Lilly/BI snag another FDA approval for a diabetes drug—Synjardy

This is the fifth FDA approval for the Eli Lilly/Boehringer Ingelheim Diabetes Alliance. 

By Nicole Gray • Aug. 28, 2015

FDA demands another study for uniQure's ultra-pricey gene therapy

Glybera has courted its fair share of controversy.

By Nicole Gray • Aug. 27, 2015

J&J/Genmab unveil promising data for a potential multiple myeloma superstar

Daratumumab made waves at the American Society of Clinical Oncology meeting earlier this summer.

By Nicole Gray • Aug. 27, 2015

FTC to FDA: Ramp up oversight on homeopathic drug makers

The trade regulatory agency points out that many of the advertising claims from homeopathic drug makers are not evidence-based.

By Nicole Gray • Aug. 27, 2015

Pfenex at the forefront: How a different biosim approach is becoming a disruptive force

We spoke with Dr. Bert Liang, Chairman of the Biosimilars Council and CEO of Pfenex, Inc., about the rapidly growing biosimilars industry in the U.S., and what comes next for Pfenex.

By Nicole Gray • Aug. 27, 2015

Sarepta wins priority review for hotly anticipated Duchenne drug

The target action date for Sarpeta's eteplirsen, a candidate for treatment of Duchenne muscular dystrophy, is February 26, 2016.

By Nicole Gray • Aug. 26, 2015

How Japan is trying to beef up its pharmaceutical industry

One proposed tactic is raising government-set drug prices to spur more innovation in R&D.

By Nicole Gray • Aug. 26, 2015

UK's NHS commissions new TB drugs for first time in 50 years

In the wake of drug-resistant TB, the NHS is taking action. 

By Nicole Gray • Aug. 26, 2015

Sarepta, Biomarin vie for DMD approval, priority review voucher

Both companies are developing drugs for the rare pediatric disease Duchenne muscular dystrophy (DMD). 

By Nicole Gray • Aug. 24, 2015

AbbVie snaps up priority review voucher from United Therapeutics for $350M

The pharma giant now has two priority review vouchers in its arsenal. 

By Nicole Gray • Aug. 19, 2015

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