February, 2023

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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.

Drugs 363
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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The non-binding draft guidance gives insight into the agency’s current outlook and recommendations for standard and expedited programs in oncology.

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Gas stove makers have a pollution solution. They're just not using it

NPR Health - Shots

Gas utilities and cooking stove manufacturers knew for decades that burners could be made that emit less pollution in homes, but they chose not to. That may may be about to change.

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Researchers find nanoparticles of a rare earth metal used in MRI contrast agents can infiltrate kidney tissue

Medical Xpress

Physicians routinely prescribe an infusion containing gadolinium to enhance MRI scans, but there is evidence that nanoparticles of the toxic rare earth metal infiltrate kidney cells, sometimes triggering severe side effects, University of New Mexico researchers have found.

Research 145
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Current treatments for cramps aren’t cutting it. Why aren’t there better options?

STAT News

One day last fall, Kiran’s period cramps became so painful they woke her up from a nap. The 19-year-old took some ibuprofen, but found little relief. “The pain was so bad, it felt like someone was punching me,” said Kiran, who asked to be referred to by only her first name for privacy. It felt “like I was giving birth.

Research 145
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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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More Trending

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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What does the science say about the origin of the SARS-CoV-2 pandemic?

NPR Health - Shots

Two U.S. intelligence agencies reportedly support the lab leak theory — with low-to-moderate confidence. No evidence has been shared. Scientists have strong evidence of animal spillover at a market.

Scientist 145
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Humans don't hibernate, but we still need more winter sleep

Medical Xpress

Whether we're night owls or morning larks, our body clocks are set by the sun. Theoretically, changing day length and light exposure over the course of the year could affect the duration and quality of our sleep. But figuring out how this applies in practice is difficult. Although studies where people assess their own sleep have suggested an increase in sleep duration during winter, objective measures are needed to determine how exactly the seasons affect sleep.

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STAT+: In about-face, Moderna vows Americans won’t have to pay for its Covid-19 vaccine

STAT News

In an unexpected shift, Moderna has decided not to ask Americans to pay for its Covid-19 vaccine, a move that follows intense criticism over initial plans to charge $110 to $130 per dose after the company pivots from government contracts to commercial distribution. The vaccine maker released a brief statement that it “remains committed” to ensuring everyone in the U.S. has access to its Covid-19 shot, regardless of whether they have health insurance coverage.

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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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Hemab raises $135m in Series B cash to treat genetic bleeding disorders

BioPharma Reporter

The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease.

Genetics 122
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US agrees to buy more doses of Novavax’s COVID shot

Bio Pharma Dive

The company said its modified contract with the federal government, which comes ahead of a planned transition to private market sales, will help it develop an updated version of its vaccine.

Sales 342
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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme. This collaboration is expected to help expedite the clinical manufacturing of RVM-V001 and future mRNA-based vaccines that target infectious diseases such as Clostriodioides difficile infection (CDI) and R

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Parents raise concerns as Florida bans gender-affirming care for trans kids

NPR Health - Shots

Florida's medical boards have voted to ban gender-affirming care for transgender youth. Families with trans children and medical providers who care for them are worried about the impact.

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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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The possible effects of cinnamon on memory and learning

Medical Xpress

Cinnamon, the well-known aromatic spice that many of us use to bake cakes and cook savory dishes, is derived from the inner bark of Cinnamomum trees. These are evergreen trees found in the Himalayas and other mountain areas, as well as in rainforests and other forests in southern China, India and Southeast Asia.

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Opinion: The haunting brain science of long Covid

STAT News

Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.

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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

Licensing 145
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Apellis wins FDA approval of first drug for type of vision loss

Bio Pharma Dive

Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety.

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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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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

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Spain approves menstrual leave, teen abortion and trans laws

NPR Health - Shots

Among the enacted changes, 16- and 17-year-olds will be allowed to undergo an abortion without parental consent. And workers suffering debilitating period pain can take paid time off.

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Chronic fatigue syndrome is associated with distinct changes in the microbiome

Medical Xpress

Over the past three years, the emergence of long-term effects associated with COVID-19 has led to increased focus on a disease with similar hallmarks and symptoms—myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Two studies publishing February 8 in the journal Cell Host & Microbe are taking a closer look at ME/CFS as it relates to the microbiome and the metabolites that microbial species produce.

Research 145
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Opinion: Disruptive science is leaping forward, not limping along

STAT News

A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h

Scientist 145
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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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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.

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Michael J. Fox Foundation funding boost for Newel Health’s Soturi

Pharma Times

Next phase of Newel Health’s digital therapeutics solution for Parkinson’s disease gains vital grant

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ERs staffed by private equity firms aim to cut costs by hiring fewer doctors

NPR Health - Shots

Increasingly, private equity firms shape staffing decisions at hospital emergency rooms, research shows. One apparent effect: Hiring fewer doctors and more health care practitioners who earn far less.

Doctors 145
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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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Telomeres, mitochondria, and inflammation: Three hallmarks of aging work together to prevent cancer

Medical Xpress

As we age, the end caps of our chromosomes, called telomeres, gradually shorten. Now, Salk scientists have discovered that when telomeres become very short, they communicate with mitochondria, the cell's powerhouses. This communication triggers a complex set of signaling pathways and initiates an inflammatory response that destroys cells that could otherwise become cancerous.

Scientist 143
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STAT+: CRISPR pioneer Feng Zhang launches new genetic delivery startup with $193 million

STAT News

Akin Akinc was scouring his email spam box last summer, looking for a missing message, when he stumbled across an unexpected email from a quite recognizable name: Feng Zhang. Zhang, one of the leading scientists in the groundbreaking field of genetic editing, had reached out two days prior to discuss a new company he was working on. Since helping to discover CRISPR-Cas9 — often referred to as molecular scissors that can cut into the genome and edit DNA — Zhang has founded at least

Genetics 142
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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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Cigna restricts coverage of new ALS drug, deepening fears about access

Bio Pharma Dive

The health insurer’s national formulary considers Amylyx Pharmaceuticals’ Relyvrio to be "experimental, investigational or unproven for any use,” and now does not recommend covering it.

Drugs 328
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time