Europe

AstraZeneca and MedImmune announced top-line results from its TULIP 1 Phase III clinical trial of anifrolumab in adults with moderate-to-severe systemic lupus erythematosus (SLE). Unfortunately, the drug didn’t meet the trials primary endpoint of statistically-significant reduction in disease activity.
There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.
FDA
Hemophilia A patients have another treatment option. This morning the U.S. Food and Drug Administration gave the nod to Bayer AG’s new treatment, Jivi (BAY94-9027).
Touting that it is helping fight the opioid epidemic, Emergent BioSolutions is acquiring Adapt Pharma. Under the terms of the deal, Emergent will pay $635 million up front and up to $100 million in cash for various sales-based milestones through 2022.
Heidelberg, Germany-based Affimed NV inked a licensing deal with Switzerland-based Roche for $96 million upfront, but that was only a fraction of the entire deal. Affimed shares rocketed, more than doubling to hit $148.07.
The United Kingdom’s government-funded health service isn’t being so nice to Gilead Science’s CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.
Roche has been hit with another departing executive. This morning the Swiss pharma giant announced that Roland Diggelmann, the chief executive officer of the company’s diagnostics division, is leaving at the end of September.
FDA
The U.S. Food and Drug Administration (FDA) approved Shire’s Takhzyro (lanadelumab-flyo) injection to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. The drug was accepted while under priority review.
Three of Vivek Ramaswamy’s companies reported activity today including corporate changes, a licensed therapy and investment of $100 million.
Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
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