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Alexion's Soliris Gets EC Orphan Status for New Treatment

April 23, 2014 10:30 am | News | Comments

Alexion Pharmaceuticals Inc. announced that the European Commission has granted an orphan drug designation to Soliris (eculizumab) for the prevention of graft rejection following solid organ transplantation. Read more...          

NIH, Broadview Ventures Fund Stroke Study

April 22, 2014 12:33 pm | News | Comments

ZZ Biotech announced that the National Institutes of Health will support a multicenter Phase 2...

Sentinel, Oncothyreon Collaborate on Cancer Drugs

April 22, 2014 12:13 pm | News | Comments

Sentinel Oncology Ltd., the small molecule drug discovery company, announced it has signed a...

FDA Accepts Gilead NDAs for HIV Drugs

April 22, 2014 11:34 am | News | Comments

Gilead Sciences Inc. announced that the FDA has accepted the company’s refiling of two New Drug...

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Novartis Reshapes Business with GSK, Lilly Deals

April 22, 2014 9:28 am | by John Heilprin | News | Comments

Swiss pharmaceutical firm Novartis AG launched a major overhaul of its business Tuesday, unveiling a series of multibillion-dollar deals with Britain's GlaxoSmithKline PLC and the U.S.'s Eli Lilly & Co. that heralds more restructuring in the fast-changing industry. Read more...

Breaking News: Gastric Cancer Drug Approved

April 22, 2014 8:56 am | News | Comments

Lilly announced that the FDA has approved Cyramza for advanced/metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on/after prior fluoropyrimidine- or platinum-containing chemotherapy. Read more...

FDA Guides Sarepta on Muscular Dystrophy Drug NDA

April 21, 2014 12:20 pm | News | Comments

Sarepta Therapeutics Inc., a developer of innovative RNA-based therapeutics, announced it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD). Read more...

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Emergent’s BioThrax Granted Orphan Drug Status

April 21, 2014 12:10 pm | News | Comments

Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis. Read more...

$14M Awarded in Suit Linking Yasmin, Stroke

April 21, 2014 10:01 am | News | Comments

A jury has awarded $14 million to a suburban Chicago woman who sued her doctor over a debilitating stroke she suffered after taking Bayer's birth control drug Yasmin. Read more...                 

Court Declines to Block Ruling in Teva Patent Case

April 21, 2014 8:30 am | by Sam Hananel | News | Comments

Supreme Court Chief Justice John Roberts on Friday declined to temporarily block a lower court ruling that opens the world's best-selling multiple sclerosis drug to competition from generic rivals next month. Read more...         

Top French Advisor Resigns Amid Drug Industry Scandal

April 18, 2014 1:06 pm | News | Comments

Aquilino Morelle, the French president's top adviser, resigned Friday following allegations of a past conflict of interest, striking a new blow to the already unpopular Francois Hollande, sought to distance himself from the new scandal. Read more...

Ivabradine Fast Tracked for Chronic HF

April 18, 2014 12:13 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has granted fast track designation for investigational ivabradine - an oral drug that inhibits the If current (“funny” current) in the sinoatrial node, the body’s cardiac pacemaker - for patients with chronic heart failure (HF). Read more...

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FDA Approves Arzerra for Chronic Lymphocytic Leukemia

April 18, 2014 12:03 pm | News | Comments

GlaxoSmithKline and Genmab announced that the FDA has approved a supplemental BLA for the use of Arzerra, a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia. Read more...

Canada is First to Approve GSK's New COPD Drug

April 18, 2014 9:43 am | News | Comments

GlaxoSmithKline announced that Incruse Ellipta has received world-first market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD. Read more...       

Canada is First to Approve GSK's New COPD Drug

April 18, 2014 9:43 am | News | Comments

GlaxoSmithKline announced that Incruse Ellipta has received world-first market authorization in Canada for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD. Read more...       

FDA OKs Merck Tablet to Reduce Ragweed Allergies

April 18, 2014 9:00 am | News | Comments

U.S. regulators have again approved Merck & Co.'s Ragwitek tablets, which dissolve quickly under the tongue, for gradually reducing seasonal allergies, this time for ragweed pollen. Read more...             

GSK Reports More Bribery Inquiries

April 17, 2014 11:24 am | News | Comments

British drugmaker GlaxoSmithKline is looking into allegations of bribery within its operations in Jordan and Lebanon. The company is also facing a corruption investigation in China and a bribery investigation in Poland and is looking into alleged bribery in Iraq. Read more...

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EC, FDA Give Orphan Status to Boehringer’s New Leukemia Drug

April 17, 2014 10:36 am | News | Comments

Boehringer Ingelheim Pharmaceuticals announced that the FDA and European Commission have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML). Read more...                   

Astellas to Pay $7.3M in Mycamine Marketing Settlement

April 17, 2014 10:13 am | News | Comments

A unit of Japanese drugmaker Astellas Pharma will pay the U.S. government $7.3 million to resolve claims it illegally marketed its antifungal drug Mycamine for children before that use was approved. Read more...            

Judge Blocks Zohydro Ban in Massachusetts

April 16, 2014 10:47 am | by Steve LeBlanc | News | Comments

A federal judge has blocked Massachusetts from banning the powerful new painkiller Zohydro after the maker of the drug, Zogenix, argued in a lawsuit that the ban ordered by Gov. Deval Patrick last month is unconstitutional. Read more...    

FDA Approves GSK's Injectable Diabetes Drug

April 16, 2014 10:00 am | News | Comments

The FDA said Tuesday it approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise. Read more...

Breaking News: EMA Warns of Falsified Herceptin

April 16, 2014 9:09 am | News | Comments

The EMA has been informed that vials of the cancer medicine Herceptin, thought to have been stolen in Italy, including from hospitals, have been tampered with and re-introduced under false credentials into the supply chain in some countries. Read more...

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 (FAD) recommending Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer, only in adults with spinal metastases who present with signs or symptoms of spinal cord compression. Read more...

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 Phase 1/2 trials. The drug candidate kills sleeping cell populations in regions of solid tumors that are metabolically compromised due to poor vascularization. Read more...

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. to settle all outstanding patent litigation related to Mylan's generic version of Generess FE. Read more...             

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...          

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