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Thursday, September 5, 2019

Cigna to offer full coverage for 2 gene therapies

Cigna‘s health services business is introducing Embarc Benefit ProtectionSM, a new offering that brings together the health services, medical management and specialty pharmacy expertise of Express Scripts, eviCore, Accredo and CuraScript SD to make breakthrough medicines more affordable and ensure access for those who need it.
Consumers will have no out of pocket payments related to the cost of the medicine and will receive personalized and expert care to assist them through their health journey.
Luxturna™ (voretigene neparvovec-rzyl), the first FDA-approved prescription gene therapy for people with inherited retinal disease, and Zolgensma® (onasemnogene abeparvovec-xioi), a gene therapy for children under 2 years old with spinal muscular atrophy, will be the first two therapies included in the Embarc Benefit Protection solution. Additional therapies may be added in the future.
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Zafgen to explore strategic alternatives

Aimed at boosting shareholder value, Zafgen (NASDAQ:ZFGN) will explore strategic alternatives that could include a merger, business combination or in-licensing.
One of the reasons for the initiative is that the company does not believe it can resolve the clinical hold on ZGN-1061 in a timely fashion. The FDA suspended clinical trials in November 2018 due to possible cardiovascular risk.
Its current cash runway should be sufficient to fund operations for more than two years.
Shares will resume trading at 7:30 am ET.
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Opioid players down on Mallinckrodt restructuring

Endo International (NASDAQ:ENDP) and Teva Pharmaceutical Industries (NYSE:TEVA) are down 11% and 3%, respectively, premarket in sympathy with Mallinckrodt’s 40% plunge in reaction to its plan to restructure in the face of thousands of opioid-related lawsuits.
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J&J’s Janssen Gets European OK for Stelara in Ulcerative Colitis

Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Cos. unit on Wednesday said the European Commission approved the expanded use of Stelara in adults with the inflammatory bowel disease ulcerative colitis.
Janssen said the approval covers adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
The European Medicines Agency’s Committee for Medicinal Products for Human Use in July recommended the expanded marketing authorization of Stelara, which was approved in 2016 for the inflammatory bowel disorder Crohn’s disease.
The U.S. Food and Drug Administration is currently reviewing Janssen’s application for Stelara in adults with ulcerative colitis.
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Bayer: Monsanto’s list of influential people was not illegal

 Bayer said a law firm it had commissioned to investigate a compilation of data on journalists, politicians and researchers by Monsanto had found no evidence of illegal behavior by the seed maker that Bayer acquired last year.

French prosecutors in May had opened an inquiry after newspaper Le Monde filed a complaint alleging that Monsanto – bought by Bayer for $63 billion – had kept files of influential people in a bid to sway public opinion on its pesticides.
“There is no question that the … stakeholder lists created were detailed, methodical, and designed to strongly advocate Monsanto’s positions to stakeholders and to the public. But … we did not find evidence to support the French media’s allegations regarding the illegality of the stakeholder lists,” Bayer quoted the report by law firm Sidley Austin LLP as saying.
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Livongo Health EPS misses by $0.05, beats on revenue

Livongo Health (NASDAQ:LVGO): Q2 Non-GAAP EPS of -$0.46 misses by $0.05; GAAP EPS of -$0.76 misses by $0.16.
Revenue of $40.89M (+155.9% Y/Y) beats by $1.15M.
Press Release
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Zafgen shares halted pending news

Nasdaq has suspended trading in Zafgen (NASDAQ:ZFGN) pending the release of news.
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