Advertisement
Government and Regulatory
Subscribe to Government and Regulatory

The Lead

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...

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...

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...

View Sample

FREE Email Newsletter

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.

FDA Approves VELCADE® Retreatment in Patients with Multiple Myeloma

August 11, 2014 8:19 am | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the FDA has approved VELCADE® for the retreatment of adult patients with multiple myeloma who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.

Advertisement

EU Approves EYLEA Injection for Diabetic Macular Edema

August 11, 2014 8:12 am | News | Comments

Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.

Regeneca Worldwide Recalls RegenESlim Appetite Control Capsules

August 8, 2014 8:31 am | News | Comments

Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is conducting a voluntary nationwide recall of its RegenESlim appetite control dietary supplement from lot # EX0616R15814 and lot #11414RE5516 because FDA analysis confirmed the presence of DMAA. 

FDA Approves ORBACTIV™ for Acute Bacterial Skin and Skin Structure Infections

August 7, 2014 8:43 am | News | Comments

The Medicines Company today announced that the FDA has approved ORBACTIV™ (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

Obama to Sign Veterans' Health Care Overhaul

August 7, 2014 8:22 am | by MATTHEW DALY, Associated Press | News | Comments

Veterans are expected to have an easier time getting government-paid health care from local doctors under a bill that President Barack Obama is set to sign into law Thursday.             

European Commission Approves Octapharma’s Nuwiq® for Hemophilia A

August 6, 2014 8:44 am | News | Comments

The European Commission has published approval of Octapharma’s Nuwiq ® (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). Nuwiq ® is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin.

Advertisement

Cubist Pharmaceuticals Issues Voluntary U.S. Recall of Certain Lots of CUBICIN

August 6, 2014 8:29 am | News | Comments

Cubist Pharmaceuticals today announced it is voluntarily recalling certain lots of CUBICIN® (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer.  

Poll: Obama Health Law is a Tale of Two Americas

August 6, 2014 8:01 am | by RICARDO ALONSO-ZALDIVAR, Associated Press | News | Comments

States that fully embraced the law's coverage expansion are experiencing a significant drop in the number of uninsured residents, according to a major new survey released Tuesday. States whose leaders still object to "Obamacare" are seeing much less change.

Obama Seeks Executive Ways to Limit Tax Inversions

August 5, 2014 5:30 pm | by Josh Lederman - Associated Press - Associated Press | News | Comments

The Obama administration is looking for steps it could take on its own to prevent American companies from reincorporating overseas to shirk U.S. taxes, aiming to sidestep a logjam in Congress, officials said Tuesday. President Barack Obama has denounced so-called tax inversions as unpatriotic and has urged Congress to stop them.

FDA Approves Lannett's Oxycodone Hydrochloride Capsules 5 mg

August 4, 2014 8:59 am | News | Comments

Lannett Company today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, of Lehigh Valley Technologies.

Genzyme Receives Label Expansion for Lumizyme® in the U.S. for the Treatment of Pompe Disease

August 4, 2014 8:40 am | News | Comments

Genzyme, a Sanofi company announced that the FDA approved a supplement to expand the indication for Lumizyme ® (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype.  

Advertisement

FDA Approves Lilly, Boehringer Diabetes Drug

August 1, 2014 1:34 pm | by The Associated Press | News | Comments

Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes . The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes.

Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

Israel's Ministry of Health Approves Pluristem's Commercial-Scale 3D Cell Manufacturing Process

July 31, 2014 10:58 am | News | Comments

Pluristem Therapeutics has announced that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa.     

FDA Approves EYLEA Injection for the Treatment of Diabetic Macular Edema

July 30, 2014 8:03 am | News | Comments

Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of EYLEA in patients with DME is 2 milligrams every two months after five initial monthly injections.

European Commission Approves Eliquis for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

July 29, 2014 8:38 am | News | Comments

Bristol-Myers Squibb and Pfizer announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway.

FDA Grants Full Approval for IMBRUVICA for Two Indications

July 28, 2014 2:39 pm | News | Comments

Pharmacyclics, Inc. announced that the FDA has granted IMBRUVICA regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.

FDA Approves Aqua Pharmaceuticals' ACTICLATE™ Tablets

July 28, 2014 9:11 am | News | Comments

ACTICLATE™ is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.                 

Can Canadian-Style Health Care Work in Vermont?

July 28, 2014 9:01 am | Videos | Comments

In Vermont, a new health care experiment is under the microscope.                                

After Six Weeks, Finally a Deal on VA Health Care

July 28, 2014 8:26 am | by MATTHEW DALY, Associated Press | News | Comments

After more than six weeks of sometimes testy talks, House and Senate negotiators have agreed on a compromise plan to fix a veterans health program scandalized by long patient wait times and falsified records covering up delays.    

Allergan's OZURDEX® Receives European Positive Opinion for the Treatment of Diabetic Macular Edema

July 25, 2014 8:03 am | News | Comments

Allergan announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX ® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema.

Study: 10M Have Gained Coverage Through Health Law

July 24, 2014 8:43 am | by Associated Press | News | Comments

A new study estimates that more than 10 million adults gained health insurance by midyear as the coverage expansion under President Barack Obama's law took hold in much of the country.           

FDA Approves New Extended-Release Oxycodone with Abuse-Deterrent Properties

July 24, 2014 7:59 am | News | Comments

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

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