Mon.Nov 21, 2022

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ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win

Fierce Pharma

ASH: AbbVie, J&J's Imbruvica under serious threat as BeiGene's Brukinsa delivers head-to-head trial win. aliu. Mon, 11/21/2022 - 16:29.

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First-in-human gene therapy trial for major cardiac syndrome

European Pharmaceutical Review

The first-in-human gene therapy trial for heart failure patients with preserved ejection fraction (HFpEF) has been approved by the US Food & Drug Administration (FDA). SRD-001, the adenovirus associated virus (AAV)-based gene therapy is delivered to cardiac ventricular muscle cells via an intracoronary infusion system (produced by Sardocor, a clinical-stage gene therapy subsidiary of Medera), to increase the protein expression and functional activity of sarcoplasmic reticulum calcium ATPase

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Pfizer's Paxlovid access brought into question as WTO set to discuss patent waiver—again

Fierce Pharma

Pfizer's Paxlovid access brought into question as WTO set to discuss patent waiver—again. aliu. Mon, 11/21/2022 - 11:21.

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Provention prices type 1 diabetes drug Tzield at $194,000

pharmaphorum

Provention Bio has priced its new type 1 diabetes (T1D) prevention therapy Tzield at $13,850 per vial – equivalent to almost $194,000 for its 14-day course – a higher level than had been predicted by industry observers. The company argues that the cost is justified as Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, fending off the time when they become highly reliant on insulins and at risk of the serious complications that can accompany advanced T1D.

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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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SpaceX, ISS partner to test remote control of drug delivery technology on orbiting laboratory

Fierce Pharma

SpaceX, ISS partner to test remote control of drug delivery technology on orbiting laboratory. ntaylor. Mon, 11/21/2022 - 05:47.

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Why You Need an ADA Compliant Healthcare Website—and How to Get One

Healthcare Success

Just like your brick-and-mortar business has to be ADA compliant, your healthcare website must also be accessible to people with disabilities. The problem? The ADA doesn’t offer clear regulations for a compliant website. The bigger problem? ADA accessibility lawsuits are on the rise. If your website isn’t accessible to people with disabilities, you could risk lawsuits, financial liabilities, and damage to your brand reputation.

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Merck’s $1.3B Imago Buyout Brings Blood Cancer Drug to Rival BMS, Incyte & GSK

MedCity News

Merck is acquiring Imago BioSciences, a clinical-stage biotech whose lead drug is in development for myelofibrosis and other blood cancers. The deal gives the pharmaceutical giant a small molecule that could provide an alternative to a class of drugs that introduce dangerous side effects.

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GSK to slash about 150 consumer commercial jobs in India

Fierce Pharma

GSK to slash about 150 consumer commercial jobs in India. zbecker. Mon, 11/21/2022 - 10:56.

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It’s Time We Get Smart About Senior Care

MedCity News

These past two years have emphasized the importance of technology more than ever before. As more seniors embrace the benefits of technology, SNFs and long-term care centers have a responsibility to their residents to implement life-changing and life-saving smart tech that’s revolutionizing senior care.

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As CEO Schultz eyes retirement, Teva taps former Sandoz head Francis as its next leader

Fierce Pharma

As CEO Schultz eyes retirement, Teva taps former Sandoz head Francis as its next leader. fkansteiner. Mon, 11/21/2022 - 08:51.

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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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E-scooters Are the Perfect Metaphor for Telehealth, Says Zocdoc’s CEO

MedCity News

To Zocdoc CEO Oliver Kharraz, it’s helpful to think about telehealth like an e-scooter, because virtual care is just one tool in the toolbox. For example, you wouldn’t use an e-scooter to get to the airport, but you might use it to visit a friend who lives a mile away. Similarly, you wouldn’t use telehealth to get a colonoscopy, but you might use it for a follow-up visit with your gastroenterologist.

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Merck agrees to acquire Imago for $1.35bn

Pharmaceutical Technology

Merck (MSD outside North America) has signed a definitive agreement for the acquisition of all outstanding shares of Imago BioSciences, through a subsidiary, for $36.00 per each share in cash or for a total equity price of nearly $1.35bn. A clinical-stage biopharmaceutical firm, Imago focuses on the development of new therapies to treat myeloproliferative neoplasms (MPNs) and other bone marrow ailments.

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New Gene Therapy Biotech Telaria Launches With Rare Skin Disease Focus

MedCity News

Telaria is developing a gene therapy for the rare skin disorder recessive dystrophic epidermolysis bullosa. The company was formed by Replay, a gene therapy biotech that forms subsidiaries that leverage its platform technologies for writing and delivering genetic medicines.

Medicine 104
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Biotech Startup Raises $5.4M to Develop AI-Designed Protein Machines and Cell Factories

PharmaTech

Biotech startup, Cradle, has raised $5.4 million in seed funding with an AI-enabled design platform that allows for the synthetic building of cell factories to produce proteins.

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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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Why Value-based Care Needs To Be the Standard for Behavioral Health

MedCity News

Compared to other areas of healthcare, behavioral health has been slow to adopt VBC models — even though they will further expand access to behavioral health services, remove barriers to care, and improve the quality of mental health and substance use care.

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The race for a new class of antibiotics

European Pharmaceutical Review

A study on the surge of new antimicrobial research has shown that despite almost a quarter of a million research papers (227,808) being published on the 12 bacterial families in the World Health Organization (WHO) global priority pathogen list of antibiotic-resistant bacteria from 2017, no new class of antibiotics has gone to market since 1987. Study data from Elsevier’s abstract and citation database Scopus, identified that 2,450 papers were published in 2021 on the pathogen WHO identified as m

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CardieX Acquires Blumio, Incorporates Its Wearable Blood Pressure Sensor

MedCity News

CardieX, a cardiovascular technology company based in both Australia and Illinois, recently acquired Blumio, a San Mateo, California-based startup focused on cardiovascular sensors. The deal will advance both companies’ vision to accurately and easily measure blood pressure without relying on the use of a cuff.

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What Matters Most: The Trends That Will Shape Pharma Marketing in 2023

Eversana Intouch

Download the White Paper. Big concepts. Big platforms. Big words. Big decisions. That’s where we all want to play. It’s easy to toss big words around, though: to be provocative, to hype, to make unsupported claims. It’s far more difficult to be precise, accurate, meaningful. To have impact. To do good work that matters. In our eighth annual trends forecast, we look at five big ideas we believe are referenced too flippantly, too often, and not given the attention and action they deserve.

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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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No Surprises Act Leads to Thousands More Disputes and Delays than Gov’t Expected

MedCity News

When the federal government enacted the No Surprises Act to lessen payment disputes between a patient or a health insurance plan and a provider, the government projected 22,000 disputes in 2022. However, between just April and September there were more than 90,000 disputes filed. .

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Why the biopharma ‘IPO playbook’ changed in 2022

PharmaVoice

Biopharma IPOs have puttered in 2022, particularly compared to the record-breaking previous year, but they might be set to rebound.

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UnitedHealthcare, AARP Team Up To Improve Access To Hearing Aids

MedCity News

Through the partnership, AARP members are able to purchase prescription and over-the-counter hearing aids through UnitedHealthcare Hearing. They’ll also be able to receive free hearing tests.

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In cancers with very low survival rates, Sellas aims higher

PharmaVoice

The company hopes its drugs can “take over where other available treatments fail” in multiple types of cancer.

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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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What Will Be 2023’s Biggest Challenge in the Employee Benefits Space? 4 Execs Weigh In

MedCity News

Uncertainty, benefits navigation, cost and innovation are some of the key challenges ahead for those in the employee health benefits space. Executives made these comments last week during the HLTH conference in Las Vegas.

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How to Network Your Way into Medical Sales

MedReps

There are many ways to get into medical sales. You can attend a special medical sales school, where you’ll learn relevant techniques and well-received lessons on how to sell devices, pharmaceuticals and more. You could also apply for jobs available at medical manufacturers straight out of college, hoping you’ll be one of the lucky ones called for an interview.

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Infex begins study of pseudomonas aeruginosa candidate RESP-X

PharmaTimes

Phase 1 research will evaluate tolerability and safety of therapy among healthy volunteers

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Warnings for Japanese pharmaceutical market may lead to more lenient price controls

Pharmaceutical Technology

Japan is currently the fourth largest market in the world. Based on GlobalData estimates, the Japanese pharmaceutical market generated JPY9.392 trillion ($67.32 billion) in total sales in 2021 and is expected to grow 1.1% in 2022 to JPY9.498 trillion ($68.08 billion). However, despite this significant market share, the Japanese market is likely to become a less attractive market for international pharmaceutical companies based on recent findings from the Office of Pharmaceutical Industry Researc

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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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Point of Care’s Fascinating Evolution

PM360

Amid all of the changes, disruption, and technological upheaval that we have witnessed in the point-of-care (POC) space over the past few years it appears marketers are more interested in this ever-expanding channel then ever before. In “State of the Point of Care Marketing Industry 2022,” a joint study by the Point of Care Marketing Association and ZS Associates, 80% of the 100 media planners and buyers surveyed considered POC to be a “critical” part of the overall advertising campaign.

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Merck bulks up in haematology, buying Imago for $1.35bn

pharmaphorum

While its fabled takeover of Seagen is yet to materialise, Merck & Co has continued to bolster its pipeline with smaller deals – with its latest a $1.35 billion agreement to buy Imago BioSciences and its bomedemstat drug candidate for blood disorders. The $36 per share, bolt-on deal helps to build Merck’s R&D portfolio as it tries to reduce the proportion of sales it makes from $17 billion-plus immuno-oncology blockbuster Keytruda (pembrolizumab), and build a franchise in haematolo

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Iveric Bio receives new therapy designation for avacincaptad pegol

PharmaTimes

FDA grants status following primary endpoint data from pivotal trials treating geographic atrophy

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With cash reserves dwindling, Oxurion plans early DME trial readout

pharmaphorum

Oxurion will carry out an interim analysis of a phase 2 trial of its last remaining clinical asset – THR-149 for diabetic macular oedema (DME) – before the end of this year as it tries to get an early take on its efficacy. With top-line results from the KALAHARI trial not due until the second half of 2023 – and cash reserves dwindling – the Belgian biotech hopes to look at the data after at least 25% of patients in the phase 2b portion of the study is completed.

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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.