Fierce Pharma
JUNE 6, 2024
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.
pharmaphorum
JUNE 6, 2024
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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
JUNE 6, 2024
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.
MedCity News
JUNE 6, 2024
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.
Fierce Pharma
JUNE 6, 2024
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.
MedCity News
JUNE 6, 2024
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.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
JUNE 6, 2024
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
Fierce Pharma
JUNE 6, 2024
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.
pharmaphorum
JUNE 6, 2024
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.
Fierce Pharma
JUNE 6, 2024
England-based rare disease drug maker Cycle Pharma revealed an $8-per-share offer for Vanda, representing a total buyout offer of $466 million.
Advertisement
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.
MedCity News
JUNE 6, 2024
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.
Fierce Pharma
JUNE 6, 2024
Would BIO support a biosecurity bill targeting drug developers?
European Pharmaceutical Review
JUNE 6, 2024
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.
Scott Burrows
JUNE 6, 2024
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.
pharmaphorum
JUNE 6, 2024
Amgen's Uplizna could become the first FDA-approved treatment for rare disease IgG4-RD, after showing efficacy in the phase 3 MITIGATE trial
Pharmaceutical Technology
JUNE 6, 2024
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.
MedCity News
JUNE 6, 2024
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.
pharmaphorum
JUNE 6, 2024
CDC recommends doxyPEP as first post-exposure antibiotic for STIs including syphilis, gonorrhoea and chlamydia
Advertisement
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.
MedCity News
JUNE 6, 2024
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.
Pharmaceutical Technology
JUNE 6, 2024
I-Mab has agreed with Bristol Myers Squibb (BMS) to assess the givastomig regimen for advanced gastric and oesophageal cancers.
MedCity News
JUNE 6, 2024
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.
Pharmaceutical Technology
JUNE 6, 2024
ArriVent BioPharma has entered a partnership with Jiangsu Alphamab Biopharmaceuticals for developing new ADCs to treat cancer.
Advertisement
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
Clarivate
JUNE 6, 2024
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
PharmaTimes
JUNE 6, 2024
Innovative antibody discovery could lead to new Parkinson’s treatments
PharmaTech
JUNE 6, 2024
Founder and CEO of Atomic AI, Raphael Townshend, explores AI’s usefulness as a tool to characterize molecular structure and advance molecule engineering.
Pharmaceutical Commerce
JUNE 6, 2024
The latest news for pharma industry insiders.
Advertisement
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
ALULA
JUNE 6, 2024
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.
pharmaphorum
JUNE 6, 2024
Italian competition authority opens antitrust probe against Novartis, Roche, Biogen and Samsung Bioepis over alleged collusion to delay the launch of Lucentis biosimilar Byooviz
Penrod
JUNE 6, 2024
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
PharmExec
JUNE 6, 2024
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.
Advertisement
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.
Expert insights. Personalized for you.
291 
Let's personalize your content