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

UPDATED: Sen. Elizabeth Warren proposes big new pharma fines to fund NIH research

The firebrand Massachusetts senator likens her proposed Medical Innovation Act to a "swear jar" for lawbreaking pharma companies with blockbuster drugs.

By Sy Mukherjee • Jan. 22, 2015

J&J: Regulatory delays in China are stymying drug approvals

Speaking at the World Economic Forum in Davos, J&J's chief scientific officer said that getting a product approved in China can take as long as seven years. J&J is not alone in facing this problem in China.

By Nicole Gray • Jan. 22, 2015

Chasing transparency in the pharmaceutical industry: How much is enough?

The Cochrane Collaboration has revealed that a large number of negative clinical trial data go unreported. But the combination of technology and advocacy may shift the way data is collected, viewed, and accessed. 

By Nicole Gray • Jan. 22, 2015

Plaintiffs wanted: Law firms seek shareholders to launch a Sanofi kickback suit

2014 was a hard year for Sanofi, with the forced departure of CEO Viehbacher and a high-profile whistleblower lawsuit involving a former employee. But 2015 could get even worse.

By Nicole Gray • Jan. 22, 2015

FDA approves likely Novartis psoriasis blockbuster Cosentyx

Cosentyx is now cleared for the treatment of moderate-to-severe plaque psoriasis in American adults.

By Sy Mukherjee • Jan. 21, 2015

Teva wins Copaxone patent protection suit in US Supreme Court

After losing a patent-protection suit related to Copaxone in the U.S. Court of Appeals for the Federal Circuit, Teva took it all the way to the top—and won.

By Nicole Gray • Jan. 21, 2015

One more push: Senators reintroduce bill to expedite antibiotic approval

Senators Orrin Hatch (R-UT) and Michael Bennett (C-CO) have reintroduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act. 

By Nicole Gray • Jan. 20, 2015

China FDA to reverse course, allow online Rx drug sales

Currently, 70% of prescription drug sales are handled through hospitals, but the China FDA (CFDA) is actively working on a policy that would allow drug manufacturers to sell medications online. 

By Nicole Gray • Jan. 20, 2015

Pfizer warns UK MDs: Lyrica is still on patent for pain

Although Pfizer's patent on Lyrica (pregabalin) for treatment of epilepsy and generalized anxiety disorder (GAD) expired last July, Pfizer is policing its patent on use of Lyrica for treating pain.

By Nicole Gray • Jan. 16, 2015

J&J: Women were inappropriately pressured to file pelvic mesh suits

According to J&J, many of the 24,000 lawsuits that it is facing over injuries caused by its vaginal-mesh implants may have been the result of unsolicited pressure from callers using unauthorized information.

By Nicole Gray • Jan. 16, 2015

Pharma stocks plunge as Switzerland discontinues fixed-price peg to euro

Stock for companies including Roche, Novartis, Actelion, and Lonza fell precipitously in the hours after Switzerland un-pegged the Swiss Franc from the euro, allowing the franc to rise rapidly.

By Nicole Gray • Jan. 16, 2015

Blast from the past: Roche's dalcetrapib, HDL-raising meds could work for some patients

After being consigned to the pharmaceutical R&D dustbin in late 2012, Roche's cholesterol treatment, dalcetrapib may be resuscitated as researchers found data indicating that it may work in a subset of patients.

By Nicole Gray • Jan. 15, 2015

Flu vaccine only 23% effective this season

With influenza levels at epidemic levels this season, the CDC has concluded that this year's inoculation is mismatched to the viral strains that are infecting Americans.

By Nicole Gray • Jan. 15, 2015

UPDATED: Gilead to appeal India's rejection of Sovaldi patent protection

"Gilead strongly defends its intellectual property," said Gilead's EVP of Corporate Medical Affairs.

By Nicole Gray • Jan. 15, 2015

FDA approves novel weight-loss device

The device works by sending intermittent electrical impulses to specific nerves via surgically-implanted electrodes.

By Nicole Gray • Jan. 15, 2015

UK's Cancer Drugs Fund gets cash infusion, but loses 16 drugs

The CDF was initially intended to be a stop-gap measure, but instead became a lifeline for patients who could not get funding through the NHS.

By Nicole Gray • Jan. 13, 2015

Merck goes after non-small cell lung cancer indication for Keytruda

Could this be another first for Keytruda, already the first FDA-approved immunotherapy cancer drug?

By Nicole Gray • Jan. 13, 2015

Mylan's REMS lawsuit against Celgene gaining traction

The lawsuit is part of the simmering controversy surrounding brand manufacturer use of REMS to prevent generic competition.

By Nicole Gray • Jan. 13, 2015

Daiichi Sankyo, DOJ reach $39 million settlement in kickback suit

From 2004 to 2011, Daiichi Sankyo allegedly paid kickbacks to doctors in the form of speaking fees at dinner programs and other events. 

By Nicole Gray • Jan. 12, 2015

Novartis seeks FDA approval for two smoker's cough drugs

FDA approval of QVA149 and NVA237, which are already cleared in Europe, could bring the company another $1.4 billion in sales.

By Nicole Gray • Jan. 9, 2015