Hopes of early end to Lilly breast cancer trial dashed

The big pharma's CDK 4/6 inhibitor will continue through its Phase 3 program as planned, but Lilly had hoped the trial would be stopped early.

By Lisa LaMotta • Aug. 10, 2016

Pfizer temporarily shutters Indian facility after inspections

Acquired in last year's Hospira deal, the site near Chennai had previously been flagged by U.S. regulators in 2013 for manufacturing violations. 

By Ned Pagliarulo • Aug. 9, 2016

BIO president defends Orphan Drug Act after op-ed criticism

Jim Greenwood, president and CEO of BIO, contends that the Orphan Drug Act has been a success, despite recent attacks saying it facilitates high drug pricing. 

By Nicole Gray • Aug. 9, 2016

Merck locks up another cancer approval for Keytruda

Merck's latest success comes on the heels of Bristol-Myers Squibb's CheckMate-026 failure in non-small cell lung cancer. 

By Nicole Gray • Aug. 8, 2016

Novartis creeps in on Pfizer's Ibrance

The Swiss giant's oncology strategy is coming together as a Breakthrough Therapy designation moves it closer to filing on one of its key growth drivers. 

By Lisa LaMotta • Aug. 4, 2016

UK court orders coverage of Gilead's HIV drug in England

The National Health Service England plans to appeal the decision, claiming it is not responsible for covering preventative treatments.

By Nicole Gray • Aug. 3, 2016

Big Pharma benefits more from breakthrough therapy designations: report

Since the designation was introduced by the FDA in 2012, most of the tagged drugs to reach the market were developed by large pharma companies rather than small biotechs. 

By Nicole Gray • Aug. 2, 2016

Teva will provide long-term API contracts to producers in 15 markets

U.S. regulators set the condition to ensure Teva does not use API supply contracts to force competitors to raise product prices.

By Edwin Lopez • July 28, 2016

FDA approves Sanofi's next-gen diabetes treatment

The long-delayed approval will allow Sanofi's Adlyxin to compete with Novo Nordisk's Victoza and Eli Lilly's Trulicity in the U.S.

By Randy Lilleston • July 28, 2016

J&J, Genmab line up second-line use for multiple myeloma med

Approved last year in the U.S., Darzalex is the first monoclonal antibody cleared by the FDA for treatment of multiple myeloma. 

By Nicole Gray • July 27, 2016

FDA strengthens warnings on class of antibiotics

Fluoroquinolones such as Levaquin and Cipro should now be reserved for last resort use in certain patients. 

By Nicole Gray • July 26, 2016

Regulators to expedite review of Merck's Ebola vaccine

Merck plans to submit its Ebola vaccine to regulatory authorities on both sides of the Atlantic next year, aiming to win approval and launch V920 by the end of 2017. 

By Nicole Gray • July 26, 2016

Stuck in regulatory limbo, PTC considers further trials for DMD drug

While US regulators found PTC's application for Translarna to be insufficient for filing last year, the drug has been on the market in Europe under a conditional approval.

By Edwin Lopez • July 25, 2016

FDA delays decision on Merck's C. diff drug

The regulator asked for more clinical trial data on bezlotoxumab and pushed its target action date back by three months. 

By Nicole Gray • July 25, 2016

Japanese government to set new controls on specialty drugs: report

Amgen's Repatha and Bristol-Myers' Opdivo will be the first drugs targeted by new guidelines, according to the Nikkei Asian Review. 

By Nicole Gray • July 25, 2016

EU regulator recommends market suspension for dozens of generics

The European Medicines Agency concluded bioequivalence studies conducted by an India-based contract researcher to support generic approvals were "flawed." 

By Edwin Lopez • July 25, 2016

After scandal, China begins vaccine inspections nationwide

Citizens were outraged earlier this year when police in China uncovered a $90 million black market for illegal vaccines, which had been sold throughout the country for years. 

By Nicole Gray • July 25, 2016

Fresh off Relistor win, Valeant hits FDA roadblock for eye drug

The regulator issued a complete response letter to Valeant, citing manufacturing deficiencies at the Bausch & Lomb facility used to produce the eye drops. 

By Ned Pagliarulo • July 22, 2016

Theranos expands compliance team with new execs, committee

But Theranos' efforts to strengthen compliance may be too late. Federal regulators recently decided to ban CEO Elizabeth Holmes from the business for two years over continued violations. 

By Nicole Gray • July 22, 2016

Glaxo failed to resolve contamination at UK plant, FDA says

The FDA "strongly urged" Glaxo to dedicate the site to only penicillin production in light of repeated contamination problems. 

By Edwin Lopez • July 20, 2016

Zafgen shuts down development of obesity drug, cuts staff

The FDA had halted development of the drug, called beloranib, last December after two patient deaths. 

By Nicole Gray • July 20, 2016

Valeant wins backing of FDA panel for psoriasis drug

While the recommendation is welcome news for a company still struggling to remake its image, Valeant could face significant competition for brodalumab. 

By Ned Pagliarulo • July 20, 2016

US, EU regulators to review Opdivo for new cancer indication

Bristol-Myers Squibb submitted yet another marketing application for Opdivo, this time in head and neck cancer. 

By Nicole Gray • July 19, 2016

FDA: Flood of orphan drug applications slowing review process

Last year the FDA received a record 472 requests for orphan drug designations, and this year's pace looks set to surpass that mark. 

By Nicole Gray , Ned Pagliarulo • July 19, 2016

PDUFA 6 procedures will include patients, biomarkers for 2018-2022

Two major biopharma industry associations, PhRMA and BIO, applauded the new iteration of the drug regulation act. 

By Nicole Gray • July 18, 2016