Fri.Nov 08, 2024

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Daiichi Sankyo links up with Korea's Alteogen on subcutaneous Enhertu in $300M licensing deal

Fierce Pharma

A subcutaneous version of Daiichi Sankyo’s AstraZeneca-partnered blockbuster antibody-drug conjugate (ADC) Enhertu could be in the works from Korea’s Alteogen following a licensing deal worth up to | Alteogen will use its human hyaluronidase hybridization platform to develop a subcutaneous formulation of the blockbuster antibody-drug conjugate.

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Eisai dials back forecasts for Alzheimer's drug Leqembi

pharmaphorum

Eisai has scaled down its sales expectations for Alzheimer's disease drug Leqembi after sluggish sales growth in the first half of the current fiscal year.

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Fierce Pharma Asia—AstraZeneca's China fallout; Pfizer's $1B plan in China; Incyte-Sun JAK dispute

Fierce Pharma

AstraZeneca's China president has been detained by Chinese authorities amid investigation into illegal importation and improper collection of patient data. | AstraZeneca confirmed its China president has been detained by Chinese authorities. Pfizer plans to invest $1 billion in China in the next five years. Sun Pharma's JAK inhibitor Leqselvi was slapped with an injunction in a lawsuit with Incyte.

Pharma 301
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AZ confirms China president has been detained

pharmaphorum

AstraZeneca has revealed that its top executive in China, Leon Wang, has been detained by Chinese authorities

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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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FDA proposes ban on main ingredient in many OTC decongestants

Fierce Pharma

Common oral medicines that have been used for decades as decongestants such as Sudafed, NyQuil and Benadryl may soon be cleared from shelves as the FDA has

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NHS Wales partners with Illumina on genomics drive

pharmaphorum

Wales has extended a scheme to harness the power of genomics to improve cancer care and prevention via an alliance with gene-sequencing giant Illumina.

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AstraZeneca and Amgen’s Tezspire succeeds in Phase III nasal polyps trial

Pharmaceutical Technology

A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.

Patients 105
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AstraZeneca, Amgen's Tezspire scores in rhinosinusitis study

Fierce Pharma

Six months after Amgen and AstraZeneca reported promising results for Tezspire (t | A phase 3 study has shown that AstraZeneca and Amgen's Tezspire provided a statistically significant and clinically meaningful reduction in polyp size and nasal congestion in patients with severe chronic rhinosinusitis with nasal polyps.

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The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls

MedCity News

While startups in highly regulated industries like healthcare and finance are almost certain to face heightened scrutiny, there are controllable factors that can offset these challenges. The post The Startup Economy is Turbulent. Here’s How Founders Can Recognize and Avoid Common Pitfalls appeared first on MedCity News.

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GSK calls it quits on trade group BIO for 2025, following exits by Takeda, UCB and more

Fierce Pharma

GSK is the latest to turn its back on prominent industry lobbying group Biotechnology Innovation Organization (BIO), following a string of exits by companies including Pfizer, UCB, WuXi AppTec and | The company opted not to renew its membership for 2025 following an annual review of its trade group associations, a spokesperson said.

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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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Measuring Impact in Digital Youth Mental Health: What Investors Look For

MedCity News

Many companies are entering the digital youth mental health space, but it’s important to know which ones are effective, according to a panel of investors at the Behavioral Health Tech conference. The post Measuring Impact in Digital Youth Mental Health: What Investors Look For appeared first on MedCity News.

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Investment fund Oaktree calls for board shakeup at Indivior, accusing company of 'value destruction'

Fierce Pharma

With Indivior’s stock price in freefall over the past year, one of the company’s top investors is taking leadership to task, accusing the firm behind the opioid addiction treatment Sublocade of “ig | Investment fund Oaktree Capital Management has called for a shakeup of Indivior’s board of directors, referring to the more than 50% stock price drop Indivior has suffered in 2024 as “unacceptable.

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There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say

MedCity News

Two executives at behavioral health care companies discussed why it’s important for provider organizations to partner with the 988 Suicide & Crisis Lifeline during a panel at the Behavioral Health Tech conference. The post There’s an Opportunity for More Providers to Partner with the 988 Lifeline, Execs Say appeared first on MedCity News.

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Future Fields looks to solve industry's biomanufacturing woes with fruit fly-based protein production

Fierce Pharma

With biomanufacturing often a limiting factor for drug developers, Canada’s Future Fields is heralding its bug-based approach to protein production as a potential salve. | With biomanufacturing often a limiting factor for drug developers, Canada’s Future Fields is heralding its bug-based approach to protein production as a potential salve. Now, after several years spent validating its manufacturing platform, the company is expanding in a big way with the debut of a new service line and factory i

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

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FDA Takes Step Toward Removal of Ineffective Decongestants From the Market

MedCity News

The FDA has proposed removing oral phenylephrine from its guidelines for over-the-counter drugs due to inefficacy as a decongestant. Use of this ingredient in cold and allergy medicines grew after a federal law required that pseudoephedrine-containing products be kept behind pharmacy counters. The post FDA Takes Step Toward Removal of Ineffective Decongestants From the Market appeared first on MedCity News.

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Daiichi Sankyo partners Alteogen on subcutaneous Enhertu

pharmaphorum

Daiichi Sankyo signs a $300m deal with Alteogen to develop a subcutaneous version of anti-HER2 cancer drug Enhertu.

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Ultra-processed food is causing a boom for obesity drug Ozempic

Pharmaceutical Technology

The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.

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Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place

MedCity News

The vast majority of older adults want to age at home. To support that goal, doctors should encourage them to consider their care options — long before they need assistance. The post Through Early Discussions About Elder Care, Doctors Can Empower Seniors to Age in Place appeared first on MedCity News.

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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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UK health data ecosystem 'is hampering research'

pharmaphorum

The UK is squandering the vast resource of NHS patient data because too many obstacles are being placed in front of researchers trying to tap into it – holding back medical advances. That is the conclusion of the much-anticipated Sudlow Review – carried out by Prof Cathie Sudlow, chief scientist of Health Data Research (HDR) UK – which found that accessing patient data can take months or even years, hampering research into areas like dementia, cancer and heart disease.

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Eisai lowers Leqembi revenue forecast after rocky entry to market

Pharmaceutical Technology

Leqembi is approved for Alzheimer’s patients in multiple territories, but questions remain over its cost-effectiveness.

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What RFK Jr.’s influence could mean for pharma

PharmaVoice

Past comments hint at the changes Robert F. Kennedy Jr. could make across the various sectors of healthcare.

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Innovative static culturing method developed

European Pharmaceutical Review

A study has reported a novel microbiology approach using TPX polymer film to culture bacteria in a liquid static culture. One key challenge of culturing in microbiology is that since oxygen does not dissolve easily in the liquid medium typically used during this process, the medium must be vigorously aerated, usually by shaking, which causes shear stress of the microorganisms, the Japanese researchers explained.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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J&J’s Balversa Gains MHRA Marketing Authorization as Monotherapy for Bladder Cancer

PharmaTech

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

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FDA Approves Johnson & Johnson’s Varipulse for Drug-Resistant Paroxysmal Atrial Fibrillation

PharmExec

The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.

FDA 52
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New Reimbursement Opportunities for Digital Mental Health Treatment in 2025: CMS’ Final Rule

Nixon Gwilt Law

CMS issued its 2025 Medicare Physician Fee Schedule (the “2025 MPFS” or “Final Rule”) on November 1, 2024. In doing so, it finalized the first-ever reimbursement for Digital Mental Health Treatment (“DMHT”) devices and services and set a promising precedent for reimbursement of digital therapeutics more broadly. The Final 2025 MPFS contains some modifications and clarifications to several elements of the original proposal released in July 2024 (the “Proposed Rule”), which we discussed in this ea

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Johnson & Johnson Submits Regulatory Applications for Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

PharmExec

Submissions to the FDA and EMA for new indication of Darzalex Faspro are based on results of the Phase III Aquila trial in patients with high-risk smoldering multiple myeloma.

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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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Top-10 Best Practices for Virtual Publication Planning and Development

Impetus Digital

A version of this article was previously published in the Journal of mHealth. The landscape of publication planning is constantly evolving with the rise of novel digital tools, artificial intelligence, and virtual collaboration platforms. As a result, traditional barriers to effective and efficient publication planning and development are being broken down, while new challenges related to compliance, data security, and global collaboration in the virtual setting have emerged.

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Key Findings of the NIAGARA and HIMALAYA Trials

PharmExec

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.

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UK Medicines Manufacturing Skills Centre Stresses Skill Development after Budget Announcement

PharmaTech

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.

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Key Findings of the NIAGARA and HIMALAYA Trials

PharmExec

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver 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