Wed.Sep 13, 2023

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Moderna aims for the stars again with ambitious drug development plan

Bio Pharma Dive

The biotech is telling investors it expects to launch as many as 15 new products in five years, a bold goal that will require a lot to go right to pull off.

Drugs 291
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FDA to start review of subcutaneous Entyvio for Crohn’s disease

Pharmaceutical Technology

The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.

Drugs 264
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FDA panel backs Alnylam drug despite doubts over benefit

Bio Pharma Dive

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

Drugs 190
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Eli Lilly’s Mounjaro approved on NHS for use in type 2 diabetes

Pharmaceutical Technology

Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).

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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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Akili cuts 40% of workforce, plans shift to non-prescription model

Bio Pharma Dive

The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

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Results from Rybrevant trial solidify Janssen’s foothold in EGFR-mutated NSCLC

Pharmaceutical Technology

Currently, NSCLC patients with EGFR exon 19 deletions or L858R substitution face limited therapeutic options after seeing disease progression post-front-line treatment.

Trials 130

More Trending

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Vaxess raises $9m to accelerate mRNA vaccine patch development

Pharmaceutical Technology

The patch allows for vaccine storage and transport at room temperature along with at-home administration.

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Grand Rounds September 8, 2023: The DEVICE Trial: An Embedded, Pragmatic Trial of Emergency Airway Management (Matthew Prekker, MD, MPH; Jonathan Casey, MD, MSc)

Rethinking Clinical Trials

   Speakers Matthew Prekker, MD, MPH Associate Professor of Emergency Medicine and Pulmonary and Critical Care Medicine Hennepin County Medical Center University of Minnesota Medical School Jonathan Casey, MD, MSc Assistant Professor of Pulmonary and Critical Care Vanderbilt University Medical Center Director, Coordinating Center, Pragmatic Critical Care Research Group Slides Keywords Critical Care Medicine, Pragmatic Trial, DEVICE, Laryngoscope Key Points Emergency tracheal intubation is a c

Trials 147
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Avalo drops three rare disease assets amid ongoing challenges

Pharmaceutical Technology

The company will divest the AVTX-800 rare disease compound series to AUG Therapeutics, with an expected completion in Q4 2023.

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September 13, 2023: PCT Grand Rounds to Feature Real-World Trial of Food Choice Incentives for Lower-Income Adults

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Pasquale Rummo of the NYU Grossman School of Medicine will present “Effect of Financial Incentives and Default Options on Food Choices of Adults With Low Income in Online Retail Settings.” The Grand Rounds session will be held on Friday, September 15, 2023, at 1:00 pm eastern. Rummo is an associate professor of population health in the NYU Grossman School of Medicine.

Trials 147
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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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Bristol Myers Squibb’s Reblozyl reinforces market share in first-line MDS Space

Pharmaceutical Technology

On August 28, the FDA approved the label expansion of Bristol Myers Squibb’s Reblozyl, which is set to improve MDS patients’ quality of life.

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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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FDA calls out eight companies for selling unapproved eye drugs

Pharmaceutical Technology

The US Food and Drug Administration has sent letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.

Drugs 130
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It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

Drugs 124
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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.

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Dewpoint and Chemify partner for cancer drug discovery

Pharmaceutical Technology

Dewpoint Therapeutics entered a collaboration with Chemify to expedite the discovery of molecules that target cancer and neurodegeneration.

Drugs 130
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HHS argues Merck 'lacks standing' to sue over Medicare price negotiations

Fierce Pharma

Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). | Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing.

Drugs 122
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Do diet drugs pull their weight?

Pharmaceutical Technology

Diet and weight-loss drugs have entered the public consciousness, particularly for their usefulness in treating obesity-related diabetes.

Drugs 130
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Moderna Axes Four Clinical Development Programs, Two AstraZeneca Had Dropped

BioSpace

During Wednesday’s annual R&D Day, Moderna said it is culling four programs from its pipeline, including two molecules that had been discontinued last year by AstraZeneca.

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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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Axolotl Biologix and Carmell Therapeutics enter merger deal

Pharmaceutical Technology

Moonshot incubator client Axolotl Biologix has finalised a merger with Carmell Therapeutics to bolster the regenerative medicine sector.

Medicine 130
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Generate Raises $273M in Series C Financing with New Investors Amgen, NVIDIA

BioSpace

In the largest biotech Series C financing so far this year, Generate:Biomedicines picked up new investors including Amgen and NVIDIA’s venture capital arm to advance its pipeline of 17 programs.

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Signal: Roche to refile subcutaneous Tecentriq with FDA after UK approval

Pharmaceutical Technology

Roche planned to launch its new subcutaneous Tecentriq formulation this year, but it will be pushed back after tweaks requested by FDA.

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Insights into New Alzheimer’s Treatments: Treating Agitation and First THC-Based Therapeutic in Trials — Interview with IGC’s Ram Mukunda and Claudia Grimaldi – Xtalks Life Science Podcast Ep. 127

XTalks

This episode features an interview with Ram Mukunda and Claudia Grimaldi from IGC Pharma , a clinical-stage pharmaceutical company focused on improving the health and well-being of patients affected by Alzheimer’s disease and bringing therapies for it to market. The company is currently conducting a Phase II study with IGC-AD1, an investigational low-dose tetrahydrocannabinol-(THC) based formulation that reduces neuropsychiatric symptoms such as agitation in dementia due to Alzheimer’s.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Menarini signs agreement for Astellas’s rheumatoid arthritis therapy

Pharmaceutical Technology

Menarini Asia-Pacific has entered a long-term exclusive agreement to license Astellas Pharma’s Smyraf to treat rheumatoid arthritis.

Licensing 130
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New Biotech Targets Rare Respiratory Disorders with Inhaled Gene Therapies

BioSpace

AlveoGene has licensed the U.K. Respiratory Gene Therapy Consortium’s InGenuiTy platform for all uses excluding the CTFR gene, which is already licensed to Boehringer Ingelheim for cystic fibrosis.

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Hasten and LIB Therapeutics enter $325m CVD drug development deal

Pharmaceutical Technology

Hasten Biopharmaceutical has signed an agreement to develop and commercialise LIB Therapeutics’ lerodalcibep in Greater China.

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Moderna looks to scale back manufacturing for COVID booster to cope with falling demand: Reuters

Fierce Pharma

While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.

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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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AbbVie Passes on License Option for Harpoon’s TriTAC Multiple Myeloma Program

BioSpace

The company declined to exercise the license option for Harpoon Therapeutics’ TriTAC HPN217 program for multiple myeloma, which targets B cell maturation antigen, or BCMA.

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Moderna CEO expects endemic COVID vaccine market will take ‘a few years’ to fully develop

Fierce Pharma

Moderna has spent the last several years riding the ups and downs of the COVID-19 pandemic. | Moderna CEO Stéphane Bancel is optimistic that the company will beat the low end of its $6 billion to $8 billion COVID vaccine sales estimate for 2023. But his optimism comes as Moderna reportedly eyes manufacturing cuts as it shifts to an endemic market response.

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Biopharma Career Fairs Make a Powerful Comeback

BioSpace

In-person events have seen a flood of demand from students who want to meet biopharma employers personally, find employers in their area and scope out the industry scene.

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5 reasons why it's so hard to find clinical trial volunteers

Antidote

Globally, there are thousands of research studies and clinical trials conducted each year, all with the shared goal of bringing new treatment options and medical devices to the market. However, approximately 80% of clinical trials are delayed or closed because of problems with recruitment.

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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