Roche CEO slams 'stupid,' 'arbitrary' UK decision to cut 17 cancer meds' funding

"It's stupid from a cost point of view," said Roche CEO Severin Schwan of the decision. "How the hell can you ignore all these [drugs'] benefits?" 

By Nicole Gray • Sept. 9, 2015

A big win for AZ as FDA clears Brilinta for long-term use

Brilinta (ticagrelor) was approved in 2011 for secondary prevention of acute coronary syndrome (ACS) events for up to one year.

By Nicole Gray • Sept. 8, 2015

The key facts to know about the FDA's new 340B drug discount guidance

The Health Resources and Services Administration (HRSA) has released updated proposed guidance outlining six criteria a patient must meet to receive discounted drugs.    

By Nicole Gray • Sept. 3, 2015

Biosimilars Council chief answers 6 key questions about biosims in the US

Dr. Bert Liang spoke with us to answer questions about the rapid pace of developments as biosimilars become a permanent part of healthcare in America.  

By Nicole Gray • Sept. 2, 2015

Pharma takes major offense to French law promoting off-label Avastin use

France allows off-label use of Roche's Avastin (bevacizumab) for age-related macular degeneration (AMD), and the industry doesn't like it. 

By Nicole Gray • Sept. 2, 2015

Alexion wins EU nod for newly acquired enzyme-replacement drug

Less than three months after completing the $8.4 billion acquisition of Synageva Biopharma, Alexion got an approval for Kanuma. 

By Nicole Gray • Sept. 2, 2015

Pharma lobbies Congress for big—and expensive—changes to patent rules

According to the Congressional Budget Office (CBO), Inter Partes Review (IPR) exemptions being pursued by the industry could cost Medicare $1.3 billion over the next decade. 

By Nicole Gray • Sept. 2, 2015

How do you solve a problem like drug shortages?

In 2011, there were 251 new drug shortages. That number has dwindled significantly—but there's still work to be done.

By Nicole Gray • Aug. 31, 2015

FDA warns: DPP-4 inhibiting diabetes meds may cause severe joint pain

The DDP-4 class includes major drugs from Merck, AstraZeneca, and Lilly/BI.

By Nicole Gray • Aug. 31, 2015

FDA's new draft guidance on naming biosimilars already drawing pushback

One main goal of the guidance is to prevent inadvertent substitution of non-interchangeable products. 

By Nicole Gray • Aug. 28, 2015

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