Flu vax committee picks next year's virus strains after 2014 debacle

The committee is trying to improve upon this year's vaccine's dismal 23% effectiveness rate.

By Nicole Gray • March 6, 2015

FDA New Drugs chief: Orexigen's sunny Contrave heart data 'likely false'

And fines, penalties, and even market withdrawal of the drug could be on the horizon if Orexigen doesn't find a way to fix this.

By Sy Mukherjee • March 6, 2015

FDA to pharma: Watch out for unapproved Facebook claims

In the last six months, the FDA has issued six warnings to six different companies for posting unapproved claims on their Facebook pages.

By Nicole Gray • March 6, 2015

21st Century Cures: Making Breakthrough Therapy designations more effective

Rep. Fred Upton (R-MI), chair of the House Energy and Commerce Committee, is aggressively pushing an agenda focused on regulatory reform—and it’s starting to happen.

By Nicole Gray • March 5, 2015

BMS' Opdivo wins lung cancer indication more than 3 months before PDUFA date

The expanded indication comes mere days after the FDA granted the drug priority review status for lung cancer.

By Nicole Gray • March 4, 2015

BI files its Pradaxa 'antidote' in North America, EU

Boehringher Ingelheim has submitted applications to the FDA, the EMA, and Health Canada for idarucizumab.

By Nicole Gray • March 4, 2015

SEC to pharma: Don't get cute with disclosing FDA dealings to investors

"Accuracy of reporting in your dealings with the FDA is critical to getting investors the information they need," SEC enforcement director Andrew Ceresney told pharma companies on Tuesday.

By Sy Mukherjee • March 4, 2015

FDA clamps down on testosterone labeling rules

The FDA is requiring that drug makers change labeling to inform users of increased risk of heart attack and stroke.

By Nicole Gray • March 4, 2015

Orexigen shoots itself in foot with early disclosure of positive Contrave heart data

Disclosure of interim evidence that Contrave (naltrexone) may prevent heart attacks (instead of causing them) should be a good thing. But Orexigen broke FDA rules and Data Monitoring Committee protocol. 

By Nicole Gray • March 4, 2015

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