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

Lilly's lung cancer drug Portrazza wins EU approval as first-line biologic

Portrazza won approval in the U.S. in November 2015, but Lilly has faced some criticism over the drug's $11,430/month price tag.  

By Nicole Gray • Feb. 25, 2016

Alibaba under siege as Chinese regulators & pharmacies fight its e-drug tracking system

On Wednesday, a group of 19 Chinese pharmacies demanded the Chinese health authorities shut down the system, citing unfair competition. 

By Nicole Gray • Feb. 24, 2016

Senate confirms Califf as FDA commissioner by an 89-4 vote

The Senate on Wednesday confirmed Dr. Robert Califf to be the next FDA commissioner by an 89-4 vote. The four lawmakers voting against Califf had voiced their concern over the FDA's role in the growing opioid crisis in the U.S. 

By Ned Pagliarulo • Feb. 24, 2016

PTC stock falls off a cliff after biotech slapped with FDA 'refusal to file'

The FDA deemed PTC Therapeutics' new drug application for its Duchenne muscular dystrophy drug Translarna to be insufficient. PTC stock's value fell over 60% in Tuesday trading. 

By Ned Pagliarulo • Feb. 24, 2016

Sanofi cashes in $245M review voucher to leapfrog Novo in crucial diabetes combo race

The French drugmaker's woes in its diabetes franchise have been real. And now it's using a pricey priority review coupon purchased from Retrophin to get a leg up in a heated battle with formidable rivals like Novo Nordisk.

By Sy Mukherjee • Feb. 24, 2016

How the opioid crisis convinced these senators to oppose advancing Califf's nomination, in charts

Although the cloture vote to advance Califf's nomination passed overwhelmingly, six senators voted against him—and almost all cited their concerns over the FDA's role in the growing opioid crisis as a reason. 

By Ned Pagliarulo • Feb. 23, 2016

FDA chief nominee Califf likely to be confirmed after clearing key Senate vote

The successful procedural vote on Monday sets up a final vote on Dr. Robert Califf's nomination for FDA commissioner, which has been rocked by some senators' concerns over his ties to pharma and the FDA's role in approving opioids.  

By Ned Pagliarulo • Feb. 23, 2016

AstraZeneca nabs two big European nods for gout & heart meds

The European Medicines Agency (EMA) has approved AZ's Zurampic for treatment of gout and the anticoagulant Brilique. 

By Nicole Gray • Feb. 23, 2016

FDA approves new UCB drug to treat epilepsy-related seizures

A substantial portion of epilepsy patients are pharmacoresistant, meaning there is a significant unmet need for new treatments. 

By Nicole Gray • Feb. 22, 2016

New Zafgen data shows obesity med's promise in diabetics—but will FDA lift its clinical hold?

The FDA placed a complete clinical hold on beloranib in December after two patients participating in trials died from blood clotting. 

By Nicole Gray • Feb. 19, 2016

One Louisiana doc's made millions blowing the whistle on big pharma. Is that problematic?

Some say the system for rewarding so-called "serial whistleblowers" can create perverse incentives. But watchdog groups like Taxpayers Against Fraud insist the focus should be on the "serial fraudsters" in the industry, and that calling out whistleblowers is missing the forest for the trees.

By Sy Mukherjee • Feb. 18, 2016

AstraZeneca scores a clutch 'breakthrough' for major bladder cancer med

The breakthrough therapy designation gives durvalumab's prospects a boost, and should help AstraZeneca catch up in the immunotherapy space. 

By Nicole Gray • Feb. 18, 2016

FDA 'refusal to file' letter sends Catalyst tumbling

The letter asked for more information on a drug designed to treat a rare muscle-wasting disease. The new drug application has become controversial because another small pharma company has been making a highly similar drug for decades and giving it away for free. 

By Ned Pagliarulo • Feb. 17, 2016

FDA expands Gilead's Harvoni label for advanced cirrhosis patients

The expanded label further boosts Harvoni's competitive advantage in the hepatitis C space. 

By Nicole Gray • Feb. 17, 2016

Amgen launches Kyprolis in the UK for multiple myeloma

The drug had previously been approved by the European Medicines Agency in November 2015. 

By Nicole Gray • Feb. 16, 2016

UK regulator smacks Glaxo with $54.4 million fine over pay-for-delay deals

The Competition and Markets Authority found that GlaxoSmithKline had paid over £50 million to generic drugmakers to slow the entry of generic Seroxat, a blockbuster antidepressant. 

By Nicole Gray • Feb. 16, 2016

Struggling Clovis to once again chase FDA favor for would-be Tagrisso competitor

Clovis' stock is down 80% since last fall, when the FDA requested more clinical data on its lead lung cancer candidate rociletinib. 

By Nicole Gray • Feb. 16, 2016

China's next big move to bolster domestic drug industry: Market consolidation

The Chinese State Council agreed to further boost local pharmaceutical innovation by strengthening R&D and bringing together a fragmented market. 

By Nicole Gray • Feb. 16, 2016

Update: Sandoz continues biosim streak, acquires rights to Pfizer's Remicade copy in Europe

Sandoz won the first US biosimilar approval for its Neupogen copy last year. 

By Ned Pagliarulo • Feb. 11, 2016

India's Ipca slammed by FDA for litany of severe data violations

The regulatory agency sent a warning letter to the firm centering on three plants from which drug exports are already banned in the U.S.

By Sy Mukherjee • Feb. 11, 2016

Report: Walgreens threatened to dissolve Theranos arrangement barring quick fixes

According to the Wall Street Journal, the drug store giant issued a "warning letter" to the embattled blood testing upstart giving it until the end of the month to resolve a number of issues which have invited federal regulatory scrutiny.  

By Sy Mukherjee • Feb. 11, 2016