Sat.Dec 10, 2022 - Fri.Dec 16, 2022

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Amgen to buy Horizon Therapeutics in year’s biggest biotech deal

Bio Pharma Dive

After outlasting rival suitors Sanofi and J&J in deal talks, Amgen agreed to a deal that values the Ireland-based maker of rare and inflammatory disease drugs at about $28 billion.

Drugs 343
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A New Dimension in New Drug Molecules Research with Nanome’s VR technology [Interview]

Pharma Mirror

The COVID-19 pandemic challenged researchers to discover life-saving treatments at an unprecedented pace. While these researchers rose to the occasion by discovering drugs faster than ever before, variants continue to challenge the world in addressing COVID-19. New innovations in computer-aided drug discovery tools could dramatically accelerate the study of new variants.

Research 264
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Amgen’s AMG-133 shows potential in competing with GLP-1RA obesity therapies

Pharmaceutical Technology

Pipeline therapies within the cardiometabolic space have recently gathered interest following the 20th World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) Hybrid Conference, which took place on 1–3 December. The spotlight was placed on many up-and-coming pharmacotherapies within the space, one of which was Amgen’s obesity therapy, AMG-133, following the company’s announcement of its Phase I therapy results last week, on 1 December.

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COVID spreading faster than ever in China. 800 million could be infected this winter

NPR Health - Shots

Scientists predict China will see the largest COVID surge of the pandemic this winter, with hundreds of millions of people infected. But some experts say that it could have been even worse.

Scientist 145
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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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Roche’s hemophilia gene therapy holds steady with longer-term data

Bio Pharma Dive

Roche’s subsidiary Spark has offered few updates on its hemophilia A treatment since being acquired in 2019. New data at ASH show the therapy can maintain levels of a key blood-clotting protein for years.

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Opinion: Hospice care needs saving

STAT News

Hospice in America is gravely ill. An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies.

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More Trending

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You can order free COVID tests again by mail

NPR Health - Shots

People are gathering indoors for the holidays, and there's been an uptick in COVID-19 cases. The federal government says you should test often to try to prevent the spread of the virus.

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Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda

Bio Pharma Dive

The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales.

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STAT+: Nine in 10 health care companies with financial stress are owned by private equity

STAT News

Almost 90% of the health care companies deemed to be under financial stress by a leading credit rating agency are owned by private equity , a stark indicator of the toll financial investors have taken on a vital sector. The striking finding is part of a new Moody’s Investors Service report released this week that shows broad turbulence throughout an industry weakened by private equity’s practice of loading companies with debt, making them less resilient to challenges like Covid-19,

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Eisai and Washington University to develop neurodegenerative disease therapies

Pharmaceutical Technology

Eisai has entered a comprehensive research partnership agreement with Washington University School of Medicine in St Louis, US, to develop potential new therapies for neurodegenerative ailments. Under the deal, the parties intend to develop treatments for diseases including Alzheimer’s and Parkinson’s. The alliance will merge the capabilities of the scientists at Washington University in the basic and clinical research in neurodegenerative ailments, such as dementia, with the wide-ranging expert

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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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Adults who neglect COVID-19 health recommendations may also neglect basic road safety, study finds

Medical Xpress

Reasons underlying hesitancy to get vaccinated against COVID-19 may be associated with increased risks of traffic accidents according to a new study in The American Journal of Medicine. Researchers found that adults who neglect these health recommendations may also neglect basic road safety. They recommend that greater awareness might encourage more COVID-19 vaccination.

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J&J’s next myeloma drug, Argenx’s second act and a new question for Bluebird: 3 ASH takeaways

Bio Pharma Dive

The year’s biggest meeting on blood diseases kicked off this past weekend. Here are three of the most important storylines to emerge from the past few days of presentations.

Drugs 300
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STAT+: Bone marrow transplant patients could be spared from ‘bland’ diet, study finds

STAT News

Whenever a hematopoietic cell transplant patient tries to get a family member to sneak food in past the nurses, Federico Stella, a resident hematologist at the University of Milan, remembers. One was a girl who tried to get her sister to bring her a panettone, a Milanese sweet bread usually eaten around the holidays. A week before Christmas, the sister tried to hide the panettone in a bag.

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CRISPR gene-editing may boost cancer immunotherapy, new study finds

NPR Health - Shots

Using CRISPR to modify certain immune cells could make cancer-fighting immunotherapy more potent for a broader set of patients. Two people who went through the treatment share their stories.

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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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Subcutaneous fat emerges as a protector of females' brains

Medical Xpress

Females' propensity to deposit more fat in places like their hips, buttocks and the backs of their arms, so-called subcutaneous fat, is protective against brain inflammation, which can result in problems like dementia and stroke, at least until menopause, scientists report.

Scientist 141
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Roche pharma division head to depart amid CEO changeover

Bio Pharma Dive

The drugmaker’s pharmaceuticals head Bill Anderson will leave on Dec. 31. Current diagnostics chief Thomas Schinecker will fill in on an interim basis before a replacement is found and Schinecker takes over as CEO in March.

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STAT+: Moderna says cancer vaccine reduces melanoma’s return by 44%

STAT News

An experimental cancer vaccine being developed by the biotechnology firm Moderna and the drug giant Merck reduced the risk that melanoma would return after surgery or that patients would die by 44%, the company said. The data, made public in a press release, represent the first evidence of an effective individualized cancer vaccine based on mRNA, the technology used in the Covid shots.

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Four ways Biogen is tackling digital innovation in neurological disease

pharmaphorum

Digital transformation in pharma is not a singular endeavour. It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Authorities are urging indoor masking in major cities as the 'tripledemic' rages

NPR Health - Shots

The CDC is advising people to practice indoor masking in nearly a tenth of U.S. counties, as three highly contagious respiratory viruses sweep the country.

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GSK gives Wave a lift with genetic medicine deal

Bio Pharma Dive

A four-year agreement between the companies comes with $170 million in cash and equity for Wave, which in recent years has dealt with clinical setbacks.

Genetics 321
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Covid vaccines averted 3 million deaths in U.S., according to new study

STAT News

This Wednesday will mark two years since nurse Sandra Lindsay became the first person in the U.S. to receive a Covid-19 vaccine outside of a clinical trial. A study released Tuesday by the Commonwealth Fund shows that in those two years, the Covid vaccines have averted over 3 million deaths in the U.S. The Centers for Disease Control and Prevention estimates that more than 1 million Americans have died from Covid-19 since the onset of the pandemic.

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Trial on safety and immunogenicity of Ebola vaccines yields promising results

Medical Xpress

Ebola epidemics occur periodically in various sub-Saharan African countries. While vaccines exist and have already received WHO Prequalification against the Zaire ebolavirus species, it is essential to pursue and intensify efforts to supplement the available data to develop a safe and effective Ebola vaccine strategies in adults and children alike.

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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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How Medicare Advantage plans dodged auditors and overcharged taxpayers by millions

NPR Health - Shots

A KHN investigation found when some Medicare Advantage plans got a rare federal audit, they couldn't produce billing records for care they said they'd provided. Some blamed fire, flood — or doctors.

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Gene therapy approval won, Bluebird takes on next challenge: selling it

Bio Pharma Dive

The biotech is still waiting to treat its first commercial patient with Zynteglo, but says it has not seen insurers deny coverage for the beta thalassemia drug.

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STAT+: Emerging class of genetically targeted drugs induce remissions in leukemia patients

STAT News

NEW ORLEANS — An emerging class of genetically targeted drugs is inducing remissions in about one-third of patients with advanced leukemia, according to updates Saturday from separate clinical trials. Two biotechs — Syndax Pharmaceuticals and Kura Oncology — are developing their own versions of so-called menin inhibitors that have the potential to become effective treatments for certain types of genetically defined acute myeloid leukemia (AML), a rapidly progressing bone mar

Genetics 141
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Researchers present advance in re-treatment with CAR T therapy

Medical Xpress

Researchers from the University of Pennsylvania's Abramson Cancer Center presented preliminary results of an ongoing Phase I clinical trial demonstrating successful re-treatment with CAR T cell therapy for patients whose cancers relapsed after previous CAR T therapy at the 2022 American Society of Hematology (ASH) Annual Meeting.

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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 major drugmaker plans to sell overdose-reversal nasal spray Narcan over the counter

NPR Health - Shots

Emergent BioSolutions has applied to the Food and Drug Administration to sell the opioid overdose-reversal drug over the counter. Addiction experts say it may be a key step to lower fentanyl deaths.

Drugs 131
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European regulators back hemophilia gene therapy

Bio Pharma Dive

The EMA’s drug review committee recommended five new drugs be approved in Europe during its December meeting, including CSL’s Hemgenix, AstraZeneca’s Imjudo and Amicus’ Pombiliti.

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STAT+: ‘We’ve got a new target’: Bispecific antibody for multiple myeloma succeeds in mid-stage trial

STAT News

NEW ORLEANS — Researchers had hoped in recent years that a protein called GPRC5D might offer a new way to get the immune system to hunt down and destroy multiple myeloma cells. Now, the results of a Phase 2 study on a bispecific antibody targeting this protein offers confirmation. The data, presented Saturday at the annual American Society of Hematology conferences, wowed a crowd of attendees, including clinicians who began excitedly imagining how to use the new drug in practice.

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Cellular 'glue' to regenerate tissues, heal wounds, regrow nerves

Medical Xpress

Researchers at UC San Francisco (UCSF) have engineered molecules that act like "cellular glue," allowing them to direct in precise fashion how cells bond with each other. The discovery represents a major step toward building tissues and organs, a long-sought goal of regenerative medicine.

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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.