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 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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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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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

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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Mayo Clinic Inpatient Hospitals 362

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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Drug Development 276

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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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.

Hospitals 360

Hospitals 360

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert — In October 2021, FDA and MHRA (United Kingdom’s Medicines and Healthcare products Regulatory Agency) jointly developed 10 guiding principles for the development of Good Machine Learning Practice (GMLP) with the goal of promoting “safe, effective, and high-quality medical devices” that are based on Artificial Intelligence/Machine Learning (AI/ML) technologies.

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Labelling Communication 115

The Pharmacist

NOVEMBER 27, 2023

The importance of the community pharmacy sector in addressing England’s health service challenges has been underlined by two recently published academic studies. The two peer-reviewed papers – Pharmacy users’ perceptions, awareness and future expectations of community pharmacy in England, and Professional stakeholders’ expectations for the future of community pharmacy practice in England – are based […] The post Studies back role of community pharmacy in solving health challenges appeared

Community Pharmacies 108

Community Pharmacies 108

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Pharmacy Management

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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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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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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The Pharmacist

DECEMBER 1, 2023

New regulatory measures tightening the rules around valproate prescribing are set to come into force from January 2024, and the Medicines and Healthcare products Regulatory Agency (MHRA) is urging healthcare organisations to adequately prepare. From the new year, the first phase of the new measures will curb the use of valproate in new male or […] The post Plan now for upcoming valproate prescribing rule changes, instructs MHRA appeared first on The Pharmacist.

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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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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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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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The Pharmacist

DECEMBER 1, 2023

Pharmacists can now initiate oral contraception and trained members of the pharmacy team can deliver blood pressure checks, with the expansion of the Pharmacy Contraception Service and the Hypertension Case-Finding Service coming into force from today (1 December 2023). As well as initiating oral contraception, pharmacists can continue to provide ongoing management of oral contraception […] The post Expanded contraception and hypertension pharmacy services go live appeared first on The Pha

Community Pharmacies 107

Community Pharmacies 107

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

DECEMBER 1, 2023

In Ukraine, a little bit of good news can go a long way, and the lifesaving work being done as a result of the President’s Emergency Plan for AIDS Relief (PEPFAR) has been a rare but reliable source of good news. That’s why the U.S. Congress’ delay in reauthorizing this program has been so difficult to hear about. Much has been written about the impact of PEPFAR since its inception in 2003.

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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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The Pharmacist

NOVEMBER 27, 2023

The service specification for the incoming Pharmacy First scheme has been published by NHS England. The service, due to start at the end of January 2024, will cover seven common conditions – earache, impetigo, infected insect bite, shingles, sinusitis, sore throat, and uncomplicated urinary tract infections in women – alongside the current elements of the […] The post Service spec for Pharmacy First unveiled by NHS England appeared first on The Pharmacist.

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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.

Chemotherapy 110

Chemotherapy 110

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 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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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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Pharma Times

DECEMBER 1, 2023

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

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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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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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Packaging Pharmaceutical Manufacturing 108

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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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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STAT

NOVEMBER 29, 2023

Ashley Conway-Anderson was prepared for a lot of things when it came to her first colonoscopy. She sought out tips to make the daylong prep more bearable. She braced herself mentally for what the doctors would find; her mother, after all, was just a couple years out of recovery from colorectal cancer. When she awoke from the procedure, she said, things seemed relatively fine.

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The Pharmacist

NOVEMBER 29, 2023

A new strain of swine flu has been detected in humans for the first time in the UK, picked up via routine testing by the patient’s GP. The UK Health Security Agency (UKHSA) will now ‘increase surveillance’ at GP surgeries in this area. There have been 50 human cases of the influenza A(H1N2)v strain globally […] The post GP surveillance to increase after human swine flu case appeared first on The Pharmacist.

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Quality Matters

NOVEMBER 27, 2023

Q&A: Building a More Resilient Medicines Supply Chain In this conversation, US Pharmacopeia (USP) Director of Regulatory and Public Policy Development Amy B. Cadwallader, Ph.D. joins the Duke-Margolis Drug Supply Chain Resilience and Advanced Manufacturing Consortium to discuss the importance of multi-disciplinary, cross-functional coordination to strengthen the medicine supply chain and global public health resilience in the face of ongoing threats, like persistent drug shortages.

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Generic Medicine Hospitals 105

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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