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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...

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...

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)...

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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...

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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...

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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...

FDA Wants Limits on Hydrocodone Painkillers

October 25, 2013 9:51 am | News | Comments

The Food and Drug Administration is recommending new restrictions on prescription medicines containing hydrocodone, the highly addictive painkiller that has grown into the most widely prescribed drug in the U.S.           

FDA Reviews 2 Promising New Drugs for Hepatitis C

October 22, 2013 12:48 pm | by Matthew Perrone, AP Health Writer | News | Comments

The U.S. Food and Drug Administration holds a public meeting this week to review two experimental medications from Johnson & Johnson and Gilead Sciences. Could the new drugs, if approved, offer a quicker, more effective approach to eliminating hepatitis C, a blood-borne disease blamed for 15,000 deaths in the U.S. this year? Find out...

Actelion's Hypertension Drug Gets FDA Approval

October 21, 2013 2:49 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has approved the use of Actelion's  orally available endothelin receptor antagonist Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression. So when will the new drug be available to patients? Find out...

Bristol Myers-Squibb Researcher Committed Misconduct

October 21, 2013 2:25 pm | by Andrew S. Wiecek, Editor | Articles | Comments

A Bristol Myers-Squibb (BMS) researcher engaged in research misconduct as a graduate student at the Medical College of Wisconsin (MCW) and as an assistant scientist at the University of Wisconsin-Madison (UWM), the U.S. Office of Research Integrity (ORI) has found. What was he specifically found guilty of? Find out...

Eddingpharm Licenses Ablynx Nanobody Therapeutic

October 18, 2013 1:40 pm | News | Comments

Ablynx has granted an exclusive, royalty-bearing license to Eddingpharm, a leading Chinese specialty pharmaceutical company, to develop and commercialise its anti-RANKL Nanobody, ALX-0141, in the mainland of the People's Republic of China, the Hong Kong and Macao Special Administrative Regions, and Taiwan, for all indications, including osteoporosis and bone metastases. Read more...

Savient Pharmaceuticals Files for Bankruptcy

October 15, 2013 1:58 pm | News | Comments

Savient Pharmaceuticals Inc. has filed voluntary petitions under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware.  So which company has Savient entered into an acquisition agreement with? Find out...

Shutdown Delays FDA Approval of Flu Vaccine

October 15, 2013 12:44 pm | News | Comments

Rep. Nita Lowey, D-N.Y., urged for an end to the government shutdown during a visit to a Rockland County, N.Y. vaccine facility that faces delays in securing approval from the U.S. FDA for its flu vaccine. What does the delay in approval for new vaccines mean for the vaccine's availability? Find out...

Former FDA Commissioner Joins J&J Board

October 14, 2013 2:01 pm | News | Comments

Johnson & Johnson announced today that Mark B. McClellan, MD, PhD, senior fellow in economic studies, and director of the Initiative on Value and Innovation in Health Care, Brookings Institution, will join the board of directors on Oct. 15, 2013. So what committees will McClellan will serve on? Find out...

FDA OKs Stem Cell Trial for Spinal Cord Injuries

October 2, 2013 1:47 pm | News | Comments

The U.S. Food and Drug Administration (FDA) has authorized the StemCells Inc.'s application for clinical testing of the company's HuCNS-SC human neural stem cells as a treatment for spinal cord injury. How successful has its international trials been so far? Find out...

FDA Continues Clinical Hold of Achillion's Hepatitis C Drug

September 30, 2013 2:32 pm | News | Comments

Achillion received a response from the U. S. Food and Drug Administration (FDA) on the clinical hold related to sovaprevir, Achillion's NS3 protease inhibitor. Although Achillion's submission addressed all issues noted in the FDA's letter, the FDA concluded that the removal of the clinical hold is not warranted. Read more...

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