September, 2022

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In surprise result, Alzheimer’s drug from Eisai, Biogen shows benefit in large trial

Bio Pharma Dive

The companies said the drug, called lecanemab, met all of its goals in the Phase 3 study. The data are a significant finding and provide stronger support for a much-debated hypothesis for treating Alzheimer’s.

Drugs 363
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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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Opinion: Doctors who knowingly spread Covid-19 lies should be held accountable

STAT News

The California State Legislature has sent a bill to Gov. Gavin Newsom that strengthens discipline for doctors who knowingly spread Covid-19 misinformation. Legislation like this is sorely needed across the country. More than two years into the pandemic, Covid-19 misinformation still runs rampant. Some comes from doctors spreading lies about unproven — and actually harmful — “treatments” for Covid-19 and promoting anti-vaccine conspiracy theories.

Doctors 145
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A box of 200 mosquitoes did the vaccinating in this malaria trial. That's not a joke!

NPR Health - Shots

Volunteers for the trial put an arm over a box with hundreds of mosquitoes carrying a genetically modified malaria parasite. Here's why they did it that way — and why the trial holds promise.

Trials 145
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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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Arcturus announces $63m award from US government to support development of self-amplifying mRNA vaccine

BioPharma Reporter

Arcturus Therapeutics has obtained an award for up to $63.2m from the Biomedical Advanced Research and Development Authority (BARDA): allowing the company to expand its current influenza vaccine program to include development of a pandemic influenza vaccine based on its proprietary self-amplifying mRNA platform.

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The discovery of a new and compounding cybersecurity threat to pharmacies

pharmaphorum

Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc

Pharmacy 138

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Micro-robots, smart toilets, and 3D bioprinted organs: the future of healthcare

Pharmaceutical Technology

It is the year 2030. You have just received the results from your whole genome sequencing test, offered through your public health provider, and discovered that you have a 75% chance of developing a rare form of cancer. But you are not panicking; your genomic data was automatically uploaded, with your permission, to your electronic health record (EHR), which is fully secured with blockchain technology.

Genome 342
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Where caregiving is a family affair, Alzheimer’s places a heavy burden on children and spouses

STAT News

HARLINGEN, Texas — Here in the Rio Grande Valley almost everyone knows, or cares for, someone with dementia. It’s not a surprise. The region has some of the nation’s highest rates of the disease. But what’s less appreciated is the enormity of the burden carried by the mostly Mexican American caregivers. In a culture where caregiving is a family affair, it’s almost unthinkable for children and spouses to place loved ones in nursing facilities or ask for outside

Nurses 145
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After being bitten by a rabid fox, a congressman wants cheaper rabies treatments

NPR Health - Shots

California Rep. Ami Bera was bitten by a rabid fox on Capitol Hill in April. He's OK, but now, he wants to make sure the cost of the lifesaving treatment isn't a burden for those who need it.

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Novo Nordisk teams up with Microsoft for faster and scaled use of AI in drug discovery

BioPharma Reporter

Novo Nordisk and Microsoft have entered a new strategic collaboration to combine Microsoftâs computational services, cloud, and artificial intelligence (AI) with Novo Nordiskâs drug discovery, development, and data science capabilities.

Drugs 119
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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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FDA drops PreCert report, new digital health guidances

pharmaphorum

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

Radiology 135
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Sangamo presses ahead with Fabry disease gene therapy

Bio Pharma Dive

Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase.

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bluebird bio wins back-to-back landmark FDA approvals for first-in-class gene therapies

Pharmaceutical Technology

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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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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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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J&J tried to block lawsuits from 40,000 cancer patients. A court wants answers

NPR Health - Shots

Critics say a legal maneuver by one of the world's wealthiest corporations could set a precedent, allowing non-bankrupt companies and rich individuals to avoid liability for wrongdoing.

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Genetically modified herpes combats advanced cancers

Pharma Times

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

Genetics 152
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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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Sarepta asks FDA to approve first gene therapy for Duchenne muscular dystrophy

Bio Pharma Dive

The application comes a year earlier than previously had been expected, as company says drug reviewers are open to accelerated review based on data from early-stage trials.

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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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AstraZeneca on the hunt for new acquisitions

Pharmaceutical Technology

Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.

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Ebola experimental vaccine trial may begin soon in Uganda

STAT News

A clinical trial of one or perhaps two experimental vaccines designed to protect against the Ebola Sudan virus could soon begin in Uganda, as long as the country agrees to allow the research to take place, an official of the World Health Organization said Wednesday. The trial could get underway within a couple of weeks and definitely before the end of October, said Ana Maria Henao-Restrepo, who heads WHO’s R&D Blueprint effort to develop drugs, diagnostics, and vaccines to respon

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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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CDC Expresses Concern Over New COVID-19 Variant BF.7

XTalks

As health authorities brace for a new wave of COVID-19 this fall, a new variant of the coronavirus has arrived on the scene. The variant, called BA.5.2.1.7 or BF.7 for short, is a spinoff of the Omicron subvariant BA.5, which is currently the dominant SARS-CoV-2 variant in the US. According to the latest data from the Centers for Disease Control and Prevention (CDC), BF.7 made up 1.7 percent of sequenced infections last week.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Bridge Bio will use Brainomix AI in lung fibrosis trial

pharmaphorum

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

Trials 128
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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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Pfizer to deliver up to six million courses of Paxlovid to Global Fund

Pharmaceutical Technology

Pfizer has entered an agreement with Global Fund to deliver up to six million courses of its oral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets), under the Covid-19 Response Mechanism (C19RM). The C19RM has been the main channel to support low- and middle-income nations in procuring Covid-19 therapies, personal protective equipment, tests and vital elements to bolster health systems.

Drugs 278
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STAT+: In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

STAT News

At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.

Drugs 145
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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New York's subway now has a 'you do you' mask policy. It's getting a Bronx cheer

NPR Health - Shots

Millions of New Yorkers embraced an "all in this together" motto during the pandemic — and many are roasting the city's transit agency over updated signs explaining its newly relaxed masking policy.

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Single IRB Approach Can Deliver More Efficient Clinical Trials

ACRP blog

Leveraged wisely by those who understand when and how to best use it, single institutional review board (IRB) review for multisite studies can be employed by clinical trial practitioners to garner faster approvals for clinical studies of vital drugs and other treatments, says Barbara E. Bierer, MD, director of the Regulatory Foundations, Ethics, and the Law Program for Harvard Catalyst, the Harvard Clinical and Translational Science Center.

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Novartis probed by Swiss authorities over ‘unlawful’ patent use

pharmaphorum

The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a “possible unlawful use of a patent to reduce competitive pressure.” The Swiss Competition Commission (COMCO) arrived unexpectedly at Novartis at dawn on Tuesday morning, to gather information on an unidentified dermatology drug, as part of a wider investigation into the drugmaker by the European Commission.

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FDA advisers back Amylyx ALS drug, reversing earlier position

Bio Pharma Dive

Committee members voted 7-2 in support of the experimental medicine, which is under a closely watched FDA review. A decision on approval is expected by the end of the month.

Drugs 351
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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.