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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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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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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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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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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Behind the rise BMS’ KarXT, the first new schizophrenia drug in decades

PharmaVoice

KarXT’s approval demonstrates Bristol Myers Squibb’s dealmaking prowess and marks a turning point for a new generation of treatments.

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Pain Meds, Cell Therapies & More: Vertex Pharma CEO Talks About What’s Next After Cystic Fibrosis

MedCity News

Vertex Pharmaceuticals is known for its cystic fibrosis drugs, but the company aims to diversify with a pipeline that reaches more therapeutic areas. CEO Reshma Kewalramani explained Vertex’s strategy during the World Medical Innovation Forum in Boston. The post Pain Meds, Cell Therapies & More: Vertex Pharma CEO Talks About What’s Next After Cystic Fibrosis 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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AZ gets sought-after lung cancer approval for Tagrisso

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

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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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“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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Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds

MedCity News

Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is based on positive results from a new study that incorporated real-world evidence. The post Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds 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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How to Make Your Sales Enablement Strategy Actually Work

Integrity Solutions

Sales enablement has become an integral component of the modern sales organization, yet there is still confusion around what sales enablement actually is and, crucially, how to really make it deliver results for your salespeople and your business. As sales leaders grapple with continual volatility and complexity in the selling ecosystem, they’ve increasingly turned to sales enablement strategies to help improve sales outcomes and drive growth more efficiently.

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

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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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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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Iterum’s oral sulopenem acceptance hinges on antibiotic stewardship efforts

Pharmaceutical Technology

Iterum Therapeutics faces a mixed reception for its therapy for uncomplicated urinary tract infections (UTIs) as experts raise concerns about antibiotic resistance.

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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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AI firm Generate signs $1bn discovery deal with Novartis

pharmaphorum

Flagship Pioneering-backed artificial intelligence startup Generate:Biomedicines has attracted another big pharma partnership, this time with Novartis.The wide-ranging deal, worth up to $1 billion, covers multiple targets and disease areas and focuses on the discovery and development of protein-based therapeutics using Generate's generative AI (genAI) platform.

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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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Contract manufacturer PCI pumps $365M+ into US, EU packaging projects

Fierce Pharma

Flush with new business, Philadelphia-based CDMO PCI Pharma Services is blueprinting multiple manufacturing outlays on both sides of the Atlantic. | PCI has “heavily invested” in new drug delivery tech at its Philadelphia headquarters, laid plans for a 545,000-square-foot expansion in Rockford, Illinois, acquired a new packaging and device assembly plant near Dublin, Ireland, and broken ground on another at its CityNorth Dublin campus.

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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 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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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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How Health Systems Can Bridge Gaps in Health Equity

MedCity News

To effectively address health disparities, organizations must implement health equity strategies that target systemic barriers and root causes. Here are strategies that can help drive comprehensive, system-wide change. The post How Health Systems Can Bridge Gaps in Health Equity appeared first on MedCity News.

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Citing enrollment challenges, Bristol Myers and 2seventy scrap Abecma trial in first-line myeloma

Fierce Pharma

Bristol Myers Squibb’s struggling CAR-T therapy Abecma has hit a major setback. | Bristol Myers Squibb’s CAR-T therapy Abecma has hit a major setback. Bristol and its partner 2seventy bio have decided to pull the plug on the phase 3 KarMMa-9 trial in first-line myeloma after struggling to enroll patients.

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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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FTC sues PBMs over 'perverse' rebate system

pharmaphorum

FTC lawsuit accuses top three PBMs of using a perverse drug rebate system to artificially inflate the price of insulin products and their profits

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50 States of Interoperability: Why One-Size-Fits-All Tech Solutions Can’t Bridge Gaps in Behavioral Health

MedCity News

The lack of consistent data standards poses a major barrier to the exchange of information across stakeholders. As providers and administrators struggle to identify the best next step to meet new standardization rules, they need a strategy tailored to the intricacies of their program, based on their specific data workflows — which might look vastly different state to state.

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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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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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European Clinical Supply Planning: Balancing Cost, Flexibility and Time