White House wins in first Medicare negotiation legal ruling
pharmaphorum
FEBRUARY 13, 2024
Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional
Sat.Feb 10, 2024 - Fri.Feb 16, 2024
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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor
Fierce Pharma
FEBRUARY 16, 2024
The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunothera | The T-cell therapy treatment class, which has transformed the treatment of certain blood cancers, has now reached the solid tumor field thanks to an FDA approval for a first-of-its-kind immunotherapy developed by Iovance Biotherapeutics.
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2024 Journal Citation Reports: Changes in Journal Impact Factor category rankings to enhance transparency and inclusivity
Clarivate
FEBRUARY 16, 2024
New – unified rankings for each of our 229 science and social science categories; no Journal Impact Factor (JIF) rankings for the arts and humanities categories The scholarly landscape is witnessing a significant increase in both the quantity and sophistication of fraudulent behaviors, posing a substantial threat to the integrity of the scholarly record.
MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine
Pharmaceutical Technology
FEBRUARY 12, 2024
The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.
AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work
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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.
AI Biotech Exscientia Fires CEO Hopkins for Relationships With Two Employees
MedCity News
FEBRUARY 13, 2024
Exscientia’s termination of CEO Andrew Hopkins is for cause and effective immediately. Grounds for termination include misconduct or behavior that brings Hopkins or the company into disrepute, according to his employment agreement.
FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies
Fierce Pharma
FEBRUARY 16, 2024
People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. | People with food allergies finally have a drug that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods.
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Vertex secures European approval for CRISPR cell therapy
European Pharmaceutical Review
FEBRUARY 13, 2024
The first CRISPR/Cas9 gene-edited therapy has been granted a marketing authorisation by the European Commission (EC). Vertex Pharmaceuticals’ CASGEVY ( exagamglogene autotemcel [exa-cel]) is conditionally approved individuals 12 years and over with severe sickle cell disease characterised by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.
EY: Health Executives Are Implementing Digital Health, But Aren’t Seeing ROI Yet
MedCity News
FEBRUARY 16, 2024
A new EY survey found that while 86% of health executives say that digital health solutions have the potential to reduce costs, 70% said they haven’t seen a return on investment so far.
'The Top Line': Gene editing's next act
Fierce Pharma
FEBRUARY 16, 2024
Gene editing’s therapeutic application has transitioned from hypothetical to reality, marked by the recent approval of a CRISPR-based therapy for sickle cell and beta thalassemia. | This week on "The Top Line," Max Bayer from Fierce Biotech explores the future of gene editing in an interview with the CEO of Verve Therapeutics.
Study backs safety of Gilead CAR-T as outpatient therapy
pharmaphorum
FEBRUARY 16, 2024
CAR-T therapies can achieve remarkable efficacy in the treatment of haematological cancers, but the risk of side effects means that the cell infusions are almost always administered to inpatients under close supervision in clinics.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
New chemotherapy treatment could benefit multiple cancer types
European Pharmaceutical Review
FEBRUARY 15, 2024
A clinical trial in malignant pleural mesothelioma (MPM) has demonstrated the first successful combination of chemotherapy with a drug targeting cancer’s metabolism developed for the asbestos-induced disease in two decades. The anti-cancer treatment combines the new drug ADI-PEG20 and traditional chemotherapy. The Phase III ATOMIC-meso trial was led by Queen Mary University of London in the UK and studied 249 patients with the disease.
Unlocking the Potential of AI-Driven Biomarkers: A New Era in Personalized Cancer Care
MedCity News
FEBRUARY 12, 2024
By leveraging AI and machine learning, researchers can analyze complex data sets, identify novel biomarkers, and provide more effective and tailored treatment options for cancer patients.
Catalent restructuring leaves 300 without jobs as CDMO awaits $16.5B Novo buyout
Fierce Pharma
FEBRUARY 15, 2024
Even as Catalent moves toward a $16.5 billion sale to Novo Holdings, hundreds of the CDMO's former staffers won't be in the mix going forward. | A recent buyout announcement didn't spare Catalent staffers from layoffs after the company this week revealed it's trimmed hundreds of jobs over the last few months. The move forms part of an ongoing restructuring scheme at Catalent.
Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia
pharmaphorum
FEBRUARY 13, 2024
Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU, after getting a green light from the European Commission.
Rare Disease Day 2024: Advocating for Awareness and Support
PM360
FEBRUARY 12, 2024
This February we celebrate the 16th annual Rare Disease Day , established in 2008, to raise awareness of the more than 7,000 identified rare diseases worldwide. Rare Disease Day is observed annually on the “rarest” day of the year, February 28th or 29th depending on leap years. Created by The European Organization for Rare Diseases (EURORDIS) , this globally coordinated event brings together industry stakeholders to advocate for increased access to medical treatment for patients, caregivers, and
Safe and Affordable Family-Forming Benefits Provide a Competitive Leg Up
MedCity News
FEBRUARY 16, 2024
Offering safe affordable family-forming programs for everyone, including vulnerable or under-served employee populations, represents an opportunity for employers to build a caring culture that also will benefit the bottom line.
Johnson & Johnson's Aurlumyn scores first FDA approval to treat severe frostbite
Fierce Pharma
FEBRUARY 14, 2024
Over the last month, for those watching HBO’s macabre “True Detective Night Country”—a TV series set in a harsh, sunless winter in a fictional Alaskan town—a continual theme is frostbite. | The FDA has approved the first medicine for severe frostbite. The U.S. regulator has signed off on Johnson & Johnson’s Aurlumyn (iloprost), an injected treatment to reduce the risk of amputation of the fingers or toes.
Freenome raises $254m for cancer tests, and other financings
pharmaphorum
FEBRUARY 16, 2024
Recent biotech financings include a $245m raise for cancer blood test company Freenome, plus big rounds for Cogent Biosciences, BioAge Labs, Latigo Biotherapeutics, ProfoundBio, and Firefly Bio
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Psychedelic treatments for mental health: Is there substance behind the hype?
Pharmaceutical Technology
FEBRUARY 15, 2024
The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.
Cigna, HelloFresh Team Up To Improve Access to Healthy Food
MedCity News
FEBRUARY 15, 2024
Through a new partnership, up to 12 million members of Cigna’s employer customers will gain access to HelloFresh’s meals at a discounted rate. Cigna and HelloFresh are also partnering to provide free meal kits to those battling food insecurity in local communities.
FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic
Fierce Pharma
FEBRUARY 14, 2024
FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10
Gilead’s CD47 woes continue, this time in solid tumours
pharmaphorum
FEBRUARY 16, 2024
Gilead Sciences has paused enrolment in clinical trials of its CD47 drug magrolimab in solid tumours, a week after dropping it for blood cancers.
How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales
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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten
Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
European Pharmaceutical Review
FEBRUARY 15, 2024
The investment… includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP [manufacturers]” Nelson Labs, a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries has announced its Itasca, Illinois laboratory in the US as a new Pharmaceutical Center of Excellence to serve the unique needs of parenteral and ophthalmic drug product (PODP) manufacturers.
FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves
MedCity News
FEBRUARY 14, 2024
Ipsen’s Onivyde is now FDA approved as a first-line treatment for metastatic pancreatic cancer, triggering a milestone payment to Merrimack Pharmaceuticals, the drug’s original developer. Merrimack plans to dissolve operations but its shareholders will receive payouts from the Ipsen payment.
Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'
Fierce Pharma
FEBRUARY 13, 2024
While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.
Apple devices enrich patent data in arthritis trial
pharmaphorum
FEBRUARY 12, 2024
Study finds that monitoring of rheumatoid arthritis patients with an Apple Watch and iPhone and AI algorithm improves on standard practices.
How to Stay Competitive in the Evolving State of Martech
Advertiser: ZoomInfo
Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr
Biologics – manufacturing trends in a modern facility
European Pharmaceutical Review
FEBRUARY 12, 2024
Bringing a therapeutic to market is a long and complex process. ‘From bench to bedside’ is a well-known aphorism that merely hints at the arduous journey drug treatments must undergo from their position as a candidate molecule or soon to be explored pathway, to becoming a tablet, injection, or infusion administered to patients worldwide. The scientific rigour of development and the various regulatory hurdles involved mark most of that journey.
The Integration of Gen AI and CPQ Systems for Personalized and Efficient Healthcare
MedCity News
FEBRUARY 16, 2024
As more and more organizations integrate Generative AI with Configure, Price, Quote (CPQ) systems, they declare their belief that we can aspire to incredible advancements in human health and well-being through digital transformation.
Alnylam changes analysis plan for key Amvuttra heart trial, jolting investors
Fierce Pharma
FEBRUARY 15, 2024
Changing a clinical trial’s statistical analysis plan on the cusp of a readout? | Changing a clinical trial’s statistical analysis plan on the cusp of a readout? That’s exactly what Alnylam just did for a closely watched study of its next-generation RNA interference therapy Amvuttra in a rare heart disease.
Innsena backs CancerX’s digital drive to improve access
pharmaphorum
FEBRUARY 15, 2024
Healthtech specialist Innsena has committed funding and expertise to CancerX, launched last year to encourage the use of digital health technologies to overcome challenges in cancer care.
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