March, 2023

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

Drugs 363
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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

Bio Pharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

Protein 357
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Idaho lawmakers pass a bill to prevent minors from leaving the state for abortion

NPR Health - Shots

The first of its kind in the country, the Idaho legislature has passed a bill allowing criminal charges for those who help a minor get an abortion out of state. The bill now goes to Gov. Brad Little.

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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response

STAT News

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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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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Low-dose radiation linked to increased lifetime risk of heart disease

Medical Xpress

Exposure to low doses of ionizing radiation is associated with a modestly increased excess risk of heart disease, finds an analysis of the latest evidence published by The BMJ today.

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

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At a Nashville hospital, the agony of not being able to help school shooting victims

NPR Health - Shots

A pediatric surgeon and his colleagues at Vanderbilt University Medical Center had prepared for a mass casualty event, but the victims of Monday's shooting had already died by the time they arrived.

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Cases of Marburg going unreported in Equatorial Guinea, WHO says

STAT News

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Getting around muscle aging by modulating the function of immune cells

Medical Xpress

Muscle is able to regenerate through a process that involves multiple steps and players, including the immune system. As our organism ages, the muscles lose the capacity to regenerate.

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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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GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Fierce Pharma

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial fkansteiner Fri, 03/24/2023 - 10:05

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InvisiShield and Gladstone partner to develop intranasal preventatives

Pharmaceutical Technology

Pre-clinical-stage biotechnology firm InvisiShield Technologies has partnered with Gladstone Institutes to develop intranasal preventatives against airborne viral infections including influenza, respiratory syncytial virus (RSV) and SARS-CoV-2. Under the partnership terms, InvisiShield will offer technical support, as well as funding to develop the intranasal preventatives.

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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

Drugs 362
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Mexican pharmacies are selling pills to U.S.travelers laced with deadly fentanyl

NPR Health - Shots

Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.

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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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Opinion: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything

STAT News

I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.

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Those who support Black Lives Matter tend to be less hesitant about vaccines, study finds

Medical Xpress

Efforts to encourage vaccination might do well to take advantage of the positive feelings and actions between different social groups, according to a study of attitudes toward vaccines among supporters of the Black Lives Matter movement.

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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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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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Mathai Mammen, former J&J executive, to become FogPharma CEO

Bio Pharma Dive

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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'Live free and die'? The sad state of U.S. life expectancy

NPR Health - Shots

A decade after a landmark report on Americans' shorter lives, the problem has only gotten worse. Unlike other wealthy nations, U.S. life expectancy has not bounced back from the pandemic.

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Opinion: There is no epidemic of autism. It’s an epidemic of need

STAT News

On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.

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Comprehensive tool measuring chronic condition burden shows reliable results compared to surveys

Medical Xpress

Researchers have evaluated the Assessment of Burden of Chronic Conditions (ABCC) scale, which was developed to improve care by facilitating shared decision making and self-management. The scale assesses and visualizes the patient's experience of one or multiple chronic conditions, and integrates it in daily care. The researchers determined it is valid and reliable in people with Chronic Obstructive Pulmonary Disease (COPD), asthma or type 2 Diabetes Mellitus (T2DM).

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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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Novo's high-dose Rybelsus win tees up regulatory filings—and new rivalries

Fierce Pharma

Novo's high-dose Rybelsus win tees up regulatory filings—and new rivalries esagonowsky Mon, 03/27/2023 - 09:19

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Covant Therapeutics Debuts with Boehringer Partnership Targeting ADAR1

BioSpace

Covant Therapeutics Debuts with Boehringer Partnership Targeting ADAR1 3/29/2023

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ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

Bio Pharma Dive

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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Michigan Democrats are getting their way for the first time in nearly 40 years

NPR Health - Shots

For the first time in decades, Democrats run the show in Michigan, passing legislative priorities they've been after for years: repealing a 1931 abortion law, repealing right-to-work and more.

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Marburg fever outbreak in Equatorial Guinea widens, WHO reports

STAT News

The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a

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Unraveling long COVID's causes and impacts

Medical Xpress

Most of the time, viruses leave our bodies as quickly as they arrived. After we suffer a week or two of fever, muscle aches, and other indignities, a surge of antibodies sends the miniature invader on its way. Case closed.

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US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi

Fierce Pharma

US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi fkansteiner Wed, 03/22/2023 - 09:50

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AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus

BioSpace

AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus 3/24/2023

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CMS removes 7 drugs from list marked for price hike penalties

Bio Pharma Dive

After revising its calculations, CMS removed Gilead’s cancer cell therapies Yescarta and Tecartus, as well as 5 other medicines, from the first set of drugs subject to rebates under a provision of the IRA.

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Sickle cell patient's success with gene editing raises hopes and questions

NPR Health - Shots

A Mississippi woman's life has been transformed by a treatment for sickle cell disease with the gene-editing technique CRISPR. All her symptoms from a disease once thought incurable have disappeared.