Novo Nordisk's weekly insulin ready for FDA

Today's Big News

Oct 5, 2022

In what could be a troubling sign of the times, U.S. bulks up supply of Amgen's radiation sickness med Nplate

Experts warn hospitals of potential COVID-flu 'twindemic'

Novo Nordisk ready to submit once-weekly insulin to FDA

Roche nets FDA approval for HER2-low breast cancer test

GSK's Jemperli matched up to Merck's Keytruda in terms of lung cancer tumor shrinkage in a phase 2 trial - Heather Landi

 

Featured

Sign of the times? US stocks up on Amgen's radiation sickness drug Nplate

Wednesday, the U.S. Department of Health and Human Services (HHS) said it’s throwing down $290 million to lock up an undisclosed amount of Amgen’s blood disorder med Nplate, which is approved to treat blood cell injuries linked to acute radiation syndrome (ARS) in kids and adults.
 

Top Stories

Experts warn that a COVID-flu ‘twindemic’ might hit hospitals hard this year

Since COVID-19 surfaced, the cases of influenza dropped to historic lows. That might not be the case this year as a “twindemic” could develop.

Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win

Novo Nordisk added the final piece to the puzzle the Danish drugmaker wanted to complete before submitting its once-weekly insulin icodec to regulators next year.

Roche nets FDA approval for HER2-low breast cancer test paired with AstraZeneca-Daiichi's Enhertu

Roche received the first FDA approval for a companion diagnostic test to identify patients carrying this HER2-low status—a more precise characterization of breast tumors that was previously more binary, relying largely on positive and negative labels.

GSK's latecomer Jemperli delivers head-to-head win versus Keytruda in lung cancer. What's next?

Merck’s Keytruda is well established as the standard treatment for newly diagnosed metastatic non-small cell lung cancer. For PD-1 latecomer Jemperli from GSK, an impressive trial showing met the tough bar established by the Merck blockbuster.

GSK hits go on pivotal TIM-3 lung cancer trial after phase 2 clears bar for advancement

GSK’s anti-TIM-3 antibody is moving into a pivotal trial after hitting the mark in the midphase portion of the study, cementing the Big Pharma’s status as a front-runner in a thinning field featuring Novartis.

3 payer CEOs among Fortune's Most Powerful Women in Business for 2022

Three health insurance CEOs earned spots on Fortune's annual ranking of Most Powerful Women in Business, with one topping the list for the second straight year.

Taking a child’s fear out of the OR using virtual reality

Before Inc. and Saritasa are working to make hospital visits a little easier for children and young teenagers by giving them a pre-op tour in virtual reality.

FDA nixes EUA ambitions for Eiger’s COVID treatment, proposes full approval pathway instead

Eiger won't be nabbing emergency use authorization for its COVID treatment after all. The company says the FDA rejected the pathway citing concerns about the trial and the general state of the pandemic in the U.S.

In $500M expansion, Merck opens one Singapore facility and breaks ground on another

Merck has opened a new secondary packaging facility to churn out vaccines and biologics. It also broke ground on a plant that will produce inhalers and is set for completion in 2026.

Desert Oasis Healthcare signs on to pilot Google Health's Care Studio for outpatient care

Medical group Desert Oasis Healthcare has jumped on board to pilot Google Health's clinical software Care Studio. It marks Google Health's third provider partnership, and its first outpatient collaboration, for its clinician-facing search tool that harmonizes healthcare data from different sources.
 
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'Podnosis': Protecting against cybersecurity attacks, measuring social determinants of health

This week on "Podnosis," we talk about how how frequent cyberattacks are impacting patient care and what hospitals and health systems can do to shore up their defenses. Also under discussion is how social drivers of health are finally being recognized by the CMS.
 

Resources

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Softgel Formulation Enables Oral Delivery of Testosterone

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What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

 

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