Sat.Nov 04, 2023 - Fri.Nov 10, 2023

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West Monroe: 64% of Health Insurer Execs Say Digital Transformation is a Top Priority

MedCity News

Despite most insurer execs saying that digital transformation is a top priority, only 8% believe the majority of their staff embrace digital transformation, according to data from West Monroe.

Insurance 113
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AbbVie, AstraZeneca, Boehringer and more face FTC's ire for 'improper' patent listings

Fierce Pharma

Pharma, you were warned. | Only two months after the Federal Trade Commission said it was eying a crackdown on improper patents listed by the FDA, the agency has filed challenges against more than 100 patents in the agency's Orange Book. The companies have 30 days to respond.

FDA 305
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How to Get into Medical Device Sales

David Bagga

Medical device sales is a burgeoning market, with jobs that have an extremely high earning potential. In 2018, the average base salary of a medical sales representative was $92,698 Medical Device Sales Career Home Blog How to Break into Medical Device Sales… How to Get into Medical Device Sales Medical device sales is a burgeoning […] The post How to Get into Medical Device Sales appeared first on.

Medical 130
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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders. In July 2023, MyMD Pharmaceuticals released results from its Phase II study in sarcopenia evaluating potential of MYMD-1 ® , its first-in-class oral TNF-α inhibitor.

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

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FTC Sees Red Over Alleged Misuse of FDA Orange Book, Puts 10 Pharmas on Notice

MedCity News

The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.

Biopharma 132
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With FDA approval, Eli Lilly's weight-loss drug Zepbound arrives to challenge Novo Nordisk

Fierce Pharma

In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. | In the Big Pharma battle to treat obesity, Novo Nordisk sprinted to an early lead, but Eli Lilly is catching up quickly. Wednesday's FDA approval of Lilly's Zepbound to treat obesity closes the gap further. In addition, Lilly said it will charge 20% less than Novo for its obesity med in an attempt to provide increased access.

FDA 325

More Trending

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Gilead reveals positive data for potential first-line adenocarcinoma treatment

European Pharmaceutical Review

Positive results for a combination treatment using the first Fc-silent investigational monoclonal antibody in pivotal clinical trials that is designed to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), have been announced. The treatment is being evaluated in patients with upper GI adenocarcinomas. Domvanalimab plus the antibody zimberelimab and chemotherapy showed encouraging overall response rate and six-month progression-free survival (PFS) rate results in a preli

Safety 114
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Biotech Startup Triveni Unveils $92M to Address Barrier to Treating Inflammation

MedCity News

Available atopic dermatitis drugs work by blocking inflammation, but Triveni Bio is developing an antibody that addresses a root cause of the chronic condition. The startup is out of stealth to advance its lead program and a pipeline of other inflammation and immunology drugs.

Leads 121
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Bayer CEO Anderson says 'radical realignment' is underway

Fierce Pharma

In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. | In three years as the pharma chief at Roche, Bill Anderson executed a massive overhaul of the division, lopping off layers of management and recharting its course. Now in his fifth month as CEO at struggling conglomerate Bayer, Anderson is focused on an even larger renovation, saying the company is on its way to a “radical realignme

Pharma 307
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AbelsonTaylor Group Receives the Healthcare Businesswomen’s Association ACE Aspire Award for its Employee Psychological Safety Initiative

PM360

Award-winning health and wellness advertising agency AbelsonTaylor Group received the inaugural ACE Aspire Award for its employee Psychological Safety Initiative from the Healthcare Businesswomen’s Association (HBA). The Award was presented yesterday at the HBA Annual Conference in Chicago. The HBA’s ACE (Advancement. Commitment. Engagement.) Awards recognize companies committed to ensuring that gender diversity and leadership opportunities for women are part of their organizational DNA.

Safety 111
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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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Sandoz and Teva achieve first-of-a-kind manufacturing certification

European Pharmaceutical Review

Sandoz and Teva have become the first organisations to qualify for the new global Minimized Risk of Antimicrobial Resistance (AMR) certification. This programme was developed by the British Standards Institute (BSI) to verify companies that are taking the necessary steps in ensuring responsible antibiotic manufacturing in the global supply chain, helping to lower the spread of AMR.

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I Used AI Tech To Find My Own Cancer Clinical Trial, and You Can Too

MedCity News

My phone chimed with a notification, signaling the availability of a new CT test result in my online health portal. “Multiple bilateral pulmonary nodules measuring up to 8mm. May represent metastatic disease.” This was several weeks after my very first mammogram–which I underwent shortly after my 40th birthday–detected an anomaly on my left breast. I soon learned I had what are called “dense” breasts, which means I have compact breast tissue and typical imaging isn’t the best screening for me.

Doctors 118
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NICE's Trikafta snub could portend another pricing standoff between Vertex and UK officials

Fierce Pharma

History may repeat for Vertex Pharmaceuticals in the U.K., where a new decision by the country’s cost-effectiveness gatekeeper threatens to spark another dispute over the cost of lifesaving cystic | Last week, the U.K.'s National Institute for Health and Care Excellence unveiled draft guidance that acknowledged the effectiveness of Vertex’s cystic fibrosis drugs Trikafta, Symkevi and Orkambi.

Medicine 298
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Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

PharmExec

Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.

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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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New method could replace microbiology CFU assay

European Pharmaceutical Review

US researchers have developed the Geometric Viability Assay (GVA), which has been shown to be a fast, cheap and sustainable method for counting microorganisms. Since it is 36 times faster than conventional methods, uses 15 times less plastic, and is low cost, Geometric Viability Assay could “replace existing viability assays and enable viability measurements at previously impractical scales”, the paper noted.

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Ventyx Drops Drug for Psoriasis as Data Look Uncompetitive in Tight TYK2 Field

MedCity News

Ventyx Biosciences is stopping work on its lead drug candidate in plaque psoriasis and psoriatic arthritis. Despite achieving the goals of its Phase 2 test in psoriasis, the results are short of those achieved by big pharmaceutical companies with molecules that address the same target.

Leads 117
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Pfizer cost-savings campaign reaches Ireland, where 100 production workers will lose jobs

Fierce Pharma

Pfizer’s $3.5 billion cost-savings drive has made its way overseas. | The layoffs at Pfizer's Newbridge, Kildare, manufacturing site are the latest in the company's effort to save $3.5 billion by 2024 amid declining demand for its COVID-19 products.

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Ten Ways to Think Differently About Small-to-Mid-Sized Pharma Launches

Eversana Intouch

Back in 2003, drugs from large pharma companies made up 36% of the late-stage R&D pipeline. By 2018, that share had fallen by about half. Meanwhile, the number of companies launching their first drug during the decade preceding 2018 more than tripled. These data are astonishing, given the perception that Big Pharma is the main driver of biopharma innovation.

Pharma 105
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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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Novo Nordisk plans multi-billion Denmark manufacturing expansion

European Pharmaceutical Review

Novo Nordisk has announced plans to invest over 42 billion Danish kroner (nearly £5 billion) starting in 2023, to expand its manufacturing facilities in Kalundborg, Denmark. According to the pharma company , the financing will add to global capacity: from manufacturing of active pharmaceutical ingredients (API) through to packaging. Most of the investment will be focused on API capacity.

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Why Provider Groups Are Denouncing CMS’ New Payment Rules

MedCity News

CMS finalized updates to its physician fee schedule for 2024, as well as finalized the rule for next year’s Outpatient Prospective Payment System (OPPS). Provider groups are displeased with the updated rules, arguing that both physicians and provider organizations need more monetary relief than what the agency is offering.

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Krystal's topical gene therapy gains steam, prompting analyst group to boost sales projection

Fierce Pharma

At the start of its first-ever conference call to present its quarterly numbers, Krystal Biotech CEO Krish Krishnan was quick to point out that the company’s positive earnings for the third quarter | Krystal Biotech's launch of Vyjuvek, the world's first topical gene therapy, has been so promising that analysts with Evercore ISI increased their 2024 sales projection to $273 million.

Sales 286
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Robotic Ankle Helps with Postural Control in Amputees

Medgadget

Researchers at North Carolina State University have developed a robotic prosthetic ankle that can provide stability for lower limb amputees. The ankle uses electromyographic sensors placed on the sites of muscles in the residual limb that then convey the intentions of the wearer with regard to movement. So far, the system has been shown to assist with postural control, which in this context refers to the many complex and unconscious movements that the muscles in our legs make to maintain balance

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Rapid HPLC method could improve formulation QC studies

European Pharmaceutical Review

A paper published by Research Square has described a rapid, simple, accurate and precise high-performance liquid chromatography with diode-array detection (HPLC-DAD) method for levofloxacin determination in liquid pharmaceutical formulations. The effectiveness of levofloxacin can be impacted by its stability in pharmaceutical formulations. This impacts the effective concentration of the drug, Mohammed et al. noted.

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A Paradigm Shift Towards Reimbursing the Root Causes of Diseases

MedCity News

Medicare needs to incentivize providers by reimbursing them for identifying and addressing social determinants of health. Doing so will ultimately improve patient health outcomes and simultaneously save risk-bearing organizations money.

Patients 114
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As Biogen's sales flatline, CEO Chris Viehbacher touts progress on Leqembi, Skyclarys and other launches

Fierce Pharma

While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plan | While Biogen CEO Chris Viehbacher seems satisfied with the company's third-quarter financial metrics, the main question at the drugmaker isn’t so much how the company’s doing now, but what its plans are for future growth, he said on a call with investors.

Sales 275
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FDA Approves Zepbound for Chronic Weight Management

PharmExec

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

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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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Innovative insomnia study aims to overcome major clinical trial bottleneck

European Pharmaceutical Review

For UK patients with severe insomnia, for whom existing therapies have not worked, a new, decentralised clinical trial is set to evaluate chloral hydrate as a short-term treatment. Evaluating chloral hydrate for insomnia While chloral hydrate is already an established treatment for insomnia, much of the published clinical data in adult patients is dated, according to clinical trials company Lindus Health and global lifecycle management healthcare company Pharmanovia.

Safety 105
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Why GLP-1s Alone Cannot Solve the Obesity Crisis

MedCity News

People with obesity should be offered a range of suitable treatments as well: behavioral, nutrition, exercise, medication and surgery, through a coordinated and holistic approach under one roof, with a care coordinator. Like cancer, obesity is a heterogeneous disease and recommendations and responses to all treatment modalities will be heterogeneous as well.

Medical 114
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Valneva wins race, gaining FDA approval for chikungunya vaccine Ixchiq

Fierce Pharma

Valneva has won the race in the U.S. | The FDA has approved the world’s first chikungunya vaccine, giving a thumbs-up to Valneva’s Ixchiq. The French company receives a priority review voucher from the FDA, which it said it will sell. It is an accelerated approval and subject to a confirmatory, real-world study.

FDA 267
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Magnetic Dressing Improves Diabetic Wound Healing

Medgadget

Researchers at the National University of Singapore have developed a magneto-responsive hydrogel wound dressing that also contains two different regenerative cell types. The hydrogel is also embedded with magnetic particles that can be stimulated using an external magnetic field. The action of the magnetic field on the gel-encapsulated particles causes mechanical stresses within the gel to act on the cells, stimulating them to grow and enhancing their regenerative potential.

Leads 102
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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.