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 30, 2023

John Mulligan, founder of biotechs like Good Therapeutics and Bonum Therapeutics, discusses how biotechs can thrive when the market is against them.

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The Guardian - Pharmaceutical Industry

NOVEMBER 26, 2023

Patients’ group says reactions to metamizole can cause sepsis and organ failure – and British and Irish people are at higher risk A patients group representing several British victims has launched legal action against the Spanish government over claims it failed to safeguard people against the potentially fatal side effects of one of the country’s most popular painkillers, involved in a series of serious illnesses and deaths.

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European Pharmaceutical Review

NOVEMBER 27, 2023

Biotech Berlin Cures, a company focusing on neutralising functional autoantibodies (fAABs), is expanding its Phase II clinical trial on Long COVID (post-COVID syndrome). into a pan-European, multi-center collaboration. The study will provide “meaningful and robust results on the efficacy and tolerability” of its lead drug candidate BC 007 in individuals with Long COVID.

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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

Communication

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 27, 2023

A drug developed by Kinnov Therapeutics halved alcohol consumption in heavy drinkers in a mid-stage study

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European Pharmaceutical Review

DECEMBER 1, 2023

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 billion. The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease. As a folate receptor alpha (FRα) with a maytansinoid payload DM4, a potent tubulin inhibitor, the biologic medicine offers expansion opportunities in e

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STAT

NOVEMBER 29, 2023

UnitedHealth Group has about 90,000 employed or affiliated doctors, approximately 10% of all physicians in the U.S. The number — disclosed Wednesday at the company’s investor day by Amar Desai, the CEO of UnitedHealth’s Optum Health division — means the company acquired or hired 20,000 doctors in the past year alone. The rapid growth of UnitedHealth’s physician base underscores how the company, which already is the country’s largest private health insure

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PharmExec

DECEMBER 1, 2023

Artificial intelligence is making it quicker to get drug candidates to the clinic, but it isn’t addressing the fundamental need to marry the right candidate and the right target to the right disease.

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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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European Pharmaceutical Review

NOVEMBER 29, 2023

Following the US Food and Drug Administration (FDA)’s approval of Ferring Pharmaceuticals’ gene therapy Adstiladrin ® (nadofaragene firadenovec-vncg) in December 2022, new long-term follow up data has been revealed. Adstiladrin is the first FDA-approved intravesical gene therapy to be authorised for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

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STAT

NOVEMBER 30, 2023

ASHEVILLE, N.C. — There was the beeping of monitors, the stiff sheets, the sterile smell of the hospital room. Mostly, there was pain. Sharp, relentless pain. Mike Messino was recovering from a successful surgery, but the nerve blocks had worn off. He spent two full hours waiting for a nurse to inject pain medication. When he’d worked in this hospital, he’d made sure patients didn’t wait longer than 15 minutes for that kind of care.

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Hospitals 363

Pharma Times

NOVEMBER 29, 2023

The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes

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BioPharma Dive

NOVEMBER 29, 2023

Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

pharmaphorum

NOVEMBER 30, 2023

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

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STAT

NOVEMBER 27, 2023

After earning her doctorate in cell biology at the University of Pennsylvania in June, Sierra Collins did what many freshly minted Ph.D.s. do — she went looking for a job at a biotech company. But what was supposed to be a straightforward search has turned into an odyssey. Collins has applied for more than 53 positions (and counting). Like a good scientist, she’s gathering data along the way and uses a spreadsheet to track each company’s size and therapeutic focus, as well a

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Outsourcing Pharma

NOVEMBER 27, 2023

It is five years this month since a ground-breaking change in UK healthcare history happened â with doctors being able to prescribe cannabis-based medicines for the first time.

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The Pharmacist

DECEMBER 1, 2023

Drafts of the 23 patient group directions (PGDs) and one protocol for the Pharmacy First service have now been published by NHS England. This follows the release earlier in the week of service specifications and the clinical pathways for the seven common conditions included in the scheme – uncomplicated urinary tract infection (UTI) in women, […] The post NHS England releases PGDs for Pharmacy First service appeared first on The Pharmacist.

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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.

European Pharmaceutical Review

NOVEMBER 30, 2023

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Following the acquisition of substantially all global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023, now that Viatris’ biosimilars operations have fully transitioned to Biocon Biologics Ltd in Europe, the company declared that this “represents another significant m

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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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PharmExec

NOVEMBER 29, 2023

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies.

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BioPharma Dive

NOVEMBER 27, 2023

One year after the U.K. drugmaker withdrew the multiple myeloma drug from the U.S. market because of negative data, new study results might crack open the door to a relaunch.

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Pharmaceutical Commerce

DECEMBER 1, 2023

In clinical trials, Keytruda plus Padcev lowered the risk of disease progression or death by 55% compared with chemotherapy in adult patients with locally advanced or metastatic urothelial carcinoma.

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Chemotherapy 110

STAT

NOVEMBER 27, 2023

About 20 million disabled people will be erased if the U.S. Census Bureau moves forward with changes to disability data collection methods. That is because many disabled people will no longer be counted as disabled by the new questions the Census is proposing to use starting in 2025 with the annual American Community Survey (ACS). As disabled people, and as scholars who study disability measurement and use disability data for our research, we have grave concerns about this proposed change.

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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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pharmaphorum

NOVEMBER 30, 2023

FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year. Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency.

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Pharmacy Management

Express Pharma

NOVEMBER 29, 2023

South Asia’s largest Trade Fair for pharma brought together over 50,000 visitors from across the globe, more than 1,500 exhibitors showcasing 10,000+ products and representation from over 80 countries Initiating a groundbreaking expedition to reshape the landscape of pharma manufacturing, CPHI & PMEC India 2023 commenced yesterday at the India Expo Centre in Greater Noida, Delhi-NCR.

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STAT

NOVEMBER 28, 2023

Hormone replacement therapies have long been approved by the Food and Drug Administration for use by cisgender patients, such as women who take estrogen when going through menopause. Now, for the first time, a nonprofit group is pursuing research with the goal of FDA approval for the use of estrogen as a gender-affirming treatment for trans and gender-diverse patients.

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Labelling 349

European Pharmaceutical Review

NOVEMBER 29, 2023

For the first time, companies across the global healthcare sector, including AstraZeneca , GSK, Novo Nordisk and Roche, have united to discuss with energy providers in China and India, about scaling renewable power across their supply chains. This step is important as these countries are key markets for pharmaceuticals manufacturing. Based on data on sales/value-based shares from various companies for APIs and Chemicals, India and China are estimated to account for up to half of materials for me

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Pharmaceutical Manufacturing 107

Pharma Times

DECEMBER 1, 2023

Every year, over 44,000 men are diagnosed with prostate cancer in England - News - PharmaTimes

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pharmaphorum

NOVEMBER 27, 2023

EVERSANA’s alliance with Amazon Web Services (AWS) on the application of generative artificial intelligence (genAI) to the pharma sector has borne its first fruit – a new tool to tackle the time-consuming and error-prone task of getting medical and regulatory content approvals.

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