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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“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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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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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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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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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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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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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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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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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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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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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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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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Mirai Bio launches with plan to help genetic med developers

pharmaphorum

Flagship Pioneering's latest biotech launch, Mirai Bio, aims to help genetic medicine developers find the best way to get their drugs to patients.The new Cambridge, Massachusetts-based company – which was set up in 2021 but makes its official launch today with $50 million in funding from Flagship – applies artificial intelligence to solve the various obstacles that can block the progress of new medicines.

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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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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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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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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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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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BMS wins approval for schizophrenia drug acquired from Karuna

Pharmaceutical Technology

The FDA has approved the first treatment for schizophrenia that targets cholinergic receptors rather than dopamine receptors.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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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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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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EC authorises LEO Pharma Anzupgo cream for chronic hand eczema

Pharmaceutical Technology

The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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Navigating Economic Uncertainty in Biopharma

MedCity News

The biopharmaceutical industry clearly isn’t going anywhere, but we’ve been in a downward business cycle. We’ve learned a lot from the pandemic and have adopted novel approaches to development and this current economic challenge will also inform us. In the meantime, adopting these strategies can de-risk your development programs. The post Navigating Economic Uncertainty in Biopharma 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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Pharmaceutical Packaging Companies in Contract Manufacturing for the Pharmaceutical Industry

Pharmaceutical Technology

Discover the leading Pharmaceutical Packaging Companies, Suppliers & Solutions. Download the free Buyer's Guide today for full details.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.