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The Lead

Canadians wait 462 days for access to new drugs

May 22, 2015 8:59 am | by Jason Lomberg, Editor, @PharmProEditor | Blogs | Comments

During the hullabaloo surrounding passage of President Obama’s signature piece of legislation, the Patient Protection and Affordable Care Act (aka, Obamacare), proponents extolled the virtues of Canada’s free healthcare system. Critics slammed that same system for its alleged wait times....

USP demands public standards for dietary supplements

May 21, 2015 10:06 am | by United States Pharmacopeial Convention | News | Comments

In recent weeks, the case of supplements containing an amphetamine-like substance called BMPEA...

J&J Pharmaceuticals Announces 10 filings for Blockbuster Drugs by 2019

May 20, 2015 10:43 am | News | Comments

At a meeting today with analysts, Johnson & Johnson's Janssen Pharmaceuticals announced...

Investigational Hep C Drugs Receive Breakthrough Therapy Designation

May 20, 2015 10:20 am | by Business Wire | News | Comments

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA)...

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FDA approves new medication to treat schizophrenia

May 20, 2015 10:12 am | by Janssen Pharmaceuticals | News | Comments

There’s a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.

Colorado Cracks Down on State's Medical Marijuana Industry

May 19, 2015 9:14 am | by KRISTEN WYATT, Associated Press | News | Comments

Colorado's governor signed into law a crackdown on medical marijuana Monday, one of two measures designed to ferret out people improperly using and selling untaxed marijuana. The law limits the number of plants caregivers can have.

Eagle Pharmaceuticals Receives Patent for Rapid Infusion Product

May 19, 2015 8:59 am | by Business Wire | Teva Pharmaceuticals Usa | News | Comments

Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes.

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Puma Biotech Stumbles With Breast Cancer Drug

May 15, 2015 11:53 am | by The Associated Press | News | Comments

Treatment results with the breast cancer drug Herceptin, as well as chemotherapy, did improve, but the drug's backers had been hoping to see better results.

ANI Acquires Rights to Testosterone Gel 1%

May 13, 2015 11:31 am | by ANI Pharmaceuticals | News | Comments

ANI Pharmaceuticals has acquired the approved new drug application ("NDA") for a testosterone gel 1% product previously licensed to Teva Pharmaceuticals.

FDA Panel Backs Vertex Combination Pill for Cystic Fibrosis

May 13, 2015 11:23 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health advisers recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients.

FDA Fast Tracks Sucampo's Cobiprostone

May 11, 2015 10:28 am | by Sucampo Pharmaceuticals | News | Comments

The FDA has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator for the prevention of oral mucositis.

FDA Questions Benefit of Cystic Fibrosis Drug From Vertex

May 8, 2015 11:39 am | by Matthew Perrone, AP Health Writer | News | Comments

The Food and Drug Administration said in an online review that the benefit was small and it is unclear if the addition of a second drug ingredient adds to the pill's effectiveness.

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Mylan Launches Generic Seasonale Tablets

May 7, 2015 11:50 am | by Mylan N.V. | News | Comments

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets.

Portola Pharmaceuticals Q1 Results

May 7, 2015 11:35 am | by Portola Pharmaceuticals | News | Comments

Portola Pharmaceuticals today provided a corporate update and reported its financial results for the first quarter.

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 is used to help control bleeding during surgery.

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 in treating coughs and upper respiratory allergies.

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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 have permitted veterans to receive information about the drug from their government doctors.

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).

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.

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.

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