STAT

NOVEMBER 28, 2023

The Food and Drug Administration said Tuesday that it is investigating whether CAR-T therapy, which uses genetically modified white blood cells to attack tumors, can in rare cases cause lymphoma, a blood cancer. “Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory

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Hospitals 363

PharmaVoice

NOVEMBER 28, 2023

Cristina Durán, formerly AstraZeneca’s chief digital officer of R&D and now head of digital health spinoff Evinova, believes data will help pharma screen and treat patients earlier in their disease.

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STAT

NOVEMBER 28, 2023

Mayo Clinic will spend $5 billion to reinvent its flagship medical campus in Rochester, Minn., infusing digital technologies into several new buildings designed to present a 21st-century vision of clinical care, the organization said Tuesday. The project, to include five new buildings with 2.4 million square feet of space, will merge Mayo’s traditional medical services with its increasing investments in artificial intelligence and digital tools.

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PharmaVoice

NOVEMBER 28, 2023

Despite one major outlier, 2023’s IPOs haven’t hit the heights of the past three years.

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Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

STAT

NOVEMBER 28, 2023

Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover the drug, I have met with Alzheimer’s patients and their loved ones who are anxious to know whether they may benefit from this new treatment. They come in hope that this new medication may slow the progression of a cruel memory-robbing and personality-eroding disease.

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BioPharma Dive

NOVEMBER 28, 2023

U.S. tax law changes enacted six years ago slashed large pharma companies' rates and saved them billions. Now, a push for an international floor could disrupt their R&D accounting.

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BioPharma Dive

NOVEMBER 28, 2023

The agency said the benefit of approved treatments like Gilead’s Yescarta still outweighs any such risk, but the alert could slow drugmaker efforts to develop the treatments for wider use.

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STAT

NOVEMBER 28, 2023

WASHINGTON — President Biden is using a Cold War-era law to stem drug shortages by boosting domestic pharmaceutical manufacturing. Biden announced the initiative at the first meeting of his supply chain resilience council. It’s based on a law, the Defense Production Act, that lets the government require private companies to make materials deemed necessary for national defense, in this case essential medicines and medical countermeasures.

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Pharmaceutical Manufacturing Hospitals 335

World Pharma News

NOVEMBER 28, 2023

The U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.

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STAT

NOVEMBER 28, 2023

Vertex Pharmaceuticals is being accused by a group of advocates and physicians of refusing to take several steps that would widen access to its pricey cystic fibrosis medicines in predominantly poor countries. In a recent Zoom call, company executives were urged to drop patent claims and implement a global pricing model reflecting R&D and production costs, which could make the treatments more affordable.

Drug Pricing 295

Drug Pricing 295

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Pharmacy Management

The Pharmacist

NOVEMBER 28, 2023

Community Pharmacy England (CPE) has defended funding plans for the soon-to-launch Pharmacy First service after analysis by the Doctors’ Association UK (DAUK) suggested GPs would receive lower payments for consultations than pharmacists. In response to DAUK’s claim, Janet Morrison, chief executive of CPE, said there were ‘fundamental differences’ between how pharmacies and GPs are paid […] The post CPE hits back after doctors’ group cries foul over pharmacy funding appeared first on The Ph

Community Pharmacies 100

Community Pharmacies 100

STAT

NOVEMBER 28, 2023

In response to strained budgets, a growing number of state and local governments across the U.S. are suing insulin makers and pharmacy benefit managers over claims the companies conspired to illegally drive up prices. In recent weeks, state officials in Utah and Arizona , and municipalities in New York, Virginia , Maryland, and Ohio have filed lawsuits alleging that the companies artificially drove up the cost of insulin, making the medication unaffordable for countless residents who have diabet

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Diabetes 290

Pharmaceutical Technology

NOVEMBER 28, 2023

Venture financing for innovative radiopharmaceutical drugs witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US.

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STAT

NOVEMBER 28, 2023

Investors , analysts, doctors, and even patients face an avalanche of news from biotech companies about their human trials of experimental drugs, and wading through all that data to draw reasonable conclusions is a challenging task. This week, STAT has published a 2023 update of its Guide to Interpreting Clinical Trial Results, which can help consumers of company readouts navigate the process.

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Drug Development 286

Express Pharma

NOVEMBER 28, 2023

Shares of the company were up about 18 per cent after the bell The U.S. health regulator on Monday approved SpringWorks Therapeutics’ (SWTX.O) drug for treating adult patients with desmoid tumors, making it the first approved treatment for this type of non-cancerous soft-tissue growth. Shares of the company were up about 18 per cent after the bell.

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STAT

NOVEMBER 28, 2023

Belgium drugmaker Argenx said Tuesday that its antibody medicine failed to achieve the goals of a late-stage study for a platelet-destroying autoimmune disorder — a setback in the company’s efforts to expand the drug’s use. Argenx shares were down 12% in early trading. The negative study, called ADVANCE-SC, was the second of two clinical trials involving the Argenx drug called efgartigimod in patients with primary immune thrombocytopenia (ITP), a debilitating condition that

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Immunity Immunization Drug Development 228

Pharma Times

NOVEMBER 28, 2023

Tafinlar and Mekinist led to a 56% overall response rate in children with BM-HGG - News - PharmaTimes

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STAT

NOVEMBER 28, 2023

WASHINGTON — A top White House official on Tuesday delivered a pointed attack at a drugmaker fighting the administration’s Medicare negotiation plan in court. Christen Linke Young, White House Domestic Policy Council’s deputy assistant to the president for health and veterans affairs, took on Bristol-Myers Squibb, which makes the blockbuster blood thinner Eliquis.

Drug Pricing 227

Drug Pricing 227

Express Pharma

NOVEMBER 28, 2023

The international agreement aims to build strong sectoral and cross-organisational collaborations to design novel methodologies to tackle future epidemics and infectious diseases Bharat Biotech and the University of Sydney Infectious Diseases Institute (Sydney ID) have announced a Memorandum of Understanding (MoU) to advance vaccine research initiatives, strengthen academic-industry partnerships and augment global efforts to combat infectious diseases.

Vaccines 95

Vaccines 95

STAT

NOVEMBER 28, 2023

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Today, we talk lots about clinical trial inconsistencies: How Canada’s trial reporting is not up to snuff, and how companies perpetually want to spin results to make their experimental medicine look more favorable.

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Drug Pricing Drug Development 173

European Pharmaceutical Review

NOVEMBER 28, 2023

Having been valued at $112 billion in 2022, the worldwide cold storage market is projected to witness a 12 percent compound annual growth rate (CAGR) between 2023 and 2032, according to a report by Towards Healthcare. Therefore, by the end of 2032, the market will value an estimated $383.05 billion, the research projected. Advancing cold storage for pharmaceuticals Temperature-sensitive pharmaceuticals requiring this type of storage include vaccines and biologics, the report explained.

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STAT

NOVEMBER 28, 2023

A study questioned colonoscopies as the gold standard of colon cancer screens. Then it raised a furor. Exact Sciences, the maker of Cologuard, touts the accuracy of its colorectal cancer screening tests — but experts want more data. Colonoscopies are time-consuming and unpleasant. How about a yogurt drink instead ?

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Express Pharma

NOVEMBER 28, 2023

Doceree Insights is available for healthcare marketers across the globe Doceree has unveiled its new offering-Insights. Inspired by tools like ChatGPT, this solution aims to transform the way pharma marketers access and interpret data. As the latest addition to the suite of AI-powered tools on the platform, Insights will empower healthcare marketers with a game-changing approach to analytics, making it easier to unravel crucial business insights from marketing campaigns.

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Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

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Pharma Times

NOVEMBER 28, 2023

Around 3,000 new cases of mesothelioma are diagnosed in the US every year - News - PharmaTimes

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Pharmaceutical Technology

NOVEMBER 28, 2023

The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.

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Vaccines Immunity Immunization 104

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. SpringWorks Therapeutics’ Ogsiveo (nirogacestat) tablets are authorised for adults with progressing desmoid tumours who require systemic treatment. A new treatment for desmoid tumours As a subtype of soft tissue sarcomas: “Desmoid tumours are rare [non-cancerous] tumours that can lead to severe pain and disability… [Ogsiveo is] the first approved tr

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Labelling 84

Pharmaceutical Technology

NOVEMBER 28, 2023

A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint

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Outsourcing Pharma

NOVEMBER 28, 2023

Outsourcing Pharma is delighted to invite you to join our not-to-be-missed webinar on one of the most important areas of the industry â patient centricity â and its solutions.

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Express Pharma

NOVEMBER 28, 2023

Over-the-counter accessibility and limited awareness compound the problem. India’s challenges, including resource scarcity and inadequate surveillance, intensify the battle against AMR Antimicrobial resistance (AMR) poses an immediate and widespread threat to global public health, primarily fueled by the indiscriminate use of antimicrobials in human, animal, and plant health domains.

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Hospitals Dosage Compounding Communication 80

Drug Channels

NOVEMBER 28, 2023

I hope everyone enjoyed the Thanksgiving holiday. Now that you’ve stretched your stomach, it's time to stretch your mind with some food for thought. In this issue: A reality check on Express Scripts’ purported “cost-based” pharmacy network Mark Cuban explains how and why the PBM market will change Why two drug prices are better than one Pharmacists sing the retail pharmacy shakeout blues Plus, two Philly legends meet at a cardiology conference!

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Drug Pricing 75

pharmaphorum

NOVEMBER 28, 2023

Putting patients at the centre of innovation starts with clinical trial access Mike.

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BioPharma Dive

NOVEMBER 28, 2023

Fresh off a $7 billion deal with Roche, the chief executive spoke with BioPharma Dive about this year’s “discordant combination” of major biotech achievements alongside market headwinds.

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Outsourcing Pharma

NOVEMBER 28, 2023

Volunteers with conditions including depression, alcohol use disorder, and anorexia are being sought by Clerkenwell Health, to join its seminal clinical trials.

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FDA Law Blog: Biosimilars

NOVEMBER 28, 2023

By Allyson B. Mullen & Jeffrey N. Gibbs — Shortly before the Thanksgiving holiday, FDA announced with no fanfare that it would be holding a Molecular and Clinical Genetics Panel meeting this Wednesday November 29. The notice ( here ) indicates that FDA plans for the panel to “discuss and make recommendations on the design of multi-cancer detection (MCD) in vitro diagnostic devices (tests) as well as potential study designs and study outcomes of interest that could inform the assessment of t

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