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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AstraZeneca’s Tagrisso receives approval in Japan for lung cancer

Pharmaceutical Technology

AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).

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

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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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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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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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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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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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House committee backs some Medicare cover for obesity drugs

pharmaphorum

The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

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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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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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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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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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Verona’s first-in-class COPD drug ‘could transform market’

pharmaphorum

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to Verona.

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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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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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Amylyx ventures into metabolic diseases market with $35.1m deal

Pharmaceutical Technology

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Mistrust in healthcare is hitting clinical trial enrolment

pharmaphorum

A survey of pharma industry executives has found that a third of them believe mistrust in the healthcare system has become a significant barrier to getting a diverse range of people to sign up for clinical trials.

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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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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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FDA go-ahead for Verona Ohtuvayre transforms US COPD exacerbator market

Pharmaceutical Technology

Data showed that Ohtuvayre significantly improved dyspnea compared to placebo in as little as six weeks and maintained this over 24 weeks.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Purdue’s bankruptcy plan in tatters as SCOTUS says no

pharmaphorum

SCOTUS rejects bankruptcy deal that would settle opioid litigation against Purdue Pharma, but also protect the Sackler family from liability.

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In bispecific rivalry, AbbVie’s Epkinly follows Roche’s Lunsumio into follicular lymphoma

Fierce Pharma

With Regeneron’s treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. | With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval.

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Embracing Technology in Nursing Education to Grow the Nursing Pipeline

MedCity News

Leveraging technology as a force multiplier can significantly help nursing programs graduate more practice-ready nurses to care for patients in their communities. The post Embracing Technology in Nursing Education to Grow the Nursing Pipeline appeared first on MedCity News.

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Investigating the Cost-Effectiveness of Durvalumab

Pharmaceutical Commerce

A study examines the economical validity of using this therapy as a treatment for unresectable stage III non–small cell lung cancer.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Vertex islet cell therapy gets type 1 diabetics off insulin

pharmaphorum

Three people with type 1 diabetes who received Vertex Pharma’s islet cell therapy VX-880 were able to come off insulin within a year

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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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Empowering Independence: The Rising Role of MLTSS in Medicaid Evolution

MedCity News

Managed long-term services and supports (MLTSS) are emerging as essential lifelines for transformation. The post Empowering Independence: The Rising Role of MLTSS in Medicaid Evolution appeared first on MedCity News.

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Novo Nordisk invests $4.1bn in manufacturing facility in NC

Pharmaceutical Technology

Novo Nordisk has unveiled a significant investment plan, committing $4.1bn to construct a second fill and finishing facility in Clayton.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.