Celgene's Abraxane approved in EU for first-line treatement of NSCLC

The drug is now approved in the E.U. for first-line treatment in combination with carboplatin in adults who are not eligible for radiation or surgery.

By Nicole Gray • March 3, 2015

Color Consistency in Pharmaceuticals: Using Spectrophotometry for Blending Powders and Plaques

Sponsored by: We use the word "color consistency" a lot when referring to products that depend on this trait for quality assurance. In the pharmaceutical industry, color consistency means a lot more than the final color outcome of a product. Color consistency in pharmaceutical powders and pl...

March 3, 2015

Sanofi's Toujeo nabs EU rec and efficacy shoutout on heels of FDA blessing

The EMA's Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Toujeo, meaning the drug will win marketing authority in major EU markets soon enough.

By Nicole Gray • March 2, 2015

Indian advisory board proposes waiving phase III for certain drugs

Drugs that have already been approved in "well regulated" markets like the U.S. and the E.U. would be granted a phase III waiver under the proposal.

By Nicole Gray • March 2, 2015

A biotech is bringing a new IUD to market—but the company's a nonprofit

San Francisco-based Medicines 360 plans to sustain itself through product sales with the help of its marketing partner, Actavis.

By Nicole Gray • March 2, 2015

EU approves first new chemical entity for Parkinson's in a decade

The drug is Newron Pharma's Xadago.

By Nicole Gray • Feb. 27, 2015

Gilead raking in billions off of foreign tax laws

In 2014, Gilead earned more in non-U.S. net profits than it recorded in non-U.S. sales. 

By Nicole Gray • Feb. 27, 2015

How 23andMe used rigorous clinical trials to win a landmark FDA authorization

And a D.C.-area physician dishes on his personal experiences with 23andMe's genetic testing kit.

By Nicole Gray • Feb. 26, 2015

Federal judge strikes down Maine's controversial prescription drug import law

PhRMA wins the first round of this legal battle. It's unclear if Maine will appeal the ruling.

By Nicole Gray • Feb. 26, 2015

FDA approves Actavis' QIDP-designated antibiotic combo

This is the fifth FDA-approved antibiotic designated as a Qualified Infectious Disease Product (QIDP).

By Sy Mukherjee • Feb. 26, 2015

UPDATE: Sanofi's likely blockbuster insulin Toujeo wins FDA approval

And now, the marketing battle begins.

By Sy Mukherjee • Feb. 25, 2015

Public Citizen requests FDA ban on certain antifungal meds

Advocates say that Ketoconazole pills' risks outweigh their benefits.

By Nicole Gray • Feb. 25, 2015

Novartis' Farydak wins FDA approval for multiple myeloma

But it comes with a black box warning and a REMS.

By Nicole Gray • Feb. 24, 2015

Lilly's long-acting insulin not ready for prime time

Despite positive phase 3 data on peglispro, the company's long-acting insulin-in-development, evidence of liver toxicity will delay FDA review at least two years—and potentially forever.

By Nicole Gray • Feb. 24, 2015

Compounding pharmacies chafe at FDA's disciplinary actions

The agency is determined to reign in compounders and impose more regulations after a well-publicized, fatal meningitis outbreak in 2012 and numerous cGMP violations.

By Nicole Gray • Feb. 23, 2015

Corgenix's 15-minute Ebola test approved by WHO

With successful positive identification of Ebola in 92% of patients in just 15 minutes, the ReEBOV Antigen Rapid Test can help identify the virus much more rapidly than conventional 24-hour tests.

By Nicole Gray • Feb. 23, 2015

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