Thu.Jun 06, 2024

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FDA cracks down on China's Hengrui in scathing manufacturing write-up

Fierce Pharma

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.

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INVEST Pitch Perfect Spotlight: How One Company Aims To Change Neonatal Feeding

MedCity News

Mother’s Milk Is Best has a medical device that increases the ability to use a mother’s milk or a donor’s milk versus other fortification processes. Last month, judges selected the company as the winner of the consumer/employer track of MedCity News’ INVEST Pitch Perfect contest. The post INVEST Pitch Perfect Spotlight: How One Company Aims To Change Neonatal Feeding appeared first on MedCity News.

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Italy opens antitrust case against Novartis, Roche and others, claiming collusion to delay biosim launch

Fierce Pharma

A new antitrust investigation in Italy has ensnared Novartis, Genentech, Biogen and Samsung Bioepis for allegedly colluding to suppress competition of a Lucentis biosimilar in the country. | Italy's antitrust agency is going after Novartis, Genentech, Biogen and Samsung Bioepis for allegedly working together to delay the launch of a Lucentis biosimilar in Italy.

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The Promise of AI for Independent Health and Wellness Practitioners: More Time, More Money, More Freedom

MedCity News

The introduction of AI into solo or group practices can assist in completing administrative tasks, organizing information faster, and supporting effective, personalized care. The post The Promise of AI for Independent Health and Wellness Practitioners: More Time, More Money, More Freedom appeared first on MedCity News.

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

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France's Orano Med debuts radiotherapy manufacturing plant near Indianapolis

Fierce Pharma

Amid a nuclear medicine boom, France’s Orano Med has chosen the U.S. to establish a manufacturing plant as it progresses on its radiopharma journey. | Orano Med—which is working on targeted alpha therapies for cancer—on Thursday inaugurated its first Alpha Therapy Laboratory (ATLab) in Brownsburg near Indianapolis, Indiana. The site marks the world’s first industrial-scale facility dedicated to production of lead-212-based radioligand therapies, the company said.

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How Payers Use Tech to Support Healthcare Transformation

MedCity News

Executives at the ViVE Payer Insights event earlier this year discussed prior authorization, AI, value-based care and the role of tech to help achieve their goals. The post How Payers Use Tech to Support Healthcare Transformation appeared first on MedCity News.

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Scott Burrows: Inspiring Franchise Business Speaker

Scott Burrows

In my journey as a keynote speaker within the franchise industry, I’ve had the honor of addressing numerous esteemed franchises, including Two Men and a Truck, Dunn Brothers Coffee, Expedia Cruise Ship Franchise Industry, Snap Fitness, the Conklin Companies, Screen Mobile, and many others. Through these engagements, I’ve shared my life-changing story and principles of success centered around Vision, Mindset, and Grit.

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Fierce Pharma Asia—Enhertu's encore; Akeso's showstopper; GenScript and Legend's US scrutiny

Fierce Pharma

AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. | AstraZeneca and Daiichi Sankyo are looking at moving their antibody-drug conjugate Enhertu into another new breast cancer patient class. Ahead of the American Society of Clinical Oncology annual meeting, a cancer antibody from Akeso and Summit Therapeutics stole the show.

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Buoyed by new obesity data, Structure files $476m offering

pharmaphorum

Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million

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Vanda, after rejecting Future Pak offer, gets $466M takeout bid from Cycle Pharma

Fierce Pharma

England-based rare disease drug maker Cycle Pharma revealed an $8-per-share offer for Vanda, representing a total buyout offer of $466 million.

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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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Mexican man dies in first human case of H5N2 bird flu

pharmaphorum

A man in Mexico has died in what the WHO has said is the first lab-confirmed human infection with the H5N2 strain of bird flu

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Would BIO support a biosecurity bill targeting drug developers? Hear CEO John Crowley’s response

Fierce Pharma

Would BIO support a biosecurity bill targeting drug developers?

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Data needed to forge the link between AI and mRNA

Pharmaceutical Technology

While the potential for using AI to develop mRNA therapeutics is now a real possibility, accurate and diverse data is needed to make it a reality.

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Providers Should Do These 3 Things to Improve Access

MedCity News

When talking about increasing access, it’s essential to remember that there is a difference between making healthcare more accessible and simply increasing patients’ access to appointments, pointed out Lee Schwamm, chief digital health officer at Yale New Haven Health System. In this article, he explains three steps hospitals can take to actually boost accessibility.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Telix prices $200m IPO in big week for radiopharma financing

pharmaphorum

Trio of radiopharma financings this week, as Telix files $200m US IPO, ITM raises $202m in a private round, and AstraZeneca invests in CDMO Nucleus.

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Tackling the Loneliness Crisis at Scale

MedCity News

The solution requires healthcare providers, community programs, and social services to work collaboratively to develop broader community-based approaches. The post Tackling the Loneliness Crisis at Scale appeared first on MedCity News.

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Amgen preps Uplizna filing for a second indication

pharmaphorum

Amgen's Uplizna could become the first FDA-approved treatment for rare disease IgG4-RD, after showing efficacy in the phase 3 MITIGATE trial

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I-Mab and BMS assess givastomig for gastric and oesophageal cancer

Pharmaceutical Technology

I-Mab has agreed with Bristol Myers Squibb (BMS) to assess the givastomig regimen for advanced gastric and oesophageal cancers.

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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.

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CDC recommends first post-exposure antibiotic for STIs

pharmaphorum

CDC recommends doxyPEP as first post-exposure antibiotic for STIs including syphilis, gonorrhoea and chlamydia

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ArriVent partners Alphamab to develop ADCs for cancer

Pharmaceutical Technology

ArriVent BioPharma has entered a partnership with Jiangsu Alphamab Biopharmaceuticals for developing new ADCs to treat cancer.

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Combination therapy may hold potential for severe viral hepatitis

European Pharmaceutical Review

Final Phase IIb data has confirmed the potential of bulevirtide 10mg in combination with pegylated interferon alfa-2a (PegIFN) as a finite therapy for adults with chronic hepatitis delta virus (HDV), according to Gilead Sciences. The new data is from the MYR204 study which investigated the efficacy and safety of the first-in-class entry inhibitor bulevirtide alone and together with PegIFN, in these patients with compensated chronic HDV infection.

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Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs

MedCity News

Three upcoming Supreme Court decisions have the potential to radically change FDA regulation of medications. The cases, which involve “Chevron deference” and the abortion pill mifepristone, were discussed on a panel during the BIO conference in San Diego. The post Why a SCOTUS Ruling on Fishing Rules Could Change How FDA Regulates Drugs appeared first on MedCity News.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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[Special Report] Trademark filing and litigation trends 2024: Insights and opportunities

Clarivate

Trademark data is a valuable resource that goes beyond legal records. While it plays a crucial role in brand protection and registration, it also provides a window into commercial activity. In our recent report Trademark Filing and Litigation Trends 2024 , we explore the insights and opportunities revealed by analyzing trademark data. Download the report The value of trademark data Every month around one million new trademark applications are filed at intellectual property offices around the wor

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Celebrating Pride: Lessons of Allyship and Inclusion

ALULA

During Pride Month, we celebrate the diversity, resilience, and authenticity of the LGBTQIA+ community. It's a time to uplift their voices, lived experiences, and the ongoing journey toward true equality and inclusion. As allies, our role is to listen, learn, and take meaningful action in supporting the LGBTQIA+ community year-round.

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Alchemab receives funding boost for Parkinson’s research

PharmaTimes

Innovative antibody discovery could lead to new Parkinson’s treatments

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Applying AI to Molecular Structure (BIO 2024)

PharmaTech

Founder and CEO of Atomic AI, Raphael Townshend, explores AI’s usefulness as a tool to characterize molecular structure and advance molecule engineering.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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Pharma Pulse 6/6/24: OpenAI Insiders Warn of a ‘Reckless’ Race for Dominance, Three Ways to Close the Urgent Talent Gap & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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What is Salesforce Life Sciences Cloud?

Penrod

What is Life Sciences Cloud? Depending on their business model, life sciences companies typically use Salesforce Sales Cloud, Health Cloud, or Service Cloud as their primary CRM. It breaks down like this: Sales Cloud B2B companies without a need to store protected health information (PHI) Service Cloud B2B or B2C companies with a need for robust, omnichannel customer service Health Cloud B2C companies or healthcare facilities with large amounts of PHI and a need to deliver robust service experie

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Bulevirtide Combination Therapy Shows Efficacy Achieving Undetectable Compensated Chronic Hepatitis Delta Virus RNA

PharmExec

Data published in the New England Journal of Medicine from Gilead’s Phase IIb MYR204 found the bulevirtide/ pegylated interferon alfa-2a combination was more effective in achieving undetectable HDV RNA compared to bulevirtide 10 mg monotherapy in the treatment of chronic hepatitis D.

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Is modular content right for your life science organization?

Vodori

In today's rapidly evolving digital landscape, the ability to efficiently manage and deliver compliant, personalized content has become crucial for pharmaceutical, medical device, diagnostic, and biotech companies. In recent years, modular content has been touted as a solution to this challenge.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.