From Reuters

Regeneron Antibodies in Demand After Trump Treatment, Doctors Seek More Data

October 8, 2020

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc REGN.O, and on Wednesday he promised to make it free to Americans while touting its benefits.

Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed.

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc REGN.O, and on Wednesday he promised to make it free to Americans while touting its benefits.

Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed.

Trump was discharged from the hospital late on Monday, just a few days after being diagnosed with COVID-19 that caused enough lung inflammation for blood oxygen levels to fall….

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Exclusive: FDA Widens U.S. Safety Inquiry Into AstraZeneca Coronavirus Vaccine – Sources

October 1, 2020

The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.

AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.

The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said….

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Explainer: Trump’s Plan to Cut Drug Prices

July 27, 2020

The orders, which range from relaxing drug importation rules to cutting Medicare payments to drugmakers, are far reaching but experts say they are unlikely to take effect in the near term and in some cases lack specifics.

The executive orders have for the most part been proposed by the Trump administration in various forms in the past, but stalled amid industry pushback.

The orders, which range from relaxing drug importation rules to cutting Medicare payments to drugmakers, are far reaching but experts say they are unlikely to take effect in the near term and in some cases lack specifics.

The executive orders have for the most part been proposed by the Trump administration in various forms in the past, but stalled amid industry pushback.

PASSING ON REBATES TO PATIENTS

Trump signed an executive order requiring that the pharmaceutical benefits managers (PBMs) that negotiate on behalf of government health plans pass the discounts they receive directly to consumers. The rule applies to Medicare Part D, a government health plan primarily for seniors. It would reverse the longstanding practice of PBMs passing a portion of savings back to the health plan itself and pocketing the remainder as profit….

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Will Gilead Price Its Coronavirus Drug for Public Good or Company Profit?

May 6, 2020

Gilead Sciences Inc (GILD.O) faces a new dilemma in deciding how much it should profit from the only treatment so far proven to help patients infected with the novel coronavirus.

The drugmaker earned notoriety less than a decade ago, when it introduced a treatment that essentially cured hepatitis C at a price of $1,000 per pill.

Public outrage over the cost of Sovaldi in 2013 – despite that it was a vast improvement over existing equally expensive therapies – ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since.

Gilead Sciences Inc (GILD.O) faces a new dilemma in deciding how much it should profit from the only treatment so far proven to help patients infected with the novel coronavirus.

The drugmaker earned notoriety less than a decade ago, when it introduced a treatment that essentially cured hepatitis C at a price of $1,000 per pill.

Public outrage over the cost of Sovaldi in 2013 – despite that it was a vast improvement over existing equally expensive therapies – ignited a national debate on fair pricing for prescription medicines that the pharmaceutical industry has fought to deflect ever since.

That backlash has subsided considerably in the midst of the coronavirus pandemic, during which drugmakers’ efforts to develop vaccines and treatments is considered essential to battling a disease that has infected some 3.7 million people and killed over 258,000 worldwide….

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U.S. Government Aims at High Insulin Prices With Plan for $35 Copay in Medicare

March 12, 2020

The Trump administration on Wednesday turned back to its pledge to fight high U.S. drug prices with a plan to limit the out-of-pocket cost for insulin, a life-saving medicine, to $35 per month for many people with diabetes who are enrolled in Medicare.

The Center for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services, is lining up drug makers and the private insurers who manage Medicare drug benefits to volunteer to test out the new pricing in 2021. Medicare drug plans cover about 46 million people aged 65 and older and with disabilities.

The Trump administration on Wednesday turned back to its pledge to fight high U.S. drug prices with a plan to limit the out-of-pocket cost for insulin, a life-saving medicine, to $35 per month for many people with diabetes who are enrolled in Medicare.

The Center for Medicare and Medicaid Services, part of the U.S. Department of Health and Human Services, is lining up drug makers and the private insurers who manage Medicare drug benefits to volunteer to test out the new pricing in 2021. Medicare drug plans cover about 46 million people aged 65 and older and with disabilities.

Insulin is made largely by three companies: Eli Lilly and Co, Novo Nordisk A/S and Sanofi SA. Both they and health insurers have begun offering discounted insulin. Eli Lilly and Sanofi said in statements that they planned to take part in the program. Novo Nordisk said in a statement that it was looking at the details of the program….

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