Mon.Jul 15, 2024

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Exploring Melbourne’s booming life sciences sector

Pharmaceutical Technology

Australia is fast becoming the place to be for innovative life sciences companies, as proved by Melbourne’s latest FDI wins from the likes of BioNTech and Moderna.

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Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

Bio Pharma Dive

Updated results show the biotech's RAS inhibitor shrank pancreatic tumors in 20% to 25% of study participants, but with high rates of side effects like rash and nausea.

Medicine 325
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New Alzheimer’s Nasal Spray Clears Toxic Tangles in Human Neurons And Mice

AuroBlog - Aurous Healthcare Clinical Trials blog

Twisted and tangled proteins are found in the brains of many of those who die with Alzheimer’s disease. Some scientists suspect these neural knots can harm and even kill brain cells, but so far in clinical trials, drugs that have tried to target the tangles have shown limited success.

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Lexeo gene therapy shows signs of heart benefit in small study

Bio Pharma Dive

The company claims the results support exploring the possibility of an accelerated approval, citing flexibility by FDA officials in reviewing rare disease gene therapies.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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PCI frames new regulations based on amendments under Jan Vishwas Act

AuroBlog - Aurous Healthcare Clinical Trials blog

The Pharmacy Council of India (PCI) has framed regulations on the manner of conducting enquiry imposing penalty and appeal procedures in case of violation of certain provisions of the Pharmacy Act, 1948, in tune with the amendments notified in the Jan Vishwas (Amendment of Provisions) Act, 2023.

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Amgen, BMS and Merck have the most exposure as Big Pharma eyes $183B patent cliff: analyst

Fierce Pharma

While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note f | While patent cliffs loom for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a July 11 research note from Morgan Stanley.

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FDA proposes cell and gene therapy site tours to help regulators learn from industry

Fierce Pharma

It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. | It's no secret that cell and gene therapies have faced manufacturing hurdles as the advanced medicines have become increasingly popular in recent years. Now, the FDA is proposing to work directly with industry through a series of facility tours that could enable both sides to learn something from each other.

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Conflict means millions of children are missing vaccinations, UN says

Pharmaceutical Technology

Global vaccine coverage is yet to return to levels seen in 2019, shortly before the Covid-19 pandemic caused immunisation programme disruption.

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Trial finds over-the-counter nasal sprays could reduce RTIs and antibiotic use

Pharma Times

Affecting parts of the body involving breathing, RTIs impact one in five people in England

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AbbVie looks to add an eighth indication for JAK inhibitor Rinvoq

Pharmaceutical Technology

AbbVie is seeking regulatory approval in the US and EU for Rinvoq as a treatment for giant cell arteritis.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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GSK moves back to its roots with new central London headquarters

Fierce Pharma

After two decades headquartered in the West London suburb of Brentford, GSK is officially coming home to central London. | After two decades headquartered in the West London suburb of Brentford, GSK's new digs are officially open and will house 3,000 workers in London's Knowledge Quarter.

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Nona Biosciences partners with Alaya.bio for CAR-T therapy

Pharmaceutical Technology

Nona Biosciences has partnered with biotechnology company Alaya.bio to work on advancing CAR-T cell therapies.

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J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer

Fierce Pharma

CAR-T specialist Legend Biotech has reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser to evaluate its options, StreetInsider

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AusperBio secures funding to advance AHB-137 for CHB

Pharmaceutical Technology

AusperBio has raised $37m in a Series A financing round to progress the clinical development of AHB-137 for chronic hepatitis B (CHB).

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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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NIHR and Diabetes UK invest nearly £3m to prevent and treat diabetes distress

Pharma Times

Almost 50% of adults living with type 1 diabetes experience high levels of diabetes distress

Research 115
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Mabwell’s 9MW2821 gains FDA fast track status for breast cancer

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted fast track designation to Mabwell’s antibody-drug conjugate (ADC).

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Germany inches closer to confidential pricing for drugs

pharmaphorum

Germany inches closer to confidential pricing for patented medicines, with passage of Medical Research Act

Medicine 114
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What is the medical definition of obesity?

Antidote

Obesity, a condition that impacts 2 out of 5 adults in the United States , has become a significant health concern, both due to the impacts it has on individuals with the condition and the effect it can have on the overall medical system. It is estimated that obesity is responsible for nearly $1.73 billion in excess treatment costs annually, compounded by the fact that individuals with obesity are far more likely to have other conditions such as hypertension, diabetes, and osteoarthritis.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Call goes out for simpler clinical trial regulation in UK

pharmaphorum

Framework governing early-stage clinical trials in the UK is stifling research and needs to be simplified, says BJCP paper

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Pharma Pulse 7/15/24: What to Know About Medication and Summer Travel, The Future of Periodontal Treatment & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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The Complexity Advantage: Why Advanced Delivery Methods Deter Generic Competition

Drug Patent Watch

The Strategic Advantage of Complex Drug Delivery Systems In the highly competitive pharmaceutical landscape, adopting complex drug delivery systems can […] Source

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Investors take issue with Taisho Pharma’s buyout price

pharmaphorum

Two investment funds have decided to contest Taisho Pharma’s recently announced management buyout plan in court

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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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Treating Rheumatoid Arthritis Patients With Biosimilars Versus Leflunomide: An Economic Evaluation

Pharmaceutical Commerce

A study explores the cost-effectiveness of combining methotrexate with various drugs as a way to combat failed methotrexate monotherapy.

Drugs 98
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Will Eli Lilly Overtake Novo Nordisk in Weight-Loss Drug Race?

BioSpace

Some analysts say so, and a recent study suggested Lilly’s tirzepatide beat Novo’s semaglutide at inducing weight loss, but there are other factors in the market race.

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Women in Science - Jasmina Jankicevic from founding organizations for prevention of HIV to CMO at Innovaderm Research

BioPharma Reporter

When she was a teenager, Dr Jasmina Jankicevic wanted to research and promote better ways for children and adults to stay healthy, or regain health and well-being.

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Novo Holdings Leads $100M Raise for Asceneuron’s Alzheimer’s Push

BioSpace

Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.

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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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Lexeo therapy gives hope to Friedreich's ataxia patients

pharmaphorum

An experimental gene therapy developed by Lexeo Therapeutics has shown early promise in treating one of the most serious complications of rare neurodegenerative disorder Friedreich's ataxia (FA).In a phase 1/2 SUNRISE-FA trial, the LX2006 therapy showed a reduction in cardiomyopathy – the most common cause of death in FA – in an initial group of patients with enlarged hearts at the start of the trial.

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Career Coach: Transition Into a Career in Biotech

BioSpace

This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.

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Vertex sues US for right to provide fertility assistance program to gene therapy patients

Fierce Pharma

To receive Vertex and CRISPR Therapeutics’ $2.2 million gene therapy Casgevy for sickle cell disease (SCD) and transfusion dependent beta thalassemia (TDT), patients must first undergo chemotherapy | Vertex has filed a lawsuit in federal court in Washington, D.C. against the U.S. Department of Health and Human Services (HHS) seeking to overturn the “erroneous legal positions” of the agency’s Office of the Inspector General (OIG).

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Cardurion Raises $260M to Advance Cardiovascular Assets

BioSpace

Backed by Bain Capital, Cardurion Pharmaceuticals will use the Series B funds to advance two assets for heart failure and other cardiovascular conditions.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.