A besieged drug industry launches major new ad campaign to woo lawmakers

The trade group PhRMA spent $18.4 million last year on federal lobbying while the biopharma sector faced intense scrutiny on drug prices.

By Nicole Gray • Feb. 9, 2016

FDA staff sounds encouraging note on Celltrion's biosim of J&J blockbuster Remicade

FDA staff said that CT-P13 is "highly similar" to Johnson & Johnson's flagship anti-inflammatory therapy.

By Nicole Gray • Feb. 7, 2016

UPDATE: Feds give Theranos one more week to respond to damaging CMS inspection

The lab testing firm originally had 10 days to fix issues at the Newark, California lab cited by the Centers for Medicare and Medicaid Services. But the agency is now giving Theranos an extension. 

By Sy Mukherjee • Feb. 5, 2016

Lundbeck wins key FDA backing for expanding depression drug Brintellix's label

Brintellix was approved for treatment of major depressive disorder in 2013—but available data shows that it also enhances cognitive function. 

By Nicole Gray • Feb. 5, 2016

FDA, Califf to overhaul opioid approval process following intense public pressure

A number of U.S. Senators have opposed Robert Califf's nomination for FDA commissioner, with most citing their concern over the FDA's role in the growing opioid crisis. 

By Ned Pagliarulo • Feb. 4, 2016

AstraZeneca's potential lung cancer blockbuster nabs EU approval

The lung cancer med, Tagrisso, was approved in the U.S. in November 2015.

By Ned Pagliarulo • Feb. 4, 2016

Old Novartis cancer flagship Gleevec heads to pharmacies as lower-cost generic

Mumbai-based Sun Pharma will be the first company to make generic Gleevec (imatinib tablets), which was introduced by Swiss pharma giant Novartis in 2001. 

By Nicole Gray • Feb. 3, 2016

Damaging House memos reveal calculated drug price increases at Turing, Valeant

Documents reviewed by the House Committee on Oversight and Government Reform reveal Turing and Valeant acquired drugs expressly to increase prices, while designing PR strategies to disguise the impact. 

By Ned Pagliarulo • Feb. 2, 2016

21st Century Cures progress may be hitting a partisan buzzsaw

Could a split in priorities derail the legislation, which once seemed destined for easy passage?

By Nicole Gray • Feb. 2, 2016

Appeals court upholds drug companies' right to manufacture generic OxyContin

Several companies, including Teva, Amneal Pharmaceuticals, and Epic Pharma have sought FDA approval to manufacture generic oxycodone.

By Nicole Gray • Feb. 2, 2016

WHO declares Zika a global health emergency, calls for greater collaboration

The WHO classified the Zika virus outbreak a "public health emergency of international concern," but did not recommend any related travel or trade restrictions. 

By Ned Pagliarulo • Feb. 1, 2016

A promising sign for 'Pfallergan' pipeline as Allergan depression med nabs 'breakthrough'

Rapastinel is a ketamine-like NMDA modulator and is currently in stage 3 development. 

By Nicole Gray • Feb. 1, 2016

Senators Manchin, Ayotte join growing opposition to Califf FDA nomination

Senator Joe Manchin (D-WV) will filibuster the nomination of Robert Califf for FDA Commissioner over concerns about the FDA's role in approving opioids and other concerns about Califf's relationship with the biopharma industry. 

By Ned Pagliarulo • Jan. 29, 2016

Eisai grabs an FDA approval for life-extending soft tissue cancer drug

Halaven (eribulin mseylate) is approved for treatment of liposarcoma, a form of soft tissue sarcoma that affects the fat cells. 

By Nicole Gray • Jan. 28, 2016

WHO warns of Zika's 'explosive spread,' convenes emergency committee

In convening the committee, the WHO Director-General cited the lack of population immunity and absence of treatments as reasons for the WHO's deep concern. 

By Ned Pagliarulo • Jan. 28, 2016

Focus on Brazil: In pursuit of the Zika vaccine

BioPharma Dive spoke with Nuno Antunes, PhD, an analyst at Decision Resources Group, about the potential costs of the Zika pandemic and what Brazil’s regulatory authority and top pharma company are doing to solve the problem.

By Nicole Gray • Jan. 27, 2016

Roche investigating off-label Avastin use after 15 Indian patients hospitalized

Roche has emphatically reiterated Avastin is not approved for intraocular use in either India or the United States. 

By Nicole Gray • Jan. 26, 2016

Amgen wins big with Kyprolis expansion in US and Repatha approval in Japan

The expanded indication for Kyprolis broadens the biotech's initial November 2012 accelerated approval.

By Nicole Gray • Jan. 25, 2016

UPDATED: Feds to reportedly unveil new findings of 'serious deficiencies' at Theranos lab

The Wall Street Journal continues its series of investigative reports centering on the embattled blood testing firm, this time asserting that CMS will soon publicly release a report finding serious violations at a Theranos facility in Newark, California. And it could have consequences for the firm's already-strained partnership with Walgreens.

By Sy Mukherjee • Jan. 25, 2016

Bristol-Myers' Opdivo notches two key regulatory victories in US, UK

Following NICE's endorsement of Opdivo for use against skin cancer, the melanoma drug won expanded approval for advanced melanoma in combination with Yervoy. 

By Ned Pagliarulo • Jan. 25, 2016

Drug firms like J&J cautious on FAAH inhibitors in wake of trial death in France

On January 15, six patients who were being tested with Bial's developmental FAAH inhibitor were seriously harmed, one of whom later died. Janssen subsequently suspended its own (separate) FAAH trial.

By Nicole Gray • Jan. 21, 2016

Biden pushes Cancer MoonShot to corporate leaders in Davos, pitches faster approvals

Vice President Joe Biden focused on how to expedite the drug approval process for promising cancer drug combinations. 

By Nicole Gray • Jan. 21, 2016

Shkreli & Valeant's interim CEO to face down Congress in pricing testimony next week

House Oversight Committee ranking member Rep. Elijah Cummings (D-MD) has been gunning for the recently-arrested biopharma gadfly and Canadian pharma giant for a while now.

By Sy Mukherjee • Jan. 20, 2016

Multiple violations cause production halt at Mylan-owned Agila's Polish plant

A regulatory filing by the Polish Main Pharmaceutical Inspectorate (GIF) revealed 29 GMP violations at an Agila-operated facility in the country. 

By Ned Pagliarulo • Jan. 20, 2016

Watchdog report spotlights significant failures in FDA postmarket drug tracking

The report from the Government Accountability Office found that roughly a quarter of the drugs approved by the FDA used an expedited review pathway. However, the FDA lacks sufficiently robust data systems to track postmarket safety issues with those drugs, according to the GAO. 

By Ned Pagliarulo • Jan. 20, 2016