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FDA to Form Workgroup to Study Drug Importation Will focus only on off-patent drugs

WASHINGTON — Health and Human Services (HHS) Secretary Alex Azar on Thursday asked the FDA to develop a working group to consider whether importation of certain prescription drugs might help bring drug prices down. “We look forward to working with [FDA] Commissioner [Scott] Gottlieb and the FDA to explore how importation could help address price... Read More »

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WASHINGTON — Health and Human Services (HHS) Secretary Alex Azar on Thursday asked the FDA to develop a working group to consider whether importation of certain prescription drugs might help bring drug prices down. “We look forward to working with [FDA] Commissioner [Scott] Gottlieb and the FDA to explore how importation could help address price… Read More »

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Three years after steep price hike, Martin Shkreli’s drug company is losing money, documents show

Martin Shkreli’s former company is losing money, watching sales of its famously costly medicine slip while considering yet another name change. Vyera Pharmaceuticals, formerly called Turing Pharmaceuticals, lost more than $1 million in the first quarter of 2018, according to financial documents obtained by STAT. Sales, driven by the $750-a-pill Daraprim, have been on the... Read More »

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Martin Shkreli’s former company is losing money, watching sales of its famously costly medicine slip while considering yet another name change. Vyera Pharmaceuticals, formerly called Turing Pharmaceuticals, lost more than $1 million in the first quarter of 2018, according to financial documents obtained by STAT. Sales, driven by the $750-a-pill Daraprim, have been on the… Read More »

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Novel Scanner Technique Can Potentially Replace Mammograms for Breast Cancer Detection

A new laser-sonic scanner technique may help women avoid the discomfort of traditional mammography procedures by offering an alternative, more efficient way to screen for breast cancer, according to a recent study. Although mammograms are effective in detecting breast cancer and reducing deaths from the disease, many women avoid having their mammograms taken as often... Read More »

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A new laser-sonic scanner technique may help women avoid the discomfort of traditional mammography procedures by offering an alternative, more efficient way to screen for breast cancer, according to a recent study. Although mammograms are effective in detecting breast cancer and reducing deaths from the disease, many women avoid having their mammograms taken as often… Read More »

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Senators press PBMs to clarify Azar’s ‘extremely disturbing’ drug pricing allegations

Two senators have asked prominent pharmacy benefit managers to address accusations from the Trump administration’s top health official that PBMs are preventing drug manufacturers from lowering prices. In letters to nine PBMs, including Express Scripts, CVS Health and OptumRx, Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., asked the companies to explain statements made by... Read More »

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Two senators have asked prominent pharmacy benefit managers to address accusations from the Trump administration’s top health official that PBMs are preventing drug manufacturers from lowering prices. In letters to nine PBMs, including Express Scripts, CVS Health and OptumRx, Sens. Elizabeth Warren, D-Mass., and Tina Smith, D-Minn., asked the companies to explain statements made by… Read More »

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For Women Over 30, There May Be A Better Choice Than The Pap Smear

BSIP/UIG via Getty Images For most women under 65, a visit to the gynecologist often includes an unpleasant necessity: a Pap smear to check for cervical cancer risk. The test involves letting a doctor or nurse scrape cells from the back of the cervix, which are visually inspected for signs of abnormality. There’s a simpler... Read More »

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BSIP/UIG via Getty Images For most women under 65, a visit to the gynecologist often includes an unpleasant necessity: a Pap smear to check for cervical cancer risk. The test involves letting a doctor or nurse scrape cells from the back of the cervix, which are visually inspected for signs of abnormality. There’s a simpler… Read More »

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How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass

Dive Brief: Alexion Pharmaceuticals is trying to get a speedy approval of its Soliris follow-on drug, announcing Tuesday it used a valuable fast pass that shaves down the regulatory review time by several months. Though it normally takes about a year for the Food and Drug Administration to clear or reject a Biologics Licensing Application... Read More »

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Dive Brief: Alexion Pharmaceuticals is trying to get a speedy approval of its Soliris follow-on drug, announcing Tuesday it used a valuable fast pass that shaves down the regulatory review time by several months. Though it normally takes about a year for the Food and Drug Administration to clear or reject a Biologics Licensing Application… Read More »

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Cancer Drug Approvals Are Speedier, But at What Cost? Safety, benefits from accelerated reviews questioned

The FDA’s breakthrough therapy designation program has led to faster approval times for cancer drugs but not necessarily better or safer drugs, according to an analysis of recent approvals. A review of cancer drugs approved from 2012 through 2017 showed that drugs receiving breakthrough therapy designation from the FDA reached the market 2 years faster... Read More »

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The FDA’s breakthrough therapy designation program has led to faster approval times for cancer drugs but not necessarily better or safer drugs, according to an analysis of recent approvals. A review of cancer drugs approved from 2012 through 2017 showed that drugs receiving breakthrough therapy designation from the FDA reached the market 2 years faster… Read More »

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Dr. Stacy’s Curbside Consult

  U.S. women are less likely than men to get statins after heart attack. That discrepancy may explain why death rates for women are higher.

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  U.S. women are less likely than men to get statins after heart attack. That discrepancy may explain why death rates for women are higher.

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Cellectis publishes description of new ‘all-in-one’ CAR-T architecture

One of the companies developing CAR-T therapies that don’t require patients to have their own T cells harvested has developed an architecture that it said could streamline manufacturing and improve safety. French biotech firm Cellectis said Tuesday that it had published a study describing the development of CubiCAR, an “all-in-one” architecture that embeds a multi-function... Read More »

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One of the companies developing CAR-T therapies that don’t require patients to have their own T cells harvested has developed an architecture that it said could streamline manufacturing and improve safety. French biotech firm Cellectis said Tuesday that it had published a study describing the development of CubiCAR, an “all-in-one” architecture that embeds a multi-function… Read More »

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Nearly Half of Patients in Trial Respond to Checkpoint Inhibitor Treatment for Common Skin Cancer

Cutaneous squamous cell carcinoma is the second most common skin cancer, with an estimated 1 million new cases diagnosed annually. However, there are currently no systemic therapies approved for the treatment of advanced cutaneous squamous-cell carcinoma in patients who show no progress with surgery or radiation. According to recent clinical trials, an immune checkpoint inhibitor... Read More »

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Cutaneous squamous cell carcinoma is the second most common skin cancer, with an estimated 1 million new cases diagnosed annually. However, there are currently no systemic therapies approved for the treatment of advanced cutaneous squamous-cell carcinoma in patients who show no progress with surgery or radiation. According to recent clinical trials, an immune checkpoint inhibitor… Read More »

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