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ELC Group Signs Regulatory Affairs Contract With Chinese Pharma Giant

April 21, 2015 10:43 am | by ELC Group | News | Comments

ELC Group, one of the fastest-growing providers of regulatory affairs services, today announces that it has been awarded a 1.5 million Euro contract by one of China’s biggest pharmaceutical companies.

Physicians Want Dr. Oz Gone From Columbia Medical Faculty

April 17, 2015 10:53 am | by Verena Dobnik, Associated Press | News | Comments

A group of top doctors has demanded Columbia University remove Dr. Oz, citing his "egregious...

Medac Pharma Announces Settlement Of Patent Infringement Lawsuits

April 16, 2015 3:17 pm | by PRNewswire | News | Comments

Medac Pharma, Inc., a privately-held pharmaceutical company, today announced that it and its...

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...

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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.

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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.

Actavis: No Apologies for Seeking Alzheimer's Drug Profits

April 14, 2015 10:45 am | by Larry Neumeister, Associated Press | News | Comments

A lawyer for Actavis urged a U.S. appeals court on Monday to let it replace a two-pill daily regimen with a single-dose version of the drug even if it cheats generic drugmakers of profits.

AstraZeneca and PatientsLikeMe Announce Global Research Collaboration

April 13, 2015 12:54 pm | by AstraZeneca | News | Comments

AstraZeneca and PatientsLikeMe have signed a five-year agreement to provide access to PatientsLikeMe’s global network in support of AstraZeneca’s patient-driven research initiatives.

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.

Botox Death Prompts Lawsuit

April 10, 2015 11:48 am | by Ray Chester, McGinnis Lochridge LLP | News | Comments

Parents of Melinda Ann "Mandy" Fortuna filed suit yesterday against Allergan, Inc., alleging that a series of off-label Botox overdoses were responsible for their daughter's death.

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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.

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.

FDA Questions Evidence for Lower-Risk Tobacco Product

April 8, 2015 10:48 am | by Matthew Perrone, AP Health Writer | News | Comments

U.S. health regulators have questions about tobacco maker Swedish Match's bid to become the first to market a smokeless tobacco product as less harmful than cigarettes.

Court: Arizona Probationers Can't Be Barred From Medical Pot

April 8, 2015 10:42 am | by Jacques Billeaud, Associated Press | News | Comments

Arizonans with medical marijuana cards cannot be barred from using the drug while on probation, the state Supreme Court concluded Tuesday in a ruling that will have ripple effects across the state.

Shares of Arena Rise Due to Weight Loss Drug Patent

April 7, 2015 12:42 pm | by The Associated Press | News | Comments

Shares of Arena Pharmaceuticals rose Tuesday after the drug developer said it received an additional patent for its weight loss drug Belviq.

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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. 

Report: Takeda Offers $2.2 Billion to Settle Actos Lawsuits

April 6, 2015 10:55 am | by Andy Szal, Digital Reporter | News | Comments

Japanese pharmaceutical company Takeda reportedly offered more than $2.2 billion to settle thousands of lawsuits over the diabetes drug Actos, according to a Bloomberg report.

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.

GNC Reaches Deal With NY AG Over Herbal Plus Products

March 30, 2015 12:43 pm | by The Associated Press | News | Comments

GNC Holdings Inc. said Monday that it has reached a deal with New York Attorney General Eric Schneiderman over its Herbal Plus products.

Potential Billion-Dollar Verdict Rests on Disputed Deadline

March 27, 2015 8:00 am | by ADAM BEAM, Associated Press | News | Comments

What does it cost to miss a deadline? For the company that makes the prescription painkiller Oxycontin, the answer could be more than $1 billion.

Justices to Hear Arguments Over EPA Mercury Limits

March 25, 2015 8:18 am | by MARK SHERMAN, Associated Press | News | Comments

The Supreme Court is taking up a challenge by industry groups and Republican-led states that want to roll back Obama administration environmental rules aimed at reducing power plant emissions of mercury and other hazardous air pollutants that contribute to respiratory illnesses, birth defects and developmental problems in children.

FDA Warns Cosmetics Companies Against Promises That 'Go Too Far'

March 24, 2015 8:04 am | by Andy Szal, Digital Reporter | News | Comments

The agency said its tracking of claims by cosmetics companies during recent years indicated a proliferation in drugs claims--defined by the FDA as "intended to treat or prevent disease, or change the body’s structure or functions"--on product packaging and in web advertising.

Herbalife Pyramid-Scheme Suit Dismissed

March 18, 2015 4:12 pm | News | Comments

A judge has dismissed a lawsuit by Herbalife shareholders who claimed that the business structure and marketing practices of the weight loss and nutritional supplements company violated the law and that they lost money in what amounts to a pyramid scheme.

Indiana Medicaid Recovers $126,000 in Lawsuit Settlement

March 17, 2015 8:05 am | News | Comments

Indiana's Medicaid program will receive more than $126,000 from a drug manufacturer that filed false claims to Medicaid and other federally funded health care programs.

Ad Industry Group Recommends That Little Remedies Stop Cold, Sore Throat Claims

March 13, 2015 2:22 pm | by Andy Szal, Digital Reporter | News | Comments

The National Advertising Division--an industry regulatory agency administered by the Council of Better Business Bureaus--investigated Prestige Brands Holdings' Little Remedies products following a complaint by Pfizer.

More Prosecutors Join NY Herbal Supplement Inquiry

March 11, 2015 8:35 am | by MARY ESCH, Associated Press | News | Comments

Prosecutors from Connecticut, Indiana and Puerto Rico have joined New York's attorney general in an investigation of the herbal supplement industry, saying they're building on the long track record of state attorneys general upholding the rights of consumers.

McNeil Consumer Healthcare Pleads Guilty to Metal Particles in Kids' Tylenol

March 11, 2015 8:23 am | by MICHAEL RUBINKAM, Associated Press; MARYCLAIRE DALE, Associated Press | News | Comments

McNeil Consumer Healthcare, of Fort Washington, Pennsylvania, acknowledged failing to take corrective action after discovering the adulterated bottles of Infants' and Children's Tylenol and Children's Motrin. The company agreed to pay $25 million to resolve the case.

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