Mon.Nov 21, 2022

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Cancer drugmaker Plexxikon gets new life as Opna Bio

Bio Pharma Dive

Eight months after Daiichi Sankyo shuttered the San Francisco Bay Area subsidiary, Plexxikon’s former CEO is resuscitating its drug research under a new name.

Drugs 317
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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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Teva taps Sandoz veteran to take over CEO post from Schultz

Bio Pharma Dive

Richard Francis will take over for the retiring Kåre Schultz on Jan. 1. He’ll face major challenges at Teva, including opioid settlements, biosimilar launches and reducing the company’s debt.

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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

Marketing 173
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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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Merck to buy blood cancer biotech Imago for $1.35B

Bio Pharma Dive

The deal is Merck’s second notable acquisition of a cancer drugmaker in the past year and a half, part of a strategy to diversify its pipeline beyond top-selling immunotherapy Keytruda.

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Nona and Dragonfly enter HCAb-based drug discovery partnership

Pharmaceutical Technology

Nona Biosciences and Dragonfly Therapeutics have signed a partnership agreement to discover and develop heavy chain only antibody (HCAb)-based drugs. Under the deal, the completely human HCAb transgenic mice platform of Nona will be used for developing completely human heavy chain only antibodies for bispecific/multi-specific therapeutic antibody generation.

Antibody 130

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November 21, 2022: HCSRN Opens Registration, Announces Opening Plenary Speaker

Rethinking Clinical Trials

The Health Care Systems Research Network (HCSRN) opened registration and announced the opening plenary speaker for its 2023 annual conference in Denver, Colorado. This year’s opening plenary session will feature keynote speaker Dr. Abdul Shaikh, population health analytics leader for the worldwide public sector at Amazon Web Services (AWS). New and emerging approaches to using AI/ML, harnessing federated data, and advancing equity-enabled innovation underscore Shaikh’s work.

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How brands can tap into wellness – lessons from influencers

Bio Pharma Dive

Our latest research uncovers new insights on how brands can truly close the wellness gap and grow within their industry sectors.

Branding 269
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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

Marketing 130
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Replay reveals second gene therapy spinout, debuting new biotech Telaria

Bio Pharma Dive

Telaria is the second spinout in Replay’s “hub-and-spoke” model, and will focus on developing a gene therapy for recessive dystrophic epidermolysis bullosa.

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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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RVAC Medicines, A*STAR partner for mRNA manufacturing expertise

Pharmaceutical Technology

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Under the partnership, the parties will establish a joint laboratory at the Bioprocessing Technology Institute (BTI) of A*STAR for developing a preclinical manufacturing platform.

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Merck KGaA outlines plan to rev up drug R&D

Bio Pharma Dive

The German company aims to, on average, launch a new medicine or major treatment indication every 18 months in a bid to boost its pharma business.

Medicine 141
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Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial

BioPharma Reporter

A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.

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Health tech companies weigh funding options amid weak IPO market

Bio Pharma Dive

Healthcare technology companies are delaying initial share sales and searching for new sources of cash. Experts don’t expect a quick recovery.

Marketing 130
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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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Hidden audits reveal millions in overcharges by Medicare Advantage plans

NPR Health - Shots

Taxpayers footed the bill for care that should have cost far less, according to records released under the Freedom of Information Act. The U.S. government may charge insurers $650 million as a result.

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Grand Rounds November 18, 2022: The FIRST-ABC Pragmatic Trials of Non-Invasive Respiratory Support In Children (Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM)

Rethinking Clinical Trials

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Padmanabhan Ramnarayan, MBBS, MD, FRCPCH, FFICM. Reader in Pediatric Critical Care. Imperial College London. Slides. Keywords. Pragmatic Clinical Trials. Key Points. Sick children, when they are acutely ill, start with standard oxygen therapy, which escalates to noninvasive respiratory support (CPAP/BIPAP or high flow nasal cannula) before invasive ventilation support in the ICU.

Trials 130
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'Sunny Makes Money': India installs a record volume of solar power in 2022

NPR Health - Shots

India, on track to become the world's most populous country, gets about 70% of its electricity from coal. But the government is aggressively investing in renewable energy — particularly solar.

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How infectious disease experts are responding to Covid nearly three years in

STAT News

The world is fast approaching the third anniversary of those days when we got our first inkling that a new disease was spreading in China. In the months that followed, normal life was suspended, then upended. At this point, everyone is well and truly sick of Covid-19 and the accommodations we have had to make to co-exist with it. So sick of it, in fact, that many people appear to have given up trying to avoid the SARS-CoV-2 virus.

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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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A cell biologist shares the wonder of researching life's most fundamental form

NPR Health - Shots

Physician Siddhartha Mukherjee explains how cellular science could lead to breakthroughs in the treatment of cancer, HIV, Type 1 diabetes and sickle cell anemia. His new book is The Song of the Cell.

Research 124
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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.

Drugs 116
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STAT+: Northwest Bio study of brain cancer vaccine still falls short

STAT News

Northwest Biotherapeutics tried again, but its experimental treatment for brain cancer still falls short. Last Thursday in JAMA Oncology, Northwest Biotherapeutics and its scientific collaborators published the results of a large clinical trial showing its personalized cancer vaccine administered to patients with brain tumors reduced the risk of death by 20% compared to a group of patients taken from “external controls.

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Dear Life Kit: How do I get out of my pandemic rut? Michelle Obama weighs in

NPR Health - Shots

The former first lady responds to an NPR listener who says that COVID has left them feeling lost and isolated. Her suggestion? 'Take a risk' and 'put yourself out there.

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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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The case for universal oral health coverage, according to a new WHO report

STAT News

On Friday, oral health advocates across the globe got an early holiday gift from their longtime wish lists. They had been waiting their whole careers — for some STAT spoke with, up to nearly half a century — for oral health to be folded into conversations calling for health care access for all. The World Health Organization’s new Global Oral Health Status report took that first step.

Licensing 105
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Intestinal microorganisms influence white blood cell levels, study finds

Medical Xpress

Intestinal bacteria composition is crucial to driving the recovery of neutrophil counts in the blood of mice following treatments such as stem cell transplants or chemotherapy.

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mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?

STAT News

This story has been adapted from the STAT Report “The future of messenger RNA: Covid-19 vaccines are just the beginning.” The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against a much older public health scourge: cancer.

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Acupuncture can relieve lower back and pelvic pain often experienced during pregnancy

Medical Xpress

Acupuncture can significantly relieve the lower back and/or pelvic pain frequently experienced by women during their pregnancy, suggests a pooled data analysis of the available evidence, published in BMJ Open.

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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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Sporting night vision goggles, a scientist probes the internal clocks that help parasites infect people

STAT News

In the 1700s, French astronomer Jean-Jacques d’Ortous de Mairan noticed that the leaves of the mimosa plant opened towards the sun and closed at dusk. His discovery was in keeping with thousands of years of observations. But de Mairan also found that the plant followed the same rhythm even in the constant darkness of a cupboard, suggesting that some innate metronome kept the plant in sync with the rotation of the earth.

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Study finds strong causal link between diastolic blood pressure and neurotic personality trait

Medical Xpress

Diastolic blood pressure—the lower of the two numbers in a blood pressure reading—is highly likely to cause neurotic personality trait, finds research published in General Psychiatry.

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Watch: This small-town pharmacy may be a model for more affordable drugs

STAT News

STAUNTON, Va. — Honest Rx operates like any other pharmacy in the United States — with one big exception. It does not accept health insurance. Pharmacist and owner Matthew Garner opened his business in 2022, after over 20 years of working in and managing other pharmacies. In that time, companies like CVS have become behemoths by merging with pharmacy benefit managers and insurers.

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NSAIDs may worsen arthritis inflammation

Medical Xpress

Taking anti-inflammatory pain relievers like ibuprofen and naproxen for osteoarthritis may worsen inflammation in the knee joint over time, according to a new study being presented next week at the annual meeting of the Radiological Society of North America (RSNA).

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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.