Mon.Jan 16, 2023

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Ending Involuntary Commitments Would Shift Burden of Montana’s Dementia Care to Strapped Communities

MedCity News

A budget estimate attached to proposed legislation in Montana raises questions about whether the state’s cash-strapped communities will have the capacity to care for patients with Alzheimer’s disease, other types of dementia or traumatic brain injuries by July 2025, when involuntary commitments would cease under the plan.

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

Pharma 121
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Scripps Spinout Belharra Unveils $130M to Catch Next Big Wave of Drug Discovery

MedCity News

Versant Ventures-backed Belharra Therapeutics has launched with $130 million in funding and a partnership with Roche subsidiary Genentech. The startup’s technology analyzes proteins in the context of the entire cell, enabling it to discover molecules that bid to targets previously deemed undruggable.

Biopharma 118
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Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

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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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J&J CEO: Our R&D Infrastructure Helps Us Maintain Innovation Amid an Uncertain Economy

MedCity News

Johnson & Johnson’s CEO believes the company will maintain its strong reputation for innovation amid changing economic conditions because of its hefty investments in research and development. He said it’s crucial to invest both internally and externally, as some of the most innovative and lucrative opportunities come from outside companies.

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US eyes link between Pfizer bivalent COVID jab and stroke

pharmaphorum

Regulatory authorities in the US are investigating a possible link between the new Pfizer/BioNTech bivalent COVID-19 booster vaccine and strokes in people aged 65 or over, but still recommend the shots. Monitoring has pointed to a possible higher risk of ischaemic stroke in the 21-day period post-vaccination in this age group compared to 22 to 44 days post-vaccination, according to an announcement on the Centre for Disease Control and Prevention (CDC) website. “Although the totality of the

Safety 109

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Celadon receives good manufacturing practice approval

PharmaTimes

MHRA approval relates to the company’s midlands-based drug development facilities

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Study adds to HRT and Alzheimer’s debate

pharmaphorum

Hormone replacement therapy (HRT) could cut the risk of Alzheimer’s in some women at elevated risk of the disease, according to researchers in the UK. The study by a team at the Universities of East Anglia and Edinburgh shows that HRT use is associated with better memory, cognition, and larger brain volumes in later life among women carrying the APOE4 gene, a well-established risk factor for Alzheimer’s.

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Important Coloring Agents in Food Products: Types, Regulations, Advantages, Disadvantages (2023)

Teachntest

Important Coloring Agents in Food Products: Types, Regulations, Advantages, Disadvantages Coloring agents in food products are used to enhance the visual appeal of food products, making it more attractive to consumers. Types of Coloring Agents They can be classified into two main categories: artificial and natural.

Food 65
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AbbVie, Lilly pull out of UK voluntary drug pricing agreement

pharmaphorum

Two top pharma companies have exited the UK’s voluntary medicines pricing agreement in protest at what the industry has said is a “punitive” system of revenue clawbacks, casting doubt on the future of the scheme in its present form. AbbVie and Eli Lilly have left the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), according to an update issued this morning by the Association of the British Pharmaceutical Industry (ABPI), which said the move has “sent a w

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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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AbbVie and Eli Lilly snub drug pricing agreement

PharmaTimes

Major industry names depart leaving UK pricing deal in serious jeopardy

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Pro sports’ COVID protocols led to real-world data impacts for pharma

PharmaVoice

After years of pioneering new methods for using data and technology to improve patient health outcomes, IQVIA’s Christina Mack is on the cusp of a research revolution.

Pharma 59
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Recessions are easy to forecast, so how can CEOs better prepare to weather the economic storm?

Curzon Consulting

4 Minutes ‘A rising tide lifts all boats’ is an aphorism associated with the idea that good CEOs can drive business growth during the good times. However, in my experience… exceptional CEOs drive remarkable growth during economic downturns! No matter what anyone tells you, recessions are easy to forecast. It’s the severity of the recession that is difficult to predict.

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Healthcare Marketing Strategies to Adopt During a Recession

LEVO Health

If you work in the healthcare industry, it’s essential to remain prepared for potential challenges that may arise, including economic recessions. While no one can predict the future with certainty, having a solid healthcare marketing strategy in place can help your practice weather any storms that may come your way. With inflation and supply chain disruptions impacting the economy, a recession may be looming in the future.

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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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James Martland

Curzon Consulting

Consultant Contact me. +44 (0)2074092857. James is a commercial strategist, with expertise across Customer Acquisition, Propositional Strategy and Product Development. He began his career in the Technology, Media and Telecoms industry, working at one of the sector’s largest firms for over three years. He aims to combine macro-strategic thinking with a detailed and practical understanding of project management and implementation.

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The Creative Floor Healthcare Awards 2023 Opens for Entries and Announces This Year’s Judges

PM360

The Creative Floor Healthcare Awards 2023 launches today and will celebrate the world’s best health and wellness creative, clients, and agency talent. The awards continue to be the only health and wellness award show in the world to donate a percentage of profits towards a Talent & Diversity Fund. The fund has raised over £160,000 to date and continues to help under-represented talent into healthcare communication agencies.

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Ono Pharmaceutical enters research deal with Monash University

Pharmaceutical Technology

Ono Pharmaceutical and Monash University have entered an option and research collaboration for the discovery and development of antibodies that target G protein-coupled receptors (GPCRs). The collaboration is focused on developing anti-GPCR antibodies, which enable the creation of new treatments for autoimmune and inflammatory diseases. Under the deal terms, the Biomedicine Discovery Institute of Monash University will lead the antibody discovery campaign for targeting two GPCRs, which are said

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Luye claims its first FDA approval, for bi-weekly schizophrenia drug

pharmaphorum

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. Rykindo has been approved for the treatment of schizophrenia and as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults by the US regulator.

FDA 52
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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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FDA Signs Mutual Recognition Agreement with Swiss Confederation

PharmaTech

The agreement will be able to let FDA and the Swiss Agency for Therapeutic Products (Swissmedic) utilize each other’s GMP inspections of manufacturing facilities, avoiding the need for duplicate inspections.

FDA 45
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FDA Approved IND for CAR T Cell That Target Metastases-Causing Breast Cancer Tumor

Pharmacy Times

The head of the CAR T cell antibody can recognize and target the growth factor in its tumor microenvironment.

FDA 65
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Pharmacovigilance Risk Assessment Committee Meeting Highlights

PharmaTech

The members reviewed the measures to minimize the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders.

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Study: Clonidine Blood Pressure Medication Could Be Used to Treat PTSD

Pharmacy Times

Clonidine works on adrenergic receptors in the brain, which are known for their role in fight-or-flight responses and are believed to be activated in post-traumatic stress disorder.

Medical 49
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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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DeepIntent Celebrates Year-Over-Year Growth as Marketers Invest in CTV

PharmExec

Adding more than 100 employees to its team in 2022, the company's growth has outpaced growth in the broader healthcare advertising segment, as pharmaceutical marketers increasingly embrace digital advertising, particularly on CTV.

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Study Evaluates Impact of Pharmacist-Led Heart Failure Transition of Care Clinics on Readmission Rates

Pharmacy Times

If patients attend their discharge appointments at pharmacist-led heart failure transition of care clinics, they are less likely to be readmitted to the hospital within 30 days.

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Laboratory balances in the pharmaceutical industry

PharmaTech

Review testing requirements for lab balances in the pharmaceutical industry described in the relevant pharmacopoeias and the associated certificates offered by Sartorius.

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Pharmacy Focus: Independent Rx Forum - DIR Changes

Pharmacy Times

Ronna Hauser of the National Community Pharmacists Association and Olin and Scotty Sykes, accountants from Sykes & Company, discuss DIR changes.

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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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Autolomous, Center for Breakthrough Medicines Reach Data Visibility Deal

Pharmaceutical Commerce

Agreement focused on streamlining and automating manufacturing of cell and gene therapies.

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Fourteen Percent of Those Who Contracted COVID-19 Face Long-Term Challenges

Pharmacy Times

Providers use "Kitchen Sink Approach" because cure proves elusive, symptomatic treatment is sketchy.

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Cost Plus Drug Company, RxPreffered Collaborate on Healthcare Accessibility

Pharmaceutical Commerce

Partnership aims to lower prescription drug costs and increase price transparency.

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FDA Approves Label Update for Semaglutide, Allowing Use as First-Line Option for Adults with Type 2 Diabetes

Pharmacy Times

Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.

Medical 49
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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.