Spark Therapeutics has announced today appointment of Daniel M. Takefman, Ph.D., as head of regulatory affairs. Dr. Takefman previously served as chief of the gene therapy branch of the Center for Biologics Evaluation and Research at the FDA, a position he held since 2006.
Mylan has confirmed that it and several subsidiaries have been sued by several Baxter...
Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...
Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics.
Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty CapsulesNovember 24, 2014 3:04 pm | News | Comments
Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.
The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.
The FDA is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.
Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.
Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington lawmakers.
Regeneron Pharmaceuticals and Sanofi have announced that the FDA has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.
Cindy Whitehead is trying to get Flibanserin, the first low libido drug for women, approved by the FDA.
Millions of people with stents that prop open clogged heart arteries may need anti-clotting drugs much longer than the one year doctors recommend now. A large study found that continuing for another 18 months lowers the risk of heart attacks, clots and other problems.
A major study lifts a cloud around Zetia and Vytorin, blockbuster drugs for lowering cholesterol. The study found that these pills modestly lower the risk of heart attacks and other problems in people at high risk for them — evidence that's been missing for more than a decade as the drugs racked up billions in sales.
The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.
Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.
Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release (ER) tablets, USP (CII) may not be therapeutically equivalent to the category reference drug Concerta®.
Health officials are scrambling to begin human testing of a handful of experimental drugs for Ebola. But the effort has sparked an ethical debate over how to study unproven medicines amid an outbreak that has killed nearly 5,000.
Par Pharmaceutical Companieshas received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
Shares of Orexigen Therapeutics jumped Monday after the company said a European Union review of its weight loss drug Contrave, which was approved in the U.S. in September, is progressing on schedule.
The Food and Drug Administration is suing one company for allegedly failing to properly test its ingredients.
Ipsen Biopharmaceuticals announced that the FDA has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.
Ranbaxy Labs has received approval from the FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively.
FDA Selects ICON to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia TrialsNovember 6, 2014 8:29 am | News | Comments
ICON has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome (PRO) measure that can be used in anti-bacterial drug development trials for hospital-acquired bacterial pneumonia (HABP).
Aeterna Zentaris announced that the company has received a Complete Response Letter (CRL) from the FDA for its New Drug Application for Macrilen, a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency. Based on its review, the FDA has determined that the NDA cannot be approved in its present form.
The quest for an Ebola treatment is picking up speed. Federal officials have unveiled a plan to test multiple drugs at once, in an umbrella study with a single comparison group to give fast answers on what works. "This is novel for us" and is an approach pioneered by cancer researchers, said Dr....
Nanova Biomaterials began manufacturing a fluoride dental varnish called StarBright about a month ago after the product received approval from the Food and Drug Administration.
Daiichi Sankyo announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSAT 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.
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