Sun.Jul 16, 2023

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Alzheimer’s Can Strike as Young as 30. These Are The Signs to Watch For.

AuroBlog - Aurous Healthcare Clinical Trials blog

Alzheimer’s disease is often thought of as a condition that only affects the elderly. But around 3.9 million people worldwide aged 30-64 live with young-onset Alzheimer’s disease – a form of dementia in which symptoms appear before the age of 65.

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BridgeBio Stages ATTR-CM Comeback with Promising Phase III Data for Acoramidis

BioSpace

Following disappointing topline data, BridgeBio’s acoramidis has scored a late-stage win in transthyretin amyloid cardiomyopathy, leading to significant survival and quality of life benefits.

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More firms join litigation against Central govt on FDC ban

AuroBlog - Aurous Healthcare Clinical Trials blog

At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

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What Does the End of the Student Loan Pause Mean for Biopharma Workers?

BioSpace

For over three years, no interest has accrued on federal student loans and no payments were required. Soon, mandatory payments will resume, leaving workers with less money in the bank.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Efficacy of an Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

JAMA Internal Medicine

This randomized clinical trial aims to determine whether a direct oral penicillin challenge is noninferior to the standard of care of penicillin skin testing followed by an oral challenge in patients with a low-risk penicillin allergy.

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Novartis Acquires DTx Pharma in Potential $1B Deal

BioSpace

The Swiss pharma is expanding its neuroscience pipeline with an upfront $500 million payment to DTx Pharma and additional payments of up to $500 million upon completion of certain milestones.

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FTC Digs Deeper into Pfizer’s $43B Buyout of Seagen

BioSpace

The Federal Trade Commission is asking for more information regarding Pfizer's planned $43 billion acquisition of Seagen, according to the latter’s Securities and Exchange Commission filing on Friday.

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New patent for Novartis drug VIJOICE

Drug Patent Watch

Annual Drug Patent Expirations for VIJOICE Vijoice is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Novartis drug VIJOICE appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Alzheimer’s Leaders Converge at AAIC in Transitional Moment for the Space

BioSpace

The 2023 Alzheimer’s Association International Conference will feature further analyses of the recent traditionally approved Leqembi and a highly anticipated update on Eli Lilly’s donanemab.

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New patent expiration for Avanir Pharms drug NUEDEXTA

Drug Patent Watch

Annual Drug Patent Expirations for NUEDEXTA Nuedexta is a drug marketed by Avanir Pharms and is included in one NDA. It is available from two suppliers. There are two patents… The post New patent expiration for Avanir Pharms drug NUEDEXTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Opinion: Who Really Pays for Drug Development? Both Government and Industry

BioSpace

Bringing new drugs to the market costs billions of dollars. It could not be done without investments by both the NIH and biopharma companies.

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New tentative approval for Msn Labs drug darunavir

Drug Patent Watch

[![darunavir structure]([link] Darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods, Lupin Ltd, and Teva Pharms Usa and, and is included in four NDAs. There are… The post New tentative approval for Msn Labs drug darunavir appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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FDA Action Alert: Verrica, Citius and Daiichi Sankyo

BioSpace

After beginning July with a splash in the Alzheimer's space, the FDA is expected to make three decisions during the next two weeks; two for cancer and one for a viral skin disease.

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First Wave faces choppy waters with cystic fibrosis drug

pharmaphorum

First Wave faces choppy waters with cystic fibrosis drug Phil.

Drugs 81
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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AAIC: First Clinical Data from an RNAi Therapeutic for Alzheimer’s Continue to Impress

BioSpace

Part B of the study, cleared to proceed in Canada, remains on hold in the U.S. due to findings from non-clinical chronic toxicology studies.

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Chatbot vs Medical Student Performance on Free-Response Clinical Reasoning Examinations

JAMA Internal Medicine

This study compares performance on free-response clinical reasoning examinations of first- and second-year medical students vs 2 models of a popular chatbot.

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Lilly bulks up in obesity with $1.93bn Versanis buy

pharmaphorum

Lilly bulks up in obesity with $1.93bn Versanis buy Phil.

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History of Present Illness Summaries Generated by a Chatbot and Senior Internal Medicine Residents

JAMA Internal Medicine

This prognostic study assesses the ability of a chatbot to write a history of present illness compared with senior internal medicine residents.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Which pharmaceutical drugs have the most drug patents in Sweden?

Drug Patent Watch

This chart shows the drugs with the most patents in Sweden. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Sweden? appeared first on DrugPatentWatch - Make Better Decisions.

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FDA Approves Sanofi and AstraZeneca’s RSV Antibody for Newborns, Infants

BioSpace

The U.S. regulator Monday approved the Beyfortus single-dose monoclonal antibody, developed jointly by the two companies, for the pediatric prevention of respiratory syncytial virus.