Sat.Sep 09, 2023 - Fri.Sep 15, 2023

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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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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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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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 approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine

Pharmaceutical Technology

The US FDA has approved Pfizer and BioNTech’s sBLA for Omicron XBB.1.5-adapted monovalent Covid-19 vaccine, COMIRNATY 2023-2024 Formulation.

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RayzeBio’s $311M, Neumora’s $250M IPOs Among Biotech’s Largest This Year

BioSpace

The two biotech companies announced initial public offering pricing Thursday, respectively, with shares beginning trading Friday and valued at more than $560 million cumulatively.

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New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs

Bio Pharma Dive

Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

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SparingVision shares trial updates for rare eye disease gene therapies

Pharmaceutical Technology

The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.

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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.

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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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The Alzheimer’s Treatment Landscape: Leqembi vs. Donanemab

BioSpace

With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.

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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.

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Calibrating cold chain systems for cell and gene therapies in a post-pandemic world

Pharmaceutical Technology

Pharmaceutical supply chain partners are trying to create an efficient cold chain system to transport cell and gene therapies.

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AstraZeneca, working to grow Fasenra’s reach, touts positive trial against GSK's Nucala in new use

Fierce Pharma

Competing to treat patients with severe eosinophilic asthma (SEA), AstraZeneca has fared well matching its IL-5 inhibitor Fasenra up against GSK’s Nucala. | AstraZeneca's Fasenra has achieved its primary endpoint in a phase 3 trial, demonstrating noninferior rates of remission in a head-to-head battle against GSK's Nucala in patients with eosinophilic granulomatosis with polyangiitis.

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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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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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Flagship-backed Generate raises $273M as its first drugs move to the clinic

Bio Pharma Dive

Since 2019, Generate has raised nearly $700 million in private financing and has now brought a monoclonal antibody into Phase 1 testing.

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Cure Genetics and Frametact seek gene cures for neurological ailments

Pharmaceutical Technology

Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.

Genetics 246
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J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

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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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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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UK biotech AlveoGene launches with plans for inhaled gene therapy

Bio Pharma Dive

The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.

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BioLineRx’s Aphexda receives FDA approval for stem cell mobilisation

Pharmaceutical Technology

BioLineRx has received the US Food and Drug Administration approval for Aphexda plus filgrastim to mobilise haematopoietic stem cells.

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FDA raises questions about Onpattro's efficacy in Alnylam's bid to challenge Pfizer in lucrative heart disease use

Fierce Pharma

Ahead of an important advisory committee meeting, the FDA has raised serious questions about Alnylam’s bid to expand Onpattro into a much larger group of patients with transthyretin amyloidosis (AT | The FDA has raised questions about Alnylam's Onpattro as the company seeks to expand the drug into a much larger group of patients with transthyretin amyloidosis (ATTR).

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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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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2Seventy CEO Leschly to step down as company cuts staff, spending

Bio Pharma Dive

Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back some of its research spending.

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CancerVAX joins forces with UCLA to develop a universal CAR-T cell therapy

Pharmaceutical Technology

CancerVAX plans to adapt its universal cancer vaccine platform to develop a universal CAR-T cell platform.

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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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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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FDA Questions Efficacy of Alnylam’s Drug in ATTR-CM Ahead of Adcomm Meeting

BioSpace

The agency's briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.

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Actio, a precision medicine startup, launches with $55M and a mouse lab partnership

Bio Pharma Dive

The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

Medicine 269
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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.

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Advanced Therapies Europe: From bench to bedside and boardroom

Drug Discovery World

Advanced Therapies Europe took place from 9-12 September 2023 in Portugal. DDW’s Megan Thomas asked attendees: What is most important to scale from discovery to commercialisation of cell and gene therapies (CGTs)? Joel Eichmann, Co-Founder, Green Elephant Biotech It always comes down to time-to-market and risk minimisation. To cover these, it is critical to choose [.

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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.