Death from French drug trial likely due to high doses of compound

The drug trial left one man dead and five others in the hospital in January. Portuguese drugmaker Bial had been testing an FAAH-enzyme inhibitor for the treatment of pain and mood disorders. 

By Ned Pagliarulo • March 10, 2016

Whistleblower sues Indian drug regulators for poor oversight

Dinesh Thakur is a well-known whistleblower who previously exposed Ranbaxy Labs for its failure to properly test drugs for safety.

By Nicole Gray • March 10, 2016

Senate HELP Committee advances seven bills as counterpart to 21st Century Cures

Republicans and Democrats on the committee have been divided over funding for the NIH and FDA, as well as over changes to the FDA's approval process. 

By Nicole Gray • March 10, 2016

FDA accepts new Keytruda data, opening door for wider indication

However, Keytruda faces stiff competition from Bristol-Myers Squibb's Opdivo, another anti-PD1 therapy which has outpaced Keytruda. 

By Nicole Gray , Ned Pagliarulo • March 9, 2016

Report: Theranos continued blood tests even as quality checks revealed flaws

The company has been under fire recently for alleged deficiencies in its proprietary finger-prick blood testing technology. 

By Ned Pagliarulo • March 9, 2016

Bristol-Myers Squibb changes Chinese sales practices amid scrutiny

A few months after it settled with the SEC over claims it paid Chinese doctors to prescribe its medicines, the pharma giant reportedly cut entertainment expense and speaking engagement payments to doctors there.

By Randy Lilleston • March 9, 2016

CMS proposes overhaul to Part B drug reimbursement

The proposed rule would test changes to how doctors and outpatient departments are reimbursed for drugs they prescribe under Medicare Part B. 

By Ned Pagliarulo • March 8, 2016

India will reportedly refrain from issuing compulsory drug licenses

The licenses enable local companies to override the patents of large pharmaceutical companies and manufacture cheap copies to boost patient access.

By Ned Pagliarulo • March 8, 2016

Senate HELP Committee to mark up 21st Century Cures legislation

The committee will consider seven bills in a morning session Wednesday as members seek to bridge a growing divide between Democrats and Republicans on a way forward. 

By Nicole Gray • March 8, 2016

Counterfeit Harvoni from India found in Israel

Flagged by Swissmedic, the fake drugs were imported through a Swiss trading firm. 

By Nicole Gray • March 8, 2016

Industry groups, doctors ask CMS to withdraw proposed Part B experiment

Accidentally posted online earlier this year, the proposal would test changes to Part B drug reimbursement rates to doctors. 

By Nicole Gray • March 8, 2016

EMA debuts new program to speed up review of innovative drugs

Called "PRIME," the program reinforces the existing accelerated assessment pathway and will increase regulatory support early in the development process of priority drugs. 

By Ned Pagliarulo • March 7, 2016

Janssen, AbbVie's Imbruvica approved by FDA for first line treatment of CLL

The drug had previously been approved for second line treatment of chronic lymphocytic leukemia (CLL), and for a smaller subset of CLL patients

By Ned Pagliarulo • March 4, 2016

FDA approves first Zika diagnostic for emergency use

Zika MAC-ELISA is an antibody-based diagnostic developed by the Centers for Disease Control and Prevention (CDC).

By Nicole Gray • March 3, 2016

FDA opposes re-authorization of pediatric priority review program: GAO report

Since the priority review program for rare pediatric diseases launched in 2012, there have been 11 requests for a pediatric voucher. Six have been awarded. 

By Ned Pagliarulo • March 3, 2016

Bayer's Essure permanent birth control gets black-box warning

Numerous problems associated with the device have prompted calls for the FDA to take it off the market. 

By Nicole Gray • March 2, 2016

UK cost regulator rejects promising cancer med Imbruvica

Janssen expressed its "extreme disappointment" in the decision by the National Institute for Health and Care Excellence. Both Janssen and co-developer AbbVie have high hopes for the leukemia drug. 

By Ned Pagliarulo • March 2, 2016

Second TAF-based HIV treatment from Gilead wins FDA approval

Odefsey relies on Gilead's successor form of tenofovir, which is the chemical backbone of several other HIV treatments working their way through US and EU regulatory review. 

By Ned Pagliarulo • March 1, 2016

Roche's asthma drug stumbles on mixed phase 3 results

The Swiss drugmaker did, however, receive some good news when its lymphoma drug won second-line approval from the FDA. 

By Nicole Gray • March 1, 2016

Boehringer/AbbVie reportedly in cancer-collaboration talks

Separately, Boehringer Ingelheim received a positive opinion from the EMA for an expanded label of its lung cancer med Giotrif. 

By Nicole Gray • March 1, 2016

Hearings begin in India on validity of Gilead patent for hep C med

The US-based Initiative for Medicines, Access, and Knowledge filed a patent opposition with the India Patent Office in 2013, hoping to have Gilead's patent for Sovaldi thrown out as invalid. 

By Ned Pagliarulo • Feb. 29, 2016

Chinese Food and Drug Administration vows to expedite drug approvals

This newest push comes as China attempts to consolidate its fragmented healthcare landscape. 

By Nicole Gray • Feb. 29, 2016

Gilead's new HIV combo drug inches closer to EU approval

The European Medicines Agency on Thursday recommended approval for Gilead's Descovy, which includes the new version of tenofovir. 

By Ned Pagliarulo • Feb. 26, 2016

AZ's deal for Acerta already showing promise as cancer drug wins orphan nod

AstraZeneca paid $4 billion for 55% of the private Acerta Pharma in mid-December 2015, believing in the promise of Acerta's lead cancer candidate. 

By Nicole Gray • Feb. 25, 2016

Banned Chinese supplier given exemption to ship chemotherapy drug to U.S.

The exemption applies solely to the chemotherapy drug daunorubicin, which is used to treat Kaposi's sarcoma and some forms of leukemia. 

By Nicole Gray • Feb. 25, 2016