Subscribe to Legal/Regulatory

The Lead

FDA Approves Merck’s Allergy Immunotherapy

April 15, 2014 12:59 pm | News | Comments

Merck announced that the FDA has approved Grastek (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use, an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis. Read more...   

NICE Recommends Firmagon for Special Cases of Advanced Prostate Cancer

April 15, 2014 11:10 am | News | Comments

The National Institute for Health and Care Excellence issued its Final Appraisal Determination (...

FDA OKs Trials for Vivolux First-in-Class Cancer Drug

April 15, 2014 10:32 am | News | Comments

Vivolux AB announced that the FDA has granted clearance to proceed with VLX600 into clinical...

Actavis Agrees to Generess FE Patent Settlement

April 15, 2014 10:22 am | News | Comments

Actavis plc announced that it has entered into an agreement with Mylan Inc. and Famy Care Ltd....

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

FDA Accepts BI, Lilly NDA for Type 2 Diabetes Combo Tablet

April 14, 2014 1:39 pm | News | Comments

Boehringer Ingelheim and Eli Lilly and Co. announced that the FDA accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes. Read more...

BMS Files NDA for HIV Combo Treatment

April 14, 2014 12:59 pm | News | Comments

Bristol-Myers Squibb announced the submission of a new drug application (NDA) to the FDA for a fixed-dose combination of atazanavir sulfate and cobicistat that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Read more...

Report: GSK Bribed Doctors in Poland

April 14, 2014 9:41 am | News | Comments

The BBC reports that pharmaceutical company GlaxoSmithKline is accused of bribing doctors to prescribe medicines in Poland. The British drug company already faces corruption probes in China and Iraq. Read more...          


Collaboration Advances Use of Antibody Drug Conjugates

April 11, 2014 1:23 pm | News | Comments

PolyTherics Ltd. announced an extension to its ThioBridge antibody drug conjugate (ADC) collaboration with MacroGenics Inc., a U.S. biotechnology company developing innovative medicines utilizing its next generation antibody technologies. Read more...

After Setback, Impax Resubmits Parkinson’s NDA

April 11, 2014 12:36 pm | News | Comments

Impax Pharmaceuticals, a division of Impax Laboratories Inc., announced today the resubmission of Impax's NDA for Rytary (IPX066) to the FDA. IPX066 is a patented extended- release capsule formulation of carbidopa and levodopa, an investigational drug for the symptomatic treatment of Parkinson's disease. Read more...

Judge Enforces Generic Frova Settlement in Favor of Mylan

April 11, 2014 10:12 am | News | Comments

Mylan Inc. confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan, settling patent litigation in connection with Mylan's generic version of Frova. Read more...   

Governor Backs Medical Marijuana Trials

April 11, 2014 9:41 am | by Kathleen Foody | News | Comments

Georgia Gov. Nathan Deal on Thursday announced two separate efforts to pursue clinical trials on a cannabis-based drug that has shown promise in helping children who suffer from seizure disorders. Read more...           

Ampio, Paladin Labs Partner on Zertane Rights

April 10, 2014 10:55 am | News | Comments

Ampio Pharmaceuticals Inc. announced that its subsidiary Vyrix Pharmaceuticals has signed an agreement with Paladin Labs Inc. to provide exclusive rights to market, sell and distribute Zertane in Canada, the Republic of South Africa, Sub-Saharan Africa and Latin America. Read more...


FDA Wants More Info on Forest’s COPD Drug

April 9, 2014 1:38 pm | News | Comments

Forest Laboratories Inc. and Almirall S.A. announced that they have recently received feedback from the FDA regarding the fixed dose combination of aclidinium and formoterol for treatment of COPD. Read more...            

FDA Stops Halozyme PEGPH20 Pancreatic Cancer Trial

April 9, 2014 1:05 pm | News | Comments

Halozyme Therapeutics Inc. announced that the FDA informed the company Tuesday that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial evaluating PEGPH20 in patients with pancreatic cancer. Read more...

Update: Arkansas AG Files Petition on Risperdal Ruling

April 8, 2014 1:47 pm | by Andrew DeMillo | News | Comments

Arkansas Attorney General Dustin McDaniel asked the state Supreme Court to reconsider its decision tossing out a $1.2 billion judgment against drugmaker Johnson & Johnson, saying justices did "significant harm" to the state and broke from 170 years of precedent. Read more...

Pharmacyclics Files Imbruvica Supplemental NDA

April 8, 2014 12:45 pm | News | Comments

Pharmacyclics Inc. announced that it has submitted a sNDA to the FDA based on data from the Phase 3 RESONATE study, a head-to-head comparison of Imbruvica versus ofatumumab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Read more... 

Zohydro Maker Sues to Block Massachusetts Ban

April 8, 2014 12:27 pm | News | Comments

The maker of Zohydro, a controversial new prescription painkiller, has filed a lawsuit in the U.S. District Court on Monday seeking to block Massachusetts' ban on local doctors prescribing and dispensing the drug. Read more...    


EU Approves Two-Dose Gardasil for Early Teens

April 8, 2014 10:29 am | News | Comments

Sanofi Pasteur MSD announced that the European Commission has granted marketing authorization for its quadrivalent HPV vaccine, Gardasil, for a two-dose schedule at zero and six months in children aged from nine to 13 years. Read more...   

Takeda, Lilly Face Penalty over Actos Cancer Cases

April 8, 2014 9:25 am | by Yuri Kageyama, AP Business Writer | News | Comments

A U.S. jury ordered Japanese drugmaker Takeda Pharmaceutical Co. and Eli Lilly and Co. to pay $9 billion in punitive damages over a diabetes medicine linked to cancer. The drug companies said they will "vigorously challenge" the decision. Read more...

Gilead Hep C Combo Gets Breakthrough Therapy Status, Priority Review from FDA

April 7, 2014 2:21 pm | News | Comments

Gilead Sciences Inc. announced that the FDA has granted priority review and a Breakthrough Therapy designation to the comapny's fixed-dose combination of ledipasvir and sofosbuvir for the treatment of chronic hepatitis C genotype 1. Read more...

FDA Approves Pradaxa for DVT, Pulmonary Embolism

April 7, 2014 2:09 pm | News | Comments

Boehringer Ingelheim announced that the FDA has approved Pradaxa for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. Read more...

Novartis Men B Vaccine Gets Breakthrough Designation from FDA

April 7, 2014 1:38 pm | News | Comments

Novartis announced that Bexsero (Meningococcal Group B Vaccine) has received a Breakthrough Therapy designation-the fourth such designation for Novartis-from the FDA. Read more...       

Meda Turns Down Mylan's Merger Proposal

April 7, 2014 8:30 am | News | Comments

Swedish drug company Meda has rebuffed an approach from generic drug maker Mylan which was looking to combine the two businesses. Meda AB says talks between the two companies have stopped "without further actions." Read more...       

Daiichi Sankyo Selling Ranbaxy to Sun Pharmaceutical

April 7, 2014 8:25 am | News | Comments

Daiichi Sankyo Co. said Monday it will sell its stake in Indian unit Ranbaxy Laboratories Ltd. to Sun Pharmaceutical Industries Ltd., as the Japanese firm shifts its generic drug business strategy. Read more...           

Mallinckrodt to Buy Questcor for $5.2B

April 7, 2014 8:17 am | News | Comments

Ireland's Mallinckrodt is buying Questcor Pharmaceuticals Inc. for a combination of stock and cash valued at about $5.2 billion, a purchase that will help to diversify Mallinckrodt's business. Read more...         

Arkansas to Ask Court to Reconsider Risperdal Fine

April 4, 2014 1:13 pm | by Andrew DeMillo | News | Comments

Arkansas Attorney General Dustin McDaniel said he plans to ask the state Supreme Court to reconsider its decision tossing out a $1.2 billion judgment against drugmaker Johnson & Johnson over the marketing of the antipsychotic drug Risperdal. Read more...

FDA Approves Easy-to-Use Heroin Overdose Antidote

April 4, 2014 10:24 am | by Lauran Neergaard and Mary Clare Jalonick | News | Comments

The FDA approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives, enabling friends and family to take the first step to save a loved one from an overdose before an ambulance arrives. Read more...

Astellas, Medivation Submit Amended MAA for New Xtandi Use

April 3, 2014 1:22 pm | News | Comments

Astellas Pharma and Medivation announced the submission of a variation to amend the European Marketing Authorization Application for Xtandi (enzalutamide) capsules for a new indication in the treatment of adult men with metastatic castration-resistant prostate cancer. Read more...

EU Committee Backs Orphan Status for Alnylam RNAi Drug

April 3, 2014 11:02 am | News | Comments

Alnylam Pharmaceuticals announced that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin-mediated amyloidosis (ATTR). Read more...

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.