CMS expands Alzheimer's PET coverage

Today’s Big News

Oct 16, 2023

With COVID sales in free fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts


As 'harvest time' arrives for Alzheimer's, neuroscientist reflects on next steps for drug development


CMS opens door to expanded Medicare coverage of diagnostic PET scans for Alzheimer’s disease


Aldeyra suggests potential FDA rejection imminent for dry eye med after 'substantive review issues'


AbbVie trumpets Skyrizi's resounding win against J&J's Stelara in Crohn's disease

 

Featured

With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion. Pfizer chalked up most of the decline to a $7 billion decrease in its projection for sales of oral antiviral Paxlovid. The company has also cut its forecast for sales of COVID vaccine Comirnaty by $2 billion.
 

Top Stories

As 'harvest time' arrives for Alzheimer's, neuroscientist reflects on next steps for drug development

Howard Fillit, M.D., remembers a time when doctors didn’t have a name for the condition that robbed elderly patients of their memory. He’s a geriatrician and neuroscientist, but also the co-founder and chief science officer for the Alzheimer’s Drug Discovery Foundation.

CMS opens door to expanded Medicare coverage of diagnostic PET scans for Alzheimer’s disease

Previously, CMS had limited reimbursements for the imaging procedure, which is capable of highlighting the disease’s telltale clumps of beta amyloid proteins within the brain.

Aldeyra suggests potential FDA rejection imminent for dry eye med after 'substantive review issues'

Aldyera came clean about the prospects of its dry eye disease med, revealing that the FDA could soon reject it due to review issues. The FDA had suggested that the company run an additional clinical trial to confirm efficacy.

AbbVie trumpets Skyrizi's resounding win against J&J's Stelara in Crohn's disease

AbbVie already shared last month that its Skyrizi had trounced Johnson & Johnson’s rival biologic drug Stelara in Crohn’s disease. Now, detailed trial results show just how decisive Skyrizi’s win is.

Ultragenyx and Mereo’s genetic bone disease treatment cuts fractures by 67%

Ultragenyx and Mereo BioPharma are out with a new slice of data from a phase 2/3 trial of its brittle bone disease treatment, showing it significantly reduced the rate of fractures. The data continue to add momentum to setrusumab as phase 3 recruitment continues.

Better Therapeutics begins rolling out digital app for Type 2 diabetes

Right on schedule, after securing FDA de novo clearance for its digital therapeutic designed to help manage Type 2 diabetes, Better Therapeutics is beginning the commercial launch of the app.

Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod

Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.

Novo Nordisk, with coffers filling with cash, buys rival to Bayer's kidney drug Kerendia in $1.3B deal

Novo Nordisk is putting its soaring sales to work, agreeing to pay up to $1.3 billion for KBP Biosciences’ phase 3 challenger to Bayer’s chronic kidney disease drug Kerendia.

Siemens Healthineers, Qure.ai partner on chest X-ray AI rollout for tuberculosis screening

Working with the Global Fund to Fight AIDS, Tuberculosis and Malaria, the companies aim to boost the adoption of AI programs that can spot the signs of TB-related lung abnormalities.

Omeros stops kidney disease phase 3 after interim review fail, cutting thread holding up stock price

Omeros has stopped a phase 3 trial of narsoplimab in kidney disease patients after an interim analysis found it was destined to fail, adding another plot line to its epic, ongoing attempt to get the candidate to market.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Unraveling Alzheimer's disease treatments

In this episode of "The Top Line," Fierce Biotech's Annalee Armstrong engages in a conversation with Howard Fillit, M.D., an expert in the field of Alzheimer's research and the co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. They delve into the pioneering work being done in Alzheimer's research, discuss the latest breakthroughs, and explore the ongoing efforts to combat this complex disease.

 

Resources

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