Thu.Aug 18, 2022

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Schrödinger names longtime biotech analyst Porges its CFO and top dealmaker

Bio Pharma Dive

Geoffrey Porges, who has spent nearly two decades researching biotechs at SVB Securities and AllianceBernstein, will now oversee and seek to grow the drug discovery specialist's network of partnerships.

Drugs 300
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Atomwise and Sanofi partner for drug discovery using AI

Pharmaceutical Technology

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally. The approach of Atomwise makes the process of drug discovery more logical and efficient by moving away from serendipitous discovery and toward a search that is structure-based.

Drugs 246
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CSL says drug for rare swelling disorder succeeds in late-stage study

Bio Pharma Dive

The company plans to soon seek approval of a once-monthly preventive drug for hereditary angioedema, a disease other drugmakers are targeting with gene editing and RNA medicines.

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Millennium hits a home run with DTC

World of DTC Marketing

Millennium Pharma’s ad and website for ENTYVIO touch all the bases with targeted patients. It shows that the team understands what it’s like for patients with severe ulcerative colitis. This is the kind of DTC that can help patients seek treatment. Empathy. Understanding what it’s like to live with health problems is the key to developing great DTC.

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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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With $2.8M gene therapy, Bluebird sets new bar for US drug pricing

Bio Pharma Dive

Approved Wednesday for severe beta thalassemia, Zynteglo will test insurers’ willingness to pay for expensive one-time treatments. Its market launch is likely to be watched carefully by other gene therapy developers.

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August 18, 2022: Rural and Remote Populations Are Focus of Funding Opportunity From NIH HEAL Initiative

Rethinking Clinical Trials

The NIH HEAL Initiative?, or Helping to End Addiction Long-Term Initiative?, announced its intent to publish a new funding opportunity for cooperative research that will accelerate implementation of nonopioid interventions for chronic pain management in rural and remote populations. The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and efficiently implementing effective interventions and evidence-based pain m

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What's behind the FDA's controversial strategy for evaluating new COVID boosters

NPR Health - Shots

Some scientists are alarmed that the agency plans to evaluate the next generation of boosters by reviewing mouse studies alone. Others say there's no time to waste waiting for human trials.

Scientist 145
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Grand Rounds August 12, 2022: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)

Rethinking Clinical Trials

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. Consuelo H. Wilkins, MD, MSCI. Senior Vice President and Senior Associate Dean. for Health Equity and Inclusive Excellence. Professor of Medicine. Vanderbilt University Medical Center. Slides. Keywords. Equity, Diversity, Recruitment. Key Points. Because the system and structures have not been built equitability, we will need to invest more and have more transparency and accountability at every level,

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States with the toughest abortion laws have the weakest maternal supports, data shows

NPR Health - Shots

Many of the states that are moving to ban abortion tend to have less access to health care, worse maternal and infant health care outcomes and weaker social supports for children and families.

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Opinion: Genetic research provides new clarity about the ‘whys’ of autism

STAT News

It was an appropriately hazy afternoon on the day my son Dylan, age two years, seven months, and sixteen days, was diagnosed with autism. The doctor was empathetic but serious when she said that he showed “symptoms consistent with an autism spectrum diagnosis.” And, she added, Dylan will need 40 hours a week of intensive, one-on-one educational therapy for at least several years.

Genetics 105
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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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Japan launches a contest to urge young people to drink more alcohol

NPR Health - Shots

Governments are watching lucrative alcohol tax revenues dry up, as people drink less. In Japan, a plan to counter that trend is running into controversy.

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‘A watershed moment for the field of gene therapy’: bluebird bio’s gene therapy Zynteglo receives FDA approval

BioPharma Reporter

The U.S. Food and Drug Administration (FDA) has approved bluebird bioâs Zynteglo (betibeglogene autotemcel), also known as beti-cel: a one-time gene therapy custom-designed to treat the underlying genetic cause of beta thalassemia in adult and pediatric patients who require regular red blood cell (RBC) transfusions.

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Mosquitoes surprise researcher with their 'weird' sense of smell

NPR Health - Shots

That's how neuroscientist Meg Younger describes her team's findings about how skeeters hone in on human aromas. And that could lead to better ways to keep us bite- and disease-free.

Research 105
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STAT+: Despite overall decline, late-stage cervical cancer cases are rising

STAT News

Cervical cancer is one of the most preventable malignancies. The introduction of HPV tests and the HPV vaccine over the past 20 years, following decades of Pap testing, have contributed to a steady decline in the disease — with one notable exception. In a new study published Thursday in the International Journal of Gynecological Cancer, researchers found the incidence of stage 4 cervical cancer has slowly but steadily increased from 2001 to 2018, a worrying and paradoxical trend that expe

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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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A rapidly spreading E. coli outbreak in Michigan and Ohio is raising health alarms

NPR Health - Shots

At least 29 people have fallen ill from the E. coli outbreak in Michigan and Ohio, and that number is likely an undercount, the CDC says. The source of the outbreak has not been found yet.

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STAT+: ‘We’re finally here’: Harvard graduate spearheads custom gene therapy for younger brother

STAT News

Richard Horgan has waited for this moment for more than three years. Last month, the Food and Drug Administration granted permission for his younger brother Terry, 27, who lives with muscular dystrophy, to receive a first-of-its-kind gene therapy that was tailor-made for his genetic mutation.

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There's a bit of good news about monkeypox. Is it because of the vaccine?

NPR Health - Shots

It's basically the same vaccine used against smallpox. Here's how it works — and whether researchers think it's playing a role in the fact that the current outbreak is starting to slow down.

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Opinion: History doesn’t have to repeat itself with stigma and monkeypox

STAT News

Ricky (not his real name), is a patient of mine: a young, gay man with a gentle soul and well-controlled HIV. He recently went to his local emergency department with a rash on his face, excruciating pain in his abdomen, and bright red blood that filled the toilet every time he had a bowel movement. Those triaging him thought the rash might be monkeypox, so they rushed him into an isolation room where he sat, alone, seeing under the door the shadows of feet going back and forth in the hallway.

Doctors 98
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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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AI-Driven Software ProstatID by Bot Image Receives FDA Clearance for Diagnosis and Detection of Prostate Cancer

XTalks

Bot Image announced that their ProstatID software received clearance from the US FDA for use in detecting and diagnosing prostate cancer by combining AI with traditional MRI scanning. Over the past several years, artificial intelligence (AI) tools have been developed by researchers with the goal of making cancer imaging and screening faster and more accurate, though there is still some skepticism around whether they are ready for larger-scale use in doctor’s offices.

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Opinion: Organ transplantation is at a crossroads. Major reform is needed

STAT News

In early August, the Senate Finance Committee held a bipartisan hearing co-chaired by Senators Ron Wyden (D-Ore.) and Charles Grassley (R-Iowa) revealing that the organ procurement and transplant system in America is badly broken. More than 41,000 transplants were performed in 2021. Yet more than 100,000 people are on the wait list for transplants, and at least 33 of them die each day.

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Endo files for bankruptcy as it agrees opioid settlement

pharmaphorum

Endo International is the latest drugmaker to file for chapter 11 bankruptcy protection in connection with opioid litigation in the US, after agreeing a $6 billion deal with creditors that includes an offer to settle outstanding lawsuits. The Ireland-domiciled company is struggling under the weight of around $8 billion in debt, and has been hamstrung by costs associated with fighting thousands of suits that accuse it of wrongdoing in its marketing and promotion of painkiller Opana ER (oxymorphon

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Listen: Private equity in autism care, a watershed FDA approval, and the future of ALS treatment

STAT News

How did autism care become a big business? Can gene therapy be profitable? And whatever happened to that $40 billion merger? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT’s Tara Bannow joins us to discuss how private equity’s mounting interest in autism care has created an untenable situation for many parents in the U.S.

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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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West makes minority investment in vaccine & biologics delivery tech developer

BioPharma Reporter

West Pharmaceutical Services has made an investment in Latch Medical, a Dublin-based company working on next-generation vaccine and biologics delivery technology.

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STAT+: Pharmalittle: FDA approves a gene therapy for a rare blood disorder; pharmacy chains ordered to pay $650 million over opioid crisis

STAT News

Hello, everyone, and how are you today? We are doing just fine, thank you, courtesy of clear blue skies and cool breezes circling about the relatively quiet Pharmalot campus. We are busy, though, firing up the coffee kettle, since a cup or three of stimulation is in order. Our choice today is maple bourbon. And of course, we are gathering items of interest to help you get started on your journey this morning.

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Frontiers Steering Committee spotlight: Megan Coder

pharmaphorum

As Frontiers Health approaches, we’re featuring interviews with members of the steering committee to give you a sneak peek of what to expect in Milan. Interested in signing up? pharmaphorum readers get a discount through this link. Though the field is still young, digital therapeutics are no longer a brand-new technology. Many different DTx offerings are in the field, being used by patients and prescribed by physicians, backed by rigorous scientific evidence.

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Akili’s deal to go public via SPAC could close soon

STAT News

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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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 shake-up at the CDC is intended to make it a more nimble organization

NPR Health - Shots

NPR's Leila Fadel speaks with Dr. Ali Khan, public health expert at the University of Nebraska Medical Center and a former CDC official, about the effects of an announced CDC reorganization.

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New drug application accepted by FDA for GSK’s momelotinib

Pharma Times

Therapy for the treatment of myelofibrosis has received significant results from phase 3 trial

Drugs 99
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Facing a monkeypox vaccines shortage, the U.S. is pursuing a new dosing strategy

NPR Health - Shots

The U.S. is facing a shortage of the monkeypox vaccine as the outbreak grows rapidly. The White House is pursuing a controversial strategy where each person only gets a fraction of the full dose.

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Chiesi’s Trimbow recommended for use within NHS Scotland

Pharma Times

The SMC approval brings much-needed boost to asthma sufferers across Scotland

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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.