Tue.Jun 20, 2023

article thumbnail

Agepha Pharma gets ancient gout remedy colchicine across FDA finish line for heart disease

Fierce Pharma

Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.

Pharma 309
article thumbnail

WHO grants emergency use listing to SK bioscience’s SKYCovione

Pharmaceutical Technology

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.

Safety 145
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

With new lawsuits, Novo Nordisk aims to crack down on compounded versions of Ozempic, Wegovy

Fierce Pharma

Three weeks after the FDA warned that some pharmacies are making unauthorized versio | Novo Nordisk filed five lawsuits in four states on Tuesday, charging health spas, clinics and pharmacies with false advertising, trademark infringement and unlawful sales of compounded versions of diabetes and weight loss drugs Ozempic and Wegovy. Novo also is planning action against other unlawful sellers, the company said.

FDA 304
article thumbnail

Feds Warn Healthcare Providers About ‘Obscure’ Ransomware Gang

MedCity News

HC3 recently warned healthcare providers about a “relatively unknown” ransomware gang named TimisoaraHackerTeam. The group leverages legitimate software tools like Microsoft’s BitLocker and Jetico’s BestCrypt to deliver its malware.

article thumbnail

European Clinical Supply Planning: Balancing Cost, Flexibility and Time

article thumbnail

Bristol Myers follows Merck's lead with its own ?lawsuit blasting IRA's Medicare negotiations

Fierce Pharma

After Merck filed a bombshell lawsuit challenging some measures in the Inflation Reduction Act (IRA), Bristol Myers Squibb has followed on with a case of its own. | After Merck took the first legal stab at the Inflation Reduction Act with a lawsuit against the Department of Health and Human Services (HHS), Bristol Myers Squibb is the latest drugmaker to allege Constitutional violations.

Leads 271
article thumbnail

Catalyst licenses Santhera Pharma’s vamorolone in North America

Pharmaceutical Technology

Santhera Pharmaceuticals and Catalyst Pharmaceuticals have signed an exclusive licence and collaboration deal for Santhera’s vamorolone in the US, Canada and Mexico. Catalyst Pharmaceuticals will gain exclusive rights to commercialise vamorolone across the region. The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity.

More Trending

article thumbnail

The Role of Artificial Intelligence and Related Technologies in Academic Publishing and How it Might Transform the Way Publishers Work

Copyright Clearance Center

The post The Role of Artificial Intelligence and Related Technologies in Academic Publishing and How it Might Transform the Way Publishers Work appeared first on Copyright Clearance Center.

98
article thumbnail

Sanofi prevails over Boehringer Ingelheim in legal battle over Zantac liabilities

Fierce Pharma

When Sanofi made an asset swap with Boehringer Ingelheim in 2016, the French company acquired BI’s healthcare business, which included heartburn medicine Zantac. | An International Chamber of Commerce arbitration tribunal has sided with Sanofi, rejecting Boehringer Ingelheim's attempt to receive liability protections for cancer claims in the United States tied to heartburn medicine Zantac.

Medicine 254
article thumbnail

What Are the Challenges in Gaining Trust in Healthcare?

MedCity News

In order to gain trust from communities, healthcare leaders will need more training on effective communication, said Dr. Vin Gupta, a pulmonologist and chief medical officer of Amazon Pharmacy. He made these comments last week during a panel at the AHIP 2023 conference in Portland.

article thumbnail

'Misinformation': AstraZeneca's China head refutes news report about potential spinoff

Fierce Pharma

AstraZeneca, the largest multinational pharma company in China, has reportedly made plans to separate its local business there in case geopolitical tensions worsen. | The largest multinational pharma company in China has reportedly made plans to separate its local business in case geopolitical tensions worsen. But the company is hitting back at the recent news report.

Pharma 239
article thumbnail

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.

article thumbnail

A Candid Conversation with Our CEO and Founder on Conquering Remote Work Challenges | Legacy MEDSearch

Legacy MEDSearch

When did you first offer flexible work policies? What led your organization to implement a flexible work environment? For almost a decade, our company has been at the forefront of embracing work from home flexibility. We recognized the importance of accommodating our exceptional team members at all stages of their lives. By providing the option to work from home, we aimed to alleviate the traditional barriers and challenges associated with a fixed office-based environment.

article thumbnail

In fraud case targeting HIV meds, Florida man gets 15 years in prison

Fierce Pharma

A year after a Florida man was arrested for his alleged involvement in a nationwide scheme to distribute fake HIV medicines, a U.S. | After reaping millions from selling adulterated HIV meds, one of the men involved in a fraud ring has been sentenced to 15 years in prison for his role in the crime.

article thumbnail

FDA Places Arcellx Cell Therapy Under a Clinical Hold After Patient Death

MedCity News

Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.

article thumbnail

AI has secured a footing in drug discovery. Where does it go from here?

PharmaVoice

The AI revolution is bringing a new era of drug discovery, and the potential for more uses is greater and faster than ever before.

108
108
article thumbnail

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

article thumbnail

Heal’s Co-Founders Launch New Startup to Help Older Patients & Their Caregivers

MedCity News

Renee Dua and Nick Desai —the husband-and-wife duo who founded physician house call company Heal in 2014 — have launched another healthcare startup. The company, called Together by Renee, said it is the first app to use generative AI to manage time-consuming healthcare tasks for older patients, those with chronic diseases and their stressed-out caregivers.

article thumbnail

FluoGuide announces head and neck cancer therapy results

PharmaTimes

The treatment is administered intravenously prior to surgery, lighting up cancer during surgery - News - PharmaTimes

94
article thumbnail

CVS Health Exec: The Behavioral Health Industry Needs a ‘Common App’ for Insurance

MedCity News

There are a lot of administrative hurdles behavioral health providers have to go through to join an insurer’s network. That’s why the industry needs something similar to the “Common App” for applying to be in-network with insurers, said Cara McNulty, president of behavioral health and mental wellbeing at CVS Health. The Common App allows students to apply to multiple colleges through one application.

article thumbnail

The spotlight is on accelerated approvals — now FDA could run a tighter ship

PharmaVoice

As the fallout of the Aduhelm approval continues, scrutiny of the speedier pathway has increased and the pressure is on to close a key gap in the regulation.

FDA 75
article thumbnail

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.

article thumbnail

Eli Lilly Bets $2.4B on Dice Therapeutics’ Oral Drugs for Psoriasis and More

MedCity News

Eli Lilly’s acquisition of Dice Therapeutics comes eight months after the biotech reported positive data from a Phase 1 study in psoriasis. Dice develops oral small molecule drugs intended to offer alternatives to biologic drugs that are injected or infused.

article thumbnail

The Top Employee Benefits Recruiters Need to be Talking About

MedReps

When it comes to luring in new employees, recruiters have a few options. Sometimes, the job itself is enough to bring in a number of hopeful applicants who want to work for their dream company. The salary is another draw as everyone wants to earn more money or maximize their earning potential. However, there’s another option out there that can capture people’s attention: employee benefits.

article thumbnail

The Crucial Role of Medical Affairs in Bridging the Educational Gap Among Healthcare Professionals in Biosimilars

MedCity News

Biosimilars represent an important therapeutic option in modern healthcare, offering cost-effective alternatives to complex biological drugs. The educational gap among healthcare professionals poses a challenge to their widespread adoption.

article thumbnail

BioSenic to deliver news on copper-arsenic trioxide combination

PharmaTimes

Immunological disorder therapy data to be shared at International Conference on Redox Medicine - News - PharmaTimes

article thumbnail

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.

article thumbnail

Ferring Receives FDA Approval on Scale-Up of Gene Therapy Adstiladrin

PharmExec

Company reportedly on schedule to make drug available in the second half of this year.

FDA 98
article thumbnail

Buy vs. Build: Bioanalytical lab

PharmaTech

With so many outsourcing/insourcing options across drug development workflows, pharmaceutical companies are faced with finding the right partner to fit the needs of their unique molecule. There are criteria to consider when outweighing the benefits and risks associated with buying or building a bioanalytical lab.

article thumbnail

Sterile Processing, Healthcare, And Medical Sales With Justin Poulin

Evolve Your Success

In the dynamic landscape of medical sales, embrace innovation, ignite change, and unleash your potential to revolutionize healthcare. Success awaits those who boldly navigate the realm of medical sales with unwavering determination and a relentless pursuit of excellence. In this episode, Samuel Adeyinka sits with a remarkable guest, Justin Poulin. Justin discusses the dynamic landscape of medical sales, offering valuable insights and insider perspectives.

article thumbnail

Clarify launches integration with Salesforce to inform physician engagement strategies with precise, on-demand insights into physician referral patterns

Clarify Health

Clarify Health is excited to announce the availability of referral pattern insights within Salesforce! Users of Salesforce for Physician Relationship Management (PRM) can now find Clarify in the Salesforce AppExchange. This integration gives users on-demand access to physician referral insights, such as physician volume, keepage rates, and loyalty status (e.g., splitter, dissenter, loyalist) within Salesforce for more productive and actionable conversations.

article thumbnail

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

article thumbnail

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant health data, having monitored more than 1 million babies, and with BabySat, combines its consumer-first expertise with hospital-grade monitoring accuracy.

article thumbnail

Drug Solutions Podcast: Emerging Methods of Vaccine Administration and Distribution

PharmaTech

Michael Schrader, CEO and co-founder of Vaxess, discusses the latest on vaccine administration and different ways the pharmaceutical industry can distribute these products with Pharmaceutical Technology editor Jill Murphy.

article thumbnail

DoH, M42 and AbbVie partner for personalised medicines in Abu Dhabi

Pharmaceutical Technology

The Department of Health Abu Dhabi (DoH) has signed a memorandum of understanding with integrated healthcare company M42 and AbbVie Biopharmaceuticals to advance personalised medicine and genomics in the city. M42 was created through the combination of Mubadala Health and G42 Healthcare. The collaboration aims to advance precision medicine for the diagnosis and treatment of non-small cell lung cancer (NSCLC) and multiple myeloma.

article thumbnail

3 pressing molecular bioanalysis factors confronting gene therapy developers

PharmaVoice

It’s exciting to be part of today’s gene therapy development community; however, three issues are at the top of the industry’s mind—the regulatory landscape, critical molecular bioanalysis considerations: biodistribution, transgene expression, vector shedding and assay-related challenges.

52
article thumbnail

Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.