Sat.Jun 17, 2023 - Fri.Jun 23, 2023

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Could novel robotic oral pill replace traditional injections?

European Pharmaceutical Review

A novel oral ‘robotic pill’ demonstrated a high success rate of drug delivery , according to clinical trial data presented at the Endocrine Society ’s annual meeting (ENDO 2023). “We believe this study provides the first clinical evidence of safe and successful delivery of the osteoporosis drug teriparatide through an oral robotic pill,” stated Arvinder Dhalla, Vice President of Clinical Development at Rani Therapeutics, which was the company that developed the technology.

Medical 98
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Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Fierce Pharma

Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. | Even after second application attempt, Intercept’s Ocaliva wasn’t the fatty liver disease breakthrough that the company had hoped it would be. Intercept is now swinging into restructuring mode, and the NASH baton passes on to Madrigal Pharma.

FDA 354
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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
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What does a medical sales rep do?

David Bagga

A medical sales rep is the person who forms a liaison between medical companies and healthcare professionals who use their products. The sales rep is the main point of contact between the two. Medical Device Sales Career Home Blog What Does a Medical Sales Rep Do? What does a Medical Sales Rep do? A medical […] The post What does a medical sales rep do?

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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4 Keys to Engaging Healthcare Consumers Digitally

MedCity News

One health system that initiated a journey mapping process for breast health services focused on connecting patients with a breast surgeon within 48 hours. But for the patient, that’s not 48 hours. That’s 10,000 moments of terror, she told them. Understanding this, the health system redesigned how it communicated with patients.

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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 353

More Trending

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Psylo signs research deal with Daiichi Sankyo for psychiatric therapies

Pharmaceutical Technology

Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.

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After Second FDA Rejection, Intercept Abandons NASH Drug and Restructures

MedCity News

The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.

FDA 119
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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 334
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Avacta announces AVA6000 dose escalation results

PharmaTimes

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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.

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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.

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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 325
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EU pharma trade body starts genomic profiling initiative to improve access

Pharmaceutical Technology

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and selected pharma and medical device companies have launched the European Coalition for Access to Comprehensive Genomic Profiling (ECGP), to promote the routine use of comprehensive genomic profiling. The ECGP aims to create multi-stakeholder outputs that will support wider coverage and reimbursement for genomic profiling through three key objectives.

Pharma 105
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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First RNA CAR-T therapy autoimmunity trial shows potential

European Pharmaceutical Review

Study data from a major trial has demonstrated RNA CAR-T (rCAR-T) therapy Descartes-08 facilitated significant and long-lasting clinical improvement in generalised myasthenia gravis (gMG). This is the first clinical trial using rCAR-T to treat autoimmunity. It is also the first successful Phase II trial using an engineered cell therapy for autoimmunity.

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FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy

MedCity News

Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease.

FDA 111
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Pfizer, GSK RSV shots get tepid recommendations from CDC advisory panel

Fierce Pharma

The Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has recommended that adults 60 and older—in consultation with their doctors—receive vacc | The CDC's Advisory Committee on Immunization Practices has recommended that adults 60 and older—in consultation with their doctors—receive vaccines to prevent lower respiratory tract disease caused by respiratory syncytial virus.

Doctors 314
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EveryLibrary Reports Tracks “Freedom to Read” Legislation

Copyright Clearance Center

The post EveryLibrary Reports Tracks “Freedom to Read” Legislation appeared first on Copyright Clearance Center.

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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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Gene therapy approved for Duchenne muscular dystrophy

European Pharmaceutical Review

The first gene therapy has been approved for certain patients from four to five years old with Duchenne muscular dystrophy (DMD). Elevidys has been authorised by the US Food and Drug Administration (FDA) for individuals with a confirmed mutation in the DMD gene without a pre-existing medical reason preventing treatment with this therapy. “Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy,” reported Dr Peter M

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Managing the Proliferation of Data From Decentralized Trials: A Successful Path Forward

MedCity News

As the industry focuses on creating a more holistic, inclusive experience, these three focus areas can help bridge the gap between patient, site, and clinical research administrators and help to modernize the clinical trial experience for all.

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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 312
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Eli Lilly and Boehringer gain FDA approval for type 2 diabetes tablets

Pharmaceutical Technology

Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children

FDA 98
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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10 years proud: Pharma’s top companies for LGBTQ+ inclusivity

PharmaVoice

These six Big Pharma companies have ranked among the best places to work for LGTBQ+ equality by the Human Rights Campaign Foundation for over 10 years. Here’s why.

Pharma 98
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PwC: Healthcare Deals Remained Strong in 2023 Despite Headwinds

MedCity News

In the 12 months leading up to May 15, health services deal volumes decreased just 4% from the year prior, a new report from PwC found. There was a 15% decrease in deal values.

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'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 310
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SFDA approves Amarin’s VASCEPA to reduce CV risk in Saudi Arabia

Pharmaceutical Technology

The SFDA of the KSA has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular risk.

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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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Greener NHS and NHS Innovation Accelerator collaborate

PharmaTimes

Partnership will help NHS to prepare for fundamental change, including reducing carbon emissions - News - PharmaTimes

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Oura Will Now Share Its Sleep Scores With CGM Providers

MedCity News

Oura — a company selling a ring that tracks peoples’ biometrics — announced new partnerships with three providers of continuous glucose monitors: January, Supersapiens and Veri. These companies will now be receiving sleep scores and other biometric data from Oura so they can see how these measurements affect users’ glucose levels and overall health.

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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 299
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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time