STAT

JANUARY 12, 2023

The percentage of U.S. kindergartners who’ve received standard childhood vaccines took a small but notable dip into the 2021-2022 school year, health officials said Thursday, amid disruptions related to Covid-19 and fears that anti-vaccine sentiment stirred up by the pandemic could be spreading to other shots. Vaccinations among children remain high, but the trend — with coverage dropping from about 95% in the 2019-2020 school year to 94% in 2020-2021 to 93% in 2021-2022, according

Vaccines 363

Vaccines 363

PharmaVoice

JANUARY 11, 2023

The chief strategy officer of Form Bio is harnessing the new company’s computing power and bioinformatics to spur a genomic revolution.

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Pharmaceutical Technology

JANUARY 13, 2023

Health Canada has granted approval to Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. Enhertu has been approved to treat HER2-low breast cancer adult patients who have previously received at least one line of chemotherapy in the metastatic setting or who have seen disease recurrence during or within six months after the adjuvant chemotherapy.

Adverse Reactions 128

Adverse Reactions Chemotherapy 128

European Pharmaceutical Review

JANUARY 11, 2023

Machine learning models used to guide the design of long-acting injectable drug formulations have been successfully tested by scientists at the University of Toronto. The research results signal the potential for machine to reduce reliance on trial-and-error testing, which slows the development of long-acting injectables (LAIs). The study was published Nature Communications and is one of the first to apply machine learning techniques to the design of polymeric long-acting injectable drug formula

Communication 122

Communication 122

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

Communication

STAT

JANUARY 11, 2023

Since long Covid emerged, how best to define it, predict it, and treat it has been up for debate, but perhaps the most urgent question for patients and providers alike has been how long it lasts. A new study analyzing nearly 2 million patient records in Israel concludes that for most people, the troubling symptoms that persist after a mild Covid infection fade away after about a year.

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PharmaVoice

JANUARY 12, 2023

Merck, Bristol Myers Squibb and others are taking small R&D steps in space that could lead to giant leaps for patients.

Drug Development 265

Drug Development 265

Pharmaceutical Technology

JANUARY 8, 2023

In 2023, the pharmaceutical industry will mark 20 years since Xolair, an anti-IgE antibody, became the first biologic approved to treat asthma. Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. Approaches like bronchodilator inhalers focus on treating both asthma and chronic obstructive pulmonary disease (COPD).

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STAT

JANUARY 12, 2023

Ready or not, health care is undergoing a massive transformation driven by artificial intelligence. But medical schools have barely started to teach about AI and machine learning — creating knowledge gaps that could compound the damage caused by flawed algorithms and biased decision-support systems. “We’re going to be at a point where we’re not going to be able to catch up and be able to call out the technology defects or flaws,” said Erkin Ötleş, a

Medical Schools 362

Medical Schools Compounding 362

PharmaVoice

JANUARY 9, 2023

How the IRLAB Therapeutics CEO is guiding the company in its development of potentially groundbreaking Parkinson’s disease treatments.

Drug Development 246

Drug Development 246

pharmaphorum

JANUARY 11, 2023

Over the past few decades, data generation has veritably exploded. However, the ‘Big Data paradigm’ is not so much concerned with the volume of that data, but how businesses and, indeed, industries can derive meaningful insights from what has become a glut of information. With the currently popular approach to artificial intelligence (AI) focussing on the Big Data paradigm, also, pharmaphorum spoke with Adityo Prakash, CEO of Verseon, about the whys and wherefores, delving deeper into the proces

Compounding 122

Compounding Drug Development 122

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PharmExec

JANUARY 11, 2023

As new forms of cell and gene therapies continue to be developed, life sciences companies and payers need to find alternative ways to pay for these expensive treatments. Value-based contracts, though slow to gain traction so far, may provide the solution these groups are looking for.

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STAT

JANUARY 10, 2023

Mistakes happen — in life, in the lab, and, inevitably, in research papers, too. Journals use corrections and retractions to resolve those mistakes. But one particularly high-profile case is now drawing fresh attention to the problems with journals’ process for addressing concerns about research integrity. Late last year, Stanford University announced that it was opening an investigation into its president, neuroscientist Marc Tessier-Lavigne, over allegations of research misconduc

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PharmaVoice

JANUARY 13, 2023

Execs at JPM sound off on moves companies can make to survive the challenging market conditions.

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pharmaphorum

JANUARY 9, 2023

Novartis’ programme providing free access to its spinal muscular atrophy (SMA) gene therapy Zolgensma is being scaled back to a dozen countries worldwide, according to the company. First introduced in 2020, the global Managed Access Programme (gMAP) has provided Zolgensma (onasemnogene abeparvovec) free of charge to nearly 300 children with the genetic disorder across 36 countries where the therapy has not yet received approval or in which no formal access pathway exists.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

European Pharmaceutical Review

JANUARY 13, 2023

The European Pharmacopoeia (Ph. Eur.) Commission (EPC) adopted the revised general monographs 2034 and 2619 , at its 174th session in November 2022 , which now includes a paragraph explaining the Ph. Eur. approach to the control of N -nitrosamine impurities. A paragraph on N -nitrosamines has been added to Substances for pharmaceutical use (2034) under ‘Production’: “ N -Nitrosamines.

Documentation 105

Documentation Vaccines 105

STAT

JANUARY 11, 2023

The air in Mexico City was once so toxic that people watched as dead birds fell out of the sky. In 1992, the United Nations declared the city the most polluted in the world, with its unregulated diesel engines, factory production, fossil-fuel powered energy plants, and widespread use of internal-combustion engines, all trapped in a high-altitude, mountain-lined valley.

Medical Schools 317

Medical Schools 317

PharmaVoice

JANUARY 10, 2023

A breakdown of the most buzzworthy executive changes so far in the new year and how they’re causing ripples in the life sciences industry.

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pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The exclusive deal – which includes an upfront payment of $10 million and up to $340 million in milestone payments at the back end – covers the use of Selecta’s immunoglobulin G (IgG) protease drug IdeXork (Xork) alongside Astellas’ AT845, currently in the phase 1/2 FORTIS study in late-o

Immunization 119

Immunization Immunity Drug Development 119

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

European Pharmaceutical Review

JANUARY 11, 2023

The largest microbiome study conducted at the highest resolution concluded the gut microbiome is involved in multiple pathways in the pathogenesis of Parkinson’s disease (PD). The findings, published in Nature Communications , show a wide imbalance in microbiome composition in people with Parkinson’s. Investigators at the University of Alabama at Birmingham, US employed metagenomics, the study of genetic material recovered directly from the stool microbiome of individuals with PD and neurologica

Communication 105

Communication 105

STAT

JANUARY 10, 2023

The Food and Drug Administration’s approach to evaluating some new medical devices might actually increase the risk that those devices will later be recalled over safety concerns. For some medical devices, the FDA requires data from studies in people to show that the device, including things like implantable heart defibrillators or stents, is safe and effective.

Medical Schools 309

Medical Schools 309

Pharma Times

JANUARY 13, 2023

Company becomes the latest member of the ABPI and galvanises the company’s UK connections

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pharmaphorum

JANUARY 9, 2023

We’re preparing to start JP Morgan week with a busy day Monday, with day 1 of the Informa Biotech Showcase, including a dedicated mini-event on Cell and Gene Therapy in the morning. Then in the evening, we’ll be at STAT@JPM for presentations by event sponsor GSK as well as the guest of honour: FDA Commissioner Robert Califf. Check below for updates throughout the day.

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European Pharmaceutical Review

JANUARY 12, 2023

The European Commission (EC) has approved Xofluza ® (baloxavir marboxil) in children aged one year and above for uncomplicated influenza and post-exposure prophylaxis of influenza. . The European Commission’s approval. The agency’s regulatory approval, based on the results of two Phase III studies, marks the first single-dose, oral influenza medicine approved in Europe for children.

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STAT

JANUARY 13, 2023

Oscar Health has excelled at one thing in particular since its inception a decade ago: burning cash. The health insurance company did not plan to be profitable immediately. It was staking its future on the new Affordable Care Act marketplaces and had to grow quickly to compete with larger insurance carriers. Oscar organized its health insurance product through an app, promoted virtual care, advertised on New York subways, and then low-balled prices in certain markets to attract young, healthy pe

Health Insurance Companies 343

Health Insurance Companies 343

Pharmaceutical Technology

JANUARY 13, 2023

The Biomedical Advanced Research and Development Authority (BARDA) has awarded a multi-year contract to the Sabin Vaccine Institute for developing and producing single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases. BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) of the US Department of Health and Human Services, will initially invest around $35m for the production of up to 100,000 doses of the Ebola Sudan virus (ChAd3-SUDV) vaccine.

Vaccines 98

Vaccines 98

pharmaphorum

JANUARY 10, 2023

mRNA specialist BioNTech has driven its partnership with UK artificial intelligence InstaDeep into top gear, agreeing to buy the company outright in a cash and equity deal that values it at up to £562 million ($683 million). The deal , billed as BioNTech’s largest to date and unveiled at the JP Morgan healthcare conference today, includes $362 million upfront with another £200 million on offer if performance targets are met.

Immunization 116

Immunization Immunity Vaccines 116

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Pharmacy Management

European Pharmaceutical Review

JANUARY 12, 2023

The Sustainable Market Initiative’s (SMI) 2022 Terra Carta Seal , which recognises global companies who are driving innovation and leadership within their industry, has been awarded to pharmaceutical companies GlaxoSmithKline PLC, Sanofi, and Samsung Biologics. Launched in January 2021, Terra Carta is a sustainability recovery plan for Nature, People and Planet.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies 105

STAT

JANUARY 7, 2023

Joan Cohrs missed her chance to grab a prescription at her usual drugstore by about 30 seconds. Cohrs walked up to the counter of an Indianapolis CVS pharmacy shortly after a metal curtain descended, closing it for lunch. She didn’t mind. The 60-year-old said she feels compassion for people in health care.

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The Guardian - Pharmaceutical Industry

JANUARY 10, 2023

Researchers find overall percentage increase from 0.06% in 2000 to 0.11% in 2019 although safety in children not fully established The proportion of children and young people prescribed antipsychotics in England has nearly doubled in just two decades, prompting concern among some experts. The powerful drugs are often used to treat major mental illnesses, such as schizophrenia, in adults.

Diabetes 98

Diabetes 98

pharmaphorum

JANUARY 8, 2023

Before the main event at JP Morgan 2023 even kicks off, we’re checking out the Sachs Associates Neuroscience Innovation Forum on Sunday. Speakers from Lilly, Boehringer Ingelheim, Takeda, and many more pharma firms big and small will present on key trends and developments in one of the most exciting areas of pharmaceutical and digital innovation. We’ll also wander over to the UC Davis Health Future & Health CEO Summit a little later this afternoon.

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European Pharmaceutical Review

JANUARY 13, 2023

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use auto-injector (AI) pen for severe asthma patients over 12 years. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca shared: “Tezspire is the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation.”.

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Labelling 98