January, 2023

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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.

Leads 122
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JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint

Fierce Pharma

JPM23, Day 1: BMS touts new launches as patent cliff looms; Regeneron's Eylea sales disappoint. esagonowsky. Mon, 01/09/2023 - 09:55.

Sales 347
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Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies

MedCity News

A collaboration between Nvidia and startup Evozyne was able to produce novel versions of a human protein never before seen in nature but with enhanced function and the same safety as native protein. The research lays the groundwork for potential new therapies for a rare inherited disorder.

Safety 143
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The impact of climate change on the pharma supply chain

Pharmaceutical Technology

Pharmaceutical supply chains are extremely vulnerable to the effects of climate change and face many challenges from sourcing to distribution. Whether it’s soaring temperatures, extreme cold snaps, or devastating floods, pharmaceutical logistics providers must ensure that shipments reach their destination in their intended condition without defect or delay.

Pharma 142
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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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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

FDA 135

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Artificial Neuron Uses Ions Like the Real Thing

Medgadget

Researchers at Linköping University in Sweden have developed artificial neurons that demonstrate 15 of the 20 characteristics of biological neural cells and can communicate with natural neurons in the body. The researchers call their device the “conductance-based organic electrochemical neuron,” or c-OECN, and it is based on materials that can conduct a negative charge, including organic electrochemical transistors and n-type conducting polymers.

Medical 125
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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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Meet the First Startup to Come Out of UC Davis Health’s Innovation Incubator

MedCity News

UC Davis Health announced the first startup to come out of its health tech innovation incubator. The company, named WellCent, is a platform that allows patients and caregivers to onboard medical devices into their home and access digital health resources.

Medical 142
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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.

Patients 128
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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.

Medical 137
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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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Bioprinted Eye Tissue to Study Retinal Diseases

Medgadget

Researchers at the National Eye Institute, which is part of the National Institutes of Health, have created a method to 3D bioprint eye tissue that forms the outer blood-retina barrier. This tissue supports the photoreceptors in the retina and is implicated in the initiation of age-related macular degeneration. The outer blood-retina barrier is the interface of the retina and the choroid, including Bruch’s membrane and the choriocapillaris.

Patients 118
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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. zbecker. Tue, 01/17/2023 - 11:49.

Safety 326
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Claiming Insulin Price Conspiracy, CA Sues Lilly, Novo Nordisk, Sanofi & PBMs

MedCity News

California’s Office of the Attorney General contends that drugmakers and pharmacy benefit managers work together to “aggressively raise the list price of insulin in lockstep with each other to artificial levels.” Insulin manufacturers deny the allegations, pointing to availability of lower-cost versions of their products.

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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. Major pharmaceutical acquisitions have taken place in recent months in the rare disease space, as the number of orphan drug approvals continues to grow.

FDA 126
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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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Smart Walking Stick for Visually Impaired People

Medgadget

Researchers at the University of Colorado at Boulder have developed a smart walking stick that can assist blind or visually impaired people to navigate their environment, from grocery shopping to finding a seat in a busy café. The system employs cameras to visualize the environment and items within it, such as products in a supermarket, and uses AI to identify objects and provide guidance for the user.

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BMS settles lawsuit with two fired employees who refused COVID vaccines

Fierce Pharma

BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30

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3 Data Management Lessons Healthcare Should Learn from Other Industries

MedCity News

Healthcare could learn from the data improvement strategies that other industries have implemented in the past decade, a new report said. For example, the military, aerospace industry and aviation sector have all developed ways to standardize data, decrease silos and make information more accessible between organizations.

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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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The importance of AI literacy in life sciences

pharmaphorum

The promise and value of artificial intelligence (AI) in life sciences are somewhat obscured by the over-generalisation of this technology. Indeed, a major misconception surrounding AI is that it’s just tech or some intangible software that we can’t understand, when, in fact, AI itself is a tool for understanding. For life sciences companies, who must continuously sift through copious amounts of data to decipher actionable insights to inform strategic decisions, AI maximises the time and money

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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

Patients 115
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Point-Of-Care Biosensor to Detect Oral Cancer

Medgadget

Researchers at the University of Florida have created a point-of-care biosensor that can rapidly detect a biomarker for oral cancer. The device uses test strips, such as those used in blood glucose tests, to spot cell proliferation regulating inhibitor of protein phosphatase 2A (CIP2A), a protein biomarker that can reveal the presence of oral cancer.

Medical 116
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JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023

Fierce Pharma

JPM23: Moderna reaped $18.4B in COVID vaccine sales last year, projects at least $5B in 2023. kdunleavy. Mon, 01/09/2023 - 10:34.

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Withings Unveils Urine Analysis Device That Sits in Your Toilet Bowl

MedCity News

Withings announced that it is developing a miniaturized platform that can analyze urine at home. The device, called U-Scan, sits within a toilet bowl and assesses specific biomarkers found in urine.

Medical 136
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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.

Medicine 119
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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.

Pharma 122
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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.

FDA 113
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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.

Media 111
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JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says

Fierce Pharma

JPM23: Pfizer entering the 'most important' 18-month stretch in company history, CEO says. esagonowsky. Tue, 01/10/2023 - 08:51.

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Biotech Financing Roundup: Belharra, NextPoint, Pathalys & More

MedCity News

Cancer continues to be a hot area of investment, and it’s the therapeutic focus of several biotech companies that have closed recent rounds of financing. Meanwhile, the investment arm of a big pharmaceutical company has an infusion of new cash to deploy in therapeutic and digital investments.

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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).

Patients 119