Sat.Oct 12, 2024 - Fri.Oct 18, 2024

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How One Investor Views the Future of Healthcare AI

MedCity News

In the future, healthcare AI startups that offer multimodal models may have an easier time raising venture capital than healthcare AI companies that don’t, according to Morgan Cheatham, vice president at Bessemer Venture Partners. The post How One Investor Views the Future of Healthcare AI appeared first on MedCity News.

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3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev

Fierce Pharma

AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.

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Lilly pledges £279m to UK for biotech hub and obesity plan

pharmaphorum

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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AlphaFold’s Nobel Prize is ‘the dawn of a new era’ in mapping drug development potential

PharmaVoice

A Nobel Prize in chemistry for Google’s DeepMind protein-structure mapping is the tip of the iceberg for advances in drug discovery and development.

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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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Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

MedCity News

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The wearable technology delivers electrical fields that kill cancer cells. The post Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer appeared first on MedCity News.

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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy

Fierce Pharma

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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More Trending

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Wave sees RNA editing validation in early trial results

PharmaVoice

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

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12 Compelling Sessions to Check Out at HLTH 2024

MedCity News

HLTH 2024, scheduled for October 20-23 at the Venetian Expo Center in Las Vegas, will highlight the shifting landscape of healthcare innovation in many different settings. Register today! The post 12 Compelling Sessions to Check Out at HLTH 2024 appeared first on MedCity News.

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GSK takes mRNA patent fight to Moderna, suing over vaccines for COVID and RSV

Fierce Pharma

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

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Pfizer rounds out haemophilia portfolio with FDA approval

pharmaphorum

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year.Marstacimab will be launched as Hympavzi to treat haemophilia A without factor VIII inhibitors and haemophilia B without factor IX inhibitors in patients aged 12 and older and is the first drug in the anti-TFPI class to be approved in the US.

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

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Cell and gene therapy approvals drive paradigm change in manufacturing

Pharmaceutical Technology

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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Nurturing the Nurturers: The Role of Parental and Caregiver Wellness in Supporting Children’s Mental Health

MedCity News

Healthcare providers play a critical role in helping caregivers recognize potential imbalances. Encouraging caregivers to access resources for self-care and respite isn’t just a nicety, it’s a clinical necessity. The post Nurturing the Nurturers: The Role of Parental and Caregiver Wellness in Supporting Children’s Mental Health appeared first on MedCity News.

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In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list

Fierce Pharma

Four days after a compounding industry group filed a lawsuit against the FDA | Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

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NIH study backs Bavarian Nordic mpox jab for adolescents

pharmaphorum

NIH study finds Bavarian Nordic's mpox vaccine is effective in adolescents, a particularly vulnerable group amid the ongoing outbreak

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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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EMA Denies Authorization of Duchenne Muscular Dystrophy Treatment, Again

PharmaTech

The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.

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Evolving Markets, Innovative Solutions: The Rise of Specialty VBC

MedCity News

This new approach is helping payors and providers unlock new value from their VBC initiatives while offering more effective and condition-specific treatment for patients. The post Evolving Markets, Innovative Solutions: The Rise of Specialty VBC appeared first on MedCity News.

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Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

Fierce Pharma

As a host of generics circle the gates, Novartis has lost another bid to waylay MSN Pharmaceuticals’ copycat of the Swiss pharma’s top-selling drug Entresto. | In a court decision filed in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld the green light that MSN won in July.

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MSD preparing to take on Beyfortus with RSV antibody

pharmaphorum

MSD reveals the data that could unlock filings for clesrovimab, a rival to Sanofi and AstraZeneca's Beyfortus for preventing infant RSV infections

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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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Healing begins with research: Promising development program on stem cells in rare diseases

Pharmaceutical Technology

RHEACELL has been researching ABCB5-positive stem cell therapies for patients with severe immune and inflammation-related diseases for which there are currently no adequate treatment options. Positive feedback from the regulatory authorities on the study program now gives reason to hope that those affected will be able to benefit from this new approach to regenerative medicine in the near future.

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Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure

MedCity News

Gilead Sciences’ Trodelvy did not meet the main overall survival goal of its confirmatory Phase 3 test. The antibody drug conjugate was awarded accelerated approval for advanced urothelial carcinoma in 2021. The post Gilead Sciences Voluntarily Pulls Drug for Bladder Cancer After Trial Failure appeared first on MedCity News.

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Gilead pulls Trodelvy's approval in bladder cancer after trial flop, FDA discussions

Fierce Pharma

After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S. | After falling short in a confirmatory clinical trial, Gilead Sciences has decided to withdraw Trodelvy as a bladder cancer treatment in the U.S.

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NICE backs first targeted therapy for ALK+ lung cancer

pharmaphorum

NICE backs NHS use of Roche's Alecensa as first adjuvant therapy for ALK+ NSCLC, and peri-operative use of MSD's Keytruda for all-comer NSCLC patients

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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

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Sanofi in talks to sell stake in consumer healthcare unit to CD&R

Pharmaceutical Technology

Sanofi has announced negotiations with Clayton Dubilier & Rice (CD&R), regarding the potential sale of a 50% controlling stake in Opella.

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Nearly 7,000 US Healthcare Devices & Records Are Exposed to the Public Internet, Research Shows

MedCity News

New research shows that there are more than 14,000 unique IP addresses across the globe exposing patients’ potentially sensitive medical information on the public internet. Nearly half of these exposures are in the U.S. The post Nearly 7,000 US Healthcare Devices & Records Are Exposed to the Public Internet, Research Shows appeared first on MedCity News.

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On road to crowded Crohn's disease market, Lilly's Omvoh bests J&J's Stelara in head-to-head study

Fierce Pharma

On a mission to collect a key Crohn’s disease approval and build out its inflammatory bowel disease (IBD) profile, Eli Lilly has notched a trial win over a major rival in a head-to-head study.&nbsp | Eli Lilly's drug outperformed Johnson & Johnson's established Stelara in a phase 3 study that looked at histologic disease responses over 52 weeks.

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Lundbeck drops in on epilepsy drug with $2.6bn Longboard bid

pharmaphorum

Neuroscience specialist Lundbeck has agreed to buy Longboard Pharmaceuticals for $2.6 billion, expanding its pipeline with an epilepsy drug tipped as a future blockbuster.The Danish drugmaker has offered $60 per share for California biotech Longboard, with the main asset in the deal bexicaserin, an oral, centrally acting serotonin 5-HT 2C receptor super-agonist in late-stage testing for seizures associated with rare forms of epilepsy.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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mRNA licensing agreements surge 800% amid GSK lawsuits

Pharmaceutical Technology

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

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Lundbeck’s Neuro-Rare Pipeline Lands Cornerstone Drug via $2.6B Longboard Pharma Acquisition

MedCity News

Lundbeck says Longboard Pharmaceuticals’ drug, bexicaserin, has potential applications in a range of rare epilepsies. Last month, the biotech began a Phase 3 clinical trial testing the drug in Dravet syndrome. The post Lundbeck’s Neuro-Rare Pipeline Lands Cornerstone Drug via $2.6B Longboard Pharma Acquisition appeared first on MedCity News.

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With Gilead coming fast, GSK bolsters case for long-acting HIV PrEP drug Apretude

Fierce Pharma

With Gilead sprinting to a likely approval next year for its long-acting pre-exposure | With GSK girding for competition from Gilead Sciences, the company has presented strong results from three real-world studies of its bi-monthly injection for HIV prevention.

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Transgene cervical cancer shot misses the mark in phase 2

pharmaphorum

Transgene's therapeutic vaccine for cervical and anogenital cancers failed a phase 2 trial, but an efficacy signal warrants further study

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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.