European Pharmaceutical Review

OCTOBER 5, 2023

Longeveron’s Phase IIa trial of its stem-cell therapy for mild Alzheimer’s has revealed in top-line results, that certain doses enabled numerical slowing/prevention of disease worsening relative to placebo. Study safety data were consistent with an established safety profile.

Safety 92

Safety Pharmaceutical Patients 92

European Pharmaceutical Review

JULY 17, 2023

Eli Lilly and Company’s TRAILBLAZER-ALZ 2 study has shown donanemab enabled nearly half of participants at earlier stage of Alzheimer’s to experience no clinical progression at one year, according to full results from the Phase III trial. Approximately half of participants met this threshold at 12 months.

Food and Drug Administration 89

Food and Drug Administration FDA Food Pharma 89

PharmaTimes

SEPTEMBER 29, 2022

Results show reduction of clinical decline in global study of people with Alzheimer's Disease

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106

Pharmacy Times

NOVEMBER 7, 2023

In May 2023, the FDA approved brexpiprazole as the first and only drug to receive approval for treatment of agitation associated with Alzheimer Disease dementia.

FDA 26

FDA 26

pharmaphorum

SEPTEMBER 29, 2022

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial.

Side effects 100

Side effects FDA Safety Patients 100

World of DTC Marketing

JUNE 1, 2021

SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.”

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Side effects FDA Patients Doctors 187

European Pharmaceutical Review

JANUARY 11, 2023

Eisai has submitted a Marketing Authorisation Application (MAA) for lecanemab, for early Alzheimer’s (mild cognitive impairment due to Alzheimer’s (AD) and mild AD dementia) patients in Europe. Clarity AD study for Alzheimer’s. This application was submitted to the European Medicines Agency (EMA).

Food and Drug Administration 83

Food and Drug Administration FDA Medicine Food 83

Pharma Marketing Network

MARCH 23, 2023

The Food and Drug Administration (FDA) has recently approved a new drug for the treatment of Alzheimer’s disease called Leqembi. This approval marks a major milestone in the fight against Alzheimer’s, which is the sixth leading cause of death in the United States and affects over 5 million people.

Food and Drug Administration 52

Food and Drug Administration FDA Consulting Food 52

Pharmaceutical Technology

MAY 30, 2023

Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut. which is the licensee of lebrikizumab, recently reported favourable outcomes for lebrikizumab through a novel secondary analysis of the Phase III clinical development programme.

Sales 105

Sales Marketing Prescription Pharma 105

Pharmacy Times

JANUARY 8, 2024

Those who were exposed to the clinically acquired stomach bacteria had a 24% increased risk of Alzheimer disease after a decade of onset.

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Pharmaceutical Technology

FEBRUARY 19, 2024

Tonmya is under clinical development by Tonix Pharmaceuticals Holding and currently in Phase I for Alzheimer's Disease.

Pharmaceutical 40

Pharmaceutical 40

pharmaphorum

OCTOBER 7, 2022

TauRx Pharma’s effort to bring a tau-targeting drug for Alzheimer’s disease (AD) to market has been a marathon, with a number of setbacks over the years, but the company reckons it may finally be getting closer to the finishing line. As it turned out, that was a false expectation.

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FDA Transportation Patients Prospecting 85

pharmaphorum

JANUARY 9, 2023

Eisai and Biogen’s Alzheimer’s therapy Leqembi will be priced at $26,500 per year – a little less than misfired predecessor Aduhelm – after getting conditional authorisation for the drug from the FDA on Friday. Aduhelm was launched at $56,000 per year, before a backlash prompted Biogen to slash it to $28,000.

FDA 90

FDA Physicians Patients Sales 90

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. If approved in these regions, it would be established as the top-selling drug for Alzheimer’s disease in the coming years.

Sales 59

Sales FDA Marketing Competition 59

Pharmaceutical Technology

DECEMBER 25, 2023

HT-6184 is under clinical development by Halia Therapeutics and currently in Phase I for Alzheimer's Disease.

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Pharmaceutical Technology

DECEMBER 20, 2023

PRI-002 is under clinical development by Priavoid and currently in Phase I for Alzheimer's Disease.

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pharmaphorum

NOVEMBER 14, 2022

Roche’s Genentech division has reported disappointing top-line results from its highly-anticipated phase 3 trial of gantenerumab in early Alzheimer’s disease, in yet another setback for an amyloid-targeting drug. Study participants in GRADUATE 1 and 2 treated with gantenerumab showed a slowing of clinical decline of -0.31

Side effects 52

Side effects Safety Patients FDA 52

European Pharmaceutical Review

NOVEMBER 8, 2022

The Gates Biomanufacturing Facility (GBF) announced the successful completion of the full cycle manufacturing of the recombinant Bulk Drug Substance (BDS) of the Alzheimer’s disease anti-Tau vaccine, AV-1980R, in collaboration with the Institute for Molecular Medicine (IMM), California. New therapeutics are needed.

Manufacturing 52

Manufacturing Medicine Leads Pharmaceutical 52

Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Alzheimer’s Disease. According to GlobalData, Phase III drugs for Alzheimer’s Disease have a 9% phase transition success rate (PTSR) indication benchmark for progressing into Filing rejected/Withdrawn.

Pharmaceutical 40

Pharmaceutical 40

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. If approved in these regions, it would be established as the top-selling drug for Alzheimer’s disease in the coming years.

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Sales FDA Marketing Competition 52

Pharmacy Times

NOVEMBER 3, 2022

Eisai plans to file for traditional approval in the United States by March 31, 2023.

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pharmaphorum

JANUARY 17, 2023

The deal extends Cambridge Cognition’s technology in the area of the use of voice-based assessments that can be used to detect and monitor health conditions, and according to the company gives it a platform “that can deliver most of the voice tasks used today by psychologists and neurologists to assess disease.”

Healthcare 95

Healthcare Healthcare Marketing Patients 95

Pharmaceutical Technology

NOVEMBER 5, 2023

AL-001 is under clinical development by Alzamend Neuro and currently in Phase II for Alzheimer's Disease.

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European Pharmaceutical Review

MARCH 6, 2023

With nearly 10 million new cases of dementia of every year 1 , the increasing prevalence of Alzheimer’s disease (AD), the most common form of the condition, has prompted researchers and the pharmaceutical industry to seek novel, effective solutions. January 2023 marked a pivotal turning point for treating Alzheimer’s.

Food and Drug Administration 76

Food and Drug Administration Safety Medicine FDA 76

Pharmaceutical Technology

DECEMBER 15, 2022

Under the deal, the parties intend to develop treatments for diseases including Alzheimer’s and Parkinson’s. Louis, Eisai is working to fulfil our human health care mission and provide potential new and targeted disease-modifying therapies with the ultimate goal of achieving a world free of neurodegenerative disease.”.

Medicine 98

Medicine Safety Sales Leads 98

pharmaphorum

JULY 11, 2022

AbbVie is pulling out of its collaboration with Alector on the development of Alzheimer’s disease candidate AL003, which aims to tackle the neurodegenerative disease by restoring reduced immune system activity in the brain. The post AbbVie cuts Alzheimer’s alliance with Alector in half appeared first on.

Patients 52

Patients 52

pharmaphorum

DECEMBER 22, 2022

One of the most highly-anticipated developments in pharma next year will be the FDA’s verdict on Eisai’s accelerated application for lecanemab in Alzheimer’s disease, due early in January. The post ICER says lecanemab data in Alzheimer’s “inconclusive” appeared first on.

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FDA Patients Marketing Pharma 78

pharmaphorum

AUGUST 2, 2022

In May, another amyloid targeting drug for Alzheimer’s disease – AC Immune and Roche’s crenezumab – missed the mark in another clinical trial and looked destined for the scrap heap like so many drugs in the class before it. So where is the sliver lining?

Side effects 52

Side effects Safety Patients Leads 52

European Pharmaceutical Review

FEBRUARY 2, 2024

The company stated that it will discontinue the development and commercialisation of ADUHELM 100 mg/mL intravenous injection and will terminate the corresponding Phase III ENVISION clinical study. ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed.

Food and Drug Administration 77

Food and Drug Administration FDA Food Marketing 77

pharmaphorum

NOVEMBER 14, 2022

Investors in TauRx Pharma have exercised warrants worth around $119 million, adding to the biotech’s financial resources as it prepares regulatory filings for tau-targeting Alzheimer’s drug hydromethylthionine mesylate (HMTM) on the back of its recently-reported LUCIDITY trial.

Transportation 52

Transportation Pharma Patients Pharmaceutical 52

pharmaphorum

JANUARY 5, 2023

With the FDA due to deliver a decision of Eisai and Biogen’s new Alzheimer’s disease candidate lecanemab tomorrow, the safety of the drug has been thrust into the spotlight by a case report detailing a fatality in one of their clinical trials.

Patients 52

Patients Safety Medicine FDA 52

Pharmaceutical Technology

JUNE 2, 2023

The drug candidate has completed a Phase IIa and Phase IIb/III clinical trial for Alzheimer’s disease, a Phase II and a Phase III trial in Rett syndrome adult patients, and a Phase II proof-of-concept trial in Parkinson’s disease.

Pharmaceutical 52

Pharmaceutical Patients 52

Pharmaceutical Technology

FEBRUARY 9, 2023

Buntanetap tartrate is under clinical development by Annovis Bio and currently in Phase III for Parkinson’s Disease. According to GlobalData, Phase III drugs for Parkinson’s Disease have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Filing rejected/Withdrawn.

Pharmaceutical 40

Pharmaceutical 40

pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

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FDA Sales Marketing Patients 59

pharmaphorum

OCTOBER 6, 2022

A bipartisan bill has been introduced in the US Congress that will try to block Centers for Medicare and Medicaid Services (CMS) restrictions on Biogen’s Alzheimer’s therapy Aduhelm being extended to newer drugs for the disease.

FDA 52

FDA Patients Marketing Sales 52

pharmaphorum

JULY 6, 2022

The FDA has started an accelerated review of Eisai and Biogen’s a new amyloid-targeting antibody lecanemab for Alzheimer’s disease, with a 6 January deadline that keep them ahead of closest rival Eli Lilly. ” The post Eisai/Biogen could get FDA verdict on new Alzheimer’s drug by 6 Jan appeared first on. .

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FDA Prospecting Marketing Patients 52

European Pharmaceutical Review

SEPTEMBER 7, 2023

In 2018, we found evidence of senescent cells in human Alzheimer’s,” stated Miranda Orr, PhD, Associate Professor of gerontology and geriatric medicine at Wake Forest University School of Medicine in the US. The post Alzheimer’s senescent cell combination therapy presents promise appeared first on European Pharmaceutical Review.

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Food and Drug Administration Medicine Food FDA 97