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Court tosses Praluent ban, gives Sanofi and Regeneron a new trial in Amgen patent battle

October 5, 2017 By Stephen Strudwick

An appeals court today tossed out a ban on Sanofi’s and Regeneron’s cholesterol drug Praluent and is giving the partners a second chance to prove they didn’t trample on Amgen patents in its development. The U.S. Court of Appeals today ruled that the judge in the trial over Praluent had made mistakes in what it […]

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Neurocrine Announces FDA Approval of 80 mg INGREZZA® Capsules for the Treatment of Tardive Dyskinesia

October 5, 2017 By Stephen Strudwick

SAN DIEGO, Oct. 5, 2017 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA® (valbenazine) capsule strength to be used for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, which was approved by […]

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FDA offers surprise OK for Mylan’s Copaxone knockoffs, slamming Teva

October 4, 2017 By Stephen Strudwick

Mylan won its years-long quest to gain an FDA OK for its copycat of Teva’s 40 mg and 20 mg doses of the multiple sclerosis drug Copaxone, triggering a series of stock moves as investors reacted quickly to the unexpected advance. Mylan had been delayed by information requests from the FDA, which prompted some analysts […]

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The new Biotech Scorecard: 10 make-or-break industry events for the fourth quarter

October 3, 2017 By Stephen Strudwick

The jam-packed September biotech catalyst calendar is behind us, which means investors are now focused on the stock-moving binary events that will take us to the end of the year. STAT is here to help. Introducing the Biotech Q4 Scorecard: Ten companies with important clinical trial and FDA milestones scheduled to read out over the […]

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Ablynx scores with blood clot drug

October 2, 2017 By Stephen Strudwick

Belgian biotech company Ablynx has received a boost with strong results from a late-stage trial into its experimental drug caplacizumab to treat a rare, life-threatening autoimmune blood clotting disorder. Acquired thrombotic thrombocytopenic purpura (aTTP) is caused by impaired activity of the ADAMTS13 enzyme and results in very low platelet count plus clot formation in small […]

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Another Alzheimer’s failure: Axovant’s drug flops in late-stage trial

September 26, 2017 By Stephen Strudwick

Yet another once-promising treatment for Alzheimer’s disease has come up short in the final stage of development, this time adding Wall Street drama to the familiar disappointment that has plagued the drug industry for decades. A pill called intepirdine, developed by the biotech startup Axovant Sciences, failed to blunt the symptoms of Alzheimer’s in a […]

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FDA rejects Janssen’s Plivensia

September 25, 2017 By Stephen Strudwick

Johnson & Johnson has been left “disappointed” after the FDA rejected its rheumatoid arthritis drug Plivensia (sirukumab). Efficacy is not the issue – but in a complete response letter to Janssen Biotech, the US regulator said that it needs additional clinical data to further evaluate its safety in the treatment of moderately to severely active […]

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3 Ways AI Is Changing Medicine

September 21, 2017 By Stephen Strudwick

Recent developments in artificial intelligence (AI) are turning science fiction into science fact — and deep learning is at the heart of these advances. These AI systems have the ability to sift through scores of data, recognize patterns, and detect differences that might be imperceptible to humans. Some applications are already achieving remarkable results. One […]

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Sanofi and Amgen, eyeing boost for PCSK9 use, tout benefits for diabetes patients

September 18, 2017 By Stephen Strudwick

The stepped-up focus on cardiovascular risks for diabetes patients isn’t an accident. Drugmakers have conducted enormous trials to gauge those risks—and, in some cases, prove their meds can actually fend them off. But it’s not just diabetes drugs in that spotlight. Just look at two sets of cholesterol drug numbers unveiled a few days ago […]

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EASD: Novo Nordisk’s combo Xultophy beat rivals at cutting LDL, blood pressure

September 13, 2017 By Stephen Strudwick

LISBON, PORTUGAL—Novo Nordisk’s combination med Xultophy, which marries its GLP-1 blockbuster Victoza and newest basal insulin Tresiba, became the latest diabetes med to show it could dampen risk factors for cardiovascular disease. The analysis, unveiled Wednesday at the European Association for the Study of Diabetes meeting in Lisbon, showed Xultophy patients had significantly lower systolic […]