Wed.Apr 17, 2024

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Partnership to advance life science professionals in drug discovery 

Drug Discovery World

The European Laboratory Research & Innovation Group (ELRIG) UK has entered into a partnership with SRG to support the advancement of science professionals in their careers. The partnership offers ELRIG’s drug discovery community access to career opportunities and provides organisations of all sizes with SRG’s talent solutions to help grow the life science sector.

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Stelara biosimilar from Alvotech, Teva approved by FDA

Bio Pharma Dive

The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.

Drugs 294
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Estetrol by Mithra Pharmaceuticals for Genitourinary Syndrome of Menopause (GSM): Likelihood of Approval

Pharmaceutical Technology

Estetrol is under clinical development by Mithra Pharmaceuticals and currently in Phase III for Genitourinary Syndrome of Menopause (GSM).

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Sage’s cognition drug fails in Parkinson’s study

Bio Pharma Dive

Following negative results, the company doesn’t plan to further test SAGE-718 in Parkinson’s. Other studies in Huntington’s and Alzheimer’s remain ongoing.

Drugs 184
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

When deciding where to base the packaging and distribution of clinical supplies, there are two major choices in Europe – countries in the European Union (EU) and those that are geographically in Europe but not part of EU, such as the UK. While there is no single right country that will always be perfect for every sponsor or every clinical trial, this webinar aims to help viewers to better understand how to not only objectively evaluate these options, but also ultimately decide whether it is the

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Lexeo wins fast track designation for Friedreich’s ataxia gene therapy

Pharmaceutical Technology

LX2006 consists of adeno-associated virus (AAV) vector carrying the frataxin gene, responsible for causing Friedreich’s ataxia.

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April 17, 2024: In This Week’s PCT Grand Rounds, 10 Years of the YODA Project

Rethinking Clinical Trials

Dr. Joseph Ross In this Friday’s PCT Grand Rounds, Joseph Ross of Yale University will present “The Yale Open Data Access (YODA) Project: 10 Years of Clinical Trial Data Sharing.” The Grand Rounds session will be held on Friday, April 19, 2024, at 1:00 pm eastern. The YODA Project promotes open science, research transparency, and the sharing of clinical research data to support healthcare research.

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TAE Life Sciences Welcomes Dr. Deepak “Dee” Khuntia to Its Board of Directors

Pharma Mirror

As an authority in radiation oncology, Dr. Khuntia joining the board of directors validates BNCT and the work TAE Life Sciences is doing to make it a mainstay of modern cancer care IRVINE, Calif.- TAE Life Sciences, a pioneer in advancing Boron Neutron Capture Therapy (BNCT) for cancer treatment, proudly announces the appointment of Dr. Deepak “Dee” Khuntia, M.D., FASTRO, to its esteemed Board of Directors.

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Canaan hires Pfizer executive, reels in $100M for biotech investing

Bio Pharma Dive

The venture firm has brought in as venture partner Uwe Schoenbeck, who most recently was the top scientist for Pfizer’s emerging science and innovation unit.

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WuXi AppTec gets grant for process for preparing dichloroacetic acid composition with low glyoxylic acid

Pharmaceutical Technology

Discover the innovative patent by WuXi AppTec Co Ltd for preparing a dichloroacetic acid composition with minimal glyoxylic acid. Learn about the process and benefits of accurate glyoxylic acid measurement.

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Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

Fierce Pharma

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said. | One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

Drugs 133
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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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TCR2 Therapeutics gets grant for recombinant nucleic acid encoding TCR fusion protein for cancer treatment

Pharmaceutical Technology

Discover the groundbreaking patent by TCR2 Therapeutics Inc for T-cell receptor fusion proteins targeting tumor cell antigens. Revolutionizing disease treatment, including cancer, with engineered T cells expressing TFPs.

Protein 130
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AI in Medical Communications: Revolutionising the present, redefining the future

pharmaphorum

Discover how AI is transforming medical communications and reshaping the future of healthcare. Learn about the latest trends, technologies, and advancements in this rapidly evolving field.

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Kaleido Biosciences gets grant for glycan therapeutic preparation for reducing gastrointestinal inflammation in immune imbalance

Pharmaceutical Technology

Discover how Kaleido Biosciences Inc's patented method using glycan therapeutics can reduce inflammation in gastrointestinal diseases with immune imbalances, offering new treatment options.

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Reshoring the UK pharmaceutical supply chain for future resilience

pharmaphorum

Learn about the importance of reshoring the UK pharmaceutical supply chain for future resilience. Discover how this strategic move can enhance local production and secure the availability of critical medications.

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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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Unity Biotechnology gets grant for senolytic agents for treating age-related eye conditions

Pharmaceutical Technology

Discover Unity Biotechnology's groundbreaking method using small molecule drugs to target senescent cells in the eye, reversing age-related conditions. A newly granted patent reveals a unique approach to promoting vascular repair in the eye, offering hope for those with ophthalmic conditions.

Drugs 130
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Sage drops dalzanemdor for Parkinson’s after trial flop

pharmaphorum

Sage Therapeutics has suffered another disappointment after deciding that it will have to drop the Parkinson’s programme for key pipeline drug dalzanemdor after it showed no benefit in a phase 2 trial. The oral positive allosteric modulator (PAM) of the NMDA receptor is being investigated to see if it can counteract mild cognitive impairment in neurodegenerative disorders, and the PRECEDENT trial in Parkinson’s is the first major readout from the drug programme.

Trials 111
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Corvus Pharmaceuticals gets grant for modulating interleukin-2-inducible T-cell kinase

Pharmaceutical Technology

Discover the groundbreaking patent by Corvus Pharmaceuticals Inc for treating T-cell lymphoma with specific compounds and compositions. Improve outcomes for patients with cutaneous and peripheral T-cell lymphoma.

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Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

Fierce Pharma

In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. | In addition to their acclaimed efficacy against diabetes and obesity, GLP-1 drugs are gaining traction for their potential to treat a variety of other common disorders. Now, two trials have shown that Eli Lilly’s weight loss product Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA).

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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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Decibel Therapeutics gets grant for hypertonic pharmaceutical composition for anti-platinum chemoprotection

Pharmaceutical Technology

Discover the groundbreaking patent by Decibel Therapeutics Inc for hypertonic pharmaceutical compositions with anti-platinum agents to prevent ototoxicity. Learn about the innovative methods and components involved.

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Treg Cell Therapy for Neurodegenerative Diseases – Interview with Dr. Howard Berman, CEO, Coya Therapeutics – Xtalks Life Science Podcast Ep. 155

XTalks

In this episode, Ayesha spoke with Howard Berman, PhD, Founder and CEO of Coya Therapeutics , a clinical-stage biotech company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. Dr. Berman founded Coya Therapeutics in 2021. Howard Berman, PhD Founder and CEO Coya Therapeutics Dr. Berman has over 18 years of entrepreneurial and industry experience working at the interplay of science and business.

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Gritstone Bio gets grant for method of identifying cassette sequence for neoantigen vaccine

Pharmaceutical Technology

Discover how Gritstone Bio Inc's patented method for designing a neoantigen vaccine cassette sequence enhances effectiveness by minimizing junction epitope risks. Explore the innovative approach outlined in the recently granted patent US11885815B2.

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Roche’s Ocrevus Achieves Near-Complete Reduction of Relapse, Lesions in MS

BioSpace

Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.

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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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Eagle Pharmaceuticals gets grant for long-term stable bendamustine-containing composition in sterile vial

Pharmaceutical Technology

Discover Eagle Pharmaceuticals Inc's patented stable bendamustine-containing composition for long-term storage. Learn about the sterile vial with antioxidants ensuring impurities less than 5% after 15 months.

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Cerevel Gets Phase III Parkinson’s Win on Heels of $8.7B AbbVie Acquisition

BioSpace

Cerevel Therapeutics on Thursday reported positive data from its Phase III TEMPO-3 trial, showing that tavapadon can significantly improve symptom control in patients with Parkinson’s disease.

Trials 108
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ORIC Pharmaceuticals gets grant for PLK4 inhibitors for treating cancer

Pharmaceutical Technology

Discover how ORIC Pharmaceuticals Inc's patent for PLK4 inhibitors could revolutionize cancer treatment. Learn about the compound's potential and pharmaceutical applications.

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Telehealth firm Cerebral faces $7m FTC fine over privacy

pharmaphorum

The FTC is seeking a $7 million fine on telehealth company Cerebral for violating patients' data privacy and making cancellation difficult.

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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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Paclitaxel albumin bound by Bristol-Myers Squibb for Pancreatic Ductal Adenocarcinoma: Likelihood of Approval

Pharmaceutical Technology

Paclitaxel albumin bound is under clinical development by Bristol-Myers Squibb and currently in Phase I for Pancreatic Ductal Adenocarcinoma.

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Weight-Loss Drug Startup Metsera Launches with $290M, Looks to Tap Lucrative Obesity Market

BioSpace

The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly.

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Everolimus by Novartis for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia): Likelihood of Approval

Pharmaceutical Technology

Everolimus is under clinical development by Novartis and currently in Phase I for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia).

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Teva, Alvotech Secure FDA Approval for Stelara Biosimilar with Early 2025 Launch

BioSpace

Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.

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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.