Fri.Oct 14, 2022

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Covalent drugs take the stage — again — in Atlas Venture’s latest startup

Bio Pharma Dive

A decade after Celgene bought the Atlas-backed Avila Therapeutics, the venture firm is building Matchpoint Therapeutics to develop covalent medicines for autoimmune diseases.

Medicine 290
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Merck and Moderna partner to develop and sell cancer vaccine

Pharmaceutical Technology

German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs. They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.

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Enliven to enter public markets through reverse merger with Imara

Bio Pharma Dive

With the IPO market still depleted, Enliven, a precision oncology company, has found a different path to the Nasdaq stock exchange.

Marketing 177
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Enliven and Imara agree to merge to advance cancer therapies

Pharmaceutical Technology

US-based pharmaceutical companies Enliven Therapeutics and Imara have entered a definitive merger deal in an all-stock transaction to advance oncology product candidates. Once the merger has closed, a clinical-stage biopharmaceutical company will be created that will operate under the name Enliven Therapeutics. The combined company will focus on advancing Enliven's pipeline of precision oncology programmes.

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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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'Where is humanity?' ask the helpless doctors of Ethiopia's embattled Tigray region

NPR Health - Shots

Civil war has blockaded the country's northern region and decimated a hospital system that serves nearly 7 million people. Without basic supplies, power and medicine, thousands are needlessly dying.

Doctors 145
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Xcell and aCGT Vector partner on cell and gene therapy development

Pharmaceutical Technology

Pharmaceutical companies Xcell Biosciences (Xcellbio) and aCGT Vector have partnered to expedite the development of cell and gene therapies. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients. aCGT Vector will offer its point-of-care, GMP-licensed manufacturing platform for validating Xcellbio's core next-generation manufacturing and analytical AVATAR AI technology for use in treating preci

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The FDA has officially declared a shortage of Adderall

NPR Health - Shots

The FDA has confirmed the nation is experiencing a shortage of Adderall after many pharmacies around the country have been unable to fill prescriptions and keep up with demand.

Pharmacy 133
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STAT+: Documents detail how pharmacy giants Walgreens, CVS, and Walmart failed patients in the opioid epidemic

STAT News

In 2011, Walgreens executives were under pressure. Amid a growing addiction crisis, and with the country already awash in prescription painkillers, the federal government was demanding accountability from the pharmacy giant for filling thousands of opioid prescriptions written by doctors in suspiciously large quantities.   Scrambling for a solution, the company’s leadership traded ideas for new ways of ensuring its pharmacies would stop filling medically illegitimate prescriptions.

Pharmacy 131
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Janssen leads effort to cut waste in digital health devices

pharmaphorum

A consortium of industry and academic groups – led by Johnson & Johnson’s pharma division Janssen – has been set up to tackle the environmental impact of digital health products, specifically aimed at minimising waste that could end up in landfill. The Digital Health in a Circular Economy (DiCE) group was formed earlier this year with the aim of developing ways to “design, collect, directly reuse, refurbish, remanufacture, and recycle digital health devices.” The programme

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STAT+: UnitedHealth plots further growth in its profitable provider division

STAT News

Insurance giant UnitedHealth Group’s strong financial showing in the third quarter was driven in part by its fast-growing provider segment, Optum Health.  UnitedHealth’s network of outpatient clinics and roughly 60,000 doctors is already more profitable than the company’s larger insurance division, UnitedHealthcare. UnitedHealth’s CEO outlined the company’s plans to expand Optum Health’s reach even further on an investor call Friday.

Doctors 116
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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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About a third of people call doctors by their first names, a new study shows

NPR Health - Shots

Researchers at the Mayo Clinic evaluated about 90,000 messages between doctors and their patients and found differences in patients' responses based on the doctor's gender and area of practice (Image credit: John Minchillo/AP)

Doctors 110
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Patient recruitment completed in Tourette syndrome study

Pharma Times

Research has demonstrated a strong safety prolife and reduced tics among participants

Research 146
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This Nigerian city has a high birth rate of twins — and no one is sure why

NPR Health - Shots

Twins appear to be unusually abundant in Nigeria's southwestern city of Igbo-Ora. For the past 12 years, the community has organized an annual festival to celebrate twins.

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Opinion: Monkeypox vaccine: a case study for real-world data

STAT News

With health emergencies becoming more common, the world needs more efficient ways to test the safety and effectiveness of drugs, even if they haven’t yet completed the lengthy series of clinical trials the Food and Drug Administration usually requires. Data from the real-world use of new drugs offers an increasingly valuable and efficient way to do this.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Odyssey Therapeutics $168 million Series B financing oversubscribed

pharmaphorum

Biotech company Odyssey Therapeutics, Inc. has announced a $168 million Series B financing, led by global venture capital firm General Catalyst, an active investor in the healthcare sector. The proceeds are to advance Odyssey’s precision immunomodulator and oncology medicine portfolio. The latest funding announcement follows the company’s $218 million Series A financing in December 2021 and brings the total capital raised to $386 million – enabling continuance of Odyssey’s mission to devel

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STAT+: Several big U.S. grocery chains are failing to stop antibiotic overuse in their meat supply chains

STAT News

Amid rising concern over antibiotic resistance, a new report finds that a dozen of the leading grocery chains in the U.S. are largely failing to take steps that are needed to prevent the spread of so-called superbugs in the food supply chain. In general, most of the companies lack any meaningful policies requiring their meat and poultry suppliers to eliminate the overuse of antibiotics.

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Kellogg’s Releases Eggo Nog for a Twist on This Year’s Holiday Breakfast

XTalks

Even though consumers are still preparing for Halloween, Kellogg’s recently released Eggo Nog ahead of the next holiday season. The cleverly named rum-based cream liqueur was created in partnership with Gatlinburg, Tennessee’s Sugarlands Distilling Co., making it the first of Eggo’s products intended for an adult (21-and-over) audience. “The holidays are exhausting for parents — from extra family responsibilities to the pressure of making the holidays perfect, parents rarely have any downtime fo

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In Fiona-ravaged Puerto Rico, hospitals were prioritized over health clinics for diesel, exacerbating rural health disparities

STAT News

When Hurricane Fiona knocked out power across the entire island of Puerto Rico, hospitals turned to diesel-fueled generators to keep the lights on and critical machines running. Community health centers — often the most accessible medical facilities in the poorest districts of the island, those hardest hit by hurricanes — couldn’t immediately do the same.

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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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Merck and Moderna to develop a personalised cancer vaccine

Drug Discovery World

Merck (MSD) and Moderna have revealed plans to work together on the development and commercialisation of an investigational personalised cancer vaccine. The companies will report data from the ongoing Phase II trial of mRNA-4157/V940 in combination with KEYTRUDA in high-risk melanoma later this year. “We have been collaborating with Merck on PCVs since 2016, and together we have made significant progress in advancing mRNA-4157 as an investigational personalised cancer treatment used in combinati

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STAT+: Up and down the ladder: The latest comings and goings

STAT News

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Reuters Pharma 2022 – Day 3 coverage

pharmaphorum

Day 3 coverage: Click here to read Reuters: Pharma 2022 Day 1 overview. Click here or the image below to read Reuters: Pharma 2022 Day 2 coverage. The post Reuters Pharma 2022 – Day 3 coverage appeared first on.

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XBiotech enrols first patient in Natrunix study

Pharma Times

Therapy involves patients with colorectal cancer at 20 medical centres

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Brain cells in a lab dish learn to play Pong — and offer a window onto intelligence

NPR Health - Shots

A dish of brain cells learned to play the 1970s video game Pong.

Research 143
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What Pharma Companies Can Expect From the Influx of Humira Biosimilars

Drug Channels

Today’s guest post comes from Steve Callahan, Senior Manager of Market Research at MMIT. Steve walks us through the expected Humira biosimilars launches and discusses potential responses from payers. To learn more, check out MMIT’s Strategic Launch Report & Evaluate Forecast solution. Read on for Steve’s insights. Read more » Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Gene therapies for prevalent diseases in Europe – the perfect storm of economic sustainability?

pharmaphorum

In this article, Research Partnership reviews why the path to commercialisation for the half a dozen approvals in Europe over the last few years has not been smooth, and shares feedback gathered from our payer network on the outlook for gene therapy market access in Europe, especially considering the shift to more prevalent diseases. In January, the Alliance for Regenerative Medicine (ARM)’s Cell and Gene State of the Industry briefing earmarked 2022 as a record year for approval of gene therapi

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The Intricacies of the Pharma Cold Chain

Pharmaceutical Commerce

How to navigate the ongoing temperature challenges surrounding storage & distribution.

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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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Elon Musk Reveals Weight Loss Injection Wegovy Helped Him Get Lean and Fit

XTalks

Elon Musk took to his favorite social media outlet Twitter recently to reveal that fasting and Novo Nordisk’s obesity drug Wegovy (semaglutide) have been the secrets behind his recent weight loss. Musk made the revelation in response to a question he received on the social media platform, which he is set to purchase after a long legal battle, about his secret to looking “awesome, fit, ripped & healthy,” saying “Fasting” helped him shed the pounds “And Wegovy.”.

Drugs 59
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Bayer get EU nod for extended use of contraceptive Mirena

pharmaphorum

Bayer’s big-selling contraceptive Mirena has been approved in Europe to provide up to eight years of pregnancy protection, which the company says is the longest of any device of its kind. The approval under the European Workshare Procedure also covers use of Mirena for the treatment of idiopathic menorrhagia (heavy menstrual bleeding) for up to eight years, according to the pharma group.

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New patent for Emd Serono drug MAVENCLAD

Drug Patent Watch

Annual Drug Patent Expirations for MAVENCLAD Mavenclad is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. There are four…. The post New patent for Emd Serono drug MAVENCLAD appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Unpacking IRB Innovations for Decentralized Clinical Trials

Advarra

In the blink of an eye, the world has gone digital. So many tasks which used to require going to a place and seeing a live human can now be accomplished from an app on our phones. Even the terms “phone” and “watch” seem antiquated, when you consider that little computer in your pocket or attached to your wrist can continuously measure your blood pressure, check your circadian rhythms, or even record changes in mobility and oxygen saturation levels.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.