Newsletter Tool

Today's Rundown

Biogen's ALS drug has failed phase 3. Will FDA approve anyway?
Conflicting federal, state COVID-19 vaccine requirements have hospitals trapped in noncompliance
Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report
A single patient is producing insulin after treatment with Vertex's new diabetes cell therapy
Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report
HLTH21: Grand Rounds Health, Doctor on Demand rebrand combined company as Included Health
Roche ushers early lung cancer into immunotherapy era with Tecentriq FDA approval. Will doctors follow?
UPDATED: Valneva soars after its COVID-19 shot tops AstraZeneca's in head-to-head trial
Philips CPAP recall still chips away at earnings, with nearly 40% drop in Q3 connected care sales
CVS Health taps new chief health equity officer
Revance's Botox rival turned away by FDA after inspectors flagged manufacturing 'deficiencies'
Takeda spinout Phathom's erosive esophogitis drug bests Prevacid in head-to-head phase 3 trial
ReCor Medical's renal denervation device misses blood pressure endpoint after European launch
Regeneron, Novo Nordisk, Lilly and AbbVie stake claims on September's list of top TV ad spenders

Featured Story

Biogen's ALS drug has failed phase 3. Will FDA approve anyway?

By Nick Paul Taylor

Stop me if you think you've heard this one before. A Biogen neurodegenerative disease prospect has failed a pivotal study, but the Big Biotech has latched onto biomarker data and “trends favoring” the treatment as it heads into talks with the FDA. Will it be enough to get the candidate to market?

Conflicting federal, state COVID-19 vaccine requirements have hospitals trapped in noncompliance

By Dave Muoio

Legal experts weigh in on the options for hospitals forced to choose between Biden's executive orders and a number of state-level bans on COVID-19 vaccine mandates.

Pfizer, Moderna will rake in a combined $93 billion next year on COVID-19 vaccine sales: report

By Kevin Dunleavy

Pfizer-BioNTech COVID-19 vaccine sales will reach $54.5 billion in 2022 and Moderna’s will hit $38.7 billion, says analytics group Airfinity. The organization puts total market sales for COVID vaccines in 2022 at $124 billion. The Airfinity numbers are radically divergent from consensus figures, The Financial Times reports.

A single patient is producing insulin after treatment with Vertex's new diabetes cell therapy

By Annalee Armstrong

Vertex is providing an initial peek at the first patient to receive a new type of diabetes cell therapy that could prevent the need for organ transplantation. A single patient with type 1 diabetes achieved a “robust” restoration of islet cell function after receiving VX-880. Restoration of these cells could allow patients to regulate insulin or even produce it on their own.

Medtronic to leap ahead in diabetes race with $300M Triple Jump purchase: report

By Andrea Park

Amid back-to-back expansions of two Class I recalls pertaining to the MiniMed insulin pump technology it acquired two decades ago, Medtronic is reportedly eyeing a purchase of another insulin pump maker.

HLTH21: Grand Rounds Health, Doctor on Demand rebrand combined company as Included Health

By Paige Minemyer

Grand Rounds Health and Doctor on Demand combined earlier this year and are now rebranding as Included Health.

Roche ushers early lung cancer into immunotherapy era with Tecentriq FDA approval. Will doctors follow?

By Angus Liu

Roche’s Tecentriq has ushered in a new era, offering the first immunotherapy option for non-small cell lung cancer patients after tumor surgery. But doctors appear reluctant to use it for now, at least for some patients.

UPDATED: Valneva soars after its COVID-19 shot tops AstraZeneca's in head-to-head trial

By Kyle LaHucik

Travel vaccine maker Valneva says its COVID-19 vaccine has topped AstraZeneca's in a head-to-head pivotal trial in the U.K. Valneva hopes to win approval in Europe for the vaccine, which is now also being tested in New Zealand.

Philips CPAP recall still chips away at earnings, with nearly 40% drop in Q3 connected care sales

By Andrea Park

Even as Philips began the process of repairing and replacing the ventilators affected by its ongoing recall of the devices, the medtech giant still saw its sales slip in the third quarter of this year, the first full quarter to feel the effects of the recall initiated in mid-June.

CVS Health taps new chief health equity officer

By Paige Minemyer

CVS Health has named Joneigh Khaldun, M.D., as its new vice president and chief health equity officer.

Revance's Botox rival turned away by FDA after inspectors flagged manufacturing 'deficiencies'

By Eric Sagonowsky

Despite a pandemic delay and an FDA warning about quality control and record-keeping problems at a production site, Revance insisted it was optimistic the agency would approve its would-be Botox rival as recently as last week. Turns out the FDA had other plans.

PM Tracker