Merck star Keytruda nabs priority review for first-line treatment of metastatic melanoma

The treatment is currently indicated for secondary treatment of the cancer. 

By Nicole Gray • Aug. 18, 2015

UPDATE: Sprout plots hiring binge after controversial female libido drug approval

Addyi has finally won a controversial FDA approval, and the drug's maker is already plotting big hiring plans. The drug's label comes with some strong warnings, and Sprout's marketing tactics are sure to be scrutinized.

By Nicole Gray , Sy Mukherjee • Aug. 18, 2015

Lawmakers set their sights on Valeant and its steep heart drug price hikes

Two high-profile lawmakers want to know why Valeant's newly acquired heart drugs, Isuprel and Nitropress, have increased by more than 300% in price. 

By Nicole Gray • Aug. 17, 2015

FDA approves OxyContin use in some children

Doctors had already been prescribing the medication off-label for years. 

By Nicole Gray • Aug. 17, 2015

Soaring drug costs at heart of military funding scuffle

The White House and some legislators want to increase military retirees' and families' co-pays over a 10-year period to help address soaring brand name and compound drug spending. 

By Sy Mukherjee • Aug. 13, 2015

FDA chastizes Duchesnay, Kim Kardashian over drug promo posts

The reality star and model has been promoting a morning sickness drug during her pregnancy. But regulators say her social media posts don't disclose all the relevant details. 

By Sy Mukherjee • Aug. 12, 2015

Armed with stronger label, can Sanofi's Toujeo perform better in the UK?

The drug is a successor to the company's flagship Lantus, which went off patent in March.

By Nicole Gray • Aug. 6, 2015

FDA to update Novartis' Gilenya label with brain-infection risk warning

The therapy is used to treat relapsing multiple sclerosis (RMS).

By Nicole Gray • Aug. 5, 2015

A rare case: Young woman with Duchenne's waiting for a cure

The odds of a girl having the disease are one in 50 million. 

By Nicole Gray • Aug. 4, 2015

Merck's hep C positioning strategy: Target toughest-to-treat patients

The company thinks there's enough money to go around in the hep C market that it can rake in cash alongside big-name competitors like Gilead.

By Nicole Gray • Aug. 4, 2015

Aprecia's Spritam becomes first FDA-approved 3D printed medication

The drug is meant to treat various types of seizures in children and adults with epilepsy. 

By Nicole Gray • Aug. 4, 2015

All-in? AstraZeneca soldiers forward with psoriasis hopeful despite suicide link

And despite the fact that these very concerns led Amgen to back out of its co-development arrangement for the drug with AZ.

By Nicole Gray • Aug. 3, 2015

FDA: Hospira infusion system vulnerable to hackers

The agency is warning hospitals away from the Symbiq Infusion System over cybersecurity vulnerabilities.

By Nicole Gray • Aug. 2, 2015

Biologic patent life emerges as sticking point in failed TPP talks

In the latest rounds of Trans-Pacific Partnership (TPP) talks in Maui, the 12 participating countries could not finalize an agreement, and pharmaceutical patents continued to be an area of contention. 

By Nicole Gray • Aug. 2, 2015

Is there a link between Teva's bribery probe and a former employee's firing?

Keisha Hall, former Teva fraud examiner and director of finance for Latin America, says there is.

By Nicole Gray • July 31, 2015

Uh-oh: Glaxo facing new corruption charges—this time, in Romania

This comes after years of similar allegations and scandals in countries like China, Syria, Iraq, and others.

By Nicole Gray • July 30, 2015

Hospira's painkiller recall is ballooning—Is Pfizer getting nervous?

Ketorolac tromethamine is a painkiller used during surgery—and is now on the FDA shortage list as Hospira has to recall even more vials of the drug.

By Nicole Gray • July 29, 2015

Report finds pharma doesn't always report serious side effects to FDA in time

Drug companies are less likely to report a serious adverse event in a timely manner when patient deaths are involved, according to the study. 

By Nicole Gray • July 28, 2015

Blockbuster Friday: Sanofi/Regeneron wins first US approval of PCSK9 cholesterol med

It's just one in a series of four major drug approvals that the agency granted on Friday. And the expected blockbuster cholesterol drugs also come with a blockbuster price tag.

By Sy Mukherjee • July 24, 2015

European regulators just announced a massive overhaul of pediatric waivers

As part of a larger effort to increase the number of clinical trials involving children, the European Medicines Agency (EMA) is revoking or modifying most pediatric waivers.

By Nicole Gray • July 24, 2015

The FDA wants to figure out DTC ad claims' effect on consumers

The FDA wants to know whether or not DTC drug ads actually change viewers' perceptions about medications.

By Nicole Gray • July 23, 2015

Amgen's Repatha becomes world's first approved PCSK9 inhibitor

Repatha (evolocumab) was approved in the E.U. for treatment of uncontrolled hypercholesterolemia when other treatment regimens are not sufficient.

By Nicole Gray • July 22, 2015

FDA chastises Vista Pharma for not paying generic drug user fees

This is the fourth time this month that the FDA has sent a warning letter to a generics company for failure to pay GDUFA fees on time.

By Nicole Gray • July 21, 2015

Bristol-Myers' rock star Opdivo continues to roll, this time in kidney cancer

An ongoing trial was stopped early after Opdivo proved more effective than everolimus in providing a survival advantage. 

By Nicole Gray • July 20, 2015

Novogen gets FDA approval for Anisina orphan drug status

Anisina is being developed to treat neuroblastoma, with a focus on children.

By Nicole Gray • July 20, 2015