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Lawsuit says Novartis’ Gleevec patent infringement suit a ‘sham’

July 1, 2015 10:31 am | by Jonathon Shacat, FDA | News | Comments

Two institutional buyers of Gleevec want to stop its manufacturer, Novartis, from delaying generic competition of the blockbuster leukemia drug, saying a patent litigation settlement between the brandmaker and generics maker Sun Pharma ...

FDA takes action against unapproved prescription ear drop products

July 1, 2015 10:22 am | by FDA | News | Comments

The U.S. Food and Drug Administration today announced its intention to take enforcement action...

Draft guidance helps designers modify ongoing clinical trials

July 1, 2015 8:24 am | by Elizabeth Orr, FDA | News | Comments

Sponsors considering whether to use an adaptive clinical trial design should select a number of...

FDA issues the Drug Supply Chain Security Act implementation

July 1, 2015 7:31 am | News | Comments

The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include...

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FDA grants peanut allergy drug breakthrough status

June 26, 2015 8:22 am | by Jason Scott, FDA | News | Comments

Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. The designation, which entitles the company to more frequent meetings with the FDA ...

Big pharma attacks FDA in free-speech lawsuit

June 19, 2015 9:36 am | by John Bechtel, FDA | News | Comments

PhRMA and the Medical Information Working Group want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using a small drugmaker’s lawsuit against the agency to press their case.

Ruling makes it easier for medical devicemakers to sue for patent infringement

June 19, 2015 7:45 am | by Elizabeth Orr, FDA | News | Comments

A U.S. Supreme Court ruling last week that patents should be presumed valid could make it easier for medical devicemakers to sue for patent infringement, a patent law attorney said. The 6-2 ruling, with one abstention ...

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Moral debate continues between drugmakers and health insurers

June 18, 2015 2:07 pm | by BUSINESS WIRE | News | Comments

Recent decisions by an FDA advisory committee in favor of approving two new cholesterol-lowering drugs will set up another chapter in the ongoing value debate between drugmakers and health insurers, according to Fitch Ratings.

FDA takes action to contravene counterfeit medicines and devices sold online

June 18, 2015 12:46 pm | by FDA | News | Comments

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines....

China FDA exempts ‘equivalent’ devices from clinical trials

June 18, 2015 12:40 pm | by Elizabeth Orr, FDA | News | Comments

Devicemakers won’t have to stage new clinical trials of their devices to gain approval in China if they can demonstrate that they’re basically equivalent to devices already on the market, Chinese regulators say.

Federal officials want to spend $20B on AIDS drugs, based on 45 cases

June 11, 2015 11:51 am | by Jane M. Orient, M.D. | Blogs | Comments

The AIDS industry and its government allies were just waiting for evidence to justify a change in policy.

Murder charge dropped against woman who induced abortion with pills

June 11, 2015 11:32 am | by KATHLEEN FOODY, RUSS BYNUM, Associated Press | News | Comments

Dougherty County District Attorney Greg Edwards dismissed a malice murder charge against 23-year-old Kenlissia Jones, who spent about three days in jail after seeking help at a hospital.

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FDA panel backs first-in-class cholesterol drug

June 10, 2015 11:55 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health advisers recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.

AM-Pharma receives FDA and EMA orphan drug designation to treat hypophosphatasia

June 9, 2015 11:13 am | by Business Wire | News | Comments

RecAP is currently in Phase II development for testing the potential treatment of acute kidney injury, with the potential to be developed for hypophosphatasia.

Georgia can't explain cloudy execution drug

June 8, 2015 11:16 am | by KATE BRUMBACK, Associated Press | News | Comments

Georgia prison officials pointed to cold storage temperatures as "the most likely cause" of the cloudiness in a lethal injection drug that halted an execution — but testing may indicate otherwise.

Family behind 'Right to Try' looks beyond the bill

June 8, 2015 11:11 am | by MARTIN SWANT, Associated Press | News | Comments

Gabe Griffin lobbied his first bill at the age of 9. It became law when he turned 10. He'll be in a wheelchair when he turns 12. Without the right drugs, his parents say he'll be dead in a decade.

FDA weighs approval of first-in-class cholesterol drug

June 8, 2015 11:05 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators said Friday that a highly-anticipated, experimental drug from Sanofi lowers bad cholesterol more than older drugs. But officials have additional questions regarding study results.

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Prison for woman who replaced fish oil with seizure meds and stool softeners

June 5, 2015 6:45 am | by Associated Press | News | Comments

U.S. Food and Drug Administration investigators determined the bottle contained 10 fish oil capsules, 70 phenytoin capsules and several stool softener pills.

NIH suspends experimental drug production

June 5, 2015 6:20 am | by Associated Press | News | Comments

Thursday's suspension leaves about 250 people in 46 NIH studies waiting to hear when they will receive other experimental treatments.

Controversy swirls around cost of hepatitis C drug

June 4, 2015 11:06 pm | by Andy Szal, Digital Reporter | News | Comments

A California woman last month sued her insurance provider over a drug to treat hepatitis C, the latest episode involving the skyrocketing costs of specialty medications.

Rutgers research promises ‘revolution’ in pharmaceutical manufacturing

June 4, 2015 4:17 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

A $6 million gift from Janssen Pharmaceuticals will help spur Rutgers’ research into “revolutionary” continuous manufacturing. 

Woman pushes for FDA approval of female libido drug

June 4, 2015 11:46 am | by Reuters | Videos | Comments

Meet Katherine Campbell — a woman testifying at an FDA meeting this week in hopes of seeing a female libido drug getting approved.

The U.S. drug shortage — by the numbers

June 2, 2015 4:07 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

The U.S. has a drug shortage problem that refuses to go away. Here's a look at what it means for manufacturers, patients and doctors.

Lannett completes acquisition of Silarx

June 2, 2015 12:19 pm | by PR Newswire | News | Comments

Lannett Company announced that it has completed the acquisition of privately held Silarx Pharmaceuticals - a manufacturer and marketer of liquid generic pharmaceutical products. 

J&J pipeline forecasting 10 new products worth $1B

June 2, 2015 12:14 pm | by PR Newswire | News | Comments

Senior leaders announced plans to file for regulatory approval of more than 10 new products between 2015 and 2019.

Concerns remain for female Viagra

June 2, 2015 12:05 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The makers of a pill intended to boost sexual desire in women will try again this week to persuade regulators that the drug warrants approval after two rejections.

U.S. drug shortage soars

June 1, 2015 11:36 am | by Fox Business | Videos | Comments

Contamination problems and the high cost of regulations have caused manufacturing delays and drug shortages that are only getting worse.

Lawmakers seek to curb skyrocketing generic drug prices

May 27, 2015 9:19 am | News | Comments

Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay ...

First FDA-approved biosimilar brings hope for CMO growth

May 22, 2015 1:02 pm | by PRNewswire | News | Comments

The FDA's recent approval of Zarxio, the first biosimilar product approved in the United States, points toward growth in the contract manufacturing marketplace, according to Kalorama Information.

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