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FDA Names Myelofibrosis Treatment an Orphan Drug

September 2, 2014 3:25 pm | News | Comments

Promedior Inc. announced that the FDA has granted an orphan drug designation for PRM-151, for the treatment of myelofibrosis, a serious, life-limiting cancer characterized by fibrosis of the bone marrow. Read more...         

Ipsen's Somatuline Gets Priority Review

September 2, 2014 3:16 pm | News | Comments

Ipsen N.A. announced that the FDA has accepted and granted priority review of its supplemental...

Amgen Submits MAA for Melanoma Treatment

September 2, 2014 2:59 pm | News | Comments

Amgen announced the submission of a Marketing Authorization Application to the European...

EC Approves Allergan's Ozurdex for DME

September 2, 2014 9:52 am | News | Comments

Allergan Inc. announced that the European Commission has extended the Marketing Authorization...

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FDA Approves Generic Megace from TWi

August 28, 2014 9:45 am | News | Comments

TWi Pharmaceuticals Inc. announced that it has received final approval from the FDA on its Abbreviated New Drug Application for megestrol acetate 125mg/ml oral suspension, the generic equivalent to Par Pharmaceutical's Megace ES. Read more...   

Allergan Sets Date for Special Shareholder Meeting

August 27, 2014 3:28 pm | by The Associated Press | News | Comments

Botox maker Allergan Inc. has set a date for a special meeting at which its shareholders will consider replacing most of its board, but it doesn't want the main proponents of that move to participate. Read more...           

FDA Clears Asterias to Begin Stem Cell Trial

August 27, 2014 3:08 pm | News | Comments

Asterias Biotherapeutics Inc. has received clearance from the FDA to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury. Read more...               

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Amgen Heart Failure Drug Gets Priority Review

August 27, 2014 2:32 pm | News | Comments

Amgen announced the FDA has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the If current ("funny" current) in the sinoatrial node. Read more...   

EC Approves BMS Drug as Hep C Combo Treatment

August 27, 2014 11:03 am | News | Comments

Bristol-Myers Squibb Co. announced that the European Commission has approved Daklinza (daclatasvir) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus infection in adults. Read more...

Japan Lab Unable to Replicate Stem Cell Results

August 27, 2014 10:22 am | by Elaine Kurtenbach, AP Business Writer | News | Comments

The Japanese laboratory that retracted a paper reporting a potentially major breakthrough in stem cell research said Wednesday its researchers have not managed to replicate the results. Read more...               

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 use of Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST). Read more...

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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 into an agreement with Eurolab Especialidades Medicinales de Eurofar S.R.L. to sell and distribute Brinavess exclusively in Argentina. Read more…    

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 Phase 3 trial for its lead program, Revolixys Kit. Read more...                           

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...                            

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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...

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...

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...                 

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