort at U.C.L.A. as director of the division of child and adolescent psychiatry at the Semel Institute for Neuroscience and Human Behavior.

The number of diagnosed cases of autism, Asperger’s syndrome and related disorders in children has been growing in recent years, largely because of increased awareness. A recent report by the Centers for Disease Control and Prevention and the Health Resources and Services Administration concluded that one in 50 children aged 6 to 17 had been found to have autism or a related disorder, a 72 percent increase since 2007.

Although more cases are being diagnosed, no drugs are approved to treat the core symptoms of the disorders, which are characterized by delays in developing effective communication and social skills. Other drugs often prescribed to people with the disorders treat difficult behaviors like aggressiveness, hyperactivity and irritability.

Dr. McCracken said developing effective treatments had been difficult because the underlying causes were poorly understood until the last few years, and some prominent efforts had failed. In 2004, the experimental drug secretin, developed by RepliGen, did not show that it worked in an advanced clinical trial, disappointing parents of children with autism who had placed their hopes in the drug.

Several major drug companies, including GlaxoSmithKline and AstraZeneca, have scaled back their research in the neurosciences because of the high failure rate, Dr. McCracken said.

Developing drugs to treat neurological disorders is difficult, in part because brain science is still evolving. The field is littered with drugs that scientists had hoped would be effective against diseases like Alzheimer’s and schizophrenia but that performed poorly in clinical trials.

Despite the setbacks, scientific advances in understanding the genetic underpinnings of autism have accelerated, leaving the door open for new drug discoveries, said Robert H. Ring, vice president of translational research at Autism Speaks, a patient advocacy group.

“Autism spectrum disorder is the brave new world of medicine development, and most companies out there — despite a lot of the retraction you’re seeing — they do recognize autism as a clear area of opportunity,” said Mr. Ring, who serves on a committee that helps select which compounds the U.C.L.A. program will test.

Some companies are pursuing treatments. Seaside Therapeutics, a private company in Cambridge, Mass., is developing drugs to treat autism and a form of mental retardation known as fragile X syndrome in a partnership with Roche.

“The approach that people have taken over the years is, ‘This person looks anxious, I’ll give them a drug I use to treat anxiety,’ ” said Dr. Randall L. Carpenter, a co-founder of Seaside and its chief executive. “We hope to treat the underlying molecular abnormality.”

Dr. McCracken said the program would identify four to eight compounds and run them through small trials in humans, testing how the drugs are absorbed and how they affect brain wave patterns that scientists say they believe are linked to autism.

“It’s taken a really long time to kind of crack open and begin to understand part of the disorder of brain biology that underpins autism,” Dr. McCracken said. “This is, to me, the most exciting time because we understand so much more than we did even five or 10 years ago.”