Thu.Dec 08, 2022

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Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs' testimony falls short

Fierce Pharma

Merck escapes nearly 1,200 Zostavax shingles vaccine lawsuits as plaintiffs' testimony falls short. fkansteiner. Thu, 12/08/2022 - 09:22.

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Kite and Daiichi Sankyo update cell therapy licensing agreement

Pharmaceutical Technology

Kite Pharma and Daiichi Sankyo have updated a partnership agreement signed in 2017 for the former’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Subsequently, in the same year, Gilead Sciences acquired Kite.

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Takeda's dengue shot scores crucial EU nod, opening the door to wider global use

Fierce Pharma

Takeda's dengue shot scores crucial EU nod, opening the door to wider global use. zbecker. Thu, 12/08/2022 - 11:16.

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2023 Pipeline Report: Testing the Limits

PharmExec

Our annual report spotlighting notable investments in new drug development captures a mix of gradual gains and giant leaps—both equally as promising—in five expanding and diverse therapeutic areas: spinal muscular atrophy, hemophilia A, intranasal and inhaled vaccines, gene-targeted therapy, and RNA therapeutics.

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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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TherapeuticsMD lays off entire workforce after licensing products out for $153M

Fierce Pharma

TherapeuticsMD lays off entire workforce after licensing products out for $153M. zbecker. Thu, 12/08/2022 - 15:35.

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Are We Missing a Vital Sign? Our Diet Can Unfold Answers To Many of Our Health Concerns

MedCity News

The implications of a ubiquitous diet vital sign are enormous. For example, what can happen if we can measure an upstream variable—such as diet quality—across populations at scale? We can prevent disease, curb the onset of disease, save money, and help health systems improve their bottom lines.

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More Trending

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Business and Passion

PharmExec

Kimberly Moran, head of rare diseases in the US for UCB, started off working in medicine but quickly learned the importance of the business side of industry—and its role in helping improve the diagnosis and access paths for underserved patient segments.

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Ex-Theranos exec Sunny Balwani gets 13 years for fraud

pharmaphorum

Ramesh “Sunny” Balwani, the former business partner of Theranos founder Elizabeth Holmes, has been sentenced to nearly 13 years in prison after being convicted of wire fraud. His sentencing comes after ex-Theranos chief executive Holmes was given more than 11 years in prison last month after also being found guilty of defrauding investors in Theranos, which said it had developed technology that could diagnose a host of diseases with just a few drops of blood taken with a finger prick, rather tha

Doctors 101
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Pharma and RWE: Hitting Its Stride

Pharmaceutical Commerce

Stakeholders are investing heavily in their ability to curate appropriate data sets and devise advanced data-analytics capabilities to harness real-world evidence (RWE) across the entire pharma lifecycle—from drug discovery and development through product launch and commercialization.

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US FDA grants EUA for Pfizer-BioNTech’s Omicron-adapted vaccine in children

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted an amendment to the Emergency Use Authorization (EUA) for Pfi z er and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years. The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group.

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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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The Key To Faster, More Efficient Clinical Trials? Patient Centricity

MedCity News

Added complexity to daily life is likely why patient dropout rates remain high, with 19% leaving studies before completion. Truly patient-centric trials will allow for broader participation, allowing patients to decide how and when they want to engage in a study.

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The mysterious UK Life Sciences Council

pharmaphorum

Just as the life sciences industry is getting vocal about how it’s faring, given the prospect of having to pay back the government 30% of NHS branded medicines sales in 2023, and as it needs to negotiate a new deal on branded medicines pricing and access that will apply from 2024 onwards – there’s been more talk about the Life Sciences Council (LSC).

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New National Tracker for Non-fatal Overdoses Is ‘a Step in the Right Direction’ to End the Opioid Crisis

MedCity News

The White House launched a new initiative to address the country’s opioid crisis — a dashboard tracking non-fatal opioid overdoses. The new tool is meant to track overdose clusters to inform better medical responses and preparedness.

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5 Pharma Trends for 2023: Challenges and opportunities in the post-COVID landscape

Tribeca Knowledge

T he pharmaceutical industry has little room for complacency in a post-COVID world. As we map out in our pharma trends for 2023, COVID-related disruption has created a whole new set of launch readiness and market access challenges for companies looking to maximise their assets in the new year.

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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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How Employers Can Support the Food as Medicine Movement

MedCity News

The Food as Medicine movement has received a lot of interest from payers and health systems recently. But employers need to get involved too, argues Dr. Bipin Mistry, chief medical officer of Alight.

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For Duchenne-focused Sarepta, gene therapy is the natural next step

PharmaVoice

The company with three marketed RNA drugs for Duchenne muscular dystrophy is taking the logical leap into gene therapies with a candidate under review at the FDA.

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Sun Pharma-Walk-In Interviews for Multiple Openings in Production / Packing Operator On 11th Dec’ 2022

Pharma Pathway

Sun Pharma-Walk-In Interviews for Multiple Openings in Production / Packing Operator On 11th Dec’ 2022. Job Description. Walk-In Interviews for Production/ Packing Departments @ Sun Pharma. Department: Production Operator/ Packing Operator-Formulation. Education: B.Sc/ ITI/ Diploma. Experience: 02 to 05 years. Position: Technician. Job Location: Dewas.

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Continuing to keep COVID-19 at bay – the pharmaphorum podcast

pharmaphorum

Flying into London recently for the Jefferies Conference, Novavax’s EVP, chief commercial officer, and chief business officer John Trizzino, together with the company’s chief medical officer Filip Dubovsky, took time out of very packed schedules indeed to speak with pharmaphorum Web editor Nicole Raleigh in a small (though not always necessarily quiet) corner of the One Aldwych Hotel on the Strand.

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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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Mark Cuban’s Cost Plus Drugs Turns Focus to Employers

MedCity News

Through the partnership, the organizations are launching EmsanaRx Plus. The product supplements employers’ current pharmacy benefit offerings and provides access to Cost Plus Drugs’ discounted medications.

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AMN Life Science Pvt. Ltd-Walk-In Interview for Quality Assurance/ Quality Control/ ADL/ F&D On 11th Dec’ 2022

Pharma Pathway

AMN Life Science Pvt. Ltd-Walk-In Interview for Quality Assurance/ Quality Control/ ADL/ F&D On 11th Dec’ 2022. Job Description. Walk-In Interview for Quality Assurance/ Quality Control/ ADL/ F&D On 11th Dec’ 2022 @ AMN Life Science Pvt. Ltd. Departments: Quality Assurance/ Quality Control/ ADL/ F&D. Designation: Officer/ Sr.

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Healthcare Deal Value Expected to Keep Decreasing in 2023, PwC says

MedCity News

The volume of healthcare deals has increased in 2022, driven in large part by private equity, according to a new PwC report. But deal values have been declining, a trend that is expected to continue into 2023.

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Micro Labs-Walk-In Interview for Quality Control Department On 10th Dec’ 2022

Pharma Pathway

Micro Labs-Walk-In Interview for Quality Control Department On 10th Dec’ 2022. Job Description. Greetings from Micro Labs, Walk-In Interview for Quality Control Department On 10th Dec’ 2022 @ Micro Labs. Department: Quality Control. Qualification: M.Sc/ B.Pharm/ M.Pharm. Experience: 02 to 09 years. Job Location: Hosur. Date of Interview: 10th Dec’ 2022.

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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.

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PRH Announces a Last Extension to Its Pandemic-Era Open-License Program

Copyright Clearance Center

The post PRH Announces a Last Extension to Its Pandemic-Era Open-License Program appeared first on Copyright Clearance Center.

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Macleods Pharmaceuticals Limited- Walk-In Interviews for Production/ QA/ QC On 16th Dec’ 2022

Pharma Pathway

Macleods Pharmaceuticals Limited- Walk-In Interviews for Production/ QA/ QC On 16th Dec’ 2022. Job Description. Macleods Pharmaceuticals Ltd is Hiring ! Walk-In Drive at Indore for Baddi & Sikkim Location. Walk-In Interviews for Production/ Quality Control/ Quality Assurance @ Macleods Pharmaceuticals Limited. Departments: Production/ Quality Control/ Quality Assurance.

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The Value of ML in Customer Targeting

Pharmaceutical Commerce

How biopharma commercial teams can leverage machine learning techniques to improve targeting of HCPs and patients.

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Hetero Labs Limited-Walk-In Interviews for Production/ Packing/ QC Departments On 10th Dec’ 2022

Pharma Pathway

Hetero Labs Limited-Walk-In Interviews for Production/ Packing/ QC Departments On 10th Dec’ 2022. Job Description. Hetero Labs Limited is one of India’s generic pharmaceutical companies and the “world’s largest producer of anti- retroviral drugs”. Hetero’s business includes APIs, generic, biosimilars, custom pharmaceutical services, and branded generics.

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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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Some Observations from Charleston (Open Access Edition)

Copyright Clearance Center

The post Some Observations from Charleston (Open Access Edition) appeared first on Copyright Clearance Center.

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ONWARD reveals ARC therapy spinal cord injury report

PharmaTimes

Implantable ARC therapy demonstrates potential to improve blood pressure regulation

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Granules India Limited- Walk-In Drive for Granulation/ Compression/ Coating/ Capsule Filling/ QC/ Warehouse/ IPQA On 10th Dec’ 2022

Pharma Pathway

Granules India Limited- Walk-In Drive for Granulation/ Compression/ Coating/ Capsule Filling/ QC/ Warehouse/ IPQA On 10th Dec’ 2022. 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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Pharma Needs to Look Internally for New Leadership

PharmExec

Companies should search within to gain talent edge.

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Clinical Supply Strategies for CROs

When a CRO is bidding on a project where clinical supplies will be one of the aspects to manage on behalf of the client via a partner, leveraging the expertise of a chosen clinical supply partner can be a valuable resource in demonstrating the CRO’s understanding of and ability to deliver upon critical drug-supply related aspects of the project, and ability to hit key milestones such as FPI for their client.