Sat.Dec 24, 2022 - Fri.Dec 30, 2022

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New tentative approval for Teva Pharms drug eltrombopag

Drug Patent Watch

[![eltrombopag structure]([link] Eltrombopag is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are eight patents protecting this compound. There are four…. The post New tentative approval for Teva Pharms drug eltrombopag appeared first on DrugPatentWatch - Make Better Decisions.

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Looking back at 2022: The top healthcare stories

Pharmaceutical Technology

The healthcare industry saw its share of ups and downs in 2022. Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions. Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced.

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FDA approval of Biogen Alzheimer’s drug was ‘rife with irregularities,’ congressional report says

Bio Pharma Dive

An investigation by two House committees concluded the FDA failed to document all its meetings with Biogen, and shifted to consider an accelerated clearance on a “substantially abbreviated timeline.

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China has stopped publishing daily COVID data amid reports of a huge spike in cases

NPR Health - Shots

China's National Health Commission said in a statement it would no longer publish daily data and that "from now on, the Chinese CDC will release relevant COVID information for reference and research.

Research 144
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Three years on, the pandemic — and our response — have been jolting. Here’s what even the experts didn’t see coming

STAT News

People who study infectious diseases and who work in public health have long known a bad pandemic would one day come. They knew such an event would overwhelm hospitals, strain supply chains, and place stresses on society that we would be ill-equipped to meet. Countries like the United States have for decades prepared to respond to such a crisis.

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India’s Hetero receives WHO approval for Nirmacom to treat Covid-19

Pharmaceutical Technology

Indian pharmaceutical company Hetero has received the World Health Organization Prequalification of Medicines Program (WHO PQ) approval for its Nirmacom (nirmatrelvir). The company stated that Nirmacom is a generic version of Pfizer ’s Covid-19 oral antiviral drug, Paxlovid, a SARS-CoV-2 main protease (Mpro) inhibitor. Hetero’s Nirmacom combi-pack will contain nirmatrelvir 150 mg (two tablets) and ritonavir 100mg (one tablet).

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More Trending

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It's not too late to get a COVID booster — especially for older adults

NPR Health - Shots

Public health officials want more Americans to get the latest COVID vaccine booster. Only 35% of people over 65 have gotten the shot, though 75% of COVID deaths are among people in this age group.

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Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report

Fierce Pharma

Biogen, FDA's inappropriate Aduhelm coordination detailed in blistering congressional report. aarmstrong. Thu, 12/29/2022 - 14:42.

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Japan’s MHLW approves AstraZeneca’s Imfinzi, Imjudo for liver, lung cancers

Pharmaceutical Technology

The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved AstraZeneca ’s immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) to treat advanced liver, biliary tract, and lung cancers. The combination of Imfinzi and Imjudo has been approved to treat unresectable hepatocellular carcinoma (HCC) in adult patients. It has also been authorised to treat unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) along with chemotherapy.

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Diabetes in youth is set to skyrocket in coming decades

STAT News

The number of young people in the U.S. with type 2 diabetes could surge by about 700% over the next four decades, with a greater burden falling on minority groups, a new model predicts. If the recent acceleration of new diagnoses persists, then 220,000 people younger than 20 would have type 2 diabetes in 2060, compared with 28,000 in 2017, the latest year for which data is available, according to projections published this month in Diabetes Care.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Feds sue AmerisourceBergen over 'hundreds of thousands' of alleged opioid violations

NPR Health - Shots

DOJ officials say the drug wholesaler could face "billions of dollars" in penalties for failing to report diversion of prescription opioid pain medications shipped to pharmacies across the U.S.

Pharmacy 140
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How to get acquisition ready – a seller’s guide to merger and acquisition in pharma

pharmaphorum

This year, the predicted flurry of merger and acquisition (M&A) activity might not have materialised. However, as we near the end of the year, there were some big moves. M&A is an integral part of the lifecycle of pharma companies and a key strategy to future-proof larger players, driving R&D activities and innovation for a competitive product pipeline.

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Gilead Sciences to buy all rights of GS-1811 from Jounce

Pharmaceutical Technology

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. The amended agreement will allow Gilead Sciences to acquire all the remaining rights for GS-1811 from Jounce Therapeutics. Certain operational obligations of the companies that are related to GS-1811 have also been terminated as part of the transaction.

Licensing 130
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It's extra important to test after New Year's gatherings, doctor says. Here's why

Medical Xpress

It's a sniffle, a tickle in the throat and a headache. Or a fever, congestion and fatigue.

Doctors 119
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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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Editors' picks: Our best global photos of 2022 range from heart-rending to hopeful

NPR Health - Shots

The eye of the camera told the stories of kangaroo care for human babies, Angola's intrepid female de-miners, Ukrainian refugees who find a warm — and familiar — welcome in Brazil and more.

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Watch: A wave of overdoses is hitting an already vulnerable population

STAT News

Francesca Coleman, known to friends as “St. Louis,” has been unhoused since the age of 15. Now 24, Coleman sleeps in Tongva park, across from the famous Santa Monica pier in California. Like many unhoused people in the Los Angeles area, Coleman uses meth in an attempt to ease chronic pain, anxiety, and depression. On a Wednesday morning in July, physician Coley King checked in with Coleman in Tongva Park.

Medicine 111
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2022 in Review: Tracking the ups and downs of pharma deals

Pharmaceutical Technology

This year, volatility resulting from the Russian war on Ukraine, residual uncertainty from the Covid-19 pandemic, and more led to fluctuating dynamics in the pharmaceutical space. However, despite external pressures, major pharma deals still came to pass, which some experts say could be a harbinger for things to come in 2023. The Covid-19 pandemic pushed most markets into free fall, leading to increased wariness for completing large mergers and acquisitions (M&As) in the pharmaceutical secto

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Experts: Underuse of COVID-19 drug Paxlovid shortchanging patients

Medical Xpress

Ira Katz bustles at his pharmacy in Atlanta's Little Five Points neighborhood this cough season, serving patients who need medicine for respiratory viruses like COVID-19. He dispenses occasional packages of Paxlovid, a drug designed to nip COVID in the bud. But there aren't as many of those Paxlovid prescriptions as there might be.

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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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Maternal deaths in the U.S. are staggeringly common. Personal nurses could help

NPR Health - Shots

The nation has the highest rate of maternal mortality among wealthy countries. A long-standing program, Nurse-Family Partnership, which supports new parents, works to address this deadly trend.

Nurses 131
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3 things to watch in chronic disease in 2023: obesity drugs, long Covid and health care costs

STAT News

The very term “chronic disease” might imply that little changes — or improves — over time. But there is a lot percolating on the chronic disease front, from the mysterious (long Covid) to well-known problems. For the millions of people in the United States who have one or more chronic conditions, a small scientific stir can lead to a huge impact.

Drugs 111
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LegoChem, Amgen partner to develop antibody drug conjugates

Pharmaceutical Technology

LegoChem Biosciences and Amgen have signed a multi-target research collaboration and license agreement to develop antibody-drug conjugates (ADC). Under the deal terms, Amgen was granted rights for the research, development, and commercialisation of ADCs that will be directed to treat up to five targets which are chosen by the company using the ConjuAll ADC technology of LegoChem.

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Ask the Pediatrician: How can I help my child feel better with a fever?

Medical Xpress

If your infant or child is older than 6 months and has a fever, they probably do not need to be treated for the fever unless they are uncomfortable.

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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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Psychedelic drugs may launch a new era in psychiatric treatment, brain scientists say

NPR Health - Shots

Psychedelic drugs were a hot topic at this year's Society for Neuroscience meeting. Researchers hope the drugs can help people with disorders like depression and PTSD.

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Study could pave way for new antiviral, as China grapples with Covid wave

STAT News

When Eric Xu fell sick and tested positive with Covid this month, he took pills of his own invention.  Paxlovid, the primary oral antiviral available in the U.S., is in short supply in China. But Xu, a prominent biochemist at the Chinese Academy of Sciences, had helped devise his own in 2021 and, as the drug’s inventor, could legally take it even as it went through clinical trials.

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Pharma manufacturing can digitalise its way round the next crisis

pharmaphorum

The turbulence of the last three years can make it seem as though pharma manufacturers have been operating in an atmosphere of non-stop crisis. COVID-19 erupted, mutated, and was supplemented by the challenges of monkeypox and the need to catch up with major treatment and immunisation backlogs accumulated during the pandemic. At the same time, the industry must address the long-term difficulty of providing essential medicines and health services to the high percentage of global population that c

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New HIV treatment shot given only twice a year could be a 'game changer'

Medical Xpress

The Food and Drug Administration has approved Sunlenca, an injectable therapy to suppress HIV for patients who suffered drug resistance to other regimens.

Drugs 116
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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China's COVID vaccines: Do the jabs do the job?

NPR Health - Shots

As case counts surge in China, rumors circulate about the effectiveness and safety of the made-in-China vaccines in use there. Here's what we know about CoronaVac and Sinopharm.

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We wish we’d written that: STAT staffers share their favorite stories of 2022

STAT News

This year, STAT deepened its footholds in a number of coverage areas, from hospitals and insurance to reproductive health to health tech. Our staff also looked with admiration — and some envy — to many other journalists doing great reporting in these spaces. Below is our annual list of STAT staffers’ favorite stories of the year, and that we wish we had written.

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Bring point of care testing to the community for a preventative, cost effective, Net Zero NHS

pharmaphorum

The vast majority of GPs are persuaded of the benefits of moving diagnostic services from the hospital to the community, according to a new survey of 200 GPs in the UK. Just 4% of would choose the hospital as the preferred location of testing, compared to 46% for the GP surgery, 18% for a community hub, 15% for a patient’s home and 12% for the pharmacy.

Nurses 98
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Ketamine found to increase brain noise

Medical Xpress

An international team of researchers including Sofya Kulikova, Senior Research Fellow at the HSE University-Perm, found that ketamine, being an NMDA receptor inhibitor, increases the brain's background noise, causing higher entropy of incoming sensory signals and disrupting their transmission between the thalamus and the cortex. This finding may contribute to a better understanding of the causes of psychosis in schizophrenia.

Research 111
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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.