From Stat

Pharma’s Ambitious New Antibiotic Venture Hires a CEO to Fix a ‘Broken’ Pipeline

February 18, 2021

Several months after a splashy announcement, an ambitious pharmaceutical industry venture to tackle antibiotic resistance has hired its first chief executive officer and received $140 million in additional funding commitments.

The AMR Action Fund, which was organized with $1 billion in pledged funds from nearly two dozen drug makers, tapped Henry Skinner, a venture capitalist and the former head of Novartis (NVS) Venture Funds, to pilot the project. The goal is to acquire or invest in small companies that can develop two to four novel antibiotics by 2030 and replenish the global supply chain with needed treatments.

Several months after a splashy announcement, an ambitious pharmaceutical industry venture to tackle antibiotic resistance has hired its first chief executive officer and received $140 million in additional funding commitments.

The AMR Action Fund, which was organized with $1 billion in pledged funds from nearly two dozen drug makers, tapped Henry Skinner, a venture capitalist and the former head of Novartis (NVS) Venture Funds, to pilot the project. The goal is to acquire or invest in small companies that can develop two to four novel antibiotics by 2030 and replenish the global supply chain with needed treatments.

“The value proposition is broken. The pipeline is not as robust as it should be and the access to capital to is extremely constrained, which is our job to fix,” said Skinner, a trained microbiologist who until recently, was a senior vice president for venture investments at Tekla Capital Management, which runs funds that invest in health care and life sciences….

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To the Delight of Generic Drug Makers, Federal Appeals Court Tosses Controversial ‘Skinny Labeling’ Decision

February 10, 2021

In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines.

At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement….

In a surprising move, a federal appeals court panel may revisit a controversial decision that has raised concerns about the ability of generic drug makers to supply Americans with lower-cost alternatives to pricey brand-name medicines.

At issue is an odd term with important implications: skinny labeling. The phrase refers to an effort by a generic company to seek regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. By doing so, the generic company seeks to avoid lawsuits claiming patent infringement….

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Comparing the Covid-19 Vaccines Developed by Pfizer, Moderna, and Johnson & Johnson

February 3, 2021

In an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store.

Soon, it seems, this ideal of a Covid-19 vaccine will be within reach.

In an ideal world, a pandemic vaccine could be delivered in a single shot, so supplies could be stretched to cover a lot of people. It would trigger no side effect more significant than a sore arm. And it would be easy to ship and store.

Soon, it seems, this ideal of a Covid-19 vaccine will be within reach.

Last Friday, Johnson & Johnson announced that a one-dose vaccine being developed by its vaccines division, Janssen Pharmaceuticals, had been shown to be 66% protective against moderate to severe Covid infection in a multicountry study. But, importantly, it was 85% effective in protecting against severe disease. And there were no hospitalizations or deaths among people in the vaccine arm of a large clinical trial….

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Here’s the Letter Amazon Sent President Biden Offering to Help With Covid-19 Vaccinations

January 20, 2021

Amazon has reached out to President Joe Biden to offer logistical and technical support for his goal of vaccinating 100 million Americans within his first 100 days in office.

In a letter sent Wednesday to Biden and shared with STAT, Dave Clark, chief executive of Amazon Worldwide Consumer, said the company is “prepared to leverage our operations, information technology, and communications capabilities and expertise to assist your administration’s vaccination efforts.”

Amazon has reached out to President Joe Biden to offer logistical and technical support for his goal of vaccinating 100 million Americans within his first 100 days in office.

In a letter sent Wednesday to Biden and shared with STAT, Dave Clark, chief executive of Amazon Worldwide Consumer, said the company is “prepared to leverage our operations, information technology, and communications capabilities and expertise to assist your administration’s vaccination efforts.”

Beyond the broader vaccination effort, Clark also noted that many of Amazon’s 800,000 U.S. employees are essential workers employed at fulfillment centers, Amazon Web Services data centers, and Whole Foods stores, which are also part of Amazon. Clark said those employees “should receive the Covid-19 vaccine at the earliest appropriate time” and added that the company already has an agreement in place with a health care provider that can administer vaccines onsite at its facilities….

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Data Fuel Debate Over Whether J&J’s One-Dose Covid Vaccine Will Measure Up

January 14, 2021

Johnson & Johnson published updated early data on its Covid-19 vaccine Wednesday, showing that it provided participants in a clinical trial with at least some immunity after one dose.

The data, published in the New England Journal of Medicine, offer only hints to a tantalizing question: Could the vaccine, given as a single shot, perform as well as the vaccines that U.S. regulators have already authorized, which are given as two?

Johnson & Johnson published updated early data on its Covid-19 vaccine Wednesday, showing that it provided participants in a clinical trial with at least some immunity after one dose.

The data, published in the New England Journal of Medicine, offer only hints to a tantalizing question: Could the vaccine, given as a single shot, perform as well as the vaccines that U.S. regulators have already authorized, which are given as two?

In the study, participants had neutralizing antibodies, measured in a unit called a geometric mean titer, of 224 to 354, on day 29 after their first vaccine dose; those levels reached 288 to 488 by day 57. These levels could be enough to produce immunity. But there was a big benefit to giving the participants a booster dose. It doubled or tripled their levels of neutralizing antibodies. The question is whether the antibody levels induced by the first dose are indeed enough, or if there are other types of immunity spurred by the vaccine that lead to protection….

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