October, 2023

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Companies Seek To Increase Life Span By A Decade Or More

Forbes: Drug Truths

But keep in mind that it’s going to be a long while before such drugs are actually available.

Drugs 326
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Vertex, CRISPR therapy for sickle cell passes FDA panel test

BioPharma Drive: Drug Pricing

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

FDA 338
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Humans are disrupting natural 'salt cycle' on a global scale, new study shows

Science Daily: Pharmacology News

A new paper revealed that human activities are making Earth's air, soil and freshwater saltier, which could pose an 'existential threat' if current trends continue. Geologic and hydrologic processes bring salts to Earth's surface over time, but human activities such as mining and land development are rapidly accelerating this natural 'salt cycle.

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Bagged, Precut Onions Tied to Salmonella Illnesses in 22 States

Drugs.com

WEDNESDAY, Oct. 25, 2023 – Federal regulators are investigating a salmonella outbreak linked to packaged, diced onions that has sickened at least 73 people across 22 states. Fifteen of the illnesses were so bad that people required.

Packaging 306
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Recap of CDD User Group Meeting – Boston 2023

Collaborative Drug

CDD Vault User Group Meeting - Cambridge Innovation Center (CIC) This year's event was marked by insightful presentations, sharing of best practices.

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More Trending

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A decade later, biotech’s CRISPR revolution is still going strong

BioPharma Drive: Drug Pricing

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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Verve gets FDA green light to run base editing study in US

BioPharma Drive: Drug Pricing

The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S. since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease.

FDA 344
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Climate report: 'Uncharted territory' imperils life on Earth

Science Daily: Pharmacology News

An international coalition of climate scientists says that the Earth's vital signs have worsened beyond anything humans have yet seen, to the point that life on the planet is imperiled.

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Pfizer to cut costs, lay off staff on waning demand for COVID products

BioPharma Drive: Drug Pricing

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

BioPharma Drive: Drug Pricing

Expert advisers are reviewing the companies’ case for approval of what could be the first medicine based on the gene editing technology. Follow their discussion here.

Therapies 334
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NIH funds research for three experimental ALS drugs

BioPharma Drive: Drug Pricing

The funding, which is part of ACT for ALS, will support expanded access studies of drugs developed by Prilenia Therapeutics, Clene Nanomedicine and Rapa Therapeutics.

Research 321
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Pfizer wins FDA approval of new meningococcal vaccine

BioPharma Drive: Drug Pricing

The clearance of the pentavalent shot Penbraya adds to Pfizer’s infectious disease portfolio as it adjusts to slumping COVID-19 vaccine sales.

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OrbiMed raises $4.3B in new funds for startup investing

BioPharma Drive: Drug Pricing

The money will be spread across three investment funds and comes at a time when investment into biotech remains shakier than in years past.

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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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Aiolos Bio raises $245M on prospect of better asthma drug

BioPharma Drive: Drug Pricing

The startup is taking aim at an inflammation-linked protein known as TSLP, which is the target of an approved asthma medicine.

Drugs 317
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Bristol Myers’ neuroscience research head explains the big pharma’s return to brain drugs

BioPharma Drive: Drug Pricing

In a wide-ranging interview, Bristol Myers’ Ken Rhodes talked biomarkers, diseases of interest and why the company is far from done with neuroscience-focused deals.

Research 316
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Novo Nordisk’s Ozempic shows kidney benefit in large study

BioPharma Drive: Drug Pricing

The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

Drugs 317
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Vertex gearing up for launch as sickle cell therapy review advances

BioPharma Drive: Drug Pricing

Executives at the biotech say they’re trying to get ahead of the payer and production challenges that will face their gene editing treatment exa-cel, which is now under FDA review.

Therapies 313
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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.

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5 FDA decisions to watch in the fourth quarter

BioPharma Drive: Drug Pricing

The regulator is considering approval of what would be the first CRISPR medicine, as well as important clearances for Alnylam, Bristol Myers, Amgen and Pfizer.

FDA 312
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After summer slump, biotech M&A has a good week

BioPharma Drive: Drug Pricing

There have been few bigger-ticket acquisitions recently. But a string of deals announced in early October may affirm the forecasts of analysts who expect M&A to tick up in the coming months.

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Sanofi to divest consumer unit, joining pharma industry shift

BioPharma Drive: Drug Pricing

The restructuring came as the French company forecast an earnings drop in 2024, prompting a stock selloff that erased about $20 billion in market value.

Marketing 305
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FDA Issues Warning on Dangers of Probiotic Products for Preemie Babies

Drugs.com

FRIDAY, Oct. 27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. The U.S. Food and Drug Administration also sent a letter to health care providers warning of.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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CVS Pulling Popular Cold Meds From Shelves After Report Deems Them to Be Useless

Drugs.com

FRIDAY, Oct. 20, 2023 -- CVS Health plans to pull cold medications that contain phenylephrine from its store shelves after federal regulators determined recently that the decongestant doesn’t work. Oral phenylephrine is an active ingredient.

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With $56M, a Mayo Clinic-backed startup takes aim at radiopharmaceutical roadblocks

BioPharma Drive: Drug Pricing

Nucleus RadioPharma, a contract developer and manufacturer, is expanding at a time when investment is pouring into the radiopharmaceutical drug field.

Drugs 298
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Latest AI Has 100% Success Rate in Spotting Melanomas

Drugs.com

FRIDAY, Oct. 13, 2023 -- The ability to detect skin cancer using artificial intelligence (AI) software has rapidly improved. New research presented Wednesday at a medical conference in Berlin shows that this AI technology now has a 100% detection.

Research 298
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Pfizer wins FDA approval for its $7B colitis drug

BioPharma Drive: Drug Pricing

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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Ketamine Nasal Spray Shows Promise Against Tough-to-Treat Depression

Drugs.com

THURSDAY, Oct. 5, 2023 -- A nasal spray containing a ketamine derivative appears to beat one of the standard drugs used for people with difficult-to-treat depression, a new clinical trial has found. The trial, of nearly 700 people with.

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Bayer opens California plant to make cell therapies

BioPharma Drive: Drug Pricing

The pharma plans for the new Berkeley facility to produce clinical, and potentially commercial, supplies of a Parkinson’s disease cell therapy being tested by its subsidiary BlueRock.

Therapies 297
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Sarepta gene therapy for Duchenne misses main goal of key study

BioPharma Drive: Drug Pricing

Yet Sarepta said it still plans to ask the FDA to expand regulatory clearance of Elevidys, which was granted an accelerated approval by the FDA in June.

Therapies 296
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‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

BioPharma Drive: Drug Pricing

The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.

Vaccine 294