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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...            

Both American Ebola Patients Discharged from Hospital

August 21, 2014 1:00 pm | by Jeff Martin and Katie Foody | News | Comments

After nearly three weeks of treatment, the two American aid workers who were infected with the...

DOJ Closes Probe into AstraZeneca Trial

August 19, 2014 3:26 pm | News | Comments

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation...

HPV Vaccine Remains Effective After Eight Years, Study Says

August 18, 2014 2:39 pm | News | Comments

A new study examined whether the HPV vaccine remains effective 8 years after initial vaccination...

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Liberia Gets ZMapp, Ponders Who Should Get It

August 14, 2014 2:50 pm | by Jonathan Paye-Layleh and Sarah DiLorenzo | News | Comments

Liberian officials faced a difficult choice Thursday: deciding which handful of Ebola patients will receive an experimental drug that could prove life-saving, ineffective or even harmful. Read more...               

Clinical Trial Evaluates Safety of Stem Cell Transplantation in Spine

August 12, 2014 2:41 pm | Videos | Comments

Researchers have launched a clinical trial to investigate the safety of neural stem cell transplantation in patients with chronic spinal cord injuries. This Phase 1 clinical trial is recruiting eight patients for the five-year study. Read more...

Ebola: Questions, Answers About Unproven Drug

August 12, 2014 2:25 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

An experimental Ebola drug has been used to treat two American aid workers and a Spanish missionary priest, and the Liberian government said that it will receive doses of the drug to treat two doctors in the country. Read more...       

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Neurovance Completes Enrollment in Abuse Liability Study

August 8, 2014 3:05 pm | News | Comments

Neurovance Inc. announced that it has completed enrollment in a human abuse liability study of centanafadine (formerly EB-1020), a novel non-stimulant being developed for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Read more...

Breath Reveals Hidden Image in Anti-Counterfeit Labels

August 7, 2014 1:00 pm | Videos | Comments

Counterfeit drugs, which at best contain wrong doses and at worst are toxic, are thought to kill more than 700,000 people per year. To fight back against counterfeiting, researchers have developed a way to make labels that change when you breathe on them, revealing a hidden image. Read more...

Cubist Recalls Some Cubicin Lots

August 6, 2014 3:25 pm | News | Comments

Cubist 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. Read more...       

C. Difficile Prophylactic Program Remains on Track

August 5, 2014 3:01 pm | News | Comments

Synthetic Biologics Inc., a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, announced that, with a new multi-service agreement in place, the company is on track to initiate Phase 1a and 1b clinical trials of SYN-004 for the prevention of Clostridium difficile. Read more...

CHMP Has More Issues with Weight Loss Drug

July 31, 2014 8:34 am | News | Comments

Orexigen Therapeutics Inc. announced it has received the Day 180 List of Outstanding Issues from the European Medicines Agency's Committee for Medicinal Products for Human Use for the NB32 (naltrexone sustained release (SR) / bupropion SR) Marketing Authorization Application. Read more...

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MedImmune Fights Pediatricians' New Advice

July 28, 2014 12:13 pm | by Lindsey Tanner, AP Medical Writer | News | Comments

A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine. Read more...            

Emulate to Commercialize Organs-on-Chips Platform

July 28, 2014 10:25 am | News | Comments

Emulate Inc. announced the company’s launch with a $12 million Series A financing to commercialize a first-in-kind, automated ‘Organs-on-Chips’ platform that mimics human physiology and diseases, while permitting real-time elucidation of molecular mechanisms of action and toxicity. Read more...

Survey Finds Sharp Increase in Teen HGH Use

July 23, 2014 1:31 pm | by David Crary, AP National Writer | News | Comments

Experimentation with human growth hormones by America's teens more than doubled in the past year, as more young people looked to drugs to boost their athletic performance and improve their looks, according to a new survey. Read more...     

Halozyme Resumes Pancreatic Cancer Trial

July 22, 2014 2:37 pm | News | Comments

Halozyme Therapeutics Inc. announced that it has resumed enrollment and dosing of patients in its ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer. Read more...               

Easing Drug-Induced Fatty Liver Disease in HIV Patients

July 22, 2014 1:40 pm | News | Comments

The only drug to receive FDA approval for reduction of the abdominal fat deposits that develop in some patients receiving antiviral therapy for HIV infection may also reduce the incidence of fatty liver disease. Read more...        

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Studies Reveal New Niacin Risks

July 17, 2014 10:54 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

New details from two studies reveal more side effects from niacin, a drug that hundreds of thousands of Americans take for cholesterol problems and general heart health. Some prominent doctors say the drug now seems too risky for routine use. Read more...

Tamoxifen Gel Effective When Applied to Breast

July 15, 2014 3:08 pm | News | Comments

A breakdown product of tamoxifen, 4-OHT, applied as a gel formulation on the breasts of women with ductal carcinoma in situ (DCIS), was as effective in reducing cell proliferation as oral tamoxifen, with fewer side effects compared with oral tamoxifen, according to a study. Read more...

Significant Increase in Antibiotic Use Across the World, Study Shows

July 11, 2014 3:23 pm | News | Comments

Global use of antibiotics is surging, according to researchers who have conducted a broad assessment of antibiotic consumption around the world. Read more...                            

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 Massachusetts, Gov. Deval Patrick on Thursday signed a law he said would address a "gray area" between state and federal oversight of the pharmacies. Read more...

Review: Gaps Between Approval, Safety Assessment of ADHD Drugs

July 10, 2014 12:00 pm | News | Comments

Over the last 60 years, the FDA approved 20 medications for ADHD based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers report. Read more...        

Childhood Vaccines Again Deemed Generally Safe

July 1, 2014 1:29 pm | by Mike Stobbe, AP Medical Writer | News | Comments

The latest analysis of childhood vaccines confirms they're generally safe. The report should be reassuring to parents, the researchers say. For example, there still is no evidence the measles-mumps-rubella vaccine causes autism. Nor is there any proof vaccines cause childhood leukemia. 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...            

Committee Recommends Nixing Cardiovascular Outcomes Trial for PAMORA Drugs

June 13, 2014 10:40 am | News | Comments

AstraZeneca announced that the majority of FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes AstraZeneca's Movantik. Read more...

'Fight the Fakes' Campaign Gains New Partners

June 6, 2014 9:40 am | News | Comments

Following the campaign's six-month anniversary, Fight the Fakes announced that eleven new partners joined the campaign to speak up and spread the word about the devastating impact of fake medicines. Read more...           

Merck's NuvaRing Settlement Finalized at $100M

June 6, 2014 8:18 am | by Jim Salter | News | Comments

A $100 million settlement involving NuvaRing, a birth-control device linked to sometimes-fatal side effects, will stand now that the vast majority of claimants have chosen to opt into the agreement. Read more...           

Janssen Withdraws EU App for IV Administered Simponi

May 19, 2014 10:42 am | News | Comments

Janssen Biologics B.V. announced that the company has withdrawn its application seeking a change to the Marketing Authorization for Simponi to add a new pharmaceutical form of intravenous administration for the treatment of adults with moderately to severely active rheumatoid arthritis. Read more...

Pradaxa Carries Higher Risk for GI Bleeding than Warfarin

May 14, 2014 10:36 am | News | Comments

The FDA recently completed a new study in Medicare patients comparing Boehringer Ingelheim's Pradaxa to warfarin, and found that  Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death, but carried and increased risk of major gastrointestinal bleeding. Read more...

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