September, 2023

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New RSV vaccines can be powerful tools, but rollout poses test

Bio Pharma Dive

Public health officials, as well as drugmakers, are trying to raise awareness of RSV among older adults at risk, and convince them to get an additional respiratory shot alongside those for COVID and flu.

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Generative AI-focused biotech startup Evozyne raises $81m

Pharmaceutical Technology

The company’s algorithms put proteins through millions of years of simulated evolution to identify potential functional candidates.

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Anthos Stops Mid-Stage Atrial Fibrillation Trial Due to ‘Unprecedented’ Efficacy

BioSpace

After evidence of “overwhelming reduction” in bleeding compared to Bayer and J&J’s Xarelto, Anthos Therapeutics has ended its Phase II atrial fibrillation study for abelacimab ahead of schedule.

Trials 145
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Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Fierce Pharma

Out with the old and in with the new: Monday, the U.S. | The FDA has approved Pfizer and Moderna’s separate vaccine formulations that target current variants of the disease. Each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old.

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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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Neuroplast spinal cord injury study milestone

Pharma Times

The trial analyses the impact of its ‘Neuro-Cells’ among patients with traumatic spinal cord injuries - News - PharmaTimes

Trials 146
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Oregon Project Extends Benefits of Clinical Trials to More Hispanics/Latinos

ACRP blog

With observations of National Hispanic Heritage Month kicking off on September 15, this year’s events will have special resonance for a team of Oregon Health & Science University (OHSU) researchers who are working to bring the benefits of clinical trials to more persons in underserved communities. Eneida R. Nemecek, MD, MS, MBA, an endowed professor of pediatrics and medical oncology and Medical Director of Clinical Research at the Knight Cancer Institute of OHSU, recently received a $625,00

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ADDF invest in BrainScope for Alzheimer’s prediction biomarker

Pharmaceutical Technology

The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.

Research 324
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10 Promising Therapies for Hard-to-Treat Cancers

BioSpace

In honor of World Cancer Research Day, BioSpace takes a deep dive into 10 therapeutic candidates with the potential to change the treatment landscape in lung, breast, colorectal cancer and more.

Research 137
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Merck and Eisai's Keytruda-Lenvima combo chalks up 2 more losses, this time in non-small cell lung cancer

Fierce Pharma

Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. | Merck and Eisai’s Keytruda-Lenvima tag team can’t seem to catch a break. Following a series of trial shortfalls this year in melanoma, colorectal cancer and head and neck squamous cell carcinoma, the duo has missed the mark in yet another set of clinical trials—this time in non-small cell lung cancer.

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Clinical trial phases: What’s the difference?

Antidote

Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed. Before any new treatment becomes available on the market, it must go through this process, as required by the FDA.

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Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

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Psycheceutical Q&A: Could topical ketamine transform PTSD treatment?

BioPharma Reporter

Psychedelics have re-emerged in the world of medicine as promising treatments for various mental health conditions, particularly post-traumatic stress disorder (PTSD).

Medicine 126
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Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

Bio Pharma Dive

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

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Nestlé divests peanut allergy treatment Palforzia to Stallergenes Greer

Pharmaceutical Technology

Nestlé has sold its peanut allergy drug Palforzia to Swiss biopharma Stallergenes Greer harma, concluding a year-long strategic review.

Allergies 299
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mRNA Vaccine Manufacturing Comes to Africa

BioSpace

The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.

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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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Novo, Lilly set to dominate $71B GLP-1 drug market by 2032: J.P. Morgan

Fierce Pharma

Demand is so strong for Novo Nordisk’s obesity drugs that the only limitation on sales—in the short term—seems to be the company’s ability to produce them. | Promising heart data for Novo Nordisk's Wegovy are a "paradigm shift," according to J.P. Morgan, which has doubled its market projection for GLP-1 diabetes and obesity treatments to $71 billion for 2032.

Drugs 139
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9 common misconceptions about clinical trial participation

Antidote

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

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AstraZeneca and SAS link up on AI and analytics

Pharma Times

Collaboration will enable teams across the organisation to increase clinical research innovation - News - PharmaTimes

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Biogen, continuing executive revamp, finds a new research head

Bio Pharma Dive

Jane Grogan, an industry veteran who worked at Genentech for over 15 years, will take over the role starting Oct. 2. She’ll fill a seat that's lacked a permanent replacement since the departure of Al Sandrock.

Research 302
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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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Signal: Kroger to pay up to $1.4bn to settle opioid crisis lawsuits

Pharmaceutical Technology

Kroger's settlement, alongside the review of the Purdue Pharma bankruptcy case, is proof that the opioid reckoning isn't over yet.

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Four Neurodegenerative Trials to Watch in Q4

BioSpace

Pivotal clinical trials in Alzheimer’s disease, Huntington’s disease, amyotrophic lateral sclerosis and multiple sclerosis are expected to read out this fall. Here's a closer look.

Trials 127
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Novartis targets first-line use for radiotherapy Lutathera with trial win in neuroendocrine tumors

Fierce Pharma

More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.

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Biopharma’s rapid transition to omnichannel marketing

pharmaphorum

In today’s episode, sponsored by Veeva, we’ll hear a roundtable discussion on this fascinating topic featuring Victoria Serra Gittermann, European customer experience lead at Veeva Systems and Sebastian Noel, Veeva’s director of multichannel strategy – moderating a discussion with two executives with first-hand experience leading this change: Andy Eeckhout, global head of CRM and digital solutions at Advanz Pharma and Mokhtar Elsayed, head of global go to market commercial transformation at Sano

Marketing 122
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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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A World Alzheimer's Month resource roundup

Antidote

Alzheimer’s disease, the most prevalent type of dementia , is diagnosed in more than 6 million Americans. Estimates project that by 2050, 13 million individuals will be diagnosed with Alzheimer’s disease. This condition ranks among the top 10 causes of death in the United States, profoundly impacting those diagnosed, their loved ones, and their caregivers.

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FDA approves updated COVID boosters from Pfizer, Moderna

Bio Pharma Dive

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect to make the reformulated shots available in the U.S. in the coming days.

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FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy

Pharmaceutical Technology

The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.

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Gilead Axes Phase III Magrolimab Trial Based on Disappointing Data

BioSpace

After picking up magrolimab in a $4.9 billion purchase of Forty Seven, a second Phase III study is being discontinued for the anti-CD47 antibody, this time in acute myeloid leukemia.

Antibody 121
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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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Decades-long regulatory odyssey ends with FDA nod for Fabre-Kramer's depression med Exxua

Fierce Pharma

Fabre-Kramer Pharmaceuticals' major depressive disorder (MDD) drug gepirone has been rejected by the FDA not once, not twice, but three times since the turn of the millennium. | Fabre-Kramer's Exxua suffered three prior FDA rejections before scoring an FDA approval for major depressive disorder last week. Its label doesn't include sexual dysfunction as an adverse reaction, which is rare among antidepressants.

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Brainomix’s e-Lung enters TIPAL trial

Pharma Times

The company will use its AI technology during a sub-study to analyse the effect of lansoprazole - News - PharmaTimes

Trials 141
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Women in Science: ScaleReady’s Jenny Stjernberg and her fervent passion for cell and gene therapies

BioPharma Reporter

At Advanced Therapies Europe 2023, BioPharma Reporter caught up with ScaleReady's Jenny Stjernberg to discuss her work at the biotech company, her journey from academia to commercial and female representation in the cell and gene therapies industry.

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Otsuka taps Shape in deal to design eye gene therapies

Bio Pharma Dive

Shape uses machine learning and high throughput screening to identify new AAV capsids in ways the company’s CEO compares to the generative AI tools Midjourney and DALLE-2.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!