January, 2023

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STAT+: Pfizer is scolded by a U.K. trade group for remarks its CEO made about vaccination

STAT

After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.

Vaccines 363
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Forks in the road lead one medical expert to a ‘game changing’ liver treatment

PharmaVoice

Durect’s chief medical officer altered his retirement plans to take a leading role at the company, which is developing a treatment for severe alcohol-associated hepatitis.

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Google and DeepMind share work on medical chatbot Med-PaLM

pharmaphorum

Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.

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Major study on DMT shows promise for depression

European Pharmaceutical Review

The first major study on the efficacy of DMT in treating any mental health condition showed a remission rate of 57 percent following a single dose, in a Phase IIa trial for major depressive disorder (MDD). “SPL026 (intravenous DMT) with supportive therapy was shown to have a significant antidepressant effect that was rapid and durable, with a remission rate of 57 percent at three months following a single dose of SPL026,” stated Dr Carol Routledge, Chief Medical and Scientific Officer at Small P

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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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Health Canada gives approval to Enhertu for breast cancer treatment

Pharmaceutical Technology

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.

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New Report: More than 160 medicines in development for mental illness

PhRMA

Mental illness represents a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree of severity, ranging from mild to moderate to severe, and may occur together.

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After ‘limping along,’ Novavax sees a path forward

PharmaVoice

With a new CEO and a long-term booster strategy, the company believes there’s plenty of room to grow in the COVID-19 vaccine space.

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

pharmaphorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe

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Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

This Q&A covers the key developments in pharmaceutical microbiology in 2022, featuring insight from pharmaceutical microbiology experts: Dr Tim Sandle, Head of Microbiology, Bio Products Laboratory Limited. Dr Tony Cundell, PhD, Principal Consultant, Microbiological Consulting, LLC. Miriam Guest, Principal Microbiologist at AstraZeneca. Regulation, particularly Annex 1, was identified as a key focus for 2022.

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AI continues to gain momentum in the biopharmaceutical industry in 2023

Pharmaceutical Technology

While the biopharmaceutical industry has been impacted and pressured by various factors such as the Covid-19 pandemic, inflation, the Ukraine-Russia war, ongoing supply chain issues, and a challenging economic environment, collaboration between pharma companies and emerging technologies providers continues to grow, especially in the research and development (R&D) field, offering some resilience in times of geopolitical and economic disruptions.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Let’s Get Social: The Ascendancy of Social Media to the Top of the Media Mix

PharmExec

Fran Pollaro talks with Amanda Powers-Han, chief marketing officer at Greater Than One, a full-experience marketing agency dedicated to healthcare, about what’s trending in early 2023 for pharma media mixes.

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Routine vaccinations drop among U.S. kindergartners for the third year in a row

STAT

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
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Patients are using social media — clinical trial experts can learn from that

PharmaVoice

Why an alliance of industry leaders is exploring the potential of social media as a treasure trove of real-world patient experience insights.

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Bayer taps Google’s quantum power for drug discovery

pharmaphorum

Bayer has signed an agreement with Google aimed at using high-level processing power to handle quantum chemistry calculations used to predict the chemical and physical properties of drug molecules at the atomic scale. The deal with the tech giant’s Google Cloud unit revolves around its tensor processing units (TPUs), artificial intelligence-powered accelerators designed to run machine learning models and computationally-intensive workloads that can be customised to specific applications.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

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.

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First CAR T-cell therapy recommended on NHS

European Pharmaceutical Review

Yescarta ® ▼(axicabtagene ciloleucel; axi-cel) is now the first chimeric antigen receptor (CAR) T-cell therapy and first personalised immunotherapy to be recommended for routine use on the NHS in England. This is based on final draft guidance from the National Institute for Health and Care Excellence (NICE). The therapy by Gilead Sciences and Kite is indicated for eligible adults with diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) who have already bee

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CARsgen and Huadong Medicine to commercialise CT053 in mainland China

Pharmaceutical Technology

CARsgen Therapeutics has announced a col labor ation with Huadong Medicine to commercialise zevorcabtagene autoleucel (zevor-cel), CT053, in mainland China. The fully human, autologous BCMA CAR T-cell product candidate of CARsgen, CT053 has been developed to treat relapsed/refractory multiple myeloma (R/R MM). It comprises autologous T cells that are modified genetically with a CAR including a complete human anti-BCMA single-chain fragment variant that has a high binding affinity.

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Stars Aligned for Pricing Model? Value-Based Contracts May be Poised for Takeoff

PharmExec

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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For most mild infections, long Covid symptoms clear after a year, large study finds

STAT

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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Position Your Pharmacy for Expansion

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.

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AstraZeneca’s newest asthma launch fills a gap as generics chip away at respiratory flagships

PharmaVoice

A longtime leader in the respiratory space, AstraZeneca has hammered another stake in the ground with its newest asthma treatment, Airsupra.

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A new dawn of the genomic age: five areas set to be transformed in 2023

pharmaphorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.

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Personalised cancer immunotherapy granted fast track designation

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Evaxion Biotech’s personalised cancer immunotherapy. The FTD is for EVX-01, in combination with Keytruda ® for patients with metastatic melanoma (MM). ”We are extremely pleased that our cancer vaccine candidate EVX-01 has received the FDA fast track designation, as it enables a potentially faster approval of the vaccine,” stated Per Norlén, CEO at Denmark-based Evaxion.

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Are we entering the era of biologics for COPD?

Pharmaceutical Technology

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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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Amvuttra recommended by NICE for amyloidosis

Pharma Times

Therapy is among the first to receive a positive draft recommendation under streamlined pilot process

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Medical schools are missing the mark on artificial intelligence

STAT

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

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Space — the next frontier in drug development

PharmaVoice

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

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AI and the Big Data paradigm – big ambitions in novel drug discovery

pharmaphorum

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

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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FDA approves long-acting injectable for schizophrenia and bipolar disorder

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Rykindo ® (risperidone) for extended-release injectable suspension. The drug is indicated as a bi-weekly treatment for schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for bipolar I disorder in adults. Rykindo ® is an atypical antipsychotic developed by Luye Pharmaceutical.

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Cell therapies might revolutionise treatment for multiple sclerosis patients

Pharmaceutical Technology

While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.

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Technology as a New Evolution in Fighting Disease

PharmaTech

Advancing the use of AI to understand the whole of a disease can reveal drug development insights that lead to drug discovery breakthroughs.

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STAT+: Medicare Advantage insurers to repay billions under final federal audit rule

STAT

The federal government will audit Medicare Advantage insurers aggressively under a rule finalized Monday, which is expected to result in billions of dollars in overpayments going back toward Medicare’s trust fund and patients over the next decade. However, federal officials watered down one of the auditing policies by giving insurers seven years of immunity from having the samples of their diagnosis coding errors extrapolated to their broader Medicare Advantage membership.

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Vaxxinity eyes global COVID-19 vaccine market with ‘next-gen’ booster

PharmaVoice

The biotech aims to complete rolling submissions with regulators in the U.K. and Australia in the first half of 2023.

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