Tue.Dec 20, 2022

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Government spending bill would tighten FDA oversight of accelerated drug approvals

Bio Pharma Dive

The proposed bill would strengthen rules around confirmatory testing, help speed product withdrawals and set up a panel of agency officials to better coordinate policy.

Drugs 306
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Bacteria Inside You May Explain Why Weight Piles on After Dieting

AuroBlog - Aurous Healthcare Clinical Trials blog

Restricting our food intake can result in a range of health benefits, including reducing the risk of obesity. But when the dieting stops, the weight often piles back on, and a new study in mice may have identified why. [link] Scientists from the Shanghai Institute of Nutrition and the Chinese Academy of Sciences think they […].

Bacteria 209
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Doubts around cancer drug target persist after Gilead, Arcus study results offer ‘mixed picture’

Bio Pharma Dive

While long anticipated trial data were technically positive, analysts questioned whether drugs aimed at ‘TIGIT’ will prove a meaningful treatment addition.

Drugs 261
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Pfizer secures rights for RSV therapeutic candidate sisunatovir in China

Pharmaceutical Technology

Biotechnology firm LianBio has announced that Pfizer opted in to secure the right to develop and commercialise the respiratory syncytial virus (RSV) therapeutic candidate, sisunatovir, in Mainland China, Hong Kong, Macau, and Singapore. The deal is pursuant to the existing strategic collaboration of the companies for expanding patient access to new therapeutics in Greater China.

Licensing 162
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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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Hearing loss biotech Otonomy plans to dissolve

Bio Pharma Dive

After trial setbacks and a restructuring, Otonomy plans to liquidate and shut down if a plan is approved by shareholders in the first quarter next year.

Trials 208
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Japan approves BMS’ Breyanzi for large B-cell lymphoma

Pharmaceutical Technology

Japan has granted approval for Bristol-Myers Squibb ’s (BMS) Breyanzi (lisocabtagene maraleucel; liso-cel) as second-line therapy to treat relapsed or refractory (r/r) large B-cell lymphoma (LBCL) patients. The treatment is indicated for usage in such patients irrespective of autologous hematopoietic stem-cell transplantation status. This approval is based on clinical trial findings in subjects with r/r aggressive B-cell non-Hodgkin lymphoma following first-line therapy.

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Catalyst Pharmaceuticals to buy US rights for Eisai’s Fycompa

Pharmaceutical Technology

Catalyst Pharmaceuticals has signed a definitive agreement with Eisai to acquire the US commercial rights for the latter’s anti-epileptic drug (AED), Fycompa (perampanel) CIII. Under the deal terms, Catalyst will also have an exclusive period to assess, review, and negotiate to buy a rare epilepsy asset in Eisai’s pipeline. Eisai will retain its rights to Fycompa in countries outside the US.

Medicine 147
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NABH to conduct 4-day dental healthcare service providers’ assessors’ training programme

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced four days dental healthcare service providers’ assessors’ training programme as per second edition of Dental Healthcare Service Providers Accreditation Standards between January 17 and January 20, 2023 in New Delhi. Last Date to receive applications is December 24, 2022.

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Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations: AcademyHealth Conference on the Science of Dissemination and Implementation in Health (December 2022)

Rethinking Clinical Trials

December 11, 2022: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop "Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Strategies for Designing Studies That Inform Care for Diverse Populations" at the 15th AcademyHealth Annual Conference on the Science of Dissemination and Implementation in Health.

Trials 130
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Downturn for top biopharma companies Q3 market cap as Covid-19 vaccine demand falls

Pharmaceutical Technology

The top 20 global biopharmaceutical companies exhibited a downward trend in aggregate market capitalisation by 9.1% from $3.45 trillion in Q2 2022 to $3.14 trillion in Q3, according to GlobalData’s Pharma Intelligence Center Companies Database. This downturn in market cap was attributed to a decline in the demand for Covid-19 vaccines and therapies.

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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FDA halts planned trial of Entrada Duchenne drug

Bio Pharma Dive

Shares in the Boston-based biotech fell on the news, which comes shortly after a deal with Vertex around another type of muscular dystrophy.

Trials 141
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‘One needs to feel safe’: Racism can put sleep — and its health benefits — out of reach

STAT News

Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.

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Developing a digital marker for coronary artery disease

Medical Xpress

Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.

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Opinion: Reducing the threat of vaccine-preventable diseases starts with kids

STAT News

Americans have been warned — again — about lax attention to routine vaccinations. This time the warning comes from measles , an age-old, vaccine-preventable disease, with an outbreak in central Ohio among nearly 80 children and counting, almost all of them unvaccinated against measles. Once well-controlled in the U.S., which has maintained “measles elimination status” for almost 20 years, this disease may no longer be a rarity as millions of children in the U.S. are m

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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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Probiotic bacteria found in fermented foods might help dispel bad breath

Medical Xpress

Probiotic bacteria usually found in fermented foods, such as yogurt, sourdough bread, and miso soup, might help dispel the embarrassment of persistent bad breath (halitosis), finds a pooled data analysis of the available evidence, published in the open access journal BMJ Open.

Bacteria 145
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Fewer abortions, more vasectomies: Why the procedure may be getting more popular

NPR Health - Shots

In response to growing abortion restrictions, many health care providers report a rising number of patients seeking vasectomy care.

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They may be 95 and older, but they still crave independence

Medical Xpress

People aged 95 and over still want to be part of society and enjoy a level of independence, despite having a more limited interaction with the world, a new study shows.

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Diabetes treatments are improving. Racial disparities are wider than ever

STAT News

Despite advancements in insulin treatments over the past three decades, disparities in outcomes have widened among people with diabetes taking them, a new study found. For example, the share of Mexican Americans taking insulin who achieved good blood-sugar control sharply dropped to 10% during the period of 2013 to 2020 from 25% during 1988 to 1994, researchers reported Tuesday in JAMA Network Open.

Insulin 105
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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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Screening of osteoporosis lags behind other diseases

Medical Xpress

A new perspective article published in The Lancet Diabetes & Endocrinology has highlighted that screening and treatment of osteoporosis lags behind other diseases, resulting in significant morbidity, mortality, and economic costs.

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STAT+: Kite to buy Tmunity Therapeutics, Carl June’s troubled CAR-T startup

STAT News

Kite Pharma, Gilead’s cell therapy subsidiary, said on Tuesday it would buy Tmunity, a biotech that was co-founded by the CAR-T pioneer Carl June but largely went dark after two patients died in a prostate cancer trial last year. The focus of the deal, however, won’t be on Tmunity’s efforts to develop cell therapies for solid tumors, the ambitious goal that helped raise over $230 million from VCs and nonprofits.

Trials 105
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Genome sequencing reveals underdiagnosed cause of long-term lung condition

Medical Xpress

Southampton clinical researchers, working as part of a UK team, have shed new light on causes of bronchiectasis, a long-term lung condition currently effecting more than 200,000 people in the UK.

Genome 111
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Transforming healthcare through sustainable and resilient data infrastructure

pharmaphorum

In the past two decades, global spending on health has doubled. Yet, optimal healthcare remains out of reach for most of the world as many countries continue to struggle with the burden of disease, growing complexity of healthcare, and persistence of health disparities. The problem is not a lack of innovation. Advancements in technology and medicine have made it possible to improve nearly every aspect of care by analysing vast amounts of data, uncovering insights into each person’s disease and e

Genome 104
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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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Common food dye can trigger inflammatory bowel diseases, say researchers

Medical Xpress

Long-term consumption of Allura Red food dye can be a potential trigger of inflammatory bowel diseases (IBDs), Crohn's disease and ulcerative colitis, says McMaster University's Waliul Khan. Researchers using experimental animal models of IBD found that continual exposure to Allura Red AC harms gut health and promotes inflammation.

Research 105
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Confusion and falsehoods spread as China reverses its 'zero-COVID' policy

NPR Health - Shots

As China lifts its stringent zero-COVID policy, public health messaging has taken a U-turn. People are grappling with the whiplash, trying to find a way to protect themselves and loved ones.

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Popular folk medicine remedy known as 'The Secret' doesn't prevent bleeding after invasive heart procedures

Medical Xpress

A popular folk medicine remedy for staunching blood, known as "The Secret," doesn't stop bleeding after invasive coronary procedures used to diagnose or treat cardiac problems, finds research published in the open access journal Open Heart.

Medicine 105
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For 'time cells' in the brain, what matters is what happens in the moment

NPR Health - Shots

The brain uses special neurons called time cells to organize our memories of events and experiences. But, despite their name, these cells don't work like a clock.

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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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Robotic bronchoscopy shows promise to improve lung biopsies, new analysis shows

Medical Xpress

Lung nodule biopsies performed with new robotic bronchoscopy technology may be safer and more effective than those done by traditional methods, a study by researchers at University of Texas (UT) Southwestern suggests.

Research 105
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CVS, Walgreens limiting purchases of children’s drugs amid cold and flu season shortages

STAT News

Caring for sick children has become extra stressful recently for many U.S. parents due to shortages of Children’s Tylenol and other medicines. Doctors and other experts say the problem could persist through the winter cold-and-flu season but should not last as long as other recent shortages of baby formula or prescription drugs.

Doctors 98
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Four decades of clinical trials: 14.2 million life-years gained, at $326 per year

Medical Xpress

Clinical trials in adults conducted within the National Cancer Institute's (NCI's) National Clinical Trials Network (NCTN) over the last four decades are estimated to have extended the lives of patients with cancer in the U.S. by at least 14.2 million life-years, according to a new analysis. Importantly, the study estimated that the costs of those gains have been quite modest: roughly $326 in federal investment for each life-year added.

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STAT+: The list of the worst biopharma CEOs of 2022: No ‘winner,’ just accountability

STAT News

I enjoy thinking about and writing the Worst CEOs of Biopharma column every year. It’s not because I’m mean or vindictive. This list is about holding people and an industry accountable. It’s a public service! Let me know in the comments or on Twitter if I missed the mark, or, more importantly, if I forgot a deserving “naughty” CEO.

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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.