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

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FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

Drugs 348
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Is Apple that naive when it comes to compliance?

World of DTC Marketing

Apple’s Health app gets new capabilities with iOS 16. The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. Will it matter? The health app will also tell users about potential interactions between medications, and it’s possible to connect with healthcare providers to see a list of past medications, get future updates, or add items to your schedule.

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IPO refuses patent to Mitsubishi for diabetes drug teneligliptin following pre-grant opposition by Glenmark Pharma

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Patent Office (IPO) has refused the patent application of Japanese drug maker Mitsubishi Tanabe Pharma Corporation for exclusive rights for its innovation related to type 2 diabetes drug teneligliptin, in favour of a pre-grant opposition filed by Mumbai-based pharma major Glenmark Pharmaceuticals Ltd. The company filed the patent application on July 11, 2012 […].

Drugs 165
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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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Third Harmonic boosts biotech with sector’s top IPO in four months

Bio Pharma Dive

The startup’s $185 million initial public offering is the largest for the sector since early May and potentially a sign of renewed investor interest in young biotechs.

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Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients. The guideline update comes after the treatment received recommendation from the health agency for treating non-severe Covid-19 in patients at increased risk of hospitalisation.

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ABAC Therapeutics embarks on research for antibiotics to combat drug resistant gram-negative bacteria

AuroBlog - Aurous Healthcare Clinical Trials blog

ABAC Therapeutics, together with the artificial intelligence (AI) company Peptris and the Foundation for Neglected Disease Research (FNDR), with scientific support from Medicines for Malaria Venture (MMV), has collaborated to optimize a new chemical structure that has shown effectiveness against gram-negative bacteria, the current threat to public health.

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Intellia offers first look at CRISPR drug for rare swelling disorder

Bio Pharma Dive

Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited.

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Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.

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Syntegon Group appoints Dr. Peter Hackel as Chief Financial Officer

Pharma Mirror

Waiblingen/Germany, The Syntegon Group, a globally leadingsupplier of processing and packaging technology, intends to appoint Dr. Peter Hackelas member of the Executive Board at the beginning of 2023. In his new position, asChief Financial Officer (CFO) Peter Hackel will be responsible for Finance &Controlling, Foreign Trade and IT of Syntegon. He will be located at Beringen,Switzerland.Peter Hackel is a well-rounded, highly accomplished executive, experienced withinSales as well as in Finan

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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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September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

Rethinking Clinical Trials

Dr. Tor Biering-Sørensen. In this Friday’s PCT Grand Rounds, Dr. Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The Grand Rounds session will be held on Friday, September 16, 2022, at 1:00 pm eastern. Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and Pragmatic Randomized Trials at the University of Copenhagen and head of the Cardio

Trials 130
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AstraZeneca claims positive results for its “add-on” drug for rare blood disease

Bio Pharma Dive

The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019.

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FDA and NIH partner for neurodegenerative disease treatment development

Pharmaceutical Technology

The US Food and Drug Administration (FDA) and the US National Institutes of Health (NIH) have unveiled a public-private partnership (PPP) to understand and develop treatments for neurodegenerative diseases. Named the Critical Path for Rare Neurodegenerative Diseases (CP-RND), the partnership will be convened by the Critical Path Institute (C-Path). It will focus on developing therapies for amyotrophic lateral sclerosis (ALS) and various other rare neurodegenerative diseases.

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Scientists debate how lethal COVID is. Some say it's now less risky than flu

NPR Health - Shots

They argue the threat posed by COVID has lessened because of preexisting immunity and access to treatment. Plus, some deaths may be incorrectly blamed on COVID. Others caution it's too soon to tell.

Scientist 145
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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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STAT+: USDA starts cracking down on companies that ship animals without timely inspections

STAT News

Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research labs for allegedly violating federal law after finding numerous instances where nearly 2,000 monkeys were shipped between facilities without required veterinary inspections. Now, the federal government appears to be acting.

Research 145
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Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data.

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ESMO 2022: the evolution of TIL therapy – a highly promising approach

Pharmaceutical Technology

Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years. As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Before TIL infusion, the patient undergoes lymphodepletion, which reduces the proportion of myeloid immune suppressive cells and creates space for the incoming lymphocytes.

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The first abortion ban passed after Roe takes effect Thursday in Indiana

NPR Health - Shots

Thursday, nearly all abortions must cease in Indiana after state lawmakers passed a full ban in August. Since Dobbs , Indiana has been a destination for those in surrounding states seeking abortions.

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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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Opinion: 6 tactics to make artificial intelligence work on the frontlines

STAT News

Artificial intelligence is a transformative tool in the workplace — except when it isn’t. For top managers, state-of-the art AI tools are a no-brainer: in theory, they increase revenues, decrease costs, and improve the quality of products and services. But in the wild, it’s often just the opposite for frontline employees who actually need to integrate these tools into their daily work.

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Mitochondrial drugs, with a twist: Pretzel Therapeutics launches with $72.5M in funding

Bio Pharma Dive

Scientists at Pretzel believe fixing mutated mitochondrial DNA with a mix of small molecule therapies and gene editing could be key to solving a number of hard-to-treat diseases.

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US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy. It should not be used along with other immunosuppressants.

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How a Texas court decision threatens Affordable Care Act protections

NPR Health - Shots

The ACA has required health insurers to provide many medical screenings and other preventive services with no out-of-pocket cost to health plan members. But a recent court decision could upend that.

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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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STAT+: Akero treatment for NASH reduces liver scarring, achieves goals of mid-stage study

STAT News

Akero Therapeutics said Tuesday that an experimental medicine improved liver scarring at twice the rate of a placebo without worsening other symptoms — achieving the main goal of a mid-stage clinical trial involving patients with the fatty liver disease known as NASH. If the encouraging study results are confirmed in later Phase 3 clinical trials, the Akero drug, called efruxifermin, could become an effective treatment for a chronic disease that has grown into one of the leading causes of

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Bristol Myers gets FDA approval for new type of psoriasis drug

Bio Pharma Dive

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

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ESMO 2022: neoadjuvant or adjuvant immunotherapy for locally advanced cancers?

Pharmaceutical Technology

The advent of immune checkpoint inhibition has arguably been the greatest breakthrough for the treatment of metastatic solid tumours, with durable complete responses observed across multiple cancer types. With success in the metastatic setting, pharma companies, researchers and physicians have invested heavily in exploring the use of immune checkpoint inhibitors (ICIs) for the treatment of locally advanced disease, hoping to increase response rates and prevent disease progression.

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The future of AI drug discovery & development in immunology and GPCR research

pharmaphorum

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. A mere six months ago Verily launched the study with Sosei Heptares – a global leader in GPCR structure-based drug design – with an aim to “prioritise protein targets for therapeutic targeting in immune-mediated disease”.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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With increased virus activity, providers urged to be alert for signs of rare polio-like syndrome in kids

STAT News

Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.

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Pfizer brings mRNA flu vaccine into Phase 3 testing

Bio Pharma Dive

The trial, expected to enroll 25,000 adults, is the second late-stage test of an mRNA flu shot to begin this year, following the June start of a Moderna study.

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Novavax and SII receive registration for Covid-19 vaccine in South Africa

Pharmaceutical Technology

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. The protein-based vaccine is indicated as a two-dose initial regimen for active immunisation for the prevention of Covid-19 in adults aged 18 years and above.

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A boil-water notice has been lifted in Jackson, Miss., after nearly 7 weeks

NPR Health - Shots

But a state health department official said concerns remain about copper and lead levels in the city water. The official said people should continue to avoid using it to prepare baby formula.

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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.