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FDA Clears IND for Lorus Blood Cancer Drug

July 28, 2014 10:53 am | News | Comments

Lorus Therapeutics Inc. announced that the FDA completed its review and cleared the company's IND application of LOR-253 for the treatment of hematologic malignancies including acute myeloid leukemia, high-risk myelodysplastic syndromes, lymphomas and multiple myeloma. Read more...

Veloxis Gets EU Marketing Authorization for Transplant Drug

July 28, 2014 10:47 am | News | Comments

Veloxis Pharmaceuticals A/S and Chiesi Farmaceutici S.p.A. announced that the European...

Compounding Pharmacy Oversight Changes Signed

July 11, 2014 2:38 pm | News | Comments

Two years after a deadly nationwide meningitis outbreak linked to a compounding pharmacy in...

DVT/PE Drug Receives Positive CHMP Opinion

June 27, 2014 2:11 pm | News | Comments

Pfizer and Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human...

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CHMP Recommends EU Approval of CF Drug

June 27, 2014 1:59 pm | News | Comments

Vertex Pharmaceuticals Inc. announced that the European CHMP has issued a positive opinion recommending the approval of Kalydeco for people with cystic fibrosis ages six and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Read more...

BMS Hep C Drug Gets Positive CHMP Opinion

June 27, 2014 1:41 pm | News | Comments

BMS announced that CHMP of the EMA has adopted a positive opinion recommending that Daklinza, an investigational, potent pan-genotypic NS5A complex inhibitor, be granted approval for use in combination with other medicinal products for the treatment of chronic HCV infection in adults. Read more...

FDA Warns of Allergic Reactions With Acne Products

June 26, 2014 1:05 pm | by Matthew Perrone, AP Health Writer | News | Comments

Federal health officials are warning consumers who use popular anti-acne treatments about rare but potentially deadly allergic reactions that can cause swelling of the face and difficulty breathing. Read more...            

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Drug Firm Exec Jailed for Insider Trading

April 23, 2014 11:58 am | News | Comments

A former pharmaceutical executive (John Lazorchak, past director of financial reporting at Celgene Corp.) has been sentenced in federal court, Newark, N.J., to 15 months in prison for his role in an insider trading scheme. Read more...

Cubist Submits Ceftolozane/Tazobactam NDA

April 21, 2014 12:27 pm | News | Comments

Cubist Pharmaceuticals Inc. announced that it has submitted a New Drug Application (NDA) to the FDA for approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. 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...

Breaking News: Cubist Recalls Cubicin Lot

April 18, 2014 2:02 pm | News | Comments

Cubist Pharmaceuticals Inc. announced it is voluntarily recalling one lot of Cubicin (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles. 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...

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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...

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...

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...

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...

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Court Backs Lilly’s Alimta Patent Until 2022

April 1, 2014 2:25 pm | News | Comments

A federal court has upheld a patent that protects an Eli Lilly lung cancer treatment from cheaper generic competition until 2022. The patent protects a vitamin treatment regimen given before the drug, Alimta, is administered to prevent side effects. Read more...

DiaVacs Diabetes Drug Gets Orphan Drug Status

January 7, 2014 12:11 pm | News | Comments

DiaVacs Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy. According to the company, DV-0100 is proprietary, novel and safe. Learn more...

New Drug Approvals from FDA Declined in 2013

January 2, 2014 3:58 pm | by Matthew Perrone, AP Health Writer | News | Comments

The FDA approved 27 first-of-a-kind drugs in 2013, down from 39 new medications in 2012, which was a 15-year high. Despite the decline, FDA officials say the tally of innovative medications approved last year is in line with the historical trend. How so? Find out... 

Sanofi To Appeal FDA's Decision on MS Drug Lemtrada

December 30, 2013 10:57 am | News | Comments

Sanofi and its subsidiary Genzyme announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. 

Novo Nordisk's Clotting Disease Drug Approved by FDA

December 23, 2013 4:03 pm | News | Comments

Novo Nordisk announced the U.S. Food and Drug Administration (FDA) has approved Tretten (coagulation factor XIII A-subunit [recombinant]) for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency. Tretten is the only recombinant treatment for congenital FXIII A-subunit deficiency—a serious, rare bleeding disorder with limited treatment options. Learn more...

GSK Malaria Drug Gets Breakthrough Designation

December 23, 2013 9:56 am | News | Comments

GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. Where is tafenoquine is approved for use so far? Find out...

United Therapeutics' Lung Disease Tablets Get FDA Approval

December 23, 2013 9:35 am | News | Comments

United Therapeutics Corporation announced that the U.S. Food and Drug Administration (FDA) has approved Orenitram (treprostinil) extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity. This approval marks the first time that the FDA has approved...

FDA Reconsiders Decision on Amarin's Drug

December 23, 2013 9:27 am | News | Comments

The FDA does not expect to take action on Amarin's supplemental application for the labeling expansion for Vascepa (icosapent ethyl) capsules on the Dec. 20, 2013 goal date because the agency is still considering Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement. So when does the FDA plan to complete its review? Find out...

New Approach to Assessing Value of Rare Disease Treatments

December 5, 2013 10:45 am | News | Comments

A study just published by the London Office of Health Economics (OHE) and its collaborators demonstrates how medicines for rare disease may be effectively valued using an innovative approach- multi-criteria decision analysis (MCDA)- that can include all relevant stakeholders, including patients' groups.

J&J to Pay $2.2B to Settle Marketing Allegations

November 4, 2013 12:38 pm | by Matthew Perrone, Associated Press | News | Comments

Johnson & Johnson and its subsidiaries have agreed to pay over $2.2 billion to resolve criminal and civil allegations of promoting three prescription drugs for off-label uses not approved by the U.S. Food and Drug Administration (FDA). For what off-label uses were J&J marketing their drugs? Find out...

FDA Approves Roche's Leukemia Drug Gazyva

November 1, 2013 11:20 am | News | Comments

The U.S. Food and Drug Administration (FDA) today approved Roche's Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first medicine approved with the FDA's Breakthrough Therapy Designation. Why was it named a Breakthrough Therapy? Find out...

Pharmalink's Drug Gets Orphan Designation

October 29, 2013 12:32 pm | News | Comments

Pharmalink AB's Busulipo, a conditioning agent for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT), has received orphan drug designation from the U.S. Food and Drug Administration (FDA). How does the company plan to advance the product towards the market? Find out...

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