Fri.Jan 06, 2023

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Fierce Pharma Asia—Eisai’s Alzheimer’s trial deaths; Moderna’s first M&A deal; GSK, WuXi's bispecific pact

Fierce Pharma

Fierce Pharma Asia—Eisai’s Alzheimer’s trial deaths; Moderna’s first M&A deal; GSK, WuXi's bispecific pact. aliu. Fri, 01/06/2023 - 10:36.

Pharma 190
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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

Medical 137
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With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch

Fierce Pharma

With Leqembi approval in Alzheimer's disease, Eisai and Biogen plot 'meticulous' launch. fkansteiner. Fri, 01/06/2023 - 12:44.

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How Much of a Risk Is a Potential Class-action Lawsuit against CommonSpirit?

MedCity News

CommonSpirit Health is facing a proposed class-action lawsuit over a ransomware attack it suffered last fall that exposed 623,774 patients’ personal data. However, hospitals’ data breach lawsuits usually never make it court, a legal expert said.

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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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Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS

Fierce Pharma

Bluebird scores $95M nest egg after selling second FDA priority review voucher to BMS. fkansteiner. Fri, 01/06/2023 - 08:42.

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Teladoc Unveils New App, Adds Spanish Language Capabilities

MedCity News

The new app allows users to seek all of Teladoc’s services — such as primary care, mental health and chronic condition management — in one spot. It is also offered in both Spanish and English.

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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.

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J&J's consumer health unit Kenvue prepares to leave the nest with IPO filing

Fierce Pharma

J&J's consumer health unit Kenvue prepares to leave the nest with IPO filing. zbecker. Fri, 01/06/2023 - 11:12.

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Serious Side Effect Sidelines Gene-Edited Sickle Cell Therapy from Graphite Bio

MedCity News

Graphite Bio voluntarily paused a Phase 1/2 test of its gene-edited therapy for sickle cell disease after the first patient in the study developed a serious blood complication. The setback will also delay plans to reach the clinic with another genetic medicine in its pipeline.

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Bioprinted Eye Tissue to Study Retinal Diseases

Medgadget

Researchers at the National Eye Institute, which is part of the National Institutes of Health, have created a method to 3D bioprint eye tissue that forms the outer blood-retina barrier. This tissue supports the photoreceptors in the retina and is implicated in the initiation of age-related macular degeneration. The outer blood-retina barrier is the interface of the retina and the choroid, including Bruch’s membrane and the choriocapillaris.

Ethics 107
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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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UK partners with BioNTech on clinical trials of mRNA cancer therapies

pharmaphorum

The UK has formed an partnership with German biotech BioNTech to provide up to 10,000 patients with access to personalised cancer therapies, in another example of the country embracing the mRNA technologies that underpinned COVID-19 vaccines. The cancer immunotherapies will mainly be provided in the context of clinical trials over the alliance, which extends out to 2030, but also covers supply of commercial therapies if approved in the interim.

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State of Financing Deals and Go-to-Market Strategy in Biotech: Q&A with Timothy Moore and Jack Mycka, Indegene

PharmExec

A chat with with Indegene's Timothy Moore, Senior Vice President, Emerging Biotech and Key Accounts and Jack Mycka, Vice President, Enterprise Medical Solutions and Emerging Biotech.

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FDA grants priority review of glofitamab for lymphoma

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche’s CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. If approved, the cancer immunotherapy would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available for individuals with an aggressive

FDA 96
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Why script-to-dispense conversion will take centre stage in 2023

pharmaphorum

With the US economy teetering on a recession, sales and marketing budgets are expected to take a hit among businesses across sectors. The pharmaceutical industry is no exception. When any organisation looks to slash its budget, the old adage about acquiring new customers costing five times as much as retaining existing customers becomes an alluring data point.

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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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GSK to pay $40 million to license multiple T cell engagers

European Pharmaceutical Review

GSK will exclusively license up to four bi- and multi-specific T cell engaging (TCE) antibodies developed using technology platforms from WuXi Biologics, a contract research, development, and manufacturing organisation (CRDMO). Licensing T cell engaging antibodies. The CRDMO will receive a $40 million upfront payment from GSK and up to $1.46 billion in additional payments for research, development , regulatory and commercial milestones across the four TCE antibodies.

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pharmaphorum launches The World Without Disease Summit – June 2023

pharmaphorum

pharmaphorum is proud to announce its inaugural “The World Without Disease Summit”: a high quality, two-day event bringing together key global leaders and innovators to explore the potential of disease interception in future health. The event has been conceived in partnership with an established industry leader in this space, Ben Wiegand, Founding Partner at CWWDA (The Connected World Without Disease Accelerator) and former senior executives at UnitedHealth and Janssen.

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Dasami Lab Pvt. Ltd.-Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023

Pharma Pathway

Dasami Lab Pvt. Ltd.-Walk-Ins for Quality Control/ Production/ Production Documentation/ EHS On 7th Jan’ 2023. Job Description. Dasami Lab Pvt. Ltd. is a Private incorporated on 24 July 2015. It is classified as Non-govt. Company and registered at Register of Companies, Hyderabad. We are leading API Bulk Drug Manufacturing Company approved by USFDA located near Choutuppal.

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Type 1 Diabetes: A Potential Cure

PharmExec

One company pursues a program for a technology they believe is a potential cure for Type 1 diabetes.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Granules India Limited- Walk-In Interviews for Freshers On 7th Jan’ 2023

Pharma Pathway

Granules India Limited- Walk-In Interviews for Freshers On 7th Jan’ 2023. Job Description. Company Profile: Granules India Limited is an Indian pharmaceutical manufacturing company based in Hyderabad, Indian. Granules manufacturing several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and rest of the world markets.

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Salary & Job Survey Finds Little Change in Publishing

Copyright Clearance Center

The post Salary & Job Survey Finds Little Change in Publishing appeared first on Copyright Clearance Center.

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Sarvotham Care Ltd-Walk-In Interviews for Formulation R&D/ Store/ Production/ Maintenance/ Engineering On 7th Jan’ 2023

Pharma Pathway

Sarvotham Care Ltd-Walk-In Interviews for Formulation R&D/ Store/ Production/ Maintenance/ Engineering On 7th Jan’ 2023. Job Description. Walk-In Interviews for Formulation R&D/ Store/ Production/ Maintenance/ Engineering On 7th Jan’ 2023 @ Sarvotham Care Ltd. Department: Formulation R&D/ Store/ Production/ Maintenance/ Engineering.

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Transgene receives approval to begin oncolytic virus trial

PharmaTimes

Study will evaluate the intravenous administration of company’s multi-armed immunotherapy

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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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Aurobindo Pharma-Hiring M.Pharm/ B.Pharm/ B.Sc/ ITI/ Diploma for Packing Dept. -Apply Now

Pharma Pathway

Aurobindo Pharma-Hiring M.Pharm/ B.Pharm/ B.Sc/ ITI/ Diploma for Packing Dept. -Apply Now. Job Description. Company Profile: Aurobindo Pharma Ltd’ (APL). APL is a growing India multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations.

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Kokum Butter in Cosmetics

Pharmatutor

Kokum Butter in Cosmetics. admin. Fri, 01/06/2023 - 15:59. Vinay Kumar Singh. . Head-Formulation. Kumar Organic Products Research Centre Pvt. Ltd., Bengaluru. Email : formulation_krc@kopresearchcentre.net.

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Apex Laboratories Pvt. Ltd- Openings for Quality Control/ Quality Assurance/ Production On 7th & 8th Jan’ 2023

Pharma Pathway

Apex Laboratories Pvt. Ltd- Openings for Quality Control/ Quality Assurance/ Production On 7th & 8th Jan’ 2023. Job Description. Apex Laboratories Pvt. Ltd is a branded formulations player who pioneered the introduction of Zinc in the pharmaceutical formulations in India. Department: Quality Control/ Quality Assurance/ Production. Qualification: M.Sc/ B.Pharm/ Diploma/ ITI.

Safety 79
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ACELYRIN acquires ValenzaBio, strengthens immunology position

pharmaphorum

ACELYRIN, Inc., a Los Angeles area-based, late-stage clinical biopharma, with additional operations in the San Francisco Bay area, has announced it is acquiring privately held ValenzaBio – which develops therapies for autoimmune and inflammatory diseases – in an all-stock transaction. The acquisition adds multiple clinical and pre-clinical immunology assets to the company’s own immunology pipeline – led by izokibep, a small therapeutic protein inhibitor of interleukin-17A (IL-17A), designed to o

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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BioNTech forms cancer immunotherapies partnership with UK Government

PharmaTimes

Collaboration will focus on providing up to 10,000 patients with personalised mRNA by 2030

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Takeda claims first phase 3 win in rare disease cTTP

pharmaphorum

Takeda has reported positive results from a phase 3 trial of its experimental therapy TAK-755 for ultra-rare disease congenital thrombotic thrombocytopenic purpura (cTTP), setting up regulatory filings for the drug. cTTP is a subtype of thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening disorder in which blood clots form in the small blood vessels throughout the body, and is caused by a deficiency in the ADAMTS13 protease enzyme.

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10 Tips for Improving Your Car Sales Techniques and Closing More Deals

Contrarian Sales Techniques

As someone who has been working in car sales for several years, I've learned a thing or two about what it takes to be successful in this field. In this post, I'll be sharing 10 tips that have helped me improve my car sales techniques and close more deals. Know your inventory inside and out One of the most important things you can do as a car salesperson is to have a thorough understanding of the vehicles you have available.

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Penrod’s 2022 Holiday Celebrations

Penrod

Penrod loves to celebrate, especially during the holiday season! Between a steps challenge, a holiday decorating party, and more, we were very busy getting into the spirit this year. Take an insider look: We began November with a toy drive through Children’s Hospital of Wisconsin. We’re proud to say we’ve donated for six consecutive years. Children’s is “[T]he region’s only independent healthcare system dedicated solely to the health and well-being of children.

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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.