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Cigna creates new program to pay for high-price gene therapies
The payer unveiled Embarc Benefit Protection, which it said would enable plans to pay a monthly, per-member fee to enroll, while patients would not have to pay anything out of pocket.
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Sumitomo pays $3B to Vivek Ramaswamy’s Roivant under new alliance
The Sumitomo Dainippon-Roivant Alliance will be wholly owned by Sumitomo, which is also taking control of five companies – and potentially six more – from Ramaswamy’s Vant family of firms.
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Part 2: The U.S. has fantastic health care, the problem is….
In part 2 of an executive interview series, CEO and physician Wyatt Decker discusses health care reinvention including technology, the human impact and physician burn-out.
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Report: MD Anderson oncologist is under consideration for FDA post
Trump is reportedly considering Dr. Stephen Hahn to head the FDA. Others reportedly under consideration include acting Commissioner Ned Sharpless and HHS assistant secretary Brett Giroir.
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FDA accepts application for Global Blood’s sickle cell disease drug
The agency granted the application for accelerated approval priority review, but is not requiring an advisory committee meeting. A confirmatory trial measuring the drug’s ability to reduce stroke risk is planned for the fourth quarter.
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Mallinckrodt stock tanks following report that it has hired restructuring advisers
Shares of the company fell 40 percent Thursday following a story late Wednesday afternoon by Bloomberg, which reported that a bankruptcy filing was a potential option.
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uBiome, once a promising microbiome startup, files for bankruptcy
A mere five months after an FBI raid, the San Francisco startup, once valued at $600 million, has filed for bankruptcy. It will continue to offer its microbiome test while also looking for a buyer.
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Cancer accounts for more than one-quarter of new drug approvals, analysis finds
Overall, the report, from the Tufts Center for the Study of Drug Development, found that new cancer drug approvals since 2010 have increased by 4 percent since the 1980s.
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Achilles Therapeutics raises $120M in Series B round for cancer cell therapy
The company is developing tumor-infiltrating lymphocyte therapies that target patient-specific neoantigens. It plans to use the money to fund Phase I/IIa studies in solid tumors.
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Vertex buys developer of preclinical cell therapy for Type 1 diabetes for $950M
The Boston-based company said it would acquire Semma Therapeutics, which is developing a stem cell-derived therapy and device for the disease. Preclinical data were announced in July, and clinical trials are planned for 2020.
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The Need for Cultural Competence in Healthcare
In order to meet the needs of patients, healthcare providers will need to promote cultural competency.
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MedCo RNA-interference cholesterol drug shows positive Phase III data
Inclisiran, which The Medicines Co. is developing with Alnylam, prevents production of PCSK9, the same protein targeted by two drugs that were the subject of a major patent lawsuit ruling last week. The company plans regulatory filings starting later this year.
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Report: HHS Secretary Azar mulls Brett Giroir as next FDA commissioner
President Donald Trump must appoint a new commissioner of the FDA by Nov. 1. Ned Sharpless has served as acting commissioner since Scott Gottlieb’s departure in March.
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USPTO agrees to Amgen’s petition to review Alexion’s patents on rare disease drug
Shares of Alexion fell more than 11 percent Friday as the office instituted an inter partes review for the drug, Soliris, in the blood disorder paroxysmal nocturnal hemoglobinuria.
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Federal judge rules in favor of Sanofi, Regeneron in patent suit over cholesterol drugs
The decision was a loss for Amgen, which had claimed that Sanofi and Regeneron’s drug Praluent infringed on its patents for the drug Repatha.
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Limit placebos in cancer drug trials to certain cases, FDA advises drugmakers
In a guidance issued Wednesday, the agency said randomized, controlled trials of cancer drugs should only use placebo in cases like when surveillance is standard of care. A bioethics expert said such principles have long existed, but it was good to see them in an official guidance.
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FDA issues warning about hepatitis C drug as dozens of patients experience worsening liver function
The agency warned against use of AbbVie’s Mavyret, Gilead Sciences’ Vesovi and Merck’s Zepatier in patients with moderate to severe liver disease amid reports of 63 patients with liver decompensation, with some cases being fatal.


















