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.
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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PharmaVoice
NOVEMBER 16, 2023
Dr. Paul Moss, a hematology expert in the U.K., conducted a study with AstraZeneca showing the alarming extent to which immunocompromised patients are burdened with COVID-19.
Pharmaceutical Technology
NOVEMBER 21, 2023
Texas AG has sued Pfizer and Tris Pharma for providing adulterated attention-deficit/hyperactivity disorder drug, Quillivant XR, to children.
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.
The Pharmacist
NOVEMBER 15, 2023
The highly anticipated Pharmacy First common conditions service in England is set to launch at the end of January, it has been announced. The news comes as part of a series of announcements confirmed by NHS England (NHSE) and Community Pharmacy England (CPE) today, which also included updates on contraception and hypertension services. And CPE […] The post Breaking: Pharmacy First to launch end of January appeared first on The Pharmacist.
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.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
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.
PharmaVoice
NOVEMBER 17, 2023
The recently observed dip was particularly acute for men, who now live an average of 5.8 fewer years than women.
PharmExec
NOVEMBER 15, 2023
Defencath is indicated for the prevention and treatment of catheter-related bloodstream infections in adults with kidney failure administered chronic hemodialysis via a central venous catheter.
Big Molecule Watch
NOVEMBER 16, 2023
Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY (exagamglogene autotemcel), marking the world’s first regulatory approval for a CRISPR-based gene-edited therapy. CASGEVY is the first medicine to be licensed that uses the innovative gene-editing tool CRISPR.
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The Guardian - Pharmaceutical Industry
NOVEMBER 7, 2023
Cure any ailment! Never known to fail! Early medicine adverts made grand claims but they look alarming today The confusion with patent medicines starts with the name, since they were rarely ever patented; manufacturers just thought it sounded cool. Bamboozling was always part of the package: from the 17th century, concoctions of water, alcohol and herbs were sold with wild claims and exotic origin stories.
BioPharma Dive
NOVEMBER 3, 2023
The company recorded a net loss in the third quarter as it “resizes” its manufacturing footprint, and now expects revenue to come in at low end of its previous guidance.
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.
PharmaVoice
NOVEMBER 13, 2023
The arsenal against the world’s deadliest creature is growing and a universal vaccine is in the works.
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.
Pharma Times
NOVEMBER 29, 2023
The new state-of-the-art facility is set to be operational in early 2024 - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 24, 2023
Epidiolex has been approved as an adjunct therapy for seizures associated with three rare forms of epilepsy in patients aged two and older.
BioPharma Dive
NOVEMBER 21, 2023
The partnership is another investment by the biotech subsidiary in artificial intelligence for drug discovery and development, continuing an industry trend.
STAT
NOVEMBER 24, 2023
Reports this week that China is experiencing a surge in respiratory infections in young children triggered flashbacks of the start of the Covid-19 pandemic among infectious disease watchers. But a rapidly organized meeting Thursday between the World Health Organization and health officials in China assuaged much of that concern. The evidence presented to the WHO team pointed to what’s sometimes called an immunity gap that was created by the pandemic.
PharmaVoice
NOVEMBER 1, 2023
From hallucinations to data privacy, pharma looks to iron out the kinks of generative AI.
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.
Pharma Times
NOVEMBER 6, 2023
The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes
Pharmafile
NOVEMBER 1, 2023
AstraZeneca has announced a collaboration and investment agreement with Cellectis for the development of next generation cell and gene therapeutics (CGTs) in areas such as oncology, immunology and rare diseases. Under terms of this agreement, AstraZeneca will utilise Cellectis’ proprietary gene editing technologies and manufacturing capabilities with the intention of designing novel CGT products. 25 […] The post AstraZeneca and Cellectis to collaborate for cell therapy and genomic medicine
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.
STAT
NOVEMBER 24, 2023
UnitedHealth Group’s Optum division is already the largest employer of physicians in the United States, but allegations in a new lawsuit suggest Optum is hungry for more. Emanate Health, a nonprofit group of hospitals and physicians in California, filed a federal lawsuit Monday, alleging Optum pushed it to agree not to compete for primary care physicians, a violation of antitrust law.
Pharmaceutical Technology
NOVEMBER 22, 2023
The funding will go towards the development of the company's four CNS candidates, with Phase II study data readouts expected by early 2025.
pharmaphorum
NOVEMBER 7, 2023
Frontiers Health 23 - Day 1 from the marvellous Auditorium della Tecnica in Rome, where we are set to bring you the biggest news stories, trends, and industry insights
Pharma Times
NOVEMBER 17, 2023
The AI system will identify those most at risk and reduce pressure on the NHS - News - PharmaTimes
PharmExec
NOVEMBER 8, 2023
Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.
BioPharma Dive
NOVEMBER 16, 2023
Clearance of Vertex Pharmaceuticals and CRISPR Therapeutics' Casgevy in the U.K. comes ahead of expected regulatory decisions in the U.S. and Europe.
STAT
NOVEMBER 16, 2023
LONDON — Regulators in the U.K. on Thursday approved a CRISPR-based medicine to treat both sickle cell disease and beta thalassemia, making it the world’s first therapy built on the revolutionary gene-editing technology and ushering in a new phase of genetic medicine. The authorization of the therapy, from Vertex Pharmaceuticals and CRISPR Therapeutics, is itself not a surprise.
Pharmaceutical Technology
NOVEMBER 29, 2023
Japan’s MHLW has approved CSL and Arcturus Therapeutics’ self-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.
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.
Pharma Times
NOVEMBER 3, 2023
Since 2022, an estimated 17,000 strokes and 4,000 deaths have been prevented - News - PharmaTimes
EMCrit Project
NOVEMBER 4, 2023
AHA Guidelines on Critical Care Toxicology EMCrit Project by Scott Weingart, MD FCCM.
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