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CNS

Set Alert for CNS

Cortexyme Alzheimer’s Study Fails; Drug Slows Cognitive Decline In Some Patients

Atuzaginstat targets a bacteria associated with Alzheimer’s disease. The higher of two doses showed a 57% slowing in cognitive decline in the Phase II/III GAIN trial in mild to moderate patients with P. gingivalis infection confirmed by saliva test.

Clinical Trials Neurology

Lilly Targets Aduhelm With Aggressive Plans For Donanemab In Alzheimer’s

Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.

Sales & Earnings Business Strategies

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a slow start for Biogen’s Aduhelm; J&J looks to transition COVID vaccine to commercial sales; 2seventy bio spins out from bluebird bio; UCB faces bimekizumab delays; and progress and setbacks in gene therapy.

Sales & Earnings Research & Development

Biogen’s Q3 Aduhelm Sales Even Worse Than Expected

Analysts expected at least $12m in third quarter sales, but the Alzheimer’s therapy brought in just $300,000. The company says educating doctors and procuring a coverage determination from CMS – not lower pricing – are key to growth.  

Launches Market Access

Sage/Biogen Delay Zuralone Filing, Commercial Path Remains Unclear

The companies will seek approval for zuranolone in MDD second-half 2022 and in PPD in first-half 2023, but that also means launch will probably happen second-half 2023.

FDA Neurology

Biogen Seeking A Path Forward After Phase III Tofersen Study Fails In ALS

The drug showed favorable but not significant trends across secondary endpoints, and greater efficacy in slower-progressing patients and those treated earlier in the disease, in a small subpopulation.

Clinical Trials Neurology

Five Multiple Sclerosis R&D Updates From ECTRIMS

With the virtual doors about to close on the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting, Scrip takes a look at some of the highlights, including data for Merck KGaA and Sanofi’s new BTK inhibitors and research showing the impact of MS therapies on COVID-19 vaccine response.

Neurology Clinical Trials

Pacira Aims For Non-Opioid Pipeline Growth With Flexion Buy

Flexion’s Zilretta is forecast to have big market potential with the growth of osteoarthritis, and Pacira’s CEO suggested there were commercial synergies with its Iovera device.

Deals M & A

Supernus Adds To CNS Portfolio, Especially In Parkinson’s, With Adamas Buyout

Building upon the May 2020 acquisition of US WorldMeds, Supernus is diversifying beyond Trokendi for epilepsy and will be able to rely on its existing commercial force for CNS products.

M & A Business Strategies

Neumora Launches With $500m To Advance Personalized Neuroscience Drugs

Combining biological insights with data science, the start-up emerges from stealth mode after two years of assembling its technology platform and R&D pipeline based on internal and external know-how.

Financing StartUps and SMEs

Takeda Halts Phase II Studies For Key R&D Asset TAK-994 In Narcolepsy

The company stopped Phase II clinical trials for TAK-994 to assess a safety signal and determine next steps for the drug, which is viewed as a key product in Takeda’s push for blockbuster revenue growth. 

Clinical Trials Drug Safety

Biohaven’s Q3 Nurtec ODT Sales Indicate Gains Across Multiple Launch Parameters

The company pre-announced $136m in third quarter sales, beating analyst consensus and signaling both increased oral CGRP inhibitor market share and improved per-prescription net revenue.

Launches Sales & Earnings
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