Legal/Regulatory
Suvorexant Raises Red Flags
May 20, 2013 11:53 am | by Matthew Perrone | News | CommentsU.S. Food and Drug Administration regulators say an experimental insomnia drug from Merck called suvorexant can help patients fall asleep, but it also carries worrisome side effects, including an increased risk of daytime drowsiness and suicidal thinking.
FDA Approves Cancer Treatment
May 16, 2013 4:21 pm | News | CommentsThe U.S. Food and Drug Administration has approved Xofigo to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.
FDA Grants Priority Review to Simeprevir
May 15, 2013 12:00 pm | News | CommentsThe U.S. Food and Drug Administration has granted Priority Review to Janssen's New Drug Application for simeprevir, an investigational NS3/4A protease inhibitor administered with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C.
Impure Drugs Cost Ranbaxy $500M
May 13, 2013 2:28 pm | by Eric Tucker | News | CommentsA subsidiary of India's largest pharmaceutical company has agreed to pay $500 million in fines and civil penalties for selling adulterated drugs and lying about tests of the medications to federal regulators. Prosecutors said the guilty plea by Ranbaxy USA Inc. represents the largest financial penalty by a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.
Lawsuit Alleges Merck Gender Discrimination
May 9, 2013 11:48 am | News | CommentsA Merck & Co. sales representative is suing the drugmaker for at least $100 million, saying Merck doesn't give women equal opportunities for advancement and that women are told they have to choose between having children and taking bigger roles at the company.
FDA Reviewing Allergy Therapy
May 8, 2013 12:47 pm | News | CommentsDrugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, itching and other symptoms temporarily.
FDA Approves Merck's Liptruzet
May 3, 2013 5:56 pm | News | CommentsMerck & Co. said that it received U.S. Food and Drug Administration marketing approval for the new combination cholesterol drug Liptruzet, which combines the company's drug Zetia with a generic version of the mega-blockbuster drug Lipitor.
Arena Withdraws Belviq Application
May 3, 2013 7:32 am | News | CommentsDrug developer Arena Pharmaceuticals Inc. announced that it is withdrawing its application for approval of the weight loss drug Belviq in Europe. The San Diego company also said that it is still waiting for a U.S. decision on the status of the drug.
EMA Panel Recommends Nuedexta
April 26, 2013 10:31 am | News | CommentsA panel that advises the European Medicines Agency recommended that Avanir Pharmaceuticals' Nuedexta be approved as a treatment for pseudobulbar affect. The drug is already approved in the U.S. Being able to sell the drug in Europe would likely increase Avanir's revenues.
European Regulators Reject Xeljanz
April 25, 2013 5:00 pm | News | CommentsPfizer Inc. said that the European Union's committee of medical experts has rejected the company's drug Xeljanz for patients with rheumatoid arthritis. The European Medicines Agency committee recommended against approving the drug because its benefits did not sufficiently outweigh its risks.
FDA Designates Lambrolizumab a Breakthrough
April 24, 2013 10:54 am | News | CommentsMerck announced that the Food and Drug Administration has designated lambrolizumab as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab's designation as a Breakthrough Therapy is intended to expedite its development and review.
Lilly's Profit Tops Expectations
April 24, 2013 10:22 am | by Tom Murphy | News | CommentsEli Lilly reported better-than-expected earnings for the first quarter and said regulators had agreed to a priority review of its potential stomach cancer treatment. The Food and Drug Administration will evaluate ramucirumab under its Breakthrough Therapy program.
New Amitiza Indication Approved
April 23, 2013 11:50 am | News | CommentsSucampo Pharmaceuticals Inc. and Takeda Pharmaceuticals said that they received U.S. regulatory to market their constipation treatment Amitiza for a new use. The Food and Drug Administration approved the pill for constipation caused by opioid pain medications used by patients with non-cancer chronic pain.
Panel Issues Split Decision on Aveed
April 18, 2013 4:46 pm | by Matthew Perrone | News | CommentsFederal health experts issued a split opinion on whether a long-acting testosterone injection from Endo Health Solutions is safe. A Food and Drug Administration panel voted 9-9 on the safety of Endo's Aveed, a drug designed to be injected once every 10 weeks to boost testosterone in men with abnormally low levels.
FDA Panel Backs Breo Ellipta
April 17, 2013 4:14 pm | News | CommentsA panel of respiratory experts voted in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease. A majority of panelists felt that the Breo Ellipta inhaler is safe and effective for long-term use and to control flare ups in patients with COPD.
Decision A Boon for Abuse-Resistant Pills
April 17, 2013 1:16 pm | News | CommentsAcura Pharmaceuticals Inc. benefited greatly from a decision by federal regulators to block new painkillers that aren't designed to resist abuse. The company sells a decongestant called Nexafed and its abuse-deterring technology is used in Pfizer Inc.'s painkiller Oxecta.
Levadex Approval on Hold
April 17, 2013 12:06 pm | News | CommentsAllergan Inc. said that the Food and Drug Administration isn't ready to approve its inhaled migraine treatment Levadex. Allergan said the FDA is concerned about elements of the manufacturing process for Levadex. The company said it is already responding to those concerns.
FDA Blocks Generic OxyContin
April 17, 2013 10:09 am | by Matthew Perrone | News | CommentsFederal health regulators will require generic versions of the best-selling painkiller OxyContin to include recent formulation changes designed to make the pill harder to abuse. The Food and Drug Administration said it would not approve any generic versions of OxyContin based on the original formulation.
Amgen Paying $25M To End Kickback Case
April 16, 2013 6:37 pm | News | CommentsThe 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.
Actavis Resumes Generic Yaz Sales
April 16, 2013 6:16 pm | News | CommentsActavis is once again selling a generic version of Bayer's oral contraceptive Yaz because a federal appeals court overturned one of the patents supporting the original. The company began selling it in January 2012, but took the drug off the market after a federal court in Nevada upheld the patent.
FDA Reviews Glaxo, Theravance Drug
April 15, 2013 1:21 pm | News | CommentsThe Food and Drug Administration has posted its review of Theravance and partner GlaxoSmithKline's combination inhaler drug to treat lung disease. The companies have asked the FDA to approve their experimental inhaler drug, Breo Ellipta, to treat complications of chronic lung disease.
Abbott Recalls Blood Glucose Meters
April 15, 2013 7:34 am | News | CommentsAbbott Laboratories is recalling its FreeStyle InsuLinx Blood Glucose Meters after finding that they display and store incorrect test results for dangerously high blood sugar levels. Johnson & Johnson announced a similar recall last month for several types of its blood glucose meters.
FDA Reassessing Avandia Risks
April 12, 2013 5:16 pm | by Matthew Perrone | News | CommentsThe 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 recent government notice.
Boston Therapeutics Wants IND Meeting
April 11, 2013 11:35 am | News | CommentsBoston Therapeutics Inc. has requested an Investigational New Drug application meeting with the U.S. Food and Drug Administration. The application will support a proposed indication of PAZ320 to reduce the elevation of post-meal blood sugar for treatment of patients with type 2 diabetes.
FDA Reviewing Merck Antifungal
April 10, 2013 2:19 pm | by Linda A. Johnson | News | CommentsMerck & Co. said that the Food and Drug Administration is reviewing its application to sell a pill form of its drug for preventing dangerous fungal infections in high-risk patients. Noxafil, known chemically as posaconazole, is already sold in a liquid form.
