Wed.Sep 13, 2023

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It's unanimous: FDA panel says decongestant drug phenylephrine does not work

Fierce Pharma

For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. | For decades, hundreds of oral decongestant products containing phenylephrine have been available in the United States over the counter. But on Tuesday, an FDA advisory committee agreed by a 16-0 vote that the ingredient does not work.

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Generative AI, RPM Were Among the Biggest Trends In Health IT Fundraising During Q2

MedCity News

Healthcare IT companies raised $1 billion in venture capital in Q2 — down slightly from the $1.3 billion raised in Q1 but up significantly from the $451.3 million raised in Q4 2022. Unsurprisingly, a lot of these investments were made in companies offering generative AI products. Another key trend was increasing cash flow to remote patient monitoring startups, likely caused by expanded reimbursement for these services.

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HHS argues Merck 'lacks standing' to sue over Medicare price negotiations

Fierce Pharma

Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). | Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing.

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Solera Health Launches Weight Management Solution for Payers and Employers

MedCity News

Solera Health recently launched a program that aims to help patients who are interested in GLP-1s gain access to lifestyle change support. It also provides educational materials on GLP-1s.

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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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Moderna looks to scale back manufacturing for COVID booster to cope with falling demand: Reuters

Fierce Pharma

While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its sh | Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.

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The problem with clinical trials (and how virtual insight-gathering can help)

Impetus Digital

A version of this article was previously published in the Journal of mHealth. These days, clinical trials are in the news pretty much daily. Whether successful or not, they can impact not only the perception of a pharmaceutical company but also their stock prices. While still the gold standard of research, clinical trials are often riddled with issues that limit their applicability to broader populations or delay market access.

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The Gigification of Healthcare

MedCity News

By leveraging technology and strategies used within the gig economy—and even tapping into the talent pool of gig workers themselves—healthcare organizations can address staffing shortages, retain and motivate more workers, and ultimately deliver better patient care.

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Ferring begins bladder cancer gene therapy rollout through focused program

Fierce Pharma

After securing approval at the end of last year for a potential alternative to bladder removal in certain bladder cancer patients, Ferring Pharmaceuticals has given the gene therapy Adstiladrin to | While it scales up manufacturing, the company is rolling out its Adstiladrin through an early, focused program at certain clinics. The program will also be used for a real world evidence study.

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MSD Ireland’s €1b facility investment achieves new milestone

European Pharmaceutical Review

MSD Ireland’s new, state-of-the-art facility in Dunboyne, Co. Meath has opened. Additionally, the company has announced expansion of its Carlow site. In total, both projects represent an investment of over €1 billion. In total, both projects represent an investment of over €1 billion” MSD Carlow runs as filling site for the launch and commercial supply of vaccines , biologics, and small molecule drug products.

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Despite FDA doubts, Alnylam wins expert backing for Onpattro expansion into rare heart disease

Fierce Pharma

After Alnylam faced FDA doubts about its bid to expand RNA-silencing drug Onpattro into a rare heart disease called transthyretin amyloidosis cardiomyopathy (ATTR-CM), the company has picked up key | An FDA advisory committed voted in favor of Alnylam's bid to expand its RNA-silencing drug Onpattro into the rare heart disease called ATTR-CM. But comments at Wednesday’s panel suggest the drug could carry a disadvantage in its upcoming clash with Pfizer.

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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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Medicare Startup Prioritizing ‘Movement As Medicine’ Snags $17M

MedCity News

Bold, a Los Angeles-based company offering a healthy aging platform for older adults, closed a $17 million Series A funding round. The startup seeks to improve the health of Medicare Advantage beneficiaries through personalized exercise programs designed to prevent falls, decrease musculoskeletal pain and boost physical activity levels.

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England's NICE backs Pfizer's Vydura as treatment for acute migraines

Fierce Pharma

Less than four months after recommending Pfizer’s Vydura (rimegepant) to prevent m | Less than four months after recommending Pfizer’s Vydura (rimegepant) to prevent migraine headaches, England’s National Institute of Care and Health Excellence (NICE) has given it a thumbs up to treat them. With the nod, approximately 13,000 patients will have access to the first treatment approved in the U.K. for episodic (acute) migraine attacks.

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What CVS Stands to Gain by Setting Up Biosimilar Subsidiary Cordavis

MedCity News

Pharmaceutical industry observers say CVS Health’s creation of Cordavis, a new biosimilar drugs company, is part of a strategy to make its move into this market as profitable as possible.

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Site Enablement: How Sponsors and CROs Can Enhance Their Clinical Trials in a Competitive Landscape

Fierce Pharma

The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to Pr | Effective site enablement must address several factors, including protocol design, training, patient recruitment and enrollment, and more.

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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.

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FDA to start review of subcutaneous Entyvio for Crohn’s disease

Pharmaceutical Technology

The FDA is also reviewing a subcutaneous formulation of Takeda’s blockbuster drug for ulcerative colitis.

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UK ATMP facility granted cGMP approval

European Pharmaceutical Review

Following a UK Medicines & Healthcare Products Regulatory Agency (MHRA) inspection, Rentschler Biopharma SE’s UK advanced therapy medicinal products (ATMP) facility has received a current good manufacturing practice (cGMP) Manufacturing Compliance Certificate. This means that the contract development and manufacturing organisation (CDMO)’s site in the Cell and Gene Therapy Catapult’s Manufacturing Innovation Centre in Stevenage, is compliant to produce adeno-associated virus (AAV) vectors fo

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Eli Lilly’s Mounjaro approved on NHS for use in type 2 diabetes

Pharmaceutical Technology

Eli Lilly has had its therapy Mounjaro (tirzepatide) approved for patients in England with type 2 diabetes (T2D).

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New regulatory relief to benefit Europe’s pharma SMEs

European Pharmaceutical Review

As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe. This move will help address the needs of Europe’s SMEs in the current economic environment.

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ABM Success Recipe: Mastering the Crawl, Walk, Run Approach

Shifting to an account-based marketing (ABM) strategy can be both exciting and challenging. Well-implemented ABM motions build engagement with high-value accounts and drive impactful campaigns that resonate with your audience. But where do you begin, and how do you progress from crawling to running? Watch now as Demand Gen experts delve into the essentials of each stage of the ABM process.

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ten23 Expands Sterile Manufacturing Capacity at VIVA 1 Facility

Pharmaceutical Commerce

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

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Eisai launches new digital business company for dementia

PharmaTimes

Theoria technologies aims to empower those affected by dementia - News - PharmaTimes

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Clarify at SHSMD Connections 2023: Case studies on using market and patient insights to accelerate strategic growth

Clarify Health

In September of 2023, marketing and strategy leaders from around the country gathered at the Society for Health Care Strategy & Market Development’s (SHSMD) annual conference in Chicago, IL. Clarify was excited to attend the conference and meet with these leaders to discuss health system growth strategies and provide real world insights during an interactive speaking session.

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UKRI’s MRC invests £2m for hard-to-treat cancers

PharmaTimes

Four research innovation teams are set to receive £500,000 each - News - PharmaTimes

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How Intent Data Helps Marketers Convert A-List Accounts

One of the biggest challenges for any B2B marketer is understanding your prospects’ next move — who is most likely to buy and when. Without these insights, marketing campaigns can feel more like guesswork, with high investment and little return. We’re here to tell you there’s a better way. By tracking buyers’ digital footprints and online activity, such as website visits, product reviews, and spikes in content consumption, you can engage prospects with a message that really resonates.

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Inspira™ Announces 510(k) FDA Submission of INSPIRA™ ART100 Towards Commercialization

Legacy MEDSearch

Inspira Technologies OXY BHN Ltd. (Nasdaq: IINN , IINNW) (the “Company” or “Inspira Technologies”), a company aiming to bring a paradigm shift to acute respiratory care by empowering breathing without lungs, announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device, to the U.S. Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024.

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Rentschler Biopharma ATMP Facility Receives MHRA Approval

PharmaTech

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

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Helping Hands: How Top Salespeople Really Operate

Contrarian Sales Techniques

More Than Just a Sale You know that friend who’s always there when you need advice? Imagine if shopping felt like that - a helpful nudge in the right direction rather than someone pushing stuff on you. That's the magic some salespeople bring to the table. I've come to realize that the best salespeople don't really 'sell'. Instead, they're like your shopping buddy, guiding you to make the best choice.

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Recipharm Partners with Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy

PharmaTech

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

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Solving the Biggest Tech Challenges in RevOps

In this eBook, we’ll run through real-world examples that show how RevOps teams can benefit from modern solutions for the access, management, and activation of their GTM data. Whether you need to improve lead response times, boost adoption of core tools, improve lead qualification, or target and automate your GTM motions, you’ll find examples of how revenue teams are solving some of the toughest problems in modern business.

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Women’s Health Landscape and New Treatment Approaches on the Horizon

PharmExec

As the industry expands on areas of women’s health with large unmet medical needs, one biotech company is targeting local, vaginal inflammation, specifically for women undergoing IVF and to address other fertility- and reproductive tract-associated health conditions.

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Nurix Announces Strategic Collaboration with Seagen

PharmaTech

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

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Results from Rybrevant trial solidify Janssen’s foothold in EGFR-mutated NSCLC

Pharmaceutical Technology

Currently, NSCLC patients with EGFR exon 19 deletions or L858R substitution face limited therapeutic options after seeing disease progression post-front-line treatment.

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Frontiers Adopts CCC Ringgold Identify Database

Copyright Clearance Center

The post Frontiers Adopts CCC Ringgold Identify Database appeared first on Copyright Clearance Center.

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Drive GTM Efficiency with Tech Stack Consolidation

Consolidating your tech stack is an effective cost-saving measure that drives GTM efficiency and adds value to your enterprise. With a cohesive, integrated tech stack, your revenue teams can deliver an excellent customer experience that sets you up to win faster than your competitors.