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Today's Rundown

GlaxoSmithKline’s HIV prevention injectable Apretude threatens Gilead with FDA blessing. But will doctors use it?
Biden buys up 500M rapid, at-home COVID tests to distribute for free in 2022
Biden announces free home COVID testing, emergency hospital support to head off winter omicron surge
Pfizer reports patient death in early-stage Duchenne gene therapy trial, halts enrollment
AbbVie, after losing Humira trade secrets case, eyes new strategy in Alvotech fight
Drug price reforms, Medicaid coverage gap in balance after Manchin opposition to Build Back Better Act
Sanofi gambles $1B upfront on preclinical oncology biotech, bagging Amunix for its pipeline of T-cell engagers
BD acquires smartphone-powered COVID test partner Scanwell Health
Acadia slims Nuplazid label expansion bid in hopes of clinching Alzheimer's dementia nod without extra studies
Lilly's atopic dermatitis med scores another late-stage win in attempt to outdo Dupixent
FDA alerts medical device makers to cybersecurity risk in popular Apache Log4j software tool
Goldman Sachs forecasts positive outlook for insurers in 2022, buoyed by shift to value-based care

Featured Story

GlaxoSmithKline’s HIV prevention injectable Apretude threatens Gilead with FDA blessing. But will doctors use it?

By Angus Liu

After making history with the first complete long-acting regimen for the treatment of HIV, GlaxoSmithKline’s ViiV Healthcare has now made a component of that therapy into a preventative option, threatening a major franchise at Gilead Sciences.

Biden buys up 500M rapid, at-home COVID tests to distribute for free in 2022

By Andrea Park

Beginning in January, Americans will be able to visit a website where they can have the tests mailed directly to their homes at no charge.

Biden announces free home COVID testing, emergency hospital support to head off winter omicron surge

By Dave Muoio

Free at-home tests, new vaccination centers and hospital bed capacity expansions are all at the crux of President Biden's omicron response.

Pfizer reports patient death in early-stage Duchenne gene therapy trial, halts enrollment

By Annalee Armstrong

Pfizer reported the death of a young male patient who was participating in an an early-stage trial for the Big Pharma’s Duchenne muscular dystrophy gene therapy. The company paused screening and dosing in the study while it works with the trial site investigator to figure out what happened.

AbbVie, after losing Humira trade secrets case, eyes new strategy in Alvotech fight

By Fraiser Kansteiner

In a recent complaint filed at the U.S. International Trade Commission (ITC), AbbVie said Alvotech "misappropriated" trade secrets linked to the production of its Humira copycat. As a result, the ITC should bar imports or sales of the biosim in the U.S., lawyers for AbbVie argued.

Drug price reforms, Medicaid coverage gap in balance after Manchin opposition to Build Back Better Act

By Robert King

Democrats are debating what healthcare items to drop in a narrower Build Back Better Act after objections from moderate Sen. Joe Manchin.

Sanofi gambles $1B upfront on preclinical oncology biotech, bagging Amunix for its pipeline of T-cell engagers

By Nick Paul Taylor

Sanofi is betting $1 billion on a preclinical pipeline of anti-cancer T-cell engagers. The upfront outlay, plus up to $225 million in milestones, is set to give Sanofi ownership of West Coast immuno-oncology player Amunix Pharmaceuticals.

BD acquires smartphone-powered COVID test partner Scanwell Health

By Conor Hale

After working this past year to pair up its rapid COVID-19 antigen test with digital smartphone capabilities, BD is making its relationship with Scanwell Health official. The medtech giant acquired Scanwell for an undisclosed amount and announced plans to fold the tech developer into its integrated diagnostic solutions business.

Acadia slims Nuplazid label expansion bid in hopes of clinching Alzheimer's dementia nod without extra studies

By Fraiser Kansteiner

After suffering a surprise rejection from the FDA in April, Acadia Pharmaceuticals is making another bid to expand the scope of its Parkinson’s disease med Nuplazid—and it hopes to do so without running additional trials.

Lilly's atopic dermatitis med scores another late-stage win in attempt to outdo Dupixent

By Annalee Armstrong

Watch out, Sanofi and Regeneron. Eli Lilly’s Dupixent rival has posted another round of data showing improvement in atopic dermatitis when combined with topical corticosteroids in a phase 3 trial.

FDA alerts medical device makers to cybersecurity risk in popular Apache Log4j software tool

By Andrea Park

A hacking risk discovered last month within the widely used Apache Log4j logging tool has been labeled “the single biggest, most critical vulnerability of the last decade” by the CEO of cybersecurity firm Tenable—and medtech developers aren’t immune.

Goldman Sachs forecasts positive outlook for insurers in 2022, buoyed by shift to value-based care

By Heather Landi

Global investment bank Goldman Sachs projects that the pursuit of value-based care could potentially bring significant payoff for big insurers in 2022. For the next two years, analysts Nathan Rich and Lindsay Golub estimate a potential 13% annual earnings per share growth for large-cap managed care organizations, more than double the firm’s 6% projection for S&P EPS growth, according to a recent report.

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Featured Story

GlaxoSmithKline’s HIV prevention injectable Apretude threatens Gilead with FDA blessing. But will doctors use it?

Top Stories

Biden buys up 500M rapid, at-home COVID tests to distribute for free in 2022

Biden announces free home COVID testing, emergency hospital support to head off winter omicron surge

Pfizer reports patient death in early-stage Duchenne gene therapy trial, halts enrollment

AbbVie, after losing Humira trade secrets case, eyes new strategy in Alvotech fight

Drug price reforms, Medicaid coverage gap in balance after Manchin opposition to Build Back Better Act

Sanofi gambles $1B upfront on preclinical oncology biotech, bagging Amunix for its pipeline of T-cell engagers

BD acquires smartphone-powered COVID test partner Scanwell Health

Acadia slims Nuplazid label expansion bid in hopes of clinching Alzheimer's dementia nod without extra studies

Lilly's atopic dermatitis med scores another late-stage win in attempt to outdo Dupixent

FDA alerts medical device makers to cybersecurity risk in popular Apache Log4j software tool

Goldman Sachs forecasts positive outlook for insurers in 2022, buoyed by shift to value-based care