Medical Device Success

SEPTEMBER 27, 2022

Reading time: 2 – 4 minutes. Fact is, women have more challenges in pursuing their careers than men. In the show notes you will find a link to the McKinsey 2021 report on Women in the Workplace that clearly spells this out. To address these challenges, Shelly O’Donovan, CEO, Authentic Influence Group is creating a Life Science Women’s Mastermind group in the MedTech Leaders community.

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Medical 130

Dominic Tyer

SEPTEMBER 30, 2022

Pharmaceutical companies with a chief marketing officer are thin on the ground, but their number will shortly see a slight increase thanks to a new appointment at Pfizer

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European Pharmaceutical Review

SEPTEMBER 30, 2022

Professor Hongsoo Choi’s team at The Department of Robotics and Mechatronics Engineering at the Daegu Gyeongbuk Institute of Science & Technology (DGIST), Korea, developed revolutionary technology that produces over 100 microrobots per minute. The collaboration with Professor Sung-Won Kim’s team at Seoul St. Mary’s Hospital, Catholic University of Korea and Professor Bradley J.

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pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The Pre-Cert pilot report. The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

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What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

Sales Management

MedCity News

SEPTEMBER 27, 2022

Prime Medicine likens its gene-editing technology to a word processor that searches for the correct place in the genome to make an edit, replacing or repairing a wide variety of target DNA. The preclinical biotech is now spelling out its future plans with the letters I-P-O.

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Pharmaceutical Technology

SEPTEMBER 30, 2022

After several setbacks, bluebird bio bounces back with two major FDA gene therapy approvals. Last month, Zynteglo (betibeglogene autotemcel), or beti-cel, was approved as a one-time potentially curative gene therapy for patients with beta-thalassaemia who require regular blood transfusions. Shortly after this, the FDA announced the accelerated approval of bluebird's Skysona (elivaldogene autotemcel), or eli-cel, on 19 September.

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Medgadget

SEPTEMBER 26, 2022

Scientists at the University of New South Wales in Australia have developed a method to produce human blood stem cell precursors from human pluripotent stem cells. The method may have use in treating cancer patients who require high doses of such blood stem cells to help replenish endogenous populations that have been destroyed by chemotherapy. The researchers exploited the tendency of cells to respond to mechanical stimuli and cultured the pluripotent stem cells in a microfluidic device that mi

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MedCity News

SEPTEMBER 28, 2022

The American Diabetes Association recently launched the Amputation Prevention Alliance — a three-year effort to decrease the number of diabetes-related amputations in the country — along with five partner organizations. The organizations will work together to advocate for policy changes, increase clinician education about caring for diabetic complications, and improve patients’ awareness of warning signs to watch out for.

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Education Patients 122

European Pharmaceutical Review

SEPTEMBER 29, 2022

According to a new report , implementing a Transferable Exclusivity Extension (TEE) system could solve the “broken economic model” for researching and developing new antibiotics in Europe. As the threat of antimicrobial resistance (AMR), sometimes called the hidden or silent pandemic , grows, new and novel antibiotics are needed to combat infections becoming more resistant to current treatments.

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PM360

SEPTEMBER 28, 2022

Market access stands at the cusp of a golden opportunity to help increase healthcare efficiency, improve outcomes, and transform the patient experience—but only if we’re brave enough to recalibrate our approach. For years, pharma’s engagement with payers has focused narrowly on securing access to treatments, with authorization and reimbursement our single-minded pursuit.

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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

Patients

pharmaphorum

SEPTEMBER 29, 2022

Biogen and Eisai have resurrected hopes that amyloid-targeting drugs could have a benefit in Alzheimer’s disease with a claim that their new drug lecanemab showed a “highly statistically significant” reduction in clinical decline in a phase 3 trial. The highly-anticipated readout from the Clarity AD has shown that lecanemab met primary and secondary endpoints in patients with early-stage Alzheimer’s, said the two companies in a joint statement – although for now only the

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Side effects FDA Safety Patients 105

MedCity News

SEPTEMBER 29, 2022

While some areas in the mental health tech space have been effective, some areas need improvement, experts said at MedCity’s Invest Digital Health conference. Providing digital mental health care can be difficult do in a cost-effective way, and many clinicians are wary of adopting technology in their practices.

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European Pharmaceutical Review

SEPTEMBER 29, 2022

Brii Biosciences , a multi-national drug development company, has published top-line results from a Phase I study evaluating its long-acting, single-dose, intramuscularly injected drug BRII-296 in postpartum depression (PPD). “We are encouraged by the possibility of providing a novel treatment option to the 900,000 people in the US affected by postpartum depression each year in which the current standard of care is suboptimal, often requiring hospitalisation, repeat therapy and daily doses of tr

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PM360

SEPTEMBER 28, 2022

Chrys Kokino has been involved in the biosimilars market prior to the first biosimilar being approved in Europe in 2006. At Roche at the time, his job was to lead a task force which was given the objective of planning a strategy to preserve and protect the companies billion-dollar originator biologics franchises as well as build a plan which would counter the introduction and use of biosimilars.

Competition 98

Competition Marketing Manufacturing Biopharma 98

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. Seagen is paying $50 million upfront for global rights to the programme, a bispecific T cell engager intended as a treatment for EGFR-positive solid tumours, with another $650 million at the back end in milestone payments.

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MedCity News

SEPTEMBER 29, 2022

The patient financial experience in the U.S. is poor — patients have a hard time understanding pricing data and they often face exorbitant prices for care and medications. This problem will only get better if the healthcare industry rids itself of price-gouging middlemen and closed-door price negotiations held by businesspeople, according to a recent healthcare innovation panel.

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European Pharmaceutical Review

SEPTEMBER 28, 2022

In a study published in the Microchemical Journal , investigators outlined the development and validation of a HPLC-MS/MS (high-performance liquid chromatography-mass spectrometry) for the determination and quantification of N -nitrosodimethylamine (NDMA) in olmesartan medoxomil. The method was able to detect, separate and quantify NDMA in the active pharmaceutical ingredient (API), manufactured tablets and marketed tablets.

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Clarivate

SEPTEMBER 27, 2022

Water is essential to survival and yet extreme, less predictable weather conditions are affecting its availability in many regions. In our blog series about Highly Cited Researchers and the UN Sustainable Development Goals (SDGs), we turn our attention to SDG 6: Clean Water and Sanitation. We analyze the emerging trends for this SDG and discuss how some of the top researchers are tackling the water crisis and its challenges related to climate change and wastewater treatment.

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Management Government Pharmaceutical Networking 98

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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.

Safety

pharmaphorum

SEPTEMBER 26, 2022

Social health—the dynamic, real-time action people take to find meaningful connections and share information that impact the health journey—has dramatically shifted the ways in which healthcare marketers can, and should, reach their desired audiences. . Through Health Union’s unique and expansive Social Health Network of more than 100,000 patient leaders; and millions of engaged patients and caregivers across a growing portfolio of more than 40 condition specific online health communities, this

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MedCity News

SEPTEMBER 27, 2022

If single use devices are inevitable, the next step after “why” needs to be an understanding of “how” medtech companies and device makers can get on the right side of the movement.

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Medical 114

European Pharmaceutical Review

SEPTEMBER 28, 2022

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. The proposed cannabis monograph provides scientifically validated methods, information on physical reference standards and acceptance criteria to establish the identity of cannabis chemotypes and content of cannabinoids and terpenes, as well as setting l

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Legacy MEDSearch

SEPTEMBER 27, 2022

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company developing the CellFX® System powered by Nano-Pulse Stimulation (NPS ) technology, announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III.

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Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

Sales

pharmaphorum

SEPTEMBER 30, 2022

Sarepta Therapeutics has followed through on its promise to file for accelerated approval of its gene therapy SRP-9001 for Duchenne muscular dystrophy (DMD), as it aims for a launch in the middle of 2023. Roche-partnered SRP-9001 (delandistrogene moxeparvovec) has been submitted for approval to treat ambulatory (walking) patients with DMD, a genetic disorder characterised by progressive muscle degeneration due to alterations in a protein called dystrophin that helps keep muscle cells intact.

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MedCity News

SEPTEMBER 27, 2022

Kaiser Family Foundation discovered Medicare Advantage plans and traditional Medicare had similar rates of satisfaction among enrollees. However, there were a select few differences between the plans, with MA enrollees more likely to get preventive care and traditional Medicare enrollees more likely to receive care from the highest-rated facilities.

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European Pharmaceutical Review

SEPTEMBER 27, 2022

The US Food and Drug Administration (FDA) have published initial guidance deliberating how ethical it is for children to take part in research trials. The guidance , called ‘Ethical Considerations for Clinical Investigations of Medical Products Involving Children’, offers advice to institutional review boards (IRBs) and the industry at large when deciding whether to include children in studies about drugs, biological products and medical devices.

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Medico Reach

SEPTEMBER 30, 2022

Teledentistry has made dental services easily accessible to patients. Customers can avail dental services right from their comfort. It includes online consultation via video calls, text messages, or live chat. That’s why the teledentistry industry is gradually evolving. In fact, the industry will likely cross $2105.76 million by 2028 , with more teledentistry companies entering the market.

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Advertiser: ZoomInfo

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

Competition

PM360

SEPTEMBER 28, 2022

The rising prevalence of type 2 diabetes has attracted the attention of many major drugmakers in recent decades, leading to innovations such as novel insulins and easier-to-use glucagon injections. However, despite being one of the biggest markets in pharma, diabetes drugmakers have a hard time standing out in the crowded field, and many patients still aren’t confident in their ability to manage their disease.

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MedCity News

SEPTEMBER 29, 2022

Eisai Alzheimer’s disease drug candidate lecanemab now has data from a pivotal study showing a statistically significant reduction in cognitive decline. Lecanemab is already under FDA review for potential accelerated approval but the agency has said that results from this larger study could support full approval of the antibody drug.

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European Pharmaceutical Review

SEPTEMBER 26, 2022

At the 2022 European Society for Medical Oncology Congress (ESMO) conference, promising results from a Phase I trial, suggesting that a novel genetically modified (GM) herpes virus eradicated or reduced advanced cancers, were presented. The GM herpes simplex virus (RP2) successfully treated twenty five percent of patients with different advanced cancers, including skin, oesophageal and head and neck cancers.

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Modus

SEPTEMBER 28, 2022

Today’s increasingly complex business environment requires sales technologies that can keep pace with buyer expectations and demands while supporting the organization’s goals (digitalization, flexible work, etc.) - especially during uncertain times. "Hype Cycles and Priority Matrices help organizations to navigate the hype and disillusionment that surround innovations and to identify high-benefit innovations.

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