Thu.Apr 04, 2024

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Trial finds benefit for GLP-1 agonist in Parkinson’s

pharmaphorum

A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.

Trials 115
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Merck puts KRAS cancer drug competitor to the test

Bio Pharma Dive

A Phase 3 study will compare Merck’s experimental KRAS inhibitor together with its immunotherapy Keytruda against Keytruda alone in lung cancer.

Drugs 282
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Hand Sanitizers Could Damage Critical Supporting Cells In The Brain

AuroBlog - Aurous Healthcare Clinical Trials blog

Chemicals found in common household disinfectants, glues, and furniture textiles could damage supporting cells in the brain during critical stages of their development, a new study based on human cell cultures and mice has found.

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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Worldwide Clinical Trials

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. However, with varying national regulatory agencies each requiring their own unique specifications, this process can be remarkably perplexing. To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016.

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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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Amylyx to pull ALS drug from market in rare move

Bio Pharma Dive

In the wake of a major trial failure, the company is withdrawing Relyvrio and cutting costs with a restructuring that involves laying off 70% of its employees.

Marketing 189
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Jan Vishwas Act amendment on Drugs & Cosmetics Act to be in force from December

AuroBlog - Aurous Healthcare Clinical Trials blog

The amended provisions under the Jan Vishwas (Amendment of Provisions) Act, 2023 notified by the Central government last year for removal of stringent punishments such as imprisonment from some of the Sections of the Drugs and Cosmetics Act, 1940, will be in force from December 31, 2024.

Cosmetics 187

More Trending

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April 4, 2024: ICD-Pieces Trial Sees No Reduction in Hospitalization for Patients With Chronic Kidney Disease

Rethinking Clinical Trials

Dr. Miguel Vazquez, principal investigator for ICD-Pieces A primary care intervention for patients with coexisting chronic kidney disease, type 2 diabetes, and hypertension did not reduce the hospitalization rate for these patients when compared to usual care, according to the ICD-Pieces study. The results of the study were published this week in the New England Journal of Medicine.

Trials 173
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F. Hoffmann-La Roche gets grant for system for identifying nucleic acid bases using nanopore technology

Pharmaceutical Technology

Discover how F. Hoffmann-La Roche's patented system uses nanopores to identify nucleic acid bases, increasing confidence in base identification. Explore the innovative approach in genomics and personalized medicine.

Genomics 147
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FDA approves new antibiotic for several hard-to-treat infections

Bio Pharma Dive

Swiss pharma Basilea has won clearance for Zevtera after a long development journey, but is still searching for a commercial partner in the U.S.

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Chiesi Farmaceutici gets grant for pharmaceutical formulation for intraduodenal administration with melevodopa and carbidopa

Pharmaceutical Technology

Discover Chiesi Farmaceutici's innovative patent for a specialized pharmaceutical formulation aimed at enhancing drug delivery efficiency for Parkinson's disease treatment. Learn about the unique composition and processes involved in this groundbreaking intraduodenal administration solution.

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

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Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Fierce Pharma

Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. | Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.

Marketing 122
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HCA Healthcare gets grant for wrist brace with advantageous lacing configuration for compression

Pharmaceutical Technology

Discover the innovative wrist brace by HCA Healthcare Inc, featuring a unique lacing system for consistent compression and effective support. Patent details included!

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Study reveals new aptamer targeting tool can detect early signs of motor neurone disease

Pharma Times

The fatal, progressive neurological condition currently affects around 5,000 people in the UK

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Incyte gets grant for treatment of various cancers using specific compound

Pharmaceutical Technology

Discover how Incyte Corp's patent targets adenosine receptors to treat cancer, inflammation, and more. Learn about the specific compound for cancer treatment.

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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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How long do clinical trials take?

Antidote

Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinical trials. Clinical trials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.

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Xencor gets grant for bispecific antibody for treating GPC3-associated cancers

Pharmaceutical Technology

Discover Xencor Inc's groundbreaking patent for novel GPC3 binding domains and bispecific antibodies targeting GPC3-associated cancers. Explore the innovative method for manufacturing these antibodies and their potential in cancer treatment.

Antibody 130
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Arbutus, Genevant gain an edge in COVID patent scrap with Moderna

Fierce Pharma

With a new order clarifying several terms of the patents at the center of Arbutus Biopharma and Genevant Sciences’ infringement suit against Moderna, the companies are one step closer in | A Delaware judge sided with Arbutus and Genevant's proposed constructions of the patent claims in question, strengthening their case against Moderna and its COVID-19 vaccine Spikevax.

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United Therapeutics gets grant for treatment of pulmonary hypertension using prostacyclin-treated stem cells

Pharmaceutical Technology

Discover a groundbreaking method for treating pulmonary hypertension with stem cells and prostacyclin. Learn more about this innovative patent from United Therapeutics Corp.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AI-powered real-world evidence generation for biotechs

pharmaphorum

Discover how AI-powered real-world evidence generation is revolutionising the biotech industry, providing valuable insights for biopharma companies to make informed decisions. Learn more about the impact of RWD on biotechs.

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Lipocine gets grant for pharmaceutical composition for treating testosterone deficiency

Pharmaceutical Technology

Discover Lipocine Inc's innovative patent for bioavailable solid state esters to treat testosterone deficiency in mammals. Learn about the unique pharmaceutical composition and release characteristics for optimal delivery and efficacy.

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Teva, forging ahead with new strategy, inks biosimilar deal with Spain's mAbxience

Fierce Pharma

As Teva advances its Pivot to Growth strategy under CEO Richard Francis, the company is making good on its pledge to beef up its biosimilar pipeline through outside deals. | Teva has unveiled a fresh in-licensing accord with Spain’s mAbxience to chip in on an investigational biosimilar spanning multiple oncology indications. Under the deal, Teva will oversee regulatory duties and marketing for the biosimilar, while mAbxience is on the hook to continue developing and manufacturing the drug at its

Licensing 117
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Addex spinoff Neurosterix debuts with $63m for developing neurological therapies

Pharmaceutical Technology

Addex has also sold its preclinical neurological assets and drug discovery platform to Neurosterix for $5.5m and 20% equity.

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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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Biden slams asthma inhaler prices in White House address

pharmaphorum

President Joe Biden has reiterated his pledge to take action against high drug prices and “beat big pharma,” singling out the cost of asthma inhalers in a speech delivered at a White House event with US Senator Bernie Sanders, a long-time critic of the industry’s pricing policies in the US.

Drugs 116
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Touchlight joins forces with University of Liverpool for NSCLC vaccine

Pharmaceutical Technology

The vaccines will be developed using Touchlight’s doggybone DNA technology, which speeds up the manufacturing process.

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Novartis finally ready for Pluvicto filing in earlier prostate cancer as patient survival data clear up

Fierce Pharma

After two delays spanning more than a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer. | After two delays spanning over a year, Novartis is finally gearing up for a high-stakes FDA application to expand the radiotherapy Pluvicto into earlier treatment of prostate cancer.

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Clinical trials and development services

Pharmaceutical Technology

Download our comprehensive list of leading specialist companies offering clinical trials and development services for free today.

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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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Conference report: Reuters Pharma USA

pharmaphorum

Last week, pharmaphorum editor-in-chief Jonah Comstock travelled to Philadelphia for Reuters Pharma USA. On today’s podcast, he chats with guest host and Deep Dive editor Eloise McLellan about his biggest takeaways from the two-day event.

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Basilea completes marathon quest with FDA approval to treat 3 types of infections

Fierce Pharma

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. | Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. The FDA has approved Basilea’s Zevtera for three different kinds of infections.

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Praia emerges with $20m for digital health platform

pharmaphorum

Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.

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Sanofi settles 4,000 Zantac state lawsuits, still faces Delaware claims

Fierce Pharma

Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. | Sanofi has agreed to settle approximately 4,000 personal injury claims from users of its heartburn drug Zantac, resolving litigation in all U.S. state courts besides Delaware, the company confirmed on Thursday.

Drugs 110
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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.