Sat.Mar 30, 2024 - Fri.Apr 05, 2024

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FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

MedCity News

The Otsuka Pharmaceutical and Click Therapeutics mobile app Rejoyn received FDA clearance for use as an adjunct to medication in the treatment of major depressive disorder. But Otsuka must overcome hurdles facing digital therapeutics products, which have yet to gain traction among payers. The post FDA Clears the First Digital Therapeutic for Depression, But Will Payers Cover It?

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European prosecutors take over investigation into deal for Pfizer COVID vaccines: Politico

Fierce Pharma

While the market for COVID-19 vaccines has been shrinking lately, an investigation into text messages between Pfizer CEO Albert Bourla and the European Commission’s President Ursula von der Leyen r | The European Public Prosecutor’s Office (EPPO) took over the investigation into COVID vaccine negotiations between the European Commission's president and Pfizer's CEO Albert Bourla, Politico reports.

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As antimicrobial resistance looms large, a nonprofit teams up with Big Pharma to intervene

PharmaVoice

AMR is a growing threat, but with little financial incentive to pick up the torch, government and nonprofit collaborations are keeping the R&D flames burning.

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Biden slams asthma inhaler prices in White House address

pharmaphorum

President Joe Biden has reiterated his pledge to take action against high drug prices and “beat big pharma,” singling out the cost of asthma inhalers in a speech delivered at a White House event with US Senator Bernie Sanders, a long-time critic of the industry’s pricing policies in the US.

Pharma 112
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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

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.

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AliveCor Isn’t Backing Down from Apple, Its ‘Bully’

MedCity News

AliveCor CEO Priya Abani argues that Apple has made a habit of taking intellectual property from smaller medical device firms in order to improve the functionalities its Apple Watch. She also believes that Apple has been able to avoid taking accountability for this by “bombarding” smaller companies with litigation it knows they won’t be able to afford — a claim that medical IP lawyers have backed up.

Medical 130
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Eli Lilly's popular diabetes drug Mounjaro to face continued supply squeeze through April, FDA says

Fierce Pharma

Amid steadily increasing demand for Eli Lilly’s popular diabetes med Mounjaro, it appears patients on multiple dose strengths may have to wait even longer than anticipated to re-up on supply. | Four dose strengths are now expected to be in short supply through April, according to the FDA. The agency previously expected the squeeze to let up at the end of March.

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Ed Schoonveld Discusses List Prices for Pharmaceuticals in the US Compared to Other Countries

Pharmaceutical Commerce

In an interwith with Pharma Commerce Editor Nicholas Saraceno, Ed Schoonveld, Value and Access Advisor, Schoonveld Advisory, explains why pharmaceutical products tend to cost more in the US than the rest of the world.

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How to Help Physicians Generate More Revenue and Make Their Patients Healthier

MedCity News

Interest in using GLP-1 drugs to reduce obesity combined with a desire by physicians to become less dependent on insurance-based reimbursement after the recent Change Healthcare cyberattack is building. The post How to Help Physicians Generate More Revenue and Make Their Patients Healthier appeared first on MedCity News.

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Bristol Myers’ Abecma wins FDA nod in earlier multiple myeloma with updated boxed warning on secondary cancer

Fierce Pharma

After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers Squibb’s CAR-T therapy Abecma into the earlier treatment of multiple myeloma. | After a short period of doubt, the FDA has followed the opinion of its advisers and moved Bristol Myers’ CAR-T therapy Abecma into the earlier treatment of multiple myeloma.

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Teva’s AUSTEDO XR Campaign Featured in MM+M

Eversana Intouch

MM+M recently named Teva Pharmaceuticals’ AUSTEDO XR campaign as their Campaign of the Week! AUSTEDO XR helps treat tardive dyskinesia (TD), a side effect of taking medications for mental illness. It’s estimated that some 85% of TD cases go undiagnosed. To help patients and HCPs recognize TD, our team partnered with Teva on two new TV spots focusing on two different journeys of characters who have TD.

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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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‘Cliff’ Countdown: Balancing Internal and External Growth

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Joerg Tritschler, a partner in Simon-Kucher’s life sciences division, explores the two major strategies big pharma companies are employing amid current macro challenges and efforts to offset looming patent losses to blockbuster brands.

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Insurer Advocacy Orgs Slam Final MA, Part D Rate Announcement

MedCity News

America’s Health Insurance Plans, the Better Medicare Alliance and the Association for Community Affiliated Plans all came out against CMS’ final 2025 Medicare Advantage and Part D rate announcement. The post Insurer Advocacy Orgs Slam Final MA, Part D Rate Announcement appeared first on MedCity News.

Insurance 116
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High-flying Vertex hikes CEO Reshma Kewalramani's pay by 30% to $20.6M

Fierce Pharma

Vertex CEO Reshma Kewalramani, M.D., made $20.6 million in 2023, which was an increase of 30% from her $15.9 million pay in 2022.

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To advance women’s leadership, an effort ‘has to be purposeful,’ says EMD Serono exec

PharmaVoice

Gender diversity in leadership “doesn’t just happen,” — it requires institutional change, from investing in women’s startups to providing more generous family leave.

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

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Trial finds benefit for GLP-1 agonist in Parkinson’s

pharmaphorum

A small study of Sanofi’s lixisenatide has suggested that the GLP-1 agonist could slow down the progression of Parkinson’s disease, pointing to another potential use for the fast-growing drug class.

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AstraZeneca’s Rare Disease Pipeline Notches Another FDA Approval

MedCity News

The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.

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Teva snares up to $150M in Abingworth funding to propel late-stage asthma rescue inhaler

Fierce Pharma

Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway with an asthma resc | Shortly after Gilead Sciences teamed up with Carlyle’s Abingworth to fuel further research on its antibody-drug conjugate Trodelvy, Teva is following a similar pathway for an asthma rescue inhaler.

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FDA Approves New Antibiotic to Treat Three Different Bacterial Infections

PharmaTech

Zevtera has been approved to treat three types of bacterial infections and has been granted Priority Review and Fast Track and Qualified Infectious Disease Product designations.

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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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mRNA therapy could provide intracellular protein replacement for rare disease

European Pharmaceutical Review

Interim data from a Phase I/II clinical trial suggest that mRNA-3927, an investigational mRNA therapy from Moderna, could be a promising treatment for propionic acidaemia. A 70 percent reduction in the risk of metabolic decompensation events was reported by eight participants in the 12-month pretreatment period, according to the trial results published in Nature. “We are excited to share the first published clinical data utilising an mRNA therapy for intracellular protein replacement,̶

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Healthcare Docket: The Telehealth Boom is Inciting Action by Lawmakers and Fraudsters Alike

MedCity News

Ever since the Covid-19 pandemic pushed telehealth to the forefront of American healthcare modalities, the genie has emerged from the lamp to quite a mixed crowd of cheerleaders and cheaters.

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AstraZeneca CEO's 2024 pay proposal under fire from influential proxy advisers

Fierce Pharma

Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. | Like clockwork, AstraZeneca CEO Pascal Soriot’s pay is under fire again. The two most influential proxy advisory firms are rallying investors to vote against the 2024 pay proposal for Soriot at the company’s annual general meeting this month.

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Merck gets grant for patent granted for tricyclic heterocycle compounds for treating HIV

Pharmaceutical Technology

Discover the groundbreaking patent by Merck & Co Inc for Tricyclic Heterocycle Compounds to combat HIV infection. Learn about the innovative formula and treatment methods for a potent solution in antiretroviral therapy.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

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

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Championing UK ATMP clinical trials

European Pharmaceutical Review

A new £17.9 million initiative announced on 21 March is set to accelerate advanced therapy development in the UK. The scheme aims to support UK advanced therapy medicinal product (ATMP) clinical trials. UK Health Minister Andrew Stephenson commented on the news, stating that the investment “reaffirms the UK’s position as a global leader in clinical research”.

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StartUPDATES: New developments from Healthcare Startups

MedCity News

Check out news from Alpha Sophia, Biolinq, EarliTec Diagnostics, and Nourish. The post StartUPDATES: New developments from Healthcare Startups appeared first on MedCity News.

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Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Fierce Pharma

Amylyx Pharmaceuticals is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. | Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.

Marketing 295
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Praia emerges with $20m for digital health platform

pharmaphorum

Healthcare system Providence has spun out a new company, Praia Health, focused on a platform to build and sustain connections between patients and health providers. The new company starts life with $20 million in Series A funding and a mission to develop the Praia Health Identity and Engagement Platform, which was launched within Providence’s digital innovation group (DIG) incubator in 2022 and already handles around 3.5 million user accounts.

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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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EP monographs allow rFC for water testing

European Pharmaceutical Review

Revised versions of two widely used European Pharmacopoeia (EP) monographs now allow the use of recombinant factor C (rFC) for testing of pharmaceutical waters. The revised monographs – Water for injections (0169) and Purified water (0008) – mean that users can select the rFC test described in Ph. Eur. 2.6.32 directly when testing pharmaceutical waters.

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Biolinq Snags $58M for ‘Smallest Biosensor in the World’

MedCity News

Biolinq raked in $58 million in capital this week. The company is developing a wearable patch that uses electrochemical sensors to measure a person’s glucose levels from the intradermal space just beneath the surface of their skin. The post Biolinq Snags $58M for ‘Smallest Biosensor in the World’ appeared first on MedCity News.

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Acorda inks $185M asset sale to Merz, files for bankruptcy after years of disappointing sales

Fierce Pharma

After years of struggling with hurdles such as generic competition and significantly lower-than-expected sales of its top meds, Acorda Therapeutics is hanging up the gloves with a $185 million deal | Merz Therapeutics, in a "stalking horse bid," agreed to pick up Acorda's Parkinson's disease med Inbrija and multiple sclerosis drug Amprya ahead of a court auction.

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Ipsen licenses Sutro ADC in $900m deal

pharmaphorum

Ipsen has expanded its oncology pipeline by licensing rights to an antibody-drug conjugate (ADC) for solid tumours from Sutro Biopharma, its first drug in the category. The deal, which has a top-end value of $900 million including $90 million in near-term payments, focuses on STRO-003, a preclinical-stage ADC targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time