Sat.Apr 29, 2023 - Fri.May 05, 2023

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Ovid partners with Waksal startup to develop drugs for rare brain disorders

Bio Pharma Dive

Founded by Sam Waksal, Graviton Biosciences is developing drugs that block an enzyme called ROCK2, which drew the interest of neurology-focused Ovid.

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Astellas Pharma agrees to buy Iveric bio for about $5.9bn

Pharmaceutical Technology

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share. Both the companies’ Boards of Directors have unanimously approved the deal.

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What really killed COVID-19 patients: It wasn't a cytokine storm, suggests study

Medical Xpress

Secondary bacterial infection of the lung (pneumonia) was extremely common in patients with COVID-19, affecting almost half the patients who required support from mechanical ventilation. By applying machine learning to medical record data, scientists at Northwestern University Feinberg School of Medicine found that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19.

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ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win

Fierce Pharma

ImmunoGen touts 'home run' as ovarian cancer drug Elahere extends lives in landmark trial win aliu Wed, 05/03/2023 - 14:50

Trials 136
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

Bio Pharma Dive

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

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Forge Biologics and Labcorp partner for gene therapies development

Pharmaceutical Technology

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Gene therapy clients will gain access to coordinated scientific expertise, drug development services and AAV manufacturing capabilities, advancing the development of new gene therapies.

More Trending

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World Asthma Day 2023: New and Promising Treatments for Asthma

XTalks

World Asthma Day 2023 is on May 2. This annual event is marked on the first Tuesday of May to boost awareness about asthma and help improve asthma care all over the world. The day was first organized in 1998 by the Global Initiative for Asthma (GINA) , a collaboration between healthcare professionals and public health officials, and has since been observed every year.

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J&J, building on CAR-T success, strikes another cell therapy deal

Bio Pharma Dive

Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.

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Vertex secures FDA clearance for infants’ cystic fibrosis therapy

Pharmaceutical Technology

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. The approval allows KALYDECO to be used in infants who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to the therapy, on the basis of clinical and/or in vitro assay results.

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New insights into liver cancer using organoids

Medical Xpress

Scientists of the Princess Máxima Center for pediatric oncology and Hubrecht Institute in the Netherlands have revealed new scientific insights into the features of fibrolamellar carcinoma (FLC), a rare type of childhood liver cancer.

Scientist 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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Arexvy Becomes World’s First RSV Vaccine

XTalks

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). GSK says the RSV vaccine will be available for older adults before this year’s RSV season, which usually starts before the winter months.

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Sanofi strikes a $150M deal for Maze’s Pompe disease drug

Bio Pharma Dive

The cash influx extends Maze’s financial runway into 2025, giving the South San Francisco company time to advance other drug candidates into testing.

Drugs 351
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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

Trials 246
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In a world where AI's impact is growing, exactly what is consciousness?

Medical Xpress

Rumors of artificial intelligence becoming sentient abound. In July of 2022, a Google engineer claimed that an AI chatbot he was working with had become self-aware. The same AI recently passed the Turing Test, once considered the gold standard for determining if something was human.

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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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Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets

Fierce Pharma

Pfizer pulls off Q1 surprise with strong sales even as COVID vaccine demand plummets kdunleavy Tue, 05/02/2023 - 09:27

Sales 125
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Lilly drug slows Alzheimer’s decline in large study

Bio Pharma Dive

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

Drugs 321
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Sanofi Canada’s Dupixent receives approval to treat EoE

Pharmaceutical Technology

Sanofi Canada has received approval from Health Canada for its Dupixent (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and in adolescent patients aged 12 years and above. It is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In Canada, it is commercialised by Sanofi Canada and Regeneron Canada.

Trials 245
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Sleep phase can reduce anxiety in people with PTSD

Medical Xpress

A new study shows that sleep spindles, brief bursts of brain activity occurring during one phase of sleep and captured by EEG, may regulate anxiety in people with post-traumatic stress disorder (PTSD).

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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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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

XTalks

Celiac disease is an autoimmune disorder that is triggered by the consumption of gluten, a protein found in barley, wheat and rye. When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. The symptoms of celiac disease can vary and may involve abdominal pain, bloating, diarrhea, weight loss, fatigue and anemia.

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Pfizer turns focus to new drugs as COVID vaccine revenue falls

Bio Pharma Dive

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

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Skin Cancer Awareness Month 2023: A roundup of outreach materials

Antidote

Every May is dedicated to Skin Cancer Awareness Month — a national observance designed to raise awareness around skin cancer and encourage people to practice smart prevention tactics as spring transitions into summer. Though skin cancer is the most common type of cancer , forming good sun safety habits can have a direct link to a reduction in its prevalence.

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Research examines key factors related to COVID-19 variant dynamics

Medical Xpress

A team of researchers at Los Alamos National Laboratory recently published the most comprehensive study of global COVID-19 variant transitions, which showed significant diversity in variant spread around the globe related to vaccination rates, number of co-circulating variants and immunity from previous infection. The paper was published in eBioMedicine.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Full Harvest is Leading the Charge Against Food Waste with Digitization

XTalks

In the US, food waste is a pervasive problem, with an estimated 30 to 40 percent of the country’s food supply going to waste each year. This amounts to around 133 billion pounds of food, worth an estimated $161 billion, being discarded annually. To combat this issue, companies like Full Harvest and others have emerged to sell surplus or imperfect produce that would otherwise be thrown away.

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Valneva, Pfizer push back timeline for Lyme disease vaccine

Bio Pharma Dive

After issues with a contract research group, the partners now expect to file an approval application for their shot in 2026, one year later than initially anticipated.

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Cytiva and Pall Life Sciences complete integration: ‘Uniting gives us the focus, expertise and talent to help our customers discover, develop and deliver the next generations of novel therapeutics’

BioPharma Reporter

Cytiva and the life sciences business of Pall Corporation are now united as one business under the Cytiva brand, with the completion of the integration announced this morning. Emmanuel Ligner, Danaher Group Executive, President and CEO of Cytiva, tells us how the company will focus its efforts moving forward to support long-term growth of the biotech industry.

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New guidance: Antibiotics should be halted upon closure of incisions

Medical Xpress

Antibiotics administered before and during surgery should be discontinued immediately after a patient's incision is closed, according to updated recommendations for preventing surgical site infections. Experts found no evidence that continuing antibiotics after a patient's incision has been closed, even if it has drains, prevents surgical site infections.

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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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Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

Pharma in Brief

On April 20, 2023, the federal government tabled legislation ( Bill C-47 ) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment ( PTA ) into Canada. Canada is required under the Canada-United States-Mexico Agreement ( CUSMA ) to adopt a PTA system by 2025. The PTA system is intended to compensate patentees for “unreasonable delays” by the patent office in issuing a patent.

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Initial launches with $75M and a new idea for targeting problematic proteins

Bio Pharma Dive

The company was co-founded by, among others, Jamie Cate, husband of CRISPR pioneer Jennifer Doudna, and Kevan Shokat, a chemical biologist whose previous work helped lead to KRAS-targeting cancer drugs.

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Community Health System-based Research with JoAnne Levy

Clinical Trial Podcast

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials. Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth. Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals, convenient ur

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Kids with nonverbal autism may still understand much spoken language

Medical Xpress

About a third of children with autism aren't able to speak—but that doesn't mean they're unable to listen and comprehend, a new study reports.

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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.