Sat.Jun 22, 2024 - Fri.Jun 28, 2024

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Daiichi’s lung cancer ADC rejected by FDA in blow to first project under Merck partnership

Fierce Pharma

In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.

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Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In

MedCity News

Multiple stakeholders are to blame for prescription drug costs, including pharmaceutical companies and PBMs, according to Merith Basey, executive director of Patients for Affordable Drugs. The post Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In appeared first on MedCity News.

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Ahead of its upcoming decision date, a competitor takes aim at KarXT

PharmaVoice

The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.

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New multiple sclerosis treatment option granted in EU

European Pharmaceutical Review

The European Commission has approved the first twice-yearly injection for relapsing and primary progressive multiple sclerosis (RMS and PPMS). Roche highlighted that as a 10-minute injection, OCREVUS ® (ocrelizumab) subcutaneous has the same twice-yearly schedule as the intravenous (IV) infusion, which was the first therapeutic to be approved for both RMS and PPMS.

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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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With FDA nod, Verona’s Ohtuvayre is set to Jack up the COPD market

Fierce Pharma

Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.

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FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP

MedCity News

Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. The post FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP appeared first on MedCity News.

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Can Moderna’s COVID-flu combo shot improve flagging vaccination rates?

PharmaVoice

A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.

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Rallying in RSV vaccine race, Pfizer gains contract win over GSK in the UK

Fierce Pharma

After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.

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AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes

MedCity News

The American Hospital Association sent letters to the Senate and House urging them to support legislation that would prevent the CMS from enforcing its final rule on minimum staffing requirements for long-term care facilities. The organization argued that the mandate could lead nursing homes to reduce capacity or close altogether. The post AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes appeared first on MedCity News.

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Zealand Pharma rakes in $1bn in funding for obesity drugs

pharmaphorum

Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.

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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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Innovative small molecule shows promise in obesity

European Pharmaceutical Review

An innovative oral small molecule GLP-1 receptor agonist enabled patients to obtain an average weight loss of 4.9 percent to 6.8 percent (least squares means) from baseline by day 28, in a Phase I trial. This was based on individuals who received the treatment in the target dose range. HUADONG MEDICINE, via its subsidiary Hangzhou Zhongmei HuaDong Pharmaceutical CO.

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AbbVie's Duopa successor in Parkinson's rejected again after FDA flags third-party manufacturer issues

Fierce Pharma

A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.

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Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms

MedCity News

The 2024 Benefit Consultant Sentiment Index published by MedCity News and sponsored by Quantum Health, now in its second year, is based on a survey of more than 100 seasoned healthcare benefits consultants who represent a cross-section of employer size. A few shared their impressions of some of the report findings. The post Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms appeared first on MedCity News.

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Virtual Publication Planning, Co-Development, and Reviews

Impetus Digital

Pharma-exclusive Webinar: Virtual Publication Planning, Co-Development, & Reviews About the webinar Join our exclusive small-group webinars to dive deep into the trends, strategies, and tips on all things Medical Publications. Learn from our expert speakers about the latest best practices for planning, co-developing, and reviewing publications and other medical materials such as peer-reviewed journal articles and consensus papers, conference abstracts and posters, educational slide decks, an

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

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Osteoporosis market expected to reach $17.9bn across 7MM by 2033

Pharmaceutical Technology

The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.

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Merck's Capvaxive gears up to challenge Pfizer's dominant Prevnar with CDC panel backing

Fierce Pharma

After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.

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Medicare Telehealth Flexibilities Will Expire In December. Congress Needs To Act Swiftly, Experts Say

MedCity News

Telehealth advocates are calling on Congress to act quickly on Medicare telehealth flexibilities, which are set to expire at the end of the year. Doing so would help key healthcare stakeholders prepare. The post Medicare Telehealth Flexibilities Will Expire In December. Congress Needs To Act Swiftly, Experts Say appeared first on MedCity News.

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New US fill finish facility receives $4.1 billion investment

European Pharmaceutical Review

Novo Nordisk has announced one of its largest manufacturing investments; $4.1 billion will support the construction of a second fill and finish facility for aseptic manufacturing in Clayton, North Carolina, US. The increased capacity will add 1.4 million ft 2 of production space, double the combined square footage of all three of the company’s existing facilities in North Carolina.

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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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Novavax seeks EMA approval for updated JN.1 Covid-19 vaccine

Pharmaceutical Technology

Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.

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Alnylam CEO touts 'big-win scenario' for Amvuttra in closely watched heart disease trial

Fierce Pharma

In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.

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What Do Experts Make of Risant Health’s Newest Acquisition?

MedCity News

While it it’s too early to judge the success of Kaiser Permanente’s Risant Health, the company’s first two acquisitions show a commitment to adjoining organizations with a strong focus on population health — as well as a dedication to spreading Kaiser’s value-based care delivery models across the country. The post What Do Experts Make of Risant Health’s Newest Acquisition?

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Don’t call it a comeback: Biotech’s CNS resurgence forges Big Pharma connections

PharmaVoice

Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.

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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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Bridging Authenticity: The Transformative Power of Allyship

ALULA

Since our Pride Month series is all about prompting more open conversations about LGBTQIA+ allyship, I took the opportunity to interview my colleague Brian Cole about his allyship journey. Not only is Brian my colleague , but he is also my dad, so it was powerful to address how features of allyship show up across our shared work, home, and social spaces.

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After stock crash and staff cuts, Amarin wins bid to revive Vascepa patent lawsuit

Fierce Pharma

The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. | Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business.

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Illumina Spin-Off Now Complete, Grail Sets Out on Its Own on the Public Markets

MedCity News

Liquid biopsy company Grail is now an independent, publicly traded company. While the separation from Illumina ends a protracted antitrust battle, Grail is still in the early stages of a long-term strategy to win regulatory validation and payor coverage for its multi-cancer early detection test. The post Illumina Spin-Off Now Complete, Grail Sets Out on Its Own on the Public Markets appeared first on MedCity News.

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FDA clears Argenx’ Vyvgart Hytrulo for rare disease CIDP

pharmaphorum

Netherlands biotech Argenx has a second FDA approval for its FcRn inhibitor Vyvgart Hytrulo, adding a new indication in chronic inflammatory demyelinating polyneuropathy (CIDP) for a drug that it hopes could find a use in more than a dozen diseases.

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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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After an obesity deal with Novo, Omega’s new business head is on the hunt for more partners

PharmaVoice

With a career focused on striking deals, Kaan Cartel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.

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Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules

Fierce Pharma

Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. | Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court.

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Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD

MedCity News

Verona Pharma’s COPD drug Ohtuvayre is a single small molecule that blocks two targets to bring patients both bronchodilation and anti-inflammatory effects. Verona executives contend their inhalable drug has key advantages over the last novel COPD medication, the orally administered roflumilast. The post Verona Pharma Drug With Dual Mechanism Lands FDA Approval in COPD appeared first on MedCity News.

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Magazine: UK’s new Netflix-style funding model for antibiotics goes live

Pharmaceutical Technology

In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time