Sat.Mar 04, 2023 - Fri.Mar 10, 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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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.

Protein 360
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STAT+: SVB, biotech’s bank of choice, just failed. It could have ripple effects

STAT News

Silicon Valley Bank, which does business with roughly half of the nation’s tech and biotech companies, failed on Friday. Now, as federal regulators step in to clean up SVB’s mess, biotech startups are left wondering: What happens to their money, and who’s going to finance the industry? On Friday morning, the Federal Deposit Insurance Corporation took control of SVB and is presiding over a sale of the firm’s assets to cover clients’ deposits.

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NYC Mayor Eric Adams is telling stores to have customers remove their face masks

NPR Health - Shots

"We are putting out a clear call to all of our shops: Do not allow people to enter the store without taking off their face mask," the mayor said. A flurry of questions ensued.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

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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

More Trending

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5 Texas Women Denied Abortions Sue The State, Saying Bans Put Them in Danger

NPR Health - Shots

The lawsuit filed on behalf of five patients who said their lives were put at risk and two physicians asks a state judge to clarify exceptions for medical emergencies under Texas law.

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

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Lilly reaches end of the road with long-studied Alzheimer’s drug

Bio Pharma Dive

Prior trial failures hadn’t halted testing of solanezumab, once Lilly’s top Alzheimer’s drug candidate. But its final study defeat may help scientists better understand how to target the brain disease.

Drugs 306
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Pfizer CEO Albert Bourla maxed out campaign contributions to Dr. Oz ahead of midterm elections

STAT News

WASHINGTON — Pfizer CEO Albert Bourla made the maximum possible campaign contribution to Mehmet Oz ahead of his failed bid last year to represent Pennsylvania in the U.S. Senate, according to federal campaign finance records. Oz is well-known for spreading medical misinformation , including touting astrology as a legitimate medical tool and the myth that apple juice contains unsafe levels of arsenic — a surprising political ally for Bourla, who runs one of the largest pharmaceutica

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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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Activist Judy Heumann led a reimagining of what it means to be disabled

NPR Health - Shots

Heumann was instrumental in pushing to expand the civil rights of Americans with disabilities and continued to advocate for disability rights around the globe. She died on Saturday at age 75.

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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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Merck drug data suggest ‘new direction’ for rare blood vessel disease

Bio Pharma Dive

Treatment with Merck’s sotatercept helped improve the exercise capacity of patients with pulmonary arterial hypertension, anticipated results from a Phase 3 study showed.

Drugs 300
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STAT+: ‘Emotional hunger’ vs. ‘hungry gut’: The attempt to subtype obesity and tailor treatments

STAT News

This is part of a series about new obesity drugs that are transforming patients’ lives, dividing medical experts, and spurring one of the biggest business battles in years. Read more about The Obesity Revolution. “Anne” is sitting in a small, wood-paneled consultation room, at the Mayo Clinic in Rochester, Minn., about to embark on yet another weight loss journey.

Doctors 133
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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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High inflation and housing costs force Americans to delay needed health care

NPR Health - Shots

Close to 40% of surveyed Americans, a record high, put off medical care last year because of finances. Americans are delaying or skipping doctor's visits, dental and vision care, and medications.

Doctors 140
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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

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AstraZeneca builds on study successes in early lung cancer

Bio Pharma Dive

The pharma’s drug Tagrisso extended survival in a trial that stirred debate at ASCO three years ago, while its immunotherapy Imfinzi reduced the risk of relapse in a different study.

Trials 300
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Opinion: Ranked to fail: Does gatekeeping affect diversity in The Match?

STAT News

For graduating medical students hoping to secure a residency training position — and that’s virtually all of them — Match Day is the most anticipated day of the year. The Match is the culmination of medical school, application preparation, interviews, and recruitment events. It’s like a traditional job search but without the room for negotiation since it is based on an algorithm that announces job placement once a year, on the third Friday of March, for all participat

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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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Walgreens won't sell abortion pills in red states that threatened legal action

NPR Health - Shots

The 20 states where Walgreens won't sell mifepristone include some where abortion remains legal. It's not clear whether other retail pharmacies will follow suit. (Image credit: Michael M.

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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

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Voyager licenses gene therapy tools to Novartis

Bio Pharma Dive

The Swiss drugmaker's decision is the latest in a string of partnership announcements for the gene therapy maker, which aims to bounce back from past research failures.

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Digital rectal examination is not useful to early detect prostate cancers, says new research

Medical Xpress

A common method of detecting prostate cancer may not be accurate enough as a reliable screening tool by itself, scientists have warned.

Scientist 145
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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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Experts weigh medical advances in gene-editing with ethical dilemmas

NPR Health - Shots

The last time this summit convened in 2018, the world was shocked to hear a scientist had created the first gene-edited babies. He was condemned, but gene-editing has continued, with some success.

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US FDA approves Shorla’s oncology drug for T-cell leukaemia

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The oncology drug has been approved to treat T-cell Lymphoblastic Lymphoma (T-LBL) and T-cell Acute Lymphoblastic Leukemia (T-ALL).

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FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency

Bio Pharma Dive

A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.

Hormones 258
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Study shows immune cells have a backup mechanism

Medical Xpress

The enzyme TBK1 is an important component of the innate immune system that plays a critical role in the defense against viruses. Upon mutation-induced loss of TBK1 function, patients show an increased susceptibility to viral infections. Strikingly, if TBK1 is not expressed at all, this clinical effect is not seen.

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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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What SNAP recipients can expect as benefits shrink in March

NPR Health - Shots

Participants in the federal food program might want to reevaluate their eligibility level for SNAP — and consider other assistance programs — as a pandemic-era supplement ends this month.

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Danaher and University of Pennsylvania partner for cell therapies

Pharmaceutical Technology

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The multi-year collaboration aims to develop new technologies which will help in improving clinical outcomes for patients. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Adaptimmune acquires struggling cell therapy rival following layoffs

Bio Pharma Dive

The planned merger between Adaptimmune and TCR2 will extend their cash runway by two years, as a biotech downturn continues to pressure companies.

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Long COVID is much less likely after omicron than after initial pandemic variant, finds new research

Medical Xpress

The omicron variant of SARS-CoV-2 is much less likely to lead to long COVID than the variant circulating at the start of the COVID-19 pandemic, new research being presented at this year's European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2023, Copenhagen, April 15-18) suggests.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.