Fierce Pharma

OCTOBER 18, 2024

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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MedCity News

OCTOBER 20, 2024

Pharmaceutical and biotech companies are using generative AI to predict drug-target interactions, optimize lead compounds, and generate novel molecular structures. During the recent MedCity News INVEST Digital Health conference, a panel discussed these applications and more. The post How Generative AI Will Find a Place in the Pharma Industry Now and in the Years to Come appeared first on MedCity News.

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Fierce Pharma

OCTOBER 17, 2024

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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pharmaphorum

OCTOBER 18, 2024

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

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Leads 105

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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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MedCity News

OCTOBER 16, 2024

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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PharmaVoice

OCTOBER 15, 2024

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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pharmaphorum

OCTOBER 14, 2024

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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Government 142

MedCity News

OCTOBER 16, 2024

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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PharmaVoice

OCTOBER 17, 2024

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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Pharmaceutical 98

Pharmaceutical Technology

OCTOBER 14, 2024

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

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Manufacturing Pharmaceutical 111

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Fierce Pharma

OCTOBER 15, 2024

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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Sales 309

pharmaphorum

OCTOBER 18, 2024

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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MedCity News

OCTOBER 16, 2024

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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Pharmaceutical Commerce

OCTOBER 18, 2024

With great power comes great responsibility. In this case, tackling these obstacles is vital to making sure that the positives of GLP-1s are not outweighed by the downfalls of improper waste disposal.

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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.

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Pharmaceutical Technology

OCTOBER 14, 2024

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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Fierce Pharma

OCTOBER 17, 2024

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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pharmaphorum

OCTOBER 16, 2024

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

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MedCity News

OCTOBER 16, 2024

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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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

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European Pharmaceutical Review

OCTOBER 18, 2024

A new immunotherapy treatment regimen (nivolumab plus doxorubicin, vinblastine, and dacarbazine (AVD)) provided a significant survival rate in advanced Hodgkin lymphoma patients, Phase III trial data shows. This new treatment could decrease long-term side effects including second cancers later in life and heart and lung conditions, according to the researchers.

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Side effects Food and Drug Administration Food Patients 59

Pharmaceutical Technology

OCTOBER 18, 2024

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

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Fierce Pharma

OCTOBER 14, 2024

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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FDA 295

pharmaphorum

OCTOBER 17, 2024

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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Patients 92

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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

Sales

MedCity News

OCTOBER 18, 2024

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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PharmaTech

OCTOBER 20, 2024

Bala Addepalli, PhD, Director, R&D New Modalities Portfolio, Waters Corporation, discussed recent advancements and current challenges in the development of large RNA therapeutics.

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Pharmaceutical Technology

OCTOBER 14, 2024

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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Fierce Pharma

OCTOBER 18, 2024

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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pharmaphorum

OCTOBER 15, 2024

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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MedCity News

OCTOBER 18, 2024

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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Clarivate

OCTOBER 17, 2024

Artificial intelligence (AI) already enhances a range of legal processes. From contract and due diligence reviews to e-discovery and legal research, early adopters of AI have seen undeniable benefits in speed, accuracy and efficiency. Today, AI promises many of the same benefits in the context of patent preparation and prosecution. However, between the decision to invest in AI-assisted patent drafting software and achieving a positive return on investment, a lot of hype and mischaracterization c

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Pharmaceutical Technology

OCTOBER 15, 2024

Huawei hosted GITEX's Industrial Digital and Intelligent Transformation Summit and launched joint solutions with partners for ten industries.

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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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