August, 2023

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Debunking Healthcare’s Recession-Proof Reputation

MedCity News

During past recessions, the healthcare sector remained relatively immune to economic downswings — but things are different now that a sweeping labor shortage and lower patient volumes have been added to the mix.

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Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse

Fierce Pharma

After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.

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Stem cell therapy delivers potential for sickle cell disease

European Pharmaceutical Review

New research published in the New England Journal of Medicine has indicated that stem cell gene therapy could provide a curative treatment for sickle cell disease (SCD). Based on new data from the Novartis Phase I/II clinical trial , which used the first therapy to target a new genetic area and use cryopreserved stem cells, trial participants reported a decrease in vaso-occlusive events.

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Peptoid Oligomers Target Viral Membranes

Medgadget

Researchers at New York University have developed a new method to target many viruses that cause disease. For viruses with a lipid membrane, which includes many that commonly cause disease, this new technique could prove to be fatal. By targeting the lipid membrane, the approach may circumvent the treatment resistance that arises when viruses mutate to alter their surface proteins, which are the most common targets for conventional anti-viral 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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Clinical trials: How AI can help providers stay TMF inspection-ready

Pharmaceutical Technology

The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits

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When Does Healthcare Marketing Become Too Niche?

PM360

As healthcare advertisers work to maximize their promotional budgets, an ongoing shift is occurring from broad-based to niche market spending. The competition lies in having the best insights and access to first-party data to secure budgets and then creating opportunities with the reach to maximize these budgets. However, while hyper-targeting can ensure dollars are maximized, a catch-22 may be missing the most critical part of the patient journey: the first point of care—or primary care provide

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Johnson & Johnson's spinoff of Kenvue provides $13.2B in potential M&A firepower

Fierce Pharma

Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.

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CGT manufacturing QC market to value $2.8b by 2031

European Pharmaceutical Review

According to a report by Transparency Market Research Inc, the global cell and gene therapy (CGT) manufacturing quality control (QC) market is anticipated to value $2.8 billion in 2031. It is projected to expand at a CAGR of 24.6 percent from 2023 to 2031. Comparatively, the market is expected to value $463.1 million by the end of 2023. With increasing research and development in the cell and gene therapy field, the demand for optimal quality control is needed to ensure the safe and efficient ma

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CCC & GO FAIR Foundation Host Forum on Building AI Strategies with FAIR Data

Copyright Clearance Center

August 24, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, in partnership with the GO FAIR Foundation , will host its inaugural FAIR Forum on “The Evolving Role of Data in the AI Era” on 18 September at Poortgebouw , the University of Leiden, the Netherlands. With new AI services being introduced on an almost daily basis, the adoption of FAIR Data Principles ( F indable, A ccessible, I nteroperable, and R eusable) is more important

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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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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The PM360 Trailblazer Awards 2023 Finalists

PM360

The finalists are in for PM360’s 15 th annual Trailblazer Awards. Established in 2009, the Trailblazer Awards recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. The awards honor achievements in eight overall categories, including Companies of the Year, CEOs of the Year, Products of the Year, Marketer of the Year, Marketing Team of the Year, Lifetime Ac

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Still Hungry for New Obesity Meds, Novo Nordisk Makes Another M&A Deal

MedCity News

Novo Nordisk is expanding its cardiometabolic drug pipeline with the acquisition of Embark Biotech, a startup developing drugs for a novel target that can suppress appetite and boost calorie burning in cells. Embark’s science comes University of Copenhagen research on a novel fat cell target.

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FDA turns down Outlook's ophthalmic version of Roche's Avastin over manufacturing, data shortfalls

Fierce Pharma

Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. | Even without an FDA approval, Roche’s cancer drug Avastin is widely used by doctors to treat certain eye diseases. Outlook Therapeutics has been trying to get an official approval for a reformulated version, but instead got a rejection letter.

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siRNA therapy shows long-term potential in lowering LDL-C

European Pharmaceutical Review

Novartis has announced that Leqvio ® (inclisiran) , the first and only small interfering RNA (siRNA) therapy indicated to reduce low-density lipoprotein cholesterol (LDL-C), has demonstrated promising long-term results. This is based on three-year follow up data from a Phase III trial, presented at the European Society of Cardiology (ESC) Congress 2023.

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

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What the Success of “Barbie” Means for Women’s Health

Eversana Intouch

“Aside from the smashing success of ‘Barbie’ setting box office records, topping more than [$1 billion] and counting, the movie is also doing something much more important than sales – shining a spotlight on women’s health. In a time where there seems to be a war waged on women’s reproductive health and autonomy, Barbie (of all symbols!

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‘We need to do better:’ A biotech CEO on standing apart from the crowd

PharmaVoice

The CEO of Cullinan Oncology is taking a small biotech to the next step and believes the temporary financial barriers are smaller than scientific progress.

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FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment

PharmaTech

FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.

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Study On Teen Mental Health App Shows High Engagement, Positive Impact

MedCity News

A study on BeMe Health, a behavioral health platform for teens, found that users engaged with the platform eight times on average over a month. The study was done in collaboration with Stanford University.

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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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Johnson & Johnson slashes price of tuberculosis drug Sirturo after relinquishing patent protections

Fierce Pharma

Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson h | Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price by 55% to $130 for a six-month course.

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European regulatory perspective on nitrosamine mitigation strategies

European Pharmaceutical Review

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated.

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FDA Offers GDUFA III Insight

PharmExec

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

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Harnessing the Power of Generational Diversity as a Competitive Advantage

PM360

For the first time in the history of business, up to five generations of employees are working together. Today’s workforce includes Traditionalists (born 1927-1945), Boomers (1946-1964), Gen X (1965-1980), Millennials (1981-1996), and Gen Z (1997-2015). Uniting people of different ages, perspectives, experiences, interests, and skillsets in shared goals is not without challenges, though multigenerational workforces are both valuable and critical to the future of work.

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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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Accelerating Rare Disease Patient Engagement

Eversana Intouch

The industry challenges faced in marketing in the rare disease space are not new. Small populations. Limited understanding of the patient or disease. Diagnostic odysseys that last, on average, seven years and are riddled with misdiagnosis. What is new, however, is the opportunity. At EVERSANA INTOUCH, our rare expertise and advanced technologies are helping solve some of the most difficult challenges in rare disease marketing.

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Developing Nursing Clinical Judgment Competency Through Virtual Reality

MedCity News

When real-life failure is not an option, practicing curated, trial-and-error simulations in VR can reduce patient risk in high-acuity scenarios. With nursing faculty also in short supply and a wave rapidly approaching retirement age, virtual reality simulations can help bridge the gap between learners needing supervised clinical experiences, and time-pressed preceptors, who have their own patients to care for in addition to guiding novices in clinical settings.

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Sanofi shakes up leadership as specialty care head Sibold departs to pursue outside opportunity

Fierce Pharma

For six years, Sanofi's specialty care chief Bill Sibold has helped the company make the most of its Regeneron-partnered immunology superstar Dupixent. | Bill Sibold, who took over the company's specialty care unit in 2017 just after Dupixent's first approval, is leaving Sanofi effective immediately. The company further shook up its leadership by appointing a new R&D head, a chief digital officer and adding an entirely new position.

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Pharmaceutical migration study sampling procedure reported

European Pharmaceutical Review

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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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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Bridging the Divide: Medical's Omnichannel Momentum

PharmExec

How pharma medical affairs and commercial teams are synchronizing their capabilities to boost omnichannel marketing strategies and better understand customer engagement needs.

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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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Finding the right flu vaccine is hard. Getting people to take it is harder.

PharmaVoice

Experts have determined the strains of this year’s flu season — now the question is whether people are too fatigued by the pandemic to be immunized.

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Team-Based Primary Care Offers a Solution for an Underachieving Healthcare System

MedCity News

Team-based primary care is needed now more than ever as our “on-demand” and mobile lives, complicated by a primary care shortage crisis, have led to a more transactional and fragmented healthcare experience.

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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