Fri.Mar 29, 2024

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Bristol Myers says KRAS drug succeeds in key trial

Bio Pharma Dive

Confirmatory results for Krazati, which Bristol Myers acquired via its buyout of Mirati, could help the drug win full approval while Amgen has been set back.

Drugs 291
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Arvinas gets grant for treatment of prostate cancer with specific compounds

Pharmaceutical Technology

Discover how Arvinas Inc's newly granted patent for compounds treating prostate cancer could revolutionize healthcare. Learn more about the potential for new drugs and therapies.

Drugs 130
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After Amgen's stumble, BMS touts KRAS confirmatory trial win for newly bought Krazati

Fierce Pharma

Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout. | Bristol Myers Squibb looks on track to overtake Amgen as the KRAS leader in lung cancer after following up its rival’s FDA setback with a positive confirmatory trial readout.

Trials 110
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Yield10 Bioscience gets grant for genetically engineered oilseed plant expressing plant protein

Pharmaceutical Technology

Discover the groundbreaking patent by Yield10 Bioscience Inc for a genetically engineered oilseed plant expressing a plant protein, revolutionizing biotechnology in agriculture.

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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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Bristol Myers Squibb's versatile Zeposia doesn't make the grade in Crohn's disease trial

Fierce Pharma

Bristol Myers Squibb’s Zeposia (ozanimod) has attracted attention as a treatment for an unusual duo of diseases—multiple sclerosis (MS) and ulcerative colitis (UC). | Bristol Myers Squibb’s Zeposia has attracted attention as a treatment for an odd pair of unrelated diseases—multiple sclerosis (MS) and ulcerative colitis (UC). But the approval roll for the sphingosine 1-phosphate (S1P) receptor modulator may be over.

Trials 103
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Sun Pharmaceutical Industries gets grant for dermal patch system for collecting physiological samples

Pharmaceutical Technology

Discover the innovative dermal patch system by Sun Pharmaceutical Industries Ltd for efficient and minimally invasive physiological sample collection. Patent US11877848B2 revolutionizes sample processing with a unique design.

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More Trending

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Crinetics Pharmaceuticals gets grant for patent granted for somatostatin modulators for treating hormone-related conditions

Pharmaceutical Technology

Discover how Crinetics Pharmaceuticals Inc's patent for compounds modulating somatostatin activity can suppress hormone secretion in mammals. Explore the detailed framework for hormone modulation and SSTR2 activity regulation.

Hormones 130
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The Rising Tide of Biopharma Manufacturing Costs

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Barry Heavey, Life Sciences Supply Chain Lead, Accenture, discusses the specific factors contributing to rising manufacturing costs.

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Gamida Cell gets grant for method of preparing transplantable NK cell fraction for transplantation

Pharmaceutical Technology

Expand transplantable NK cell fractions for cancer treatment with Gamida Cell's patented method. Culturing, supplementing, and storing cells ensure improved outcomes for cancer patients.

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Report claims WuXi shared US client IP with China

pharmaphorum

Report claims US intelligence services advised the authors of the BIOSECURE Act that WuXi AppTec shared confidential data on US clients with the Chinese government

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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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Rohto Pharmaceutical gets grant for ophthalmic composition for treating myopia with crocetin and ginkgo leaf

Pharmaceutical Technology

Discover Rohto Pharmaceutical's patented ophthalmic composition with crocetin and ginkgo leaf extract, proven to prevent and treat myopia in all ages. Explore the groundbreaking method for treating axial myopia and ocular diseases.

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'Unprecedented' demand for Eli Lilly's Zepbound sparks US supply constraints

Fierce Pharma

Once again, a medicine in the popular GLP-1 class of diabetes and weight loss therapies is facing supply hurdles. | While the drug is not listed on the FDA's shortage list, some pharmacies are facing supply issues. Amazon Pharmacy, for instance, notes that several dosage strengths are "unavailable.

Pharmacy 100
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Angelini gets grant for method for labelling reels using robot and application roller

Pharmaceutical Technology

Revolutionize your labeling process with Angelini Spa's patented method using a robot and label printer to efficiently attach printed labels to reels. Patent Publication Number: US11884443B2.

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Disappointment for BMS as Zeposia fails Crohn’s study

pharmaphorum

Bristol-Myers Squibb's Zeposia has failed to outperform placebo in its first phase 3 test in Crohn's disease

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Chong Kun Dang Pharmaceutical gets grant for injectable composition of testosterone undecanoate for testosterone deficiency treatment

Pharmaceutical Technology

Discover the innovative injectable composition of testosterone undecanoate by Chong Kun Dang Pharmaceutical Corporation. Patented for treating testosterone deficiency, this composition offers enhanced stability and ease of use during injection.

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Teva, following Hikma complaint, alleges Amarin 'locked up' Vascepa ingredient to block generics

Fierce Pharma

A little more than a year after Hikma Pharmaceuticals accused Amarin of “deliberately and meticulously” hamstringing supplies of the main ingredient in its only marketed drug, Vascepa, to thwart po | A little more than a year after Hikma Pharmaceuticals accused Amarin of “deliberately and meticulously” hamstringing supplies of the main ingredient in its only marketed drug, Vascepa, to thwart potential generic competition, Teva Pharmaceuticals has levied a similar challenge.

Marketing 107
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CSL gets grant for method of reducing GVHD risk in hct patients with a1at

Pharmaceutical Technology

Discover how CSL Ltd's patented method using alpha-1 antitrypsin (A1AT) can reduce the risk of graft versus host disease in hematopoietic cell transplantation patients. Published as US11857610B2, this groundbreaking approach offers hope for improved outcomes.

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog

By John W.M. Claud & Kalie E. Richardson — While Covid is in the rear view for most of us, FDA has had a tough time shaking off the effects of the pandemic on its inspection output. Inspections went down—way down—during the pandemic. In March 2020 , FDA temporarily postponed all foreign and domestic and routine surveillance facility inspections.

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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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EC approves Merck’s KEYTRUDA regimen for NSCLC treatment

Pharmaceutical Technology

The EC has approved Merck’s KEYTRUDA regimen for adult patients with resectable non-small cell lung cancer at increased recurrence risk.

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New tentative approval for MYLAN drug efavirenz, emtricitabine and tenofovir alafenamide

Drug Patent Watch

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.

Drugs 59
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Intravacc, Primrose to advance conjugate vaccine development

Pharmaceutical Technology

Intravacc and Primrose Bio have announced a strategic collaboration aimed at bolstering the conjugate vaccine development and supply.

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The unrecognized threat of PAD

Fierce Pharma

This week on “The Top Line,” we explore peripheral arterial disease, a serious health issue that is often overlooked and undermanaged. | This week on “The Top Line,” join Editor-in-Chief of Fierce Life Sciences and Healthcare Ayla Ellison as she sits down with Kumar Madassery, M.D., Director of Peripheral Vascular Intervention & CLI Program at Rush University Medical Center, to explore peripheral arterial disease—a serious health issue that is often overlooked and undermanaged.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Gilead’s Vemlidy expands label to treat paediatric chronic HBV

Pharmaceutical Technology

Vemlidy was first approved to treat adults with HBV in 2016. Its label was expanded in 2022 for use in patients 12 years and older.

Drugs 130
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Pharma Pulse 3/29/24: Social Media Users Turn to Twitter for Guidance on Birth Control, Wider Availability of Oral Contraceptives & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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China NMPA accepts Astellas’ sBLA for urothelial cancer treatment

Pharmaceutical Technology

The CDE of the China NMPA has accepted Astellas Pharma’s sBLA for enfortumab vedotin plus KEYTRUDA to treat urothelial cancer.

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Which pharmaceutical drugs have the most drug patents in Japan?

Drug Patent Watch

This chart shows the drugs with the most patents in Japan. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.

Drugs 52
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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.

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FDA extends review period for Applied Therapeutics’ govorestat NDA

Pharmaceutical Technology

The US FDA has extended the review period for Applied Therapeutics' NDA for govorestat to treat classic galactosemia.

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The backbone of breakthroughs: Insights into clinical trial supply management

pharmaphorum

Explore the key aspects of clinical trial supply management, including insights on Clinigen and its role in supporting clinical research trials. Learn how this backbone of breakthroughs can drive success in clinical trials.

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PTC Therapeutics gets grant for treatment of huntington’s disease using compound of formula (IBBL)

Pharmaceutical Technology

Discover the groundbreaking patent granted to PTC Therapeutics Inc for treating Huntington's disease with innovative compounds and pharmaceutical compositions. Explore the potential of Formula (I) and its various forms for effective treatment.

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Today’s Most Promising Therapeutic Areas for Dealmaking

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, discusses the hottest therapeutic settings for dealmaking activity at the moment—and one platform approach in particular poised to be at the center of future M&A and licensing pursuits.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.