Sat.Sep 21, 2024 - Fri.Sep 27, 2024

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Considering Covering GLP-1s? Here’s What You Need to Know

MedCity News

Though chronic disease treatment is rapidly expanding, balancing the latest medication with proven initiatives can help employers manage rising healthcare costs wherever you fall on the GLP-1 coverage spectrum. The post Considering Covering GLP-1s? Here’s What You Need to Know appeared first on MedCity News.

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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

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“PBMs favour high list prices”- Novo Nordisk CEO targets PBMs in US Senate hearing

Pharmaceutical Technology

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

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Pfizer pulls sickle cell med Oxbryta off market after deaths

pharmaphorum

Pfizer is voluntarily withdrawing its sickle cell drug Oxbryta after a review revealed an imbalance of deaths in clinical trials

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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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AI Holds Promise, But Concerns Around Costs and Data Remain

MedCity News

The new generation of healthcare AI innovation is promising, but there are some problems that remain when it comes to AI, such as data generalization and the high cost of adopting new tools, pointed out Dr. Arash Harzand. The post AI Holds Promise, But Concerns Around Costs and Data Remain appeared first on MedCity News.

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Novo Nordisk CEO prepares to defend Ozempic, Wegovy US pricing at Senate hearing

Fierce Pharma

After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.

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Ipsen crosses EU finish line with Alagille syndrome drug

pharmaphorum

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.

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Two Venture Investors Offer Their Takes on the State of Biotech Investing Today

MedCity News

The way venture capital firms invest in biotech startups has changed. Veteran VCs Chris Garabedian and Arjun Goyal offered their perspectives during a panel discussion at the World Medical Innovation Forum. The post Two Venture Investors Offer Their Takes on the State of Biotech Investing Today appeared first on MedCity News.

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UCB rapidly bolsters blockbuster potential for Bimzelx with 3 new FDA approvals

Fierce Pharma

Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.

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UNICEF secures one million mpox vaccines for Africa

Pharmaceutical Technology

Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.

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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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SEC charges Cassava over 'misleading' Alzheimer's claims

pharmaphorum

Cassava Sciences will pay $40m to settle SEC charges that it made misleading claims about a phase 2b study of Alzheimer's candidate simufilam.

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Unpacking the Epic-Particle Health Dispute: When It Started, What’s Being Alleged & What It Means for the Industry

MedCity News

Following a months-long dispute, data platform Particle Health filed an antitrust lawsuit against Epic, alleging that the EHR giant is using its dominance in the market to prevent competition in the payer platform space. Particle believes the lawsuit is an “unprecedented challenge” to Epic’s market power, while Epic thinks the startup’s claims are “baseless.

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Vertex taps Lonza to help produce global supply of cutting-edge CRISPR therapy Casgevy

Fierce Pharma

With the launch of Casgevy gaining momentum, Vertex Pharmaceuticals is adding another link to its gene-editing therapy supply chain. | Vertex has inked a long-term supply agreement with Swiss CDMO Lonza to crank out global commercial supply of Casgevy. Under the deal, Lonza will produce Casgevy from its cell therapy manufacturing facilities in Geleen in the Netherlands and, eventually, its plant in Portsmouth, New Hampshire.

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Pharmaceutical Excellence Awards 2024: West Pharmaceutical Services 

Pharmaceutical Technology

West Pharmaceutical Services is a winner in the Safety category in the 2024 Pharmaceutical Technology Excellence Awards.

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

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World leaders seek 10% cut in antibiotic resistance deaths

pharmaphorum

World leaders seek 10% cut in antibiotic resistance deaths Phil.

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How AI Humanizes Mental Healthcare

MedCity News

The integration of AI into mental healthcare is more advanced than many realize because it’s not always obvious; frequently, it’s providing support to free up clinicians to spend more time with their patients or to get more patients into treatment. The post How AI Humanizes Mental Healthcare appeared first on MedCity News.

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Bluebird bio lays off 25% of workforce as gene therapy pioneer struggles to stay afloat

Fierce Pharma

After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%. | After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%, or nearly 100 employees.

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FDA approves AstraZeneca FluMist ‘flu vaccine for self-administration

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.

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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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Vicebio raises $100m for vaccines and other bio financings

pharmaphorum

Our periodic round-up of financings in the biotech sector is led by an impressive nine-figure round for UK vaccines developer Vicebio, with GC Therapeutics, Genespire, and 858 Therapeutics also in on the action.London, UK-based Vicebio raised $100 million in a Series B that will help to fund the development of its Molecular Clamp technology to produce improved, more potent vaccines that are simpler to manufacture.

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FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades

MedCity News

Bristol Myers Squibb’s Cobenfy treats schizophrenia by going after a different target than currently available antipsychotic drugs, which is intended to offer better efficacy and safety. The drug came from the pharma giant’s $14 billion acquisition of Karuna Therapeutics. The post FDA Approval of Bristol Myers Drug Makes It the First Novel Schizophrenia Med in Decades appeared first on MedCity News.

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Experts support FDA's plan for biomarker-based restriction on PD-1 drugs in stomach cancer

Fierce Pharma

The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. | The days of broad stomach cancer labels for PD-1 inhibitors appear to be numbered. A group of external advisers to the FDA voted 10-2 that the use of PD-1 inhibitors in first-line, HER2-negative gastric cancer is not favorable in patients who have PD-L1-negative tumors.

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Telix acquires RLS Radiopharmacies to expand US manufacturing presence

Pharmaceutical Technology

Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.

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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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MSD hits a hurdle with its LAG-3 programme

pharmaphorum

MSD's combination of PD-1 inhibitor Keytruda and experimental LAG-3 inhibitor favezelimab has failed a phase 3 trial in patients with previously treated PD-L1-positive microsatellite stable (MSS) metastatic colorectal cancer.An analysis of data from the 447-patient KEYFORM-007 study revealed that the fixed-dose combination of Keytruda (pembrolizumab) and favezelimab was unable to extend overall survival (OS) compared to standard care with kinase inhibitor regorafenib and trifluridine and tipirac

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How AI Can Help Hospitals Overcome Patient Flow Barriers

MedCity News

Artificial intelligence (AI) holds potential to forecast and predict where hospital leaders should direct limited resources such as clinicians, staff, and beds to improve operational efficiency and drive better patient outcomes. The post How AI Can Help Hospitals Overcome Patient Flow Barriers appeared first on MedCity News.

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With success in myasthenia gravis trial, Amgen's Uplizna looks set up to add new indication

Fierce Pharma

Three months after Amgen revealed that Uplizna had aced a phase 3 trial in immunoglobulin G4-related disease (IgG4), the company said the anti-CD-19 antibody has excelled in a study against another | Three months after Amgen revealed that Uplizna had aced a phase 3 trial in IgG4, the company said the anti-CD-19 antibody has excelled in a study against another neurologic disorder, myasthenia gravis.

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EMA CHMP recommends AstraZeneca’s Fasenra to treat EGPA

Pharmaceutical Technology

The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).

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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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Novo Nordisk CEO reticent on lowering semaglutide prices

pharmaphorum

Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.

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Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage

MedCity News

Responsible procurement and handling of data and digital marketing insights by hospitals can generate useful information to improve patient wellness and operational efficiency without compromising compliance. The post Personalize Patient Care with Confidence Through Efficient, HIPAA-Compliant Data Usage appeared first on MedCity News.

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AstraZeneca’s Tagrisso follows up ASCO standing ovation with key lung cancer FDA nod

Fierce Pharma

In June, at the American Society of Clinical Oncology (ASCO) conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer (NSCLC) blockbuster Tag | In June at the ASCO conference in Chicago, when AstraZeneca discussed results from a phase 3 trial of its non-small cell lung cancer blockbuster Tagrisso, the presentation received a standing ovation.

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First-in-class therapy approved for schizophrenia

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) for schizophrenia in adults. “Today’s landmark approval of our first-in-class treatment for schizophrenia marks an important milestone for the community, where after more than 30 years, there is now an entirely new pharmacological approach for schizophrenia — one that has the potential to change the treatment paradigm,” shared Dr Chris Boerner , PhD, Board Chair and Chief Executive Officer at Bristo

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time