Policy & Regulation News

Mylan's Matrix Laboratories Limited has received approval from the U.S. FDA for its generic version of Wyeth's Protonix? DR Tablets.

The U.S. Food and Drug Administration today approved Viibryd tablets to treat major depressive disorder in adults.

The U.S. FDA is asking manufacturers of prescription combination products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule.

The FDA approved 21 new drugs last year--fewer than both 2009 and 2008. Among these approvals six are biologics and 15 are small molecule drugs.

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from FDA for its supplemental New Drug Application a lower-volume (0.5mL) injection of glatiramer acetate.

Congressional investigators want the FDA to broaden its probe of Johnson & Johnson's manufacturing to include contract manufacturers as well as company facilities.

EMA has issued an opinion recommending approval of Teysuno? (S-1), a novel oral anti-cancer agent, for treatment in adults with advanced gastric cancer when given in combination with cisplatin.

FDA announced that the agency is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

The European Medicines Agency has confirmed that the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.

FDA inspectors aren't convinced that Johnson & Johnson ($JNJ) is doing enough to fix problems at its troubled Fort Washington, PA, plant.

FDA says it's time for the agency to get with the R&D program, issuing new draft guidelines aimed at speeding development work by encouraging joint applications.

The U.S. Food and Drug Administration is warning that accidental ingestion of Tessalon (benzonatate) by children younger than 10 years can result in serious side effects or death.

How much liability do generics makers bear? That's one question the U.S. Supreme Court says it will answer next year.

At a 2-day meeting next week of a federal dental products panel, there will be no vote on whether to ban or restrict the use of dental amalgam.

An FDA advisory panel endorsement can make a big difference for a biotech company, especially if the vote puts you in the lead of a hotly contested drug development race.

The FDA has posted on its web site a letter it sent to Allergan, Inc. for direct mail regarding the company's eye drug Lumigan.

Bristol-Myers Squibb Company announced that FDA has accepted for review a supplemental Biologics License Application (sBLA) for the subcutaneous formulation of ORENCIA? (abatacept)

The U.S. Attorney for the District of Massachusetts issued the following news release.

Broadening the use of two prostate drugs into cancer prevention didn't win a thumbs-up from FDA's expert advisors.

FDA staffers today unveiled their concerns about the risk of high levels of toxicity of AstraZeneca's ($AZN) experimental thyroid cancer drug vandetanib.

After years of debate over their safety, FDA has moved to withdraw painkillers Darvon and Darvocet, plus the multitude of generic copycats.

NICE has recommended trastuzumab in combination with cisplatin and either capecitabine or 5-fluorouracil as an option for Certain Patients with metastatic gastric cancer.

Pharmaceutical companies have been asked to comment on revised European Union (EU) guidelines on good practice regarding the outsourcing of medicine manufacturing.

The U.S. FDA says Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used .

Advanced Cell Technology says it has gained FDA approval to launch the second human study of an ESC therapy. ACT.

The European Medicines Agency and the Massachusetts Institute of Technology in the US have announced an innovative research partnership.

European regulators have adopted a guideline on biosimilar antibody drugs; industry can expect its publication in a couple of weeks.

Mold in a class 100 production room and holes in a ceiling at a CP Pharmaceuticals plant in Wrexham, U.K., are part of a list of violations identified by FDA inspectors in Warning Letter 320-11-002.

Hungary is planning to change write-off rules for R&D costs for pharma firms, according to a draft bill submitted to parliament.

The U.S. Food and Drug Administration has teamed up with the U.S. Centers for Disease Control and Prevention to support Get Smart About Antibiotics Week (Nov. 15-21).

German lawmakers blessed Chancellor Angela Merkel's healthcare reform plans, limiting the industry's power to set prices.

The U.S. government has just added its weight to the tug-of-war over generic versions of Lovenox.

Pfizer violated the California Unfair Competition Law by illegally promoting the Neurontin epilepsy drug.

The FDA is requiring Biodel to essentially go back and start a late-stage development program from scratch.

FDA and Justice Department officials have been talking up possible prosecution of individual managers, rather than just their companies.

The US Food and Drug Administration (FDA) has approved Novartis’ Afinitor (everolimus) tablets to treat adults and children with benign brain tumours associated with tuberous sclerosis.

FDA today issued a complete response letter for Vivus' Qnexa, one of three closely-watched obesity drugs up for approval.

FDA has announced that the American Association for Laboratory Accreditation has accredited the Laboratory Quality System programme in the Center for Laboratory Quality System.

The European Medicines Agency (EMA) has endorsed a new policy on handling written requests for access to its scientific documents.

The FDA has issued a Complete Response Letter to Arena Pharmaceuticals rejecting an immediate approval for the weight drug lorcaserin.

The FDA has posted on its web site a letter sent to Alcon Research about a convention graphic the company submitted for its eye care drug Travatan Z.

UnitedHealth is ramping up a reimbursement test that could have long-term effects on sales of the most expensive cancer drugs.

Agency officials worry that a recently released study will persuade clinicians that the combo isn't as risky as FDA has warned.

FDA 20 October 2010 approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

Pharma execs may be criminally prosecuted for off-label marketing violations.

The European Commission confirmed the positive opinion of the European Medicines Agency approving TWYNSTA?.

Last week the leading names in healthcare finance met in Miami (FL, USA) to discuss the causes and effects of the new healthcare reform.

FDA's experts will wrangle over safe use of Amgen and Johnson & Johnson's blockbuster anemia drugs.

New Subcutaneous Administration Provides another Mode of Delivery For Patients with Primary Immunodeficiency

National day of awareness to be held on November 13, 2010 in thousands of communities across the country on the heels of President Obama signing of the Safe and Secure Drug Disposal Act

Patent applications published 6 October 2010

Patent applications published 29 September 2010

Patent applications published 22 September 2010

Patent applications published 15 September 2010

Patent applications published 8 September 2010

Patent applications published 1 September 2010

FDA is warning there is a possible risk of a rare type of thigh bone (femoral) fracture in people who take drugs known as bisphosphonates to treat osteoporosis.

The FDA warns that the Precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis.

The U.S. Supreme Court Tuesday rejected a petition by several drug makers, allowing lawsuits over an alleged link between drugs and breast cancer to proceed.

FDA is now offering formatted data on product recalls. It's part of the HHS Open Government Initiative to make data publicly available.

Irish drug developer Warner Chilcott PLC said Monday the U.S. Food and Drug Administration has approved its new drug for treating postmenopausal osteoporosis.

Tesetaxel has been designated as an Orphan Drug by the European Medicines Agency for gastric cancer .

FDA has granted 510(k) clearance for a dipstick immunoassay as an aid in the diagnosis of respiratory syncytial virus (RSV) in symptomatic pediatric patients younger than 6 years.

In a warning letter, FDA scolds Actelion for failing to report 3,500 deaths in patients using the company's drugs Tracleer and Ventavis, both treatments for pulmonary arterial hypertension.

The National Institute for Health and Clinical Excellence has reversed itself on early Alzheimer's treatment, opening the door for broader use of drugs from Eisai, Shire and Novartis.

US District Judge George Steeh, in Detroit, Michigan, ruled on October 7 that the nation's constitution permits the federal government to require individuals to obtain health insurance coverage as part of the historic ACA.

The FDA public hearing on 'Development and Distribution of Patient Medication Information for Prescription Drugs' shows that FDA is urged to 'Put Patients First'.

Organised by Highlands and Islands Enterprise (HIE), the P4 Digital Healthcare Convention is focusing on the innovative use of modern technology to promote health and prevent illness.

The European Parliament has revised its pharmacovigilance legislation to improve the early detection of rogue side effects and enhance patient safety.

One drugmaker prevails in an antitrust case, and all drugmakers could benefit.

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

The National Institutes of Health will award $9.4 million during 3 years to support four research projects in regulatory science. This research is conducted in partnership with FDA, which will contribute approximately $950,000.

Russian regulators have their eyes on Novo Nordisk.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion regarding Merck KGaA marketing authorization application for Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis ...

The cancer drug Herceptin is in the middle of a tug-of-war between its maker, Roche's Genentech, and GlaxoSmithKline.

The Department of Justice wants to take the reins in a whistleblower suit claiming Wyeth mismarketed its transplant drug Rapamune.

Biopharma execs will soon get a chance to contribute their thoughts about the new regulations governing the development of biosimilars.

Bayer is slowly but surely settling lawsuits over its bleeding drug Trasylol.

Medicines Co. is another step closer to clearing its patent protection on its key money-earner Angiomax.

Amphastar is taking its battle with Momenta Pharmaeuticals to federal court, albeit in a roundabout way.