April 21, 2017

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Welcome to FierceLifeSci Weekly Digest, your roundup of the biggest and most popular stories from each of our publications.

Featured Story

FDA stuns Lilly and Incyte with CRL for much-anticipated RA drug baricitinib

Even with a three-month extension, Eli Lilly was unable to quell FDA concerns about the safety risks of its highly anticipated rheumatoid arthritis drug baricitinib. Instead, it received a complete response letter saying more work must be done.

Top Stories Of The Week

Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag

As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA "breakthrough" tag for its eagerly awaited JULIET trial.

The world's most pricey drugs, from a $1.2M gene therapy to a $450K lymphoma med

Biogen's Spinraza may have raised eyebrows for its $750,000 first-year price, but the rare disease field is no stranger to expensive meds. They're pricey to develop and target few patients. Here's a list of the world's most expensive drugs, where Spinraza's annual $375,000 doesn't even break the top 10.

Novartis drug development chief outlines CAR-T research commitment

Despite reports that linked Novartis to cutting back on its cell therapy work, the Swiss major says it is going full steam ahead for its CAR-T research as a potential approval for its candidate appears on the horizon.

Pfizer's Xeljanz stands to win from Lilly's baricitinib stunner

Eli Lilly & Co.’s Olumiant rejection surprise Friday has one obvious beneficiary: Pfizer and its rival rheumatoid arthritis med, Xeljanz. It’s not only Pfizer in line for a potential benefit, either; AbbVie's whole RA franchise could win.

Newly discovered HIV reservoir could point the way to cures

Drugs that fight HIV have proven effective at suppressing the virus, but the search for a permanent cure has turned up empty so far. Most of that research has focused on finding ways to wipe out the virus from the immune system’s T cells. Now a discovery by scientists at the University of North Carolina suggests that a different approach is in order.

FDA document lays out issues undermining approval of AstraZeneca's ZS Pharma drug

The FDA has twice rejected AstraZeneca’s application for a new drug to treat hyperkalemia because of manufacturing concerns. The reasons why became a little clearer Wednesday when the agency posted a document outlining the issues that have regulators furrowing their brows.

CRO Chiltern, valued at $1.3B, could be up for sale: Reuters

U.K.-based CRO Chiltern has put itself up for sale as it continues the bullish M&A run for contract research groups that has seen a host of deals, JVs and mergers over the last 2 years.

With new online tool, MSF invites Pfizer, GSK investors to weigh in on vaccine pricing

After years of protesting against Pfizer and GlaxoSmithKline’s pneumococcal vaccine pricing, Médecins Sans Frontières is empowering pharma investors to get involved.

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