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The Lead

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:46 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes.

Baxter Recalls One Lot of Potassium Chloride Injection

September 17, 2014 3:00 pm | News | Comments

Baxter International Inc. announced today it is voluntarily recalling one lot of Potassium...

FDA Clears Constipation Drug Movantik

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

Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by...

Concerns Raised over 'Obamacare' Abortion Coverage

September 16, 2014 8:30 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

A nonpartisan congressional agency is raising new questions about compliance with a key...

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Hurdles for Obama Health Law in Second Sign-Up Season

September 15, 2014 8:39 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

Potential complications await consumers as President Barack Obama's health care law approaches its second open enrollment season, just two months away. Don't expect a repeat of last year's website meltdown, but the new sign-up period could expose underlying problems with the law itself that are less easily fixed than a computer system.

FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency

September 15, 2014 8:31 am | News | Comments

Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

Chemical Industry Tries to Shape Regulations

September 12, 2014 3:31 pm | by FREDERIC J. FROMMER, Associated Press | News | Comments

The powerful chemical industry is putting its lobbying muscle behind legislation that would establish standards for chemicals used in products from household goods to cellphones and plastic water bottles — but also make it tougher for states to enact their own regulations.

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Hospira Recalls One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection

September 12, 2014 8:38 am | News | Comments

Hospira is initiating a voluntary nationwide user-level recall of one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. This action is due to one confirmed customer report of particulate in a single unit.

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 8:13 am | News | Comments

The drug is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.

Lilly Receives European Marketing OK for Insulin

September 10, 2014 10:58 am | News | Comments

European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.        

Prescription Drug Abuse is "Public Health Crisis," says Attorney General

September 9, 2014 8:57 am | Videos | Comments

Attorney General Eric Holder is announcing a new nationwide 'take-back' program to help combat prescription drug abuse, a problem he calls an "urgent and growing threat."              

FDA Approves Use of Menactra Vaccine for Booster Immunization Against Potentially Deadly Disease

September 8, 2014 2:55 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the use of Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.

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Pharmacy Creations Recalls Four Product Lots Due to Potential Non-Sterility

September 8, 2014 9:56 am | News | Comments

Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile.

FDA Approves Two New Indications for Epaned

September 8, 2014 9:54 am | News | Comments

Silvergate Pharmaceuticals today announced that the FDA approved Epaned (enalapril maleate Powder for Oral Solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunctio.    

Keryx Gets FDA Approval for New Kidney Disease Drug

September 5, 2014 12:06 pm | News | Comments

The FDA approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death. Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2B.

FDA Approves Keytruda for Advanced Melanoma

September 4, 2014 3:49 pm | News | Comments

The U.S. Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.       

Regeneca Worldwide Expands Voluntarily Recall of Regeneslim Appetite Control Capsules

September 2, 2014 9:04 am | News | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is expanding the voluntary nationwide recall of its RegeneSlim appetite control dietary supplement to include lot #823230415, lot #EX0616r 15813, Lot # EX0616R15814 and Lot #11414re5516 because FDA analysis confirmed the presence of DMAA.

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Senate Hopeful Defends Role in Irish Pharmaceutical Firm's Merger

September 2, 2014 8:24 am | by KYLE POTTER, Associated Press | News | Comments

Years before Burger King sized up a Canadian headquarters in a hunt for lower taxes, Republican U.S. Senate candidate Mike McFadden's investment firm was involved in a merger that moved an American pharmaceutical company to Ireland and significantly dropped its tax rate.

Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

European Commission Approves Bristol-Myers Squibb’s Daklinza

August 27, 2014 8:20 am | News | Comments

Bristol-Myers Squibb Company today 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 (HCV) infection in adults.

Ligand Partner GlaxoSmithKline Receives FDA Approval for Promacta®/Revolade™

August 27, 2014 8:07 am | News | Comments

Ligand Pharmaceuticals Incorporated announced that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application (sNDA) for the once-daily use of Promacta®/Revolade™ (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

Fresenius Kabi Receives FDA Approval for Kabiven® and Perikabiven®

August 26, 2014 9:19 am | News | Comments

Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven ® and Perikabiven ®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States.

FDA Approves Iroko Pharmaceuticals’ ZORVOLEX for Management of Osteoarthritis Pain

August 25, 2014 8:23 am | News | Comments

Iroko Pharmaceuticals, LLC,  announced today the United States Food and Drug Administration (FDA) has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.   

Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible Particulates

August 14, 2014 9:05 am | News | Comments

Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.

FDA Approves New Sleeping Drug from Merck

August 13, 2014 4:29 pm | by The Associated Press | News | Comments

Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.

FDA Approves Lung Preservation Machine

August 13, 2014 8:13 am | News | Comments

The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other deadly respiratory diseases.      

Deadline to Clear Up Health Law Eligibility Near

August 13, 2014 8:06 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

The clock is ticking for hundreds of thousands of people who have unresolved issues affecting their coverage under the new health care law. The Obama administration said Tuesday that letters are going out to about 310,000 people whose citizenship or immigration details don't match what the government has on file.

FDA Approves DNA-Based Test for Colon Cancer

August 12, 2014 8:33 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Cologuard test from Exact Sciences detects irregular mutations in stool samples that can be an early warning sign of cancer. Patients who test positive for the mutations should undergo a colonoscopy to confirm the results.    

FDA Approves INVOKAMET for the Treatment of Adults with Type 2 Diabetes

August 11, 2014 8:26 am | News | Comments

INVOKAMETT provides the clinical attributes of INVOKANA (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes.

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