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.

Drugs 331
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Roche opens new institute to advance research in human model systems

Pharmaceutical Technology

Roche has opened a new institute to accelerate research and development (R&D) in the area of human model systems such as organoids. Situated in Basel, Switzerland, the newly launched Institute of Human Biology (IHB) will accommodate scientists and bioengineers from academia and the pharmaceutical sector. Researchers at IHB will study human biology and speed up the adoption of human model systems in pharmaceutical R&D in addition to clinical practice.

Research 321
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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.

Medicine 145
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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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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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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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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.

Drugs 278

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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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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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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.

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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.

Engineer 144
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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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J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year

Fierce Pharma

J&J's consumer group Kenvue set for $41B IPO, the largest US market debut in more than a year esagonowsky Thu, 05/04/2023 - 09:58

Marketing 123
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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 328
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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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Evidence of consciousness-like activity in the dying brain

Medical Xpress

Reports of near-death experiences—with tales of white light, visits from departed loved ones, hearing voices, among other attributes—capture our imagination and are deeply engrained in our cultural landscape.

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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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Endogena finalises enrolment for retinitis pigmentosa trial

Pharma Times

The treatment is a small molecule that activates endogenous retinal stem and progenitor cells

Trials 132
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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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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 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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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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Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy

Fierce Pharma

Teva, MedinCell win FDA approval for slow-release schizophrenia drug Uzedy kdunleavy Mon, 05/01/2023 - 07:35

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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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Pathbreakers: The journey of first generics

Pharmaceutical Technology

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. First generics are the first opportunity manufacturers have to market new generic drug products in the US. In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma,

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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.

Research 141
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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!

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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

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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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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).

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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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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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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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Tenaya’s cardiomyopathy gene therapy gets fast track boost

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). If successful, TN-201 would be a first-in-class disease-modifying gene therapy for MYBPC3-associated HCM. In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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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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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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Apellis reports strong start for new vision loss drug

Bio Pharma Dive

Higher-than-expected sales of the geographic atrophy therapy Syfovre pushed shares in Apellis higher, and could add to speculation about a takeover.

Drugs 308