Pfizer on fire with early FDA nod for blockbuster Ibrance, $15B Hospira buyout

The company has been struggling with past and pending patent expirations. But the events of the last two days go a long way towards addressing that.

By Nicole Gray • Feb. 5, 2015

Merck's hep C treatment loses FDA breakthrough status

Blame Sovaldi, Harvoni, and Viekira Pak.

By Nicole Gray • Feb. 5, 2015

Another FDA warning letter for India-based Apotex

The letter cites serious manufacturing violations.

By Nicole Gray • Feb. 4, 2015

UK first in world to legalize '3-person DNA' babies to curb genetic disorders

UK's Parliament made history on Tuesday by approving a law that would allow babies to be created from the DNA of two women and one man.

By Sy Mukherjee • Feb. 3, 2015

FTC: Ranbaxy must sell acne drug to Torrent Pharma before Sun takeover

As the proposed acquisition of Ranbaxy by Sun Pharmaceuticals moves forward, the U.S. Federal Trade Commission is enforcing an anti-competitive requirement.

By Nicole Gray • Feb. 3, 2015

Active Pharmaceutical Ingredient Detection Using Spectrophotometers: An Investment that Pays Off

Sponsored by: Knowing the active pharmaceutical ingredients in your over-the-counter and prescription medications is a must in today’s health care industry. Mistakes in prescriptions, miscalculated doses, and drug interactions are all genuine concerns in a world where drug choices and ...

Feb. 3, 2015

FDA approves new Zohydro ER pankiller formulation

The new version of Zohydro ER features a new type of abuse-deterrence, Beadtek. Despite this feature, critics are complaining that there are not sufficient data to ensure abuse deterrence.

By Nicole Gray • Feb. 3, 2015

Ireland threatens to cap drug prices

The Irish government is considering capping prices on older medications, because drug makers are unwilling to lower prices.

By Nicole Gray • Feb. 3, 2015

UPDATE: Obama budget proposes historic, direct Medicare drug price negotiations

It would be a game-changing shift in an era of high-priced specialty drugs. But PhRMA is already hitting back hard—and does the plan even have a chance of passing a Republican Congress?

By Sy Mukherjee • Feb. 2, 2015

Shire's Vyvanse nabs FDA approval for binge-eating disorder

ADHD drug Vyvanse is now FDA-approved for treatment of binge-eating disorder (BED), based on strong phase III data showing that it is superior to placebo in terms of curbing BED.

By Nicole Gray • Feb. 2, 2015

What will the new federal budget mean for pharmaceutical R&D tax credits?

The Senate Finance Committee has vowed to reform the tax code. What does it mean for pharma and R&D tax credits? 

By Nicole Gray • Feb. 1, 2015

J&J's Imbruvica gets expanded label for rare blood cancer treatment

Until recently, there were no treatments for Waldenstroms macroglobulinemia (WM), a rare blood cancer.

By Nicole Gray • Jan. 30, 2015

Some UK cystic fibrosis patients being denied breakthough treatment

At $307,000 per year, Vertex's Kalydeco has some UK payers balking.

By Nicole Gray • Jan. 30, 2015

J&J under continued scrutiny for off-label pediatric use of Risperdal

After paying a $2.2 billion settlement to the Department of Justice in 2013, J&J is again under fire for failing to warn parents about certain Risperdal side effects, including boys growing breasts.

By Nicole Gray • Jan. 30, 2015

Pfizer dodges class-action trial with $400 million settlement

Pfizer has been accused of misleading statements and off-label marketing involving Bextra (valdecoxib) and other drugs.

By Nicole Gray • Jan. 29, 2015

4 things you need to know about the sweeping FDA reform bill Congress just proposed

The 21st Century Cures initiative has bipartisan support. And it could be the biggest U.S. healthcare shakeup since Obamacare, transforming core elements of the regulatory and clinical trials pathway.

By Sy Mukherjee • Jan. 28, 2015

Counterfeit Roche cancer drug smuggler gets 30 months in jail

Sabahaddin Akman, owner of Turkey-based Ozay Pharmaceuticals, is going to prison for 30 months for smuggling fake cancer drugs into the U.S.

By Nicole Gray • Jan. 27, 2015

Rumor mill churns as Duke's Dr. Robert Califf appointed FDA deputy commish

In his new role at the FDA, Dr. Califf will have a huge amount of responsibility. Could it be in preparation for a future role as the head of the agency?

By Nicole Gray • Jan. 27, 2015

Teva wins big as FDA approves its generic Nexium

Generic esomeprazole, used to reduce stomach acid and treat gastroesophageal reflux disease (GERD), is expected to be one of the biggest generic drug launches ever. 

By Nicole Gray • Jan. 27, 2015

GSK denies reports of imminent job cuts in China

Since its well-publicized bribery scandal in China, GSK has been working hard to boost sales—while also vigorously denying rumors of job cuts.

By Nicole Gray • Jan. 26, 2015

Shire pleased as NPS Pharma wins Natpara approval

The FDA's approval of Natpara (recombinant human parathyroid hormone) bodes well as Shire gets close to completing its $5.2 billion acquisition of NPS Pharma,. 

By Nicole Gray • Jan. 26, 2015

EMA suspending almost 50 drugs over flawed CRO clinical studies

The FDA has yet to take action on the issue, which involves serial data manipulation by an India-based CRO.

By Nicole Gray • Jan. 26, 2015

Novartis nabs FDA nod for group B meningitis vaccine Bexsero

Bexsero, which was used on an emergency basis in 2013 in response to a meningitis outbreak at two U.S. universities, is now FDA-approved for regular use.

By Nicole Gray • Jan. 26, 2015

Sanofi/Regeneron off to the races with priority review of cholesterol game-changer

Sanofi/Regeneron's BLA for PCSK9 candidate Praluent (alirocumab) has nabbed an FDA priority review based on massive ongoing trials involving more than 23,000 patients.

By Sy Mukherjee • Jan. 26, 2015

EU approves Genzyme's Cerdelga for type 1 Gaucher patients

Cerdelga (eliglustat) won U.S. approval last August.

By Nicole Gray • Jan. 23, 2015