Wed.Nov 29, 2023

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STAT+: UnitedHealth Group now employs or is affiliated with 10% of all physicians in the U.S.

STAT

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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ACMT Toxicology Visual Pearl: Needle to Necrosis

ALiEM - Pharm Pearls

Which of the following agents, when injected along with heroin, is associated with the skin changes pictured? Cocaine Fentanyl Methamphetamine Xylazine Photo by Dr. Matthew Salzman Reveal the Answer 4. Xylazine Background Xylazine is a synthetic substance approved by the U.S. Food and Drug Administration for veterinary use, specifically for its muscle relaxant, sedative, and analgesic effects [1].

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STAT+: Colon cancer prevention paradox: Higher-risk patients pay more for colonoscopy

STAT

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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Pharma benefited from basing business overseas. An international tax effort could spur a rethink.

PharmaVoice

U.S. tax law changes 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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Position Your Pharmacy for Expansion

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.

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With latest tranche, U.K. Biobank has genome sequences from 500,000 people available for research

STAT

LONDON — Data from half a million people’s whole genome sequences are now available to researchers worldwide, as the U.K. Biobank on Thursday debuted the latest addition to what it aims to be the world’s most comprehensive health data resource. The Biobank has been building its collection over 20 years, with 500,000 volunteers recruited to provide survey responses about their health, medical records, tests of molecular markers, and imaging scans.

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Octave Bioscience is navigating the Parkinson’s labyrinth with Michael J. Fox’s help

PharmaVoice

A grant from the notorious Parkinson’s foundation has sped up Octave’s timeline to further advance biomarker development in the field.

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Are Predetermined Change Control Plans on the road to Global Harmonization?

FDA Law Blog: Biosimilars

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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STAT+: Cigna, Humana in talks to merge into health insurance giant, per report

STAT

Cigna and Humana are in discussions to merge, a potential move that would create a health insurance and prescription drug benefits titan with approximately $300 billion of annual revenue. A proposed transaction would almost certainly prompt a close review from antitrust enforcers at the Department of Justice and the Federal Trade Commission. A merged Cigna-Humana would further consolidate the market for pharmacy benefit managers.

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Milner Therapeutics to establish new genomics laboratory for drug discovery

Pharma Times

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

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Texas abortion case puts doctors’ agency in treating pregnancy complications in the spotlight

STAT

The Texas Supreme Court on Tuesday heard a case that could end up deciding whether abortion in the state should be protected under its constitution when it’s provided for medical reasons. Also at stake is the issue of how much agency doctors have to exercise their medical judgment in the treatment of the most complicated pregnancies — a power that the case’s plaintiffs claim has been lost under Texas’s current abortion laws.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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FDA names chief scientist Bumpus as Woodcock’s successor

BioPharma Dive

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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STAT+: FDA chief scientist to replace Woodcock

STAT

WASHINGTON — The Food and Drug Administration’s chief scientist will replace retiring Janet Woodcock as principal deputy commissioner of the agency next year, the FDA commissioner announced Wednesday. Namandjé N. Bumpus was named chief scientist in June of last year. The chief scientist works closely with the FDA’s product centers, and Bumpus played a big role in the expansion of the agency’s regulation of cosmetics.

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FDA Investigating Risk of Secondary Cancers in Patients Administered CAR T-Cell Therapy

PharmExec

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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STAT+: Blood cancers may arise from CAR-T cells, but experts think only in very rare cases

STAT

The announcement on Tuesday that the Food and Drug Administration was investigating whether CAR-T immunotherapy had itself caused blood cancers initially appeared to be a significant blow to one of the brightest spots in cancer care. But experts quickly cautioned that risk of this complication is probably minuscule compared to the known risk of secondary cancers from other cancer therapies like chemotherapy and radiation.

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16th CPHI & PMEC India 2023 redefines pharma landscape

Express Pharma

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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Opinion: Listen: What we take for granted after 30 years of Prozac

STAT

When Prozac first entered the psychiatry scene in in the late ’80s, the profession was still Freud’s territory. Many considered taking medication to treat depression a failure. But that was all about to change, as early stewards like psychiatrist Peter Kramer refused to shy away from the new drug’s potential. These days, he says that people take for granted all of the progress that’s been made with antidepressant treatment in the past three decades.

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GP surveillance to increase after human swine flu case

The Pharmacist

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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U.S. life expectancy rose in 2022, but it remains below its pre-pandemic level

STAT

NEW YORK — U.S. life expectancy rose last year — by more than a year — but still isn’t close to what it was before the Covid-19 pandemic. The 2022 rise was mainly due to the waning pandemic, Centers for Disease Control and Prevention researchers  said Wednesday. But even with the large increase, U.S. life expectancy is only back to 77 years, 6 months — about what it was two decades ago.

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GP and pharmacy bus project steers Newcastle health drive

The Pharmacist

A partnership between Newcastle GP Services and Newcastle University’s School of Pharmacy has seen the launch of a community health bus, providing the city’s residents with a range of healthcare services. The purpose-built bus will be visiting a variety of locations in the city, staffed by registered nurses, Newcastle pharmacy students and Northumbria University nursing […] The post GP and pharmacy bus project steers Newcastle health drive appeared first on The Pharmacist.

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STAT+: Saudi VC loops Novo Nordisk, other biotech VCs into new longevity incubator

STAT

The Hevolution Foundation, a Saudi investment firm focused on aging science, said Wednesday that it is launching an incubator that will bring together experts from the scientific community, pharma, and multiple biotech VCs. The incubator, called the Breakthrough Innovation Alliance, will give up to $1 million apiece to 10 different research initiatives over the next three years, allowing scientists and entrepreneurs to run preclinical research to determine whether the ideas hold any promise.

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CSL, Arcturus get first approval for self-assembling RNA jab

pharmaphorum

Japan’s medicines regulator has approved the first vaccine based on self-assembling RNA, a spin on the mRNA technology used in current shots, which is designed to deliver greater efficacy with a lower dose.

Vaccines 101
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Flagship Pioneering crosses the pond, opens a European front

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with the latest twist for a futuristic cancer therapy, big money for longevity research, and a dispatch from London.

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10th edition of India Pharma Awards at CPHI celebrates a decade of excellence and innovation in pharma industry

Express Pharma

The selection process was guided by EY and evaluated by a distinguished jury, including a Preliminary Online Jury meet and finalist presentations The India Pharma Week 2023, started from 28 th November till 30 th November on the sidelines of the CPHI show. Day one marked the 10 th annual India Pharma Awards, hosted by Informa Markets, and CEO roundtable discussion.

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BioMarin secures hemophilia gene therapy coverage in Germany

BioPharma Dive

Drawn-out negotiations led to a lower price than initially expected, but analysts called the agreement a step forward for the biotech company.

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Japan grants approval for CSL and Arcturus’ Covid-19 vaccine 

Pharmaceutical Technology

Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

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Gilead to lay off staff at cell therapy unit Kite

BioPharma Dive

The cuts will impact 7% of the cancer drug division’s employees, although about 90 new roles will be created around “areas of growth.

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Ferring reveals long-term data for cancer gene therapy

European Pharmaceutical Review

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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FDA kicks off review of Karuna’s schizophrenia drug KarXT

pharmaphorum

Karuna Therapeutics said this morning that the FDA has formally started its review of KarXT, aiming to become the first drug to reach the market for schizophrenia with a new mechanism of action in decades.

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'High Severity' Flu Season Among Children Spotlights Importance of Vaccination

PharmExec

The CDC’s Morbidity and Mortality Weekly Report show pediatric influenza hospitalization rates returned to levels that preceded the COVID-19 pandemic.

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AbbVie cues up filing for c-Met ADC in lung cancer

pharmaphorum

AbbVie is preparing to file for accelerated approval of telisotuzumab vedotin (Teliso-V) as a treatment for some patients with lung cancer after the drug hit the mark in a pivotal phase 2 trial.

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VPAS is dead, long live VPAG—could the UK’s new clawback revision save the day?    

Pharmaceutical Technology

After months of negotiations, the UK's DHSC and the Association of the British Pharmaceutical Industry emerged with a plan on to replace VPAS.

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What’s on the Horizon in Pharma Marketing & Innovation: Q&A With Faruk Capan, Chief Innovation Officer at EVERSANA

PharmExec

Capan discusses the industry is embracing new technologies and how these use cases may evolve in the coming year.

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Pharma unite to secure renewable energy in key manufacturing markets

European Pharmaceutical Review

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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FDA opens investigation into secondary cancer risk with CAR-T therapies

Pharmaceutical Technology

The agency has received reports of T-cell malignancies in patients who have previously received CAR-T cell immunotherapies.

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Government ‘exploring’ making HIV PrEP available in GP practices and pharmacies

The Pharmacist

The government is looking at making HIV pre-exposure prophylaxis (PrEP) available in settings other than specialist sexual health services, including GP practices and pharmacies. Pre-Exposure Prophylaxis (PrEP) is used to reduce the risk of getting HIV and can currently only be prescribed on the NHS by specialist sexual services. However, the government is exploring opportunities […] The post Government ‘exploring’ making HIV PrEP available in GP practices and pharmacies appeared first on

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