FDA to review Pfizer's rare lung disease drug for women

Rapamune (sirolimus) is intended to treat lymphangioleiomyomatosis (LAM), a rare, progressive, often fatal lung disease that affects reproductive-aged women.

By Nicole Gray • Feb. 23, 2015

Holoclar makes history: Europe approves West's first stem-cell therapy

Chiesi, a privately held Italian company, has received approval in the EU for Holoclar for the treatment of eye burns.

By Nicole Gray • Feb. 23, 2015

In historic reversal, FDA approves 23andMe genetic test for Bloom Syndrome

And it could herald a sea change in the way the agency regulates the marketing of direct-to-consumer genetic testing.

By Sy Mukherjee • Feb. 20, 2015

New Jersey residents' parting gift to Roche: A lawsuit

As Roche prepares to depart its closed Clifton, NJ location to make way for a new private medical school, local residents are ready to initiate a class-action suit demanding environmental remediation.

By Nicole Gray • Feb. 20, 2015

Why FDA's label expansion for Celgene's Revlimid could foretell a global sales surge

Revlimid (lenalidomide) is now approved for use in newly diagnosed patients with multiple myeloma.

By Nicole Gray • Feb. 19, 2015

Shanghai official to serve 19 years over GSK bribery case

Huang Fengping, former deputy director for the Shanghai Municipal Commission of Health and Family Planning, has been sentenced to 19 years in jail by a Chinese court.

By Nicole Gray • Feb. 18, 2015

Sprout Pharma submits 'women's Viagra' for approval once again

After being FDA-rejected twice—and with a great deal of fanfare from supporters—Sprout Pharmaceuticals is resubmitting flibanserin for the treatment of female sexual desire. 

By Nicole Gray • Feb. 18, 2015

FDA reopens conversation about controversial generic labeling rules

In 2013, the FDA proposed a controversial rule that could allow generic drug companies to update their labels with new safety information, even if that info isn't part of the reference product's label. 

By Nicole Gray • Feb. 17, 2015

3 charts that show why 2014 was a record year for US orphan drugs

From designation requests to product approvals, orphan drugs in the U.S. shattered records in 2014. 

By Sy Mukherjee • Feb. 17, 2015

NAFTA patent spat rages on between Canada and Lilly

A battle that started two years ago rages on as Lilly accuses Canada of not protecting patent rights, while Canada calls Lilly's efforts to obtain additional patents for two of its antipsychotics "scattershot."

By Nicole Gray • Feb. 17, 2015

Eisai, Pfizer, and Novartis meds get FDA love over the long weekend

Who said Friday the 13th has to be unlucky, especially right before Valentine's Day?

By Sy Mukherjee • Feb. 13, 2015

AZ to settle Nexium kickback case for $7.9M

AstraZeneca was charged with paying millions to maintain exclusive status for Nexium on Medco's formulary of government-funded drugs. 

By Nicole Gray • Feb. 13, 2015

Teva's internal probe turns up 'likely' corruption

Teva affiliates in Russia and other countries may have provided false information to local authorities about marketing and promotions.

By Nicole Gray • Feb. 12, 2015

EMA defends data black-out policy for AbbVie's Humira

Transparency experts are fuming over the European Medicine Agency's decision to omit certain data from a Humira Clinical Study Report (CSR).

By Nicole Gray • Feb. 12, 2015

Riken stem cell saga continues as Obokata and other scientists face reprimands

The government-funded Japanese research institution is blaming scientist Haruko Obokata and three of her research colleagues for publishing false data in top journals, including Nature.

By Nicole Gray • Feb. 12, 2015

Former Merck financial analyst to plead guilty to insider trading

Between 2012 and 2014, Zachary Zwerko passed confidential information about three stocks to a product manager at BNY Mellon.

By Nicole Gray • Feb. 11, 2015

Nanotrending: FDA adopts another nanotech standard

Since January 2014, the FDA has adopted three nanotech standards—representing a new area of regulation and a new era of nanomedicine.

By Nicole Gray • Feb. 11, 2015

Another one bites the dust: FDA to revoke breakthrough status for BMS hep C med, too

With Gilead and AbbVie as front-runners in the brave new world of hepatitis C treatments, BMS is joining Merck at the back of the line.

By Nicole Gray • Feb. 11, 2015

Former MN gov demands more trial transparency at UMN in wake of '04 suicide

Former Gov. Arne Carlson also called for additional details about the death of a University of Minnesota study subject in 2004.

By Nicole Gray • Feb. 11, 2015

Merck fights back after BC Health Ministry drops diabetes drug

Merck fielded a survey in which 85% of doctors said that drug substitution on economic grounds is bad for patients in light of the agency's decision to drop a diabetes med.

By Nicole Gray • Feb. 10, 2015

Roche's blockbuster Lucentis nabs fourth FDA approval

Lucentis is now cleared for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

By Nicole Gray • Feb. 9, 2015

FDA proposes new consumer-friendly print drug ad guidance

After years of requiring comprehensive warnings in package inserts, the FDA is endorsing warnings on drug labels that highlight the most serious risks and use less technical language. 

By Nicole Gray • Feb. 9, 2015

Arkansas settles Vertex Medicaid suit over pricey Kalydeco

The state will no longer require cystic fibrosis (CF) patients to use standard therapy for 12 months before becoming eligible for Kalydeco (ivacaftor), a $311,000-per-year drug.

By Nicole Gray • Feb. 9, 2015

Why the FDA wants to double inspectors at Indian manufacturing facilities

It's not because of the manufacturing-related issues you might suspect.

By Nicole Gray • Feb. 6, 2015

FDA simplifies compassionate use process in a big way

Many physicians have complained that the amount of documentation required by the Expanded Access Program is cumbersome.

By Nicole Gray • Feb. 6, 2015