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September 01, 2017

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

Featured Story

Novartis crosses FDA finish line with monumental CAR-T leukemia approval

In a historic day for cancer treatment and the larger biopharma industry, Novartis notched an FDA approval for its CAR-T treatment tisagenlecleucel, to be marketed as Kymriah, to treat pediatric and young adult patients with a form of acute lymphoblastic leukemia.

Top Stories Of The Week

Kite's CAR-T medication, cancer candidates draw choosy Gilead for $12B pipeline-building buyout

Kite Pharma and its hotly anticipated CAR-T med nabbed an $11.9 billion buyout offer from Gilead Sciences, which has been shopping for oncology assets to diversify away from its flagging hepatitis C franchise. The deal beefs up Gilead's pipeline and puts it toe-to-toe with Novartis for the nascent CAR-T cancer therapy market.

Special Report—The top 10 cardiovascular drugs in the world

Cardiovascular drugs may not be the top field in terms of sales or market growth rate. But heart disease and related ailments remain the biggest cause of death in the U.S. We’ve put together this list in advance of this weekend’s European Society of Cardiology meeting in Barcelona as a state-of-the-market snapshot.

Special Report—The top companies in medtech by 2016 revenue

2016 was the year of the makeover. The top 10 medtech players are all in varying stages of transformation. Some companies, like Philips and Siemens, are well into their metamorphoses, while others, such as Boston Scientific and Johnson & Johnson, made moves to overhaul their medtech businesses.

How will Gilead price CAR-T? With Kite buy, the top biotech joins Novartis in spotlight

Gilead executives didn't disclose much about their CAR-T pricing thoughts after the deal's announcement, but analysts expect Axi-Cel to rank among the world's most expensive. That puts Gilead alongside Novartis in stepped-up scrutiny for pricing on medications developed with federal funding.

AstraZeneca, Takeda ink Parkinson’s co-development deal

AstraZeneca has teamed up with Takeda to co-develop its preclinical Parkinson’s disease candidate MEDI1341. The deal sees Takeda commit to paying AstraZeneca up to $400 million (€332 million) for the chance to co-develop the alpha-synuclein antibody.

FDA refuses Acorda NDA for Parkinson's drug candidate because of manufacturing issues

With generics threatening its main moneymaking medication and an investor threatening its independence, Acorda has been pinning its hopes on approval of a new Parkinson’s disease drug. But that is now in jeopardy because of questions the FDA has about its manufacturing readiness.  

Boosting immunotherapy by targeting cells’ recycling centers

A team of researchers at the University of California has discovered an existing drug that boosts the production of immune cells known as “memory” CD8+ T cells. The finding could enhance both cancer immunotherapy and vaccine development.

FDA targets rogue clinic using Sanofi's smallpox vaccine in unapproved cancer therapy

As part of a crackdown on stem cell treatment centers, the FDA seized a controlled smallpox vaccine from a clinic that had mixed it into an illegitimate cancer therapy. The Sanofi vaccine, which the government restricts for biodefense, is part of a national emergency stockpile.

Parexel posts sales ‘beyond expectation’ as it preps for merger

Parexel says it has delivered revenue “beyond expectation” in one of its last financials before being merged into Pamplona Capital Management in a $5 billion deal.

Resources

[Webinar] Five ways to make your patient support program a success

Join this webinar to learn how to design, deliver, and measure a successful patient support program. Presented by Nareda Mills, Ashfield's SVP of Patient Services in the US, you’ll discover how to improve adherence and improve patient outcomes using 5 key methods.

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