Advertisement
Legal/Regulatory
Subscribe to Legal/Regulatory

The Lead

New Statin Guidelines are an Improvement, Study Shows

August 26, 2014 3:18 pm | News | Comments

New national guidelines can improve the way statin drugs are prescribed to patients at risk for cardiovascular disease, a study has found. Read more...                             

FDA Approves Additional Promacta Indication

August 26, 2014 3:14 pm | News | Comments

GSK announced that the FDA has approved a supplemental New Drug Application for the once-daily...

Cardiome, Eurolab Partner on Brinavess Distribution

August 26, 2014 11:00 am | News | Comments

Cardiome Pharma Corp. announced that its subsidiary, Correvio International Sàrl, has entered...

Regado Biosciences Permanently Halts Phase 3 Trial

August 25, 2014 3:08 pm | News | Comments

Regado Biosciences Inc. announced the permanent termination of enrollment in its REGULATE-PCI...

View Sample

FREE Email Newsletter

Daily news and top headlines for drug research professionals

Zorvolex Approved for Management of Osteoarthritis Pain

August 25, 2014 3:03 pm | News | Comments

Iroko Pharmaceuticals LLC announced that the FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. Read more...                 

FDA Gives Insys Pharmaceutical Cannabidiol Orphan Status

August 25, 2014 2:57 pm | News | Comments

Insys Therapeutics Inc. announced that the FDA has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioblastoma multiforme (GBM). Read more...                 

Vivus Acquires Patent Rights to Qsymia Ingredient

August 25, 2014 2:51 pm | News | Comments

Vivus has acquired a group of patents covering one of the main ingredients behind its weight loss drug Qsymia from Janssen Pharmaceuticals. Read more...                            

Advertisement

Janssen Affiliate Cilag to Acquire Covagen AG

August 25, 2014 10:34 am | News | Comments

Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it has acquired Covagen AG. Read more...                           

Allergan Reviews Meeting Requests in Valeant Takeover Bid

August 23, 2014 2:23 pm | by Linda A. Johnson, AP Business Writer | News | Comments

Botox maker Allergan Inc. is reviewing shareholder requests for a special meeting to consider replacing most of its board, a change fellow drugmaker Valeant Pharmaceuticals International Inc. is seeking as part of the hostile takeover attempt. Read more...

Alabama Ruling on Drug Warnings Draws Suspicion

August 23, 2014 11:25 am | by Jay Reeves | News | Comments

Business isn't buying the Alabama Supreme Court's attempt to limit the fallout from its decision saying brand-name drugmakers can be held liable for warnings on generic medication produced by other companies. Read more...         

Mylan Launches First Generic Klor-Con Extended-Release Tablets

August 22, 2014 3:46 pm | News | Comments

Mylan Inc. announced that it has launched Potassium Chloride Extended-release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg), which is the generic version of Upsher-Smith's Klor-Con. Read more...                

Antitope, University College London Collaborate on Fully Humanized Antibodies

August 22, 2014 11:06 am | News | Comments

Antitope Ltd. and University College London are pleased to announce that they will collaborate to humanize an anti-LRG1 antibody as part of a MRC-funded translational research and product development program being undertaken by the UCL Institute of Ophthalmology. Read more...

Advertisement

EMA Accepts Ceftolozane/Tazobactam MAA for Review

August 22, 2014 10:54 am | News | Comments

Cubist Pharmaceuticals announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. Read more...

FDA Clears Eliquis for New Use Against Blood Clots

August 21, 2014 3:28 pm | by The Associated Press | News | Comments

Bristol-Myers Squibb and Pfizer said Thursday that federal regulators have expanded approval of their blood thinner Eliquis to treat two types of dangerous blood clots. Read more...                    

New Hydrocodone Restrictions to Take Effect

August 21, 2014 1:00 pm | News | Comments

The federal government is finalizing new restrictions on hundreds of medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S. Read more...            

Emergent, MorphoSys Collaborate on Prostate Cancer Drug

August 21, 2014 11:39 am | News | Comments

Emergent BioSolutions and MorphoSys announced an agreement for the joint development and commercialization of Emergent’s preclinical bi-specific antibody, ES414, targeting prostate cancer, under the terms of which Emergent will receive an upfront payment of US$20 million and milestone payments of up to US$163 million. Read more...

Eisai Submits EU Marketing Authorization for Anti-Epileptic

August 21, 2014 11:34 am | News | Comments

Eisai has submitted a Marketing Authorization Application to the European Commission for its first-in-class anti-epileptic drug (AED) Fycompa (perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Read more...

Advertisement

FDA Approves GSK Asthma Drug

August 21, 2014 11:29 am | News | Comments

GlaxoSmithKline plc announced that the FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Read more...

FDA Approves New Drug for Gaucher's Disease

August 20, 2014 1:45 pm | News | Comments

The FDA approved a new capsule-based drug to treat Gaucher's disease. Regulators approved the new drug, Cerdelga, for patients with the Type 1 form of the rare genetic disorder. Read more...                 

Rating U.S. Drug Development Programs

August 20, 2014 11:10 am | by Chris Plaford, CFA, Chief Executive Officer, Claravant Analytics LLC | Articles | Comments

According to industry estimates, the majority of drugs in development will never make it to FDA approval. While a lack of efficacy is often a key factor, many clinical programs are derailed due to avoidable setbacks that can cause delays and significantly increase costs. Read more...

Oramed Snags Oral Insulin Patent in Spain

August 20, 2014 10:40 am | News | Comments

Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that the Intellectual Property Department of Spain has granted the company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins." Read more...

Roche, Garvan Partner on Genomics Technologies

August 20, 2014 10:18 am | News | Comments

Roche and the Garvan Institute of Medical Research announced a collaboration to develop new technologies for targeted epigenomic analysis using DNA sequencing, bringing together the genomics expertise and infrastructure at the Garvan Institute and target enrichment products from Roche NimbleGen. Read more...

FDA Accepts NDA for BI’s COPD Combo

August 19, 2014 3:45 pm | News | Comments

Boehringer Ingelheim announced that the FDA accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler. Read more...           

DOJ Closes Probe into AstraZeneca Trial

August 19, 2014 3:26 pm | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action. Read more...               

Gamida Cell, Novartis Sign Option Agreement

August 19, 2014 11:56 am | News | Comments

Gamida Cell, a world leader in stem cell expansion technologies and therapeutic products, announced that it has signed an investment and option agreement with Novartis Pharma AG, under which Novartis will invest $35 million in Gamida Cell. Read more...

Eisai, Zeria Collaborate on Proton Pump Inhibitor in Japan

August 19, 2014 11:44 am | News | Comments

Eisai Co. Ltd. and Zeria Pharmaceutical Co. Ltd. announced that they have concluded a license agreement concerning E3710, a novel proton pump inhibitor (PPI) discovered and developed in-house by Eisai, which shows promise as a best-in-class treatment. Read more...

FDA Tentatively Approves Lilly, BI Insulin Glargine

August 19, 2014 11:37 am | News | Comments

The U.S. Food and Drug Administration granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Read more...

FDA Approves Biogen's MS Drug Plegridy

August 18, 2014 2:06 pm | News | Comments

Biogen Idec said Friday that federal regulators have approved the specialty drugmaker's new treatment for people with relapsing forms of multiple sclerosis. Read more...                        

CDC Scientist Kept Quiet About Flu Blunder

August 18, 2014 2:02 pm | by Mike Stobbe, AP Medical Writer | News | Comments

A government scientist kept silent about a potentially dangerous lab blunder and revealed it only after workers in another lab noticed something fishy, according to an internal investigation. Read more...              

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