Wed.Jan 17, 2024

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Bayer CEO Bill Anderson makes his mark with major restructuring, 'significant' job cuts

Fierce Pharma

Bayer is launching a sweeping business overhaul as the German conglomerate sees “no viable alternative.” | Bayer is launching a sweeping business overhaul that will “come at the expense of many managerial employees,” as the German conglomerate sees “no viable alternative.

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CMS Finalizes Rule Streamlining Prior Authorization Process

MedCity News

CMS finalized a rule on Wednesday that included set deadlines for affected payers to complete prior authorization requests. Several organizations came out in support of the rule.

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Trending Sources

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US agency nixes Seagen patent, handing Daiichi Sankyo a win in long-running Enhertu entanglement

Fierce Pharma

After years of patent litigation between cancer drug developers Daiichi Sankyo and Seagen, the U.S. Patent and Trademark office (U.S. PTO) has handed Daiichi the latest win in the saga. | After a Texas jury sided with Seagen a patent spat, the U.S. Patent and Trademark Office has invalidated the patent in question.

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AMA President: Medicare Physician Pay Cuts Will Have ‘Dire’ Impact if Not Reversed

MedCity News

The Medicare physician pay cuts that went into effect January 1 is a “disaster for the profession,” said Dr. Jesse Ehrenfeld, president of the AMA, during an interview at CES 2024. Getting the pay cut reversed is a top priority for the organization.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With $1.2B stock sale, GSK offloads more of its stake in consumer health spinoff Haleon

Fierce Pharma

GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022. | GSK is sticking to its plan to gradually monetize its stake in Haleon, the consumer health business the British pharma giant spun off in 2022.

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Is General Catalyst Buying Summa Health a Good Idea? Only Time Will Tell

MedCity News

General Catalyst just announced its plans to acquire Summa Health, an Ohio-based health system. Leaders from across the healthcare industry aren’t sure how the deal will play out, given the novel nature of the deal and the involvement of one of the country’s most prominent VC firms.

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PointClickCare Acquires CPSI’s Post-Acute EHR Subsidiary

MedCity News

CPSI sold American HealthTech — its subsidiary that provides an EHR platform for the post-acute care market — to post-acute health IT vendor PointClickCare. American HealthTech’s customers have already begun transitioning to PointClickCare’s platform.

Marketing 101
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Women’s health gap estimated at $1trn in new report

pharmaphorum

The disparity in access to healthcare between women and men around the world is often talked about but has never been given a dollar value – until now.

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The Prohibitive Economics of Weight Care

MedCity News

How we discuss overweight and obese diagnoses and how we treat those patients is slowly starting to improve. However, there’s still a lot of work to be done – in how we manufacture, market, and manage life-changing weight care medications, as well as how we expand access and improve adherence to them.

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New anti-smoking drug set for rapid NHS rollout

pharmaphorum

Oral cytisine therapy for smoking cessation from Consilient Health will launch in the UK next week, helping to alleviate a shortage of prescription drugs to help people quit

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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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Forta Health Rakes In $55M to Empower Family Caregivers

MedCity News

Forta Health raised $55 million in Series A funding on Wednesday. The startup offers a platform to help family caregivers quickly access care to manage their loved ones’ chronic conditions. The startup’s first area of focus is autism spectrum disorder (ASD).

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How do you gain an employer’s attention in a medical sales interview?

Global Edge Recruiting

Global Edge Recruiting How do you gain an employer’s attention in a medical sales interview? How can you show an employer you have a winning spirit in a medical sales interview? Medical sales is about winning. In fact, just about every sales position is about winning. Winning the bid, winning the sale, winning the contract…it is all the same. In medical sales, you are always trying to win business for […] The post How do you gain an employer’s attention in a medical sales interview?

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New Technology Adoption During Times of Crisis: 3 Key Lessons for Biopharma Innovators

MedCity News

In the face of these multifaceted threats, the need for innovative healthcare solutions becomes increasingly urgent. It underscores the vital role of the biopharmaceutical industry in not only addressing immediate health crises but also contributing to the broader resilience and well-being of humanity in times of adversity.

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Coya stretches lead drug’s development to Parkinson’s and dementia

Pharmaceutical Technology

Coya plans to file investigational new drug applications for COYA 302 in amyotrophic lateral sclerosis and frontotemporal dementia later this year.

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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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Cell Therapy Startup With Stanford Roots Unveils $75M to Seek Inflammation Cures

MedCity News

Startup TrX1 develops cell therapies that function like a particular type of regulatory T cell, or Treg, whose role includes dampening inflammation and inducing long-term tolerance. Based on research from Stanford, TrX1’s lead program is a potential therapy for preventing graft-versus-host disease.

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An enduring COVID mystery: Why some do fine and others die

PharmaVoice

The infectious disease market could be shifting toward a future not only focused on the microbe, but on the unique genetic attributes of the host.

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Takeda gains US FDA approval for HYQVIA to treat CIDP

Pharmaceutical Technology

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

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First CRISPR drug Casgevy gets swift second approval

pharmaphorum

FDA has approved Vertex and CRISPR Therapeutics' Casgevy as first CRISPR based therapy for transfusion-dependent thalassaemia.

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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.

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Novel heart failure drug could halt disease progression

European Pharmaceutical Review

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. Findings from the Phase III trial ATTRibute-CM showed the novel drug is safe and can achieve near-complete stabilisation of TTR proteins, which play a key role in disease progression of ATTR-CM.

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Seagen patent in Daiichi Sankyo ADC dispute nixed by USPTO

pharmaphorum

The US patent office has invalidated the only Seagen patent cited in a lawsuit claiming infringement by Daiichi Sankyo’s breast cancer therapy Enhertu.

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FDA approves Vertex’s gene-edited therapy for beta thalassemia

Pharmaceutical Technology

The US FDA has approved Vertex's CASGEVY, a gene-edited cell therapy, to treat transfusion-dependent beta thalassemia.

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Ban on Apple Watches with pulse oximetry renews in US

pharmaphorum

US federal court renews ban on Apple Watches with blood oxygen feature that infringes patents held by Masimo, but tech giant says it has a workaround

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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.

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StemSight and ERS Genomics focus on collaboration

PharmaTimes

License agreement concerns development of cell therapies for corneal blindness

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The evolving presence of AI in telemedicine for behavioural health

Pharmaceutical Technology

AI in telemedicine for behavioural health can revolutionise patient access to treatment, lower costs and identify urgent concerns.

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New Machine Learning Model May Accelerate Drug Development

Pharmaceutical Commerce

Researchers from the University of Cambridge collaborated with Pfizer to develop a platform combining automated experiments with artificial intelligence to predict chemical reactions.

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Avoid “narrow national interest” in fighting next pandemic, WHO chief says

Pharmaceutical Technology

Speaking at Davos, WHO chief Dr. Ghebreyesus said learning lessons from the Covid-19 pandemic is a priority in fighting Disease X.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Gene-Edited Cell Therapy Casgevy Gains FDA Approval for Transfusion-Dependent Beta Thalassemia

PharmExec

Vertex Pharmaceuticals' and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease.

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HyQvia Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance

Pharmaceutical Commerce

Patients with chronic inflammatory demyelinating polyneuropathy administered HyQvia showed a statistically significant difference between relapse rates compared with placebo.

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Bupa is leveraging its unique position to develop IoT and AI features

Pharmaceutical Technology

The British health insurance and coverage provider is well-placed to invest in new technology due to its payment structure.

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FDA Approves CRISPR/Cas9 Gene-Edited Cell Therapy Casgevy for Transfusion-Dependent Beta Thalassemia

Pharmaceutical Commerce

The list price of Casgevy for transfusion-dependent beta thalassemia has yet to be released, however, the cost for the treatment in sickle cell disease is $2.2 million.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.