India's Serum Institute chases fast-track approval for dengue treatment as cases spike

New Delhi is facing the worst outbreak of dengue fever in five years.

By Nicole Gray • Sept. 23, 2015

Clinton calls out Turing & Shkreli on wild price hike, releases pharma cost cap plan

When the Democratic presidential front-runner tweeted her plans to release a drug price-control plan on Monday, the Nasdaq Biotech Index dropped nearly 5%. 

By Nicole Gray • Sept. 22, 2015

Bristol-Myers' immuno-oncology star Opdivo nabs kidney cancer priority review

The drug is currently approved for the treatment of advanced melanoma and advanced squamous non-small cell lung cancer (NSCLC). 

By Nicole Gray • Sept. 22, 2015

Shire's once-daily extended-release ADHD drug now approved in Europe

It can be used to treat attention-deficit hyperactivity disorder (ADHD) in patients aged six to 17. 

By Nicole Gray • Sept. 22, 2015

2nd time's the charm for Allergan, Richter antipsychotic drug

Cariprazine was rejected by the FDA in 2013, but won approval this time around based on new phase 3 data. 

By Nicole Gray • Sept. 21, 2015

Obama's FDA chief nominee received more than $200K in industry fees

Dr. Robert Califf has close ties to the biopharma industry.

By Nicole Gray • Sept. 21, 2015

Why several FDA reviewers recommended not approving female libido med Addyi

One reviewer was concerned that the combination of Addyi (flibanserin 100 mg) and alcohol was tested mainly in men.

By Nicole Gray • Sept. 17, 2015

AbbVie, Janssen chase first-line approval of Imbruvica for CLL

The medication is currently indicated as a second-line treatment. 

By Nicole Gray • Sept. 16, 2015

UPDATE: Obama nominates Robert Califf as next FDA commissioner

If confirmed, the former Duke University School of Medicine Vice Chancellor and professor of medicine will lead the agency during a critical period of change and regulatory overhauls. 

By Sy Mukherjee • Sept. 16, 2015

10th Indian pharma plant this year makes FDA's do-not-import list

Once again, the problem at hand is production quality. 

By Nicole Gray • Sept. 15, 2015

Federal task force narrows aspirin use guidelines, suggests cancer benefit

According to new guidelines, low-dose aspirin use in the target group can help prevent heart attacks and stroke, while also reducing colon cancer risk.

By Nicole Gray • Sept. 15, 2015

A tale of two painkillers: Collegium gets FDA panel rec that eludes Purdue

Concerns over dosing compliance led the panel to overwhelmingly reject Purdue's pain pill despite abuse-deterring properties.

By Nicole Gray • Sept. 14, 2015

Amgen goes after once-monthly dosing option for Repatha

For most patients treated with the PCSK9 med, dosing is 140 mg every other week. 

By Nicole Gray • Sept. 14, 2015

How to stop a biopharma compliance breach before it happens

We spoke with two experts from PA Consulting to find out why the number of compliance breaches seems to be increasing—and what the industry can do about it. 

By Nicole Gray • Sept. 10, 2015

FDA concerned about dosing risk with Collegium's opioid painkiller

Unlike most opioid painkillers, Xtampza, which is under FDA review, should be taken after eating to maximize effectiveness.

By Nicole Gray • Sept. 10, 2015

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