Sat.Feb 10, 2024 - Fri.Feb 16, 2024

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White House wins in first Medicare negotiation legal ruling

pharmaphorum

Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional

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FDA approves Iovance’s Amtagvi as first T-cell therapy for a solid tumor

Fierce Pharma

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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MHRA agrees licence change for Pfizer-BioNTech’s Comirnaty vaccine

Pharmaceutical Technology

The UK MHRA has granted approval for a variation in licence of Pfizer-BioNTech’s Comirnaty XBB.1.5 vaccine targeting Omicron variant.

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2024 Journal Citation Reports: Changes in Journal Impact Factor category rankings to enhance transparency and inclusivity

Clarivate

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.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

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.

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Positive results for MAIA’s SCLC treatment published in Nature Communications

PharmaTimes

The aggressive type of cancer accounts for 13% of all lung cancer cases worldwide

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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

Fierce Pharma

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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More Trending

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Dermatology pharma Alys launches with $100m from Medicxi

pharmaphorum

Medicxi has combined six biotechs with dermatology medicines in development in a single drugmaker, called Alys Pharma, which starts life with $100 million in financing.

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First UK patients receive experimental mRNA therapy for cancer in global trial

PharmaTimes

The phase 1/2 Mobilize trial is evaluating the safety and efficacy of mRNA-4359

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'The Top Line': Gene editing's next act

Fierce Pharma

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.

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The Integration of Gen AI and CPQ Systems for Personalized and Efficient Healthcare

MedCity News

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.

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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

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Gilead’s CD47 woes continue, this time in solid tumours

pharmaphorum

Gilead Sciences has paused enrolment in clinical trials of its CD47 drug magrolimab in solid tumours, a week after dropping it for blood cancers.

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Psychedelic treatments for mental health: Is there substance behind the hype?

Pharmaceutical Technology

The success of recent trials treating mental health problems with psychedelic therapies has driven a rapid rise in investment in the area.

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Biogen CEO plots long-term turnaround after analysts brand company's recent results as 'weak'

Fierce Pharma

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.

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Why One Google Cloud Exec Thinks HHS’ New Cybersecurity Guidelines Are A Step In The Right Direction

MedCity News

HHS recently published guidance outlining voluntary cybersecurity performance goals for the healthcare sector. Taylor Lehmann, a cybersecurity executive at Google Cloud, noted that “what is on HHS paper will most likely become what is in the actual final rulemaking or new regulatory requirements that become law.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Biogen’s Skyclarys is first EU drug for Friedreich’s ataxia

pharmaphorum

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.

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Stroke brain-bleed deaths predicted to increase by 40% in the UK

PharmaTimes

In Europe, stroke-related brain-bleed deaths are expected to increase by 8.

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J&J consumer health spinoff Kenvue telegraphs 100-plus layoffs in California, New Jersey

Fierce Pharma

While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a swanky new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the tran | While Johnson & Johnson’s consumer health spinoff Kenvue prepares to move into a new headquarters in Summit, New Jersey, it appears some staffers won’t be joining the company in the transition.

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EY: Health Executives Are Implementing Digital Health, But Aren’t Seeing ROI Yet

MedCity News

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.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Astellas pledges $800m to Kelonia CAR-T alliance in cancer

pharmaphorum

Astellas has signed a deal with Kelonia Therapeutics that aims to push the boundaries of what can be achieved with CAR-T therapies in immuno-oncology

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Closed Loop Medicine shares results of proprietary technology for hypertension

PharmaTimes

CLM-HT01 improved blood pressure and minimised adverse reactions in patients

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Novartis, zeroing in on innovative meds, launches strategic review of India outfit

Fierce Pharma

A Novartis subsidiary in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines. | A Novartis subsidiary handling old products in India has become the target of a strategic review as the Swiss pharma focuses its efforts on newer medicines.

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Safe and Affordable Family-Forming Benefits Provide a Competitive Leg Up

MedCity News

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.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

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

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Study backs safety of Gilead CAR-T as outpatient therapy

pharmaphorum

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.

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Vertex secures European approval for CRISPR cell therapy

European Pharmaceutical Review

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.

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Alnylam changes analysis plan for key Amvuttra heart trial, jolting investors

Fierce Pharma

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.

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FDA Approves New First-Line Med for Pancreatic Cancer as Drug’s Initial Developer Dissolves

MedCity News

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.

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How to Stay Competitive in the Evolving State of Martech

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

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Exercise ‘may be better than drugs for depression’

pharmaphorum

Exercise matched psychotherapy and was more effective than medication as a treatment for #depression in a meta-analysis of randomised clinical trials

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UK Agency targets blood thinners in personalised medicine pursuit

Pharmaceutical Technology

The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.

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With FDA nod for Onivyde combo, Ipsen ends 10-year drought in newly diagnosed pancreatic cancer

Fierce Pharma

It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. | It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.

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Cigna, HelloFresh Team Up To Improve Access to Healthy Food

MedCity News

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.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time