A Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns the products are not sterile and may contain bacteria, Food and Drug Administration officials said Sunday.
More than half of those trials targeted six of the most debilitating chronic diseases — asthma, cancer, diabetes, heart disease, mental illness and stroke — and led to safer and more effective treatments, according to the report presented by Gov. Paul LePage, the drug industry and business leaders.
The Office of Fair Trading alleges GlaxoSmithKline concluded agreements which infringed competition law with Alpharma Limited, Generics (UK) Ltd and Norton Healthcare Ltd. over the supply of paroxetine, a cheaper version of Seroxat. The watchdog says GSK's conduct amounted to an abuse of its dominant position in the same market.
The Justice Department said Amgen paid kickbacks to Omnicare Inc. and PharMerica Corp., which sell drugs to long-term care providers like nursing homes and hospitals, and Kindred Healthcare Inc., which runs long-term acute care hospitals and nursing and rehabilitation centers.
Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others.
The Food and Drug Administration said late Tuesday it would not approve any generic versions of OxyContin based on the original formulation because it "poses an increased potential for certain types of abuse." The FDA decision is a key victory for Purdue Pharma LP, which spent years developing a tamper-resistant version of the blockbuster pain pill.
The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster drug Avandia, which was severely restricted in 2010 due to concerns about its impact on the heart. Regulators announced the highly unusual move in a government notice published on Friday.
Royalty Pharma says Monday that it's raising its bid for Irish drugmaker Elan Corp. PLC to as much as $12 per share, or $7.2 billion. Royalty Pharma, a private company based in New York, offered in February to buy the company for $11 per share, or about $6.5 billion. Elan rejected that bid.
Drug developer XenoPort Inc. said Friday that there's a shortage of its restless leg syndrome treatment Horizant. The company said it's received word from patients unable to fill their Horizant prescriptions. XenoPort hopes that a new stock of Horizant will be in pharmacies in June, but the timing is uncertain.
The Food and Drug Administration says it has uncovered troubling sterility problems at 30 specialty pharmacies that were inspected following a recent outbreak of meningitis caused by contaminated drugs. The agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs.
Lilly spokesman Scott MacGregor declined to disclose the specific number of cuts, which will happen by July 1, but did say it totals less than 1,000 full-time employees. Lilly, which is headquartered in Indianapolis, had about 17,150 U.S. employees at the end of last year and 38,350 total.
Drug maker Bristol-Myers Squibb Co. has announced a $250 million expansion of its central Massachusetts manufacturing complex that will eventually employ an additional 350 workers. The expansion announced Thursday will add space for developing biotechnology drugs, called biologics, and for manufacturing those products for clinical trials.
Online court records say 42-year-old Hua Jun Zhao was indicted Tuesday on charges of computer fraud and lying to a federal agent. A previous charge of economic espionage was superseded by the indictment, meaning it no longer applies unless he's indicted on that charge as well.
Generic drugmaker Actavis Inc. and brand-name drugmaker Valeant Pharmaceuticals International Inc. said Wednesday they have reached agreements allowing Actavis to sell copycat versions of two medicines for skin conditions years before their patents expire.
A treatment pulled off the market 30 years ago has won Food and Drug Administration approval again as the only drug specifically designated to treat morning sickness. That long-ago safety scare, prompted by hundreds of lawsuits claiming birth defects, proved to be a false alarm.
Obagi Medical Products Inc. said Wednesday that Canadian drugmaker Valeant Pharmaceuticals boosted its offer to buy the dermatology products maker, topping a bid made a day ago by a German rival. Obagi said it struck a deal with Valeant Pharmaceuticals International Inc. that calls for it to pay $24 per share, or a total of about $418.3 million, for the company.
BIND Therapeutics said Wednesday that Pfizer Inc. has agreed to pay it $160 million per drug as part of a collaboration to develop targeted medicines using nanotechnology which use particles measured in billionths of a meter. BIND is developing an experimental group of targeted, programmable medicines called Accurins to treat cancer, heart disease and inflammatory disorders.
Late last month, Valeant struck a deal with Obagi to pay $19.75 per share, or a total of about $343.7 million, for the company. Merz said Tuesday that it had been in private talks with Obagi before that deal was announced and wasn't aware that it was considering signing a deal with another company so quickly.
A federal lawsuit alleges that thieves who broke into an Eli Lilly and Co. warehouse in Connecticut three years ago and stole more than $60 million worth of drugs obtained a copy of a report that revealed weaknesses in the building's security system.
The drugmaker also plans to spend about $80 million on some other projects, including a product inspection center. A company spokesman said the city's metropolitan development commission must approve tax abatements before construction can start.
India, Indonesia and some other developing countries have been bucking that trend. They've been shooting down Western patents and licensing local pharmaceutical companies to make cheap generic versions of medicines that most of their residents otherwise could not afford.
India's Supreme Court on Monday rejected drug maker Novartis AG's attempt to patent an updated version of a cancer drug in a landmark decision that health activists say ensures poor patients around the world will get continued access to cheap versions of lifesaving medicines.
Irish drug and medical device maker Covidien said Friday that a federal court in Connecticut has awarded it $176.5 million after ruling that a Johnson & Johnson unit infringed on three of its ultrasonic surgical products patents. The lawsuit against J&J's Ethicon Endo-Surgery Inc. was related to Ethicon's Harmonic line of ultrasonic surgical products.
The move is part of a fast-growing trend among major international pharmaceutical companies to put factories and research centers in emerging markets that the industry increasingly is targeting for growth. Paris-based Sanofi said it plans to spend about $75 million to build the factory in Ho Chi Minh City.
The treatment, a tablet that quickly dissolves under the tongue, could become the first alternative available in the U.S. to getting a long series of uncomfortable allergy shots. Both methods work by gradually desensitizing the patient's immune system to the substance triggering the allergic reaction.