May 12, 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

INC Research and inVentiv Health merge in another major CRO deal

Quintiles and IMS Health came together last year in a massive $19 billion megamerger, and now INC and inVentiv are looking to follow suit, combining into one new major company that will, according to the pair, make it the second largest biopharmaceutical outsourcing provider in the world.

Top Stories Of The Week

Roche’s shocking Tecentriq fail raises red flag for bladder cancer rivals

Roche’s Tecentriq wasn’t supposed to fail its phase 3 trial in second-line bladder cancer. But that’s what it just did—and the data shortfall not only endangers the drug’s conditional FDA approval, but could augur trouble ahead for other checkpoint inhibitors that followed Tecentriq into the field.

Investors spooked by Kite CAR-T death, but biotech remains confident

Kite Pharma was off by 15% in morning trading after it announced the death of a patient in late April of cerebral edema—the very same fatal outcome that beset rival Juno’s Rocket trial, killing five people and its CAR-T program for JCAR015.

Parexel seeking $4B sale: WSJ

Not a week seems to go by without a CRO sale rumor: Chiltern, INC Research and PPD (which in fact was recapitalized last week) are two of the most recent, and now the Wall Street Journal is adding Parexel to that list.

Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning

Last year, the FDA called for stronger heart-failure warnings on the label of AstraZeneca Type 2 diabetes med Onglyza. And now, AstraZeneca and former partner Bristol-Myers Squibb are being hit with 14 lawsuits related to the med’s heart-failure risks.

Seattle kills off $2B Immunomedics deal as biotech’s CEO and founder axed

Seattle Genetics has terminated a major drug tie-up with Immunomedics after intense legal battles, as Immunomedics revealed that it has axed its president and CEO Cynthia Sullivan.

Just what Sanofi and Regeneron wanted: A Dupixent rollout so zippy, it's fueling bigger sales forecasts

Sanofi and Regeneron’s new atopic dermatitis drug Dupixent is off to the kind of start drugmakers aim for, judging by the number of prescriptions written so far. And that has analysts hiking their global sales estimates for 2017, with some surpassing $300 million.

We asked, you brainstormed: Witty, insulting and serious nominees for Valeant's new name

Though naming experts might be among our readers, our readers aren’t all naming experts. You are, however, a creative bunch. For our Valeant renaming poll, we had to set aside plenty of witticisms, insults and suggestions semiserious to serious to come up with our shortlist of six. Voting's open through Sunday.

Abbott debuts smartphone-compatible insertable cardiac monitor

Abbott announced the CE mark and launch of its smartphone-compatible insertable cardiac monitor, designed to help physicians remotely diagnose arrhythmias, such as atrial fibrillation, and guide their therapy decisions.

FDA blasts Indian drugmaker that made investigators inspect filthy plant in the dark

A number of companies have tried to keep FDA inspectors from getting a thorough look through their manufacturing plants, but none have gone to the extraordinary lengths of the Vikshara Trading & Investments plant in Gujarat, India, whose products the FDA banned over the deceptions.

Harvard professor launches research institute focused on ‘extracellular’ proteins

Harvard professor Timothy Springer has always been interested in developing antibodies targeting proteins that are “extracellular”—meaning they reside in bodily fluids, outside of cell walls. But he found that funding was lacking. So he created the Institute for Protein Innovation, which launched in Boston today. He spoke to FierceBiotechResearch about the new institute.

GlaxoSmithKline ends Vaxem Hib production, costing Takeda a planned launch in Japan

Takeda’s plan to launch a Haemophilus influenzae type B vaccine in Japan has ended in smoke as manufacturer GlaxoSmithKline has terminated production of Vaxem Hib.

Resources

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