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FDA Accepts Shire's sNDA for Vyvanse

September 15, 2014 3:43 pm | News | Comments

Shire announced that the FDA has accepted for filing with priority review a supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) capsules as a treatment for adults with binge eating disorder (BED). Read more...     

FDA Committee Backs Approval of Natpara for Treatment of Hypoparathyroidism

September 15, 2014 3:37 pm | News | Comments

NPS Pharmaceuticals Inc. announced that the FDA's...

Cardio3 BioSciences to Continue Phase 3 Heart Therapy Trial

September 15, 2014 10:53 am | News | Comments

Cardio3 BioSciences SA (C3BS) announced it has...

FDA Approves New Indication for the Use of Xtandi

September 11, 2014 2:51 pm | News | Comments

Astellas Pharma and Medivation announced that FDA...

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Relmada Files Clinical Trial App for D-Methadone in Canada

September 11, 2014 10:40 am | News | Comments

Relmada Therapeutics Inc. announced that it has filed a Clinical Trial Application (CTA) with Heath Canada to conduct two pharmacokinetic studies with d-methadone. Read more...                      

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 9:57 am | News | Comments

U.S. regulators are greenlighting a new weight-loss drug called Contrave, the third in a string of approvals for anti-obesity treatments. The drug was developed by Orexigen Therapeutics Inc., based in La Jolla, California. Read more...      

Method May Enable Portable Detection of ‘Bath Salts’

September 10, 2014 2:30 pm | News | Comments

Despite being outlawed in 2012 in the United States, the synthetic drugs known as “bath salts” are still readily available in some retail shops. To help law enforcement, scientists are developing a novel method that could be the basis for the first portable, on-site testing device for identifying the drugs. Read more...

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Mylan to Acquire Arixtra Rights for $225M

September 10, 2014 2:24 pm | News | Comments

Mylan Inc. announced that its subsidiary Mylan Ireland Ltd. has entered into an agreement to acquire the U.S. commercialization, marketing and intellectual property rights relating to Arixtra Injection, and the authorized generic, from Aspen Global Inc. Read more…

Drug Safety Report Details 49,000 Undisclosed Side Effect Reports

September 10, 2014 1:45 pm | News | Comments

Healthcare informatics company AdverseEvents Inc. released a special drug safety report that includes an analysis of 48,971 unreleased FAERS reports. Read more...                         

FDA Committee Votes Against Actavis Hypertension Drug

September 10, 2014 10:31 am | News | Comments

Actavis confirmed that the FDA Cardiovascular and Renal Drugs Advisory Committee has voted to recommend against approval of Actavis' NDA for the fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. Read more...   

EC Grants Marketing Authorization for Lilly-BI Insulin

September 10, 2014 9:28 am | News | Comments

The European Commission (EC) granted marketing authorization for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged two years and above. Read more...    

FTC Sues AbbVie, Teva Over Generic AndroGel

September 8, 2014 2:34 pm | News | Comments

The Federal Trade Commission is suing drugmakers AbbVie and Teva, saying they conspired to temporarily keep generic versions of AbbVie's low-testosterone drug AndroGel off the market. Read more...               

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EU Approves Roche's RoACTEMRA for RA

September 8, 2014 10:43 am | News | Comments

Roche announced that RoACTEMRA (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA. Read more...                       

FDA Lifts Partial Hold on OncoMed's Cancer Drug

September 5, 2014 2:52 pm | News | Comments

OncoMed Pharmaceuticals announced that the FDA removed the partial clinical hold on the company's ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials. Read more...                        

WHO Backs Use of Survivors' Blood as Ebola Treatment

September 5, 2014 2:42 pm | News | Comments

The World Health Organization recommends that doctors should use blood from survivors to treat patients in an effort to combat the biggest-ever outbreak of Ebola. Read more...                      

Newly Approved Kidney Drug Gets Unexpected Safety Warning

September 5, 2014 2:34 pm | News | Comments

Keryx Biopharmaceuticals received approval Friday for a pill to treat complications of kidney disease in dialysis patients, but the company's stock fell as investors reacted to an unexpected safety warning in the drug's prescribing label. Read more...

Actavis Antibiotic NDA Accepted, Deemed QIDP

September 5, 2014 10:27 am | News | Comments

Actavis plc confirmed that the FDA has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections and Complicated Intra-Abdominal Infections. Read more...

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U.S. to Give $75M to Expand Ebola Care Centers

September 5, 2014 10:19 am | by Jonathan Paye-Layleh and Sarah DiLorenzo | News | Comments

The American aid agency announced Thursday it would donate $75 million to fund 1,000 more beds in Ebola treatment centers in Liberia and buy 130,000 more protective suits for health care workers. Read more...            

FDA OKs Merck Cancer Drug, 1st in New Class

September 5, 2014 8:29 am | by Linda A. Johnson, AP Business Writer | News | Comments

Merck & Co. on Thursday won the first U.S. approval for a new kind of cancer drug with big advantages over chemotherapy and other older cancer treatments. Read more...                       

FDA Puts Merck's Relebactam on Fast Track as QIDP

September 4, 2014 2:57 pm | News | Comments

Merck announced that the FDA has designated relebactam, the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. Read more...            

J&J to Accelerate Ebola Vaccine Development

September 4, 2014 2:40 pm | News | Comments

J&J announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak. Read more...

Flexion Advances OA Drug Development Plan by One Year

September 4, 2014 11:16 am | News | Comments

Based on a recent meeting with the U.S. Food and Drug Administration (FDA) to review the clinical development program for Flexion’s lead drug candidate FX006, the company announced it will initiate a Phase 3 clinical trial for FX006 in late 2014. Read more...

Bayer Submits App in Japan for New Eylea Indication

September 4, 2014 11:05 am | News | Comments

Bayer HealthCare announced that Bayer Yakuhin Ltd. has submitted an application for marketing authorization for aflibercept solution for injection into the eye for patients with macular edema secondary to branch retinal vein occlusion (BRVO). Read more...

Debiopharm's Antibiotic Named QIDP by FDA

September 4, 2014 10:44 am | News | Comments

Debiopharm Group announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Read more...       

Takeda Ordered to Pay $6B in Diabetes Drug Case

September 4, 2014 10:26 am | News | Comments

Takeda Pharmaceutical Co. said Thursday it has been ordered by a U.S. district court to pay $6 billion in punitive damages over a lawsuit filed by a man who claimed his bladder cancer was caused by Takeda's diabetes medicine Actos. Read more...  

Eisai Sells U.S. Rights to Zonegran

September 3, 2014 3:13 pm | News | Comments

Eisai Inc. announced it has entered into an agreement with Concordia Pharmaceuticals Inc. to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to Zonegran. Read more...                

Actinium Eyes Orphan Drug Designation for AML Treatment

September 3, 2014 3:09 pm | News | Comments

Actinium Pharmaceuticals Inc. announced it has filed an Application for Orphan Drug Designation with the FDA for Actimab-A, a radiolabeled antibody being developed for newly diagnosed AML in patients over 60. Read more...         

Exelixis to Cut 70% of Staff After Disappointing Trial Results

September 3, 2014 3:02 pm | News | Comments

Exelixis Inc. announced that COMET-1, the Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer, did not meet its primary endpoint. As a result, Exelixis will initiate a significant workforce reduction. Read more...

FDA: Little Evidence to Support Testosterone Drugs

September 3, 2014 2:56 pm | by Matthew Perrone | News | Comments

The FDA says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. Read more...       

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