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Teva Announces Adrucil Recall

May 5, 2015 11:44 am | News | Comments

Teva announced a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter.

FDA Approves Spray-On Surgical Sealant

May 1, 2015 10:46 am | by FDA | News | Comments

The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It...

Vernalis, Tris Pharma Receive FDA Approval for Tuzistra XR

May 1, 2015 10:36 am | by Vernalis | News | Comments

Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine...

House Denies VA Docs On Medical Marijuana Advice

May 1, 2015 10:13 am | by Andrew Taylor, Associated Press | News | Comments

The GOP-controlled House barely rejected a bid by supporters of medical marijuana that would...

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FDA Approves First Generic Abilify

April 29, 2015 11:22 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole).

Catalent Awarded Grant as Part of a Vaccine Research Consortium

April 23, 2015 10:45 am | by Catalent | News | Comments

Catalent announced that it has received a significant project grant as part of a consortium looking to evaluate, develop and manufacture thermo stable and cold-chain independent nano-pharmaceutical virosome-based vaccine candidates.

FDA Approves First Generic To Treat MS

April 17, 2015 12:16 pm | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

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OriGen Biomedical Issues Nationwide Recall

April 16, 2015 11:20 am | by OriGen Biomedical | News | Comments

OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.

Ending Religious Waivers For Vaccines Back For Heated Debate

April 15, 2015 2:55 pm | by The Associated Press | News | Comments

California lawmakers are preparing for another round of heated talks Wednesday on whether the state should prevent parents from seeking vaccination exemptions for their children because of religious or personal beliefs.

Obama Says Ebola-Fighting Goal is to Prevent Any New Cases

April 15, 2015 2:51 pm | by The Associated Press | News | Comments

President Barack Obama is citing major gains in fighting the Ebola outbreak in West Africa and says the goal now is to prevent any new cases.

French Lawmakers OK Healthcare Bill Targeting Anorexia

April 15, 2015 10:53 am | by Sylvie Corbet, Associated Press | News | Comments

Too-thin models, too much drinking, sexy cigarette packs: France's parliament is cracking down on all of these in a sweeping bill designed to improve public health and trim public health costs.

Congress OKs Bill Reshaping Medicare Doctors' Fees

April 15, 2015 10:48 am | by Alan Fram, Associated Press | News | Comments

The Senate gave final approval late Tuesday to the $214 billion bipartisan measure, which permanently recasts how Medicare reimburses doctors for treating over 50 million elderly people.

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Report: Policy Stunting Growth of German Pharma Industry

April 15, 2015 10:34 am | by Andy Szal, Digital Reporter | News | Comments

A 2011 law overhauling the German pharmaceutical industry will be the biggest impediment to growth in the sector over the next several years, according to a new report.

PBOA Hosts Workshop

April 15, 2015 10:29 am | by Pharma & Biopharma Outsourcing Association | News | Comments

On March 30, the Pharma & Biopharma Outsourcing Association (PBOA) held its first Regulatory/Legislative Workshop.

Australia to Withhold Payments from Parents Against Vaccine

April 14, 2015 10:54 am | by Rod McGuirk, Associated Press | News | Comments

The crackdown comes as similar moves to limit vaccination waivers in the United States have proved to be deeply divisive.

Big Retailers Pull Sales of Weight-Loss Supplements With Dangerous Chemical

April 10, 2015 3:30 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

The issue also intensified criticisms of the FDA.

Tekmira to Resume Ebola Drug Trials

April 10, 2015 12:00 pm | by Tekmira Pharmaceuticals | News | Comments

The FDA has notified Tekmira that the partial clinical hold on TKM-Ebola has been modified. Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks.

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Baxter Recalls IV Solutions

April 10, 2015 11:42 am | by Baxter International | News | Comments

Baxter International Inc. announced today it is voluntarily recalling select lots of IV solutions to the hospital/user level due to the potential presence of particulate matter.

EU Approves Roche’s Avastin Therapy

April 9, 2015 12:06 pm | by Roche | News | Comments

The European Commission (EU) approved Avastin in combination with standard chemotherapy for the treatment of adult patients with carcinoma of the cervix.

Fast Track for BioBlast Pharma

April 9, 2015 11:53 am | by BioBlast Pharma | News | Comments

The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).

Obama: Health Care Law an 8 Out of 10, Lawsuit a 'Last Gasp'

April 8, 2015 2:40 pm | by The Associated Press | News | Comments

He says the biggest challenge is getting more states to expand Medicaid coverage.

Prolong Flagship Product Granted Orphan Drug Designation

April 8, 2015 10:57 am | by Prolong Pharmaceuticals | News | Comments

Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.

Hospira gets FDA Warning

April 7, 2015 4:17 pm | by AP | News | Comments

Drug and medical device maker Hospira said that it received a warning letter from the FDA following an Italian factory inspection. The agency said it found problems with procedures that are supposed to prevent sterile products from being contaminated, and found fault with Hospira's inspections procedures. It also said the company should have better security protecting data generated during its manufacturing process.

American with Ebola is Improving

April 7, 2015 4:12 pm | by AP | News | Comments

Officials say an American healthcare worker who contracted Ebola while volunteering in Sierra Leone has improved to good condition at a federal hospital. He is being treated at the NIH hospital in Bethesda, Maryland.

New Patent for Low-Sodium Bendamustine

April 7, 2015 12:29 pm | by Eagle Pharmaceuticals | News | Comments

Eagle Pharmaceuticals, Inc. today announced a patent for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. 

Asia Agencies Purchase U.S. Simulation Software

April 6, 2015 12:01 pm | by Simulations Plus | News | Comments

Simulations Plus announced that several regulatory agencies around the world have added licenses of software for pharmaceutical discovery and development within the past three months.

Pfizer Stops China Vaccine Sales as Import License Expires

April 2, 2015 1:45 pm | by The Associated Press | News | Comments

Pfizer has stopped selling its Prevnar 7 pneumonia vaccine in China after its import license expired, but the U.S. drugmaker still intends to launch the world's most widely used vaccine, Prevnar 13, in that market.

Indiegogo Campaign to Develop Medical Cannabis in Ireland

April 2, 2015 1:28 pm | by GreenLight Health | News | Comments

An Irish healthcare company has launched a crowdfunding campaign on Indiegogo to raise funds to research and develop affordable medical cannabis.

HHS Contracts to Develop New Ebola Drug

March 31, 2015 11:54 am | by U.S. Department of Health & Human Services | News | Comments

HHS awarded approximately $12 million today to BioCryst Pharmaceuticals of Durham, North Carolina, for the advanced development of a promising experimental drug for Ebola, including preparing for large-scale manufacturing of the drug and conducting related studies.

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