🏥 Breaking Boundaries in Healthcare:

🌟 Discover the latest advancements revolutionizing the industry. From tackling antimicrobial resistance 💪 to AI-generated drugs 💊 and high-tech wound healing 🩹, this issue of PhaMed TransBrief brings you the most compelling stories. 📰 Explore the FDA’s new tools for food traceability 🍔, game-changing acquisitions 💰, clinical trial breakthroughs 🎉, AI’s impact on healthcare 🤖, and the latest drug approvals 💊.

Stay informed and captivated by the future of healthcare innovation. 🚀

Table of Contents

PhaMed Top Stories

Antimicrobial resistance will be worse than COVID — we have to act now

The overuse of antibiotics is leading to antimicrobial resistance (AMR), a phenomenon where antibiotics become less effective against infectious diseases. AMR is spreading rapidly and has been identified as one of the top 10 public health threats by the World Health Organization. By 2050, AMR could cause up to 10 million deaths annually, surpassing the human impact of the COVID-19 pandemic. In the United States alone, drug-resistant infections affect at least 2.8 million people each year, with healthcare costs totaling over $4.6 billion. AMR endangers patients’ lives, as some infections become resistant to all available treatments, leading to devastating consequences. To combat AMR, policymakers, pharmaceutical companies, payers, hospitals, and health systems must take large-scale action. This includes reforming investment in antibiotic development and payment models. The bipartisan PASTEUR Act aims to deliver innovative antibiotics and support antibiotic stewardship programs in healthcare facilities. If action is not taken, AMR could reverse the progress made in modern medicine.

PhaMed Laws

FDA Publishes New FAQs and Tools for the Food Traceability Rule

The FDA has released new FAQs and tools for the FSMA Food Traceability Rule to clarify its application to specific situations and commodities. The FAQs are based on industry interactions and questions sent via the Technical Assistance Network, and additional tools are available on the FDA’s traceability website, including:

• Updates to the Risk-Ranking Model for Food Tracing
• Clarification on nut butters
• New supply chain examples
• Fact sheets on recordkeeping for produce farms
• Guide to getting started with the Food Traceability Rule
• Foreign language translations of the interactive tool and supply chain examples.

The compliance date for the Food Traceability Rule is January 20, 2026.

Lawmakers call for transparency on PBM practices

PhaMed Game Changers

Enovis acquired Novastep

Enovis acquires Novastep 🏥 and its foot and ankle surgical platform, strengthening their position in the growing bunion segment and furthering their international strategy. Financial terms are undisclosed. 💰💼

Lilly to Acquire DICE Therapeutics, Sigilon, and Emergence Therapeutics

Eli Lilly and Company acquires DICE Therapeutics for $2.4B to boost autoimmune disease treatments. They’re also acquiring Sigilon Therapeutics, Inc. for over $300 million to enhance their diabetes pipeline. Additionally, they plan to acquire Emergence Therapeutics, a startup developing antibody-drug conjugates for cancer.

Australian startup Psylo advances depression treatment with Japanese pharma firm Daiichi Sankyo

Psylo and Daiichi Sankyo, Inc. are teaming up to develop new psychiatric treatments for chronic mental illness. They’ll be working out of an office in Philadelphia.

Luciole acquires German medical device company, Spiegelberg

Luciole Medical AG acquires Spiegelberg GmbH & Co. KG, a German medical device company to boost next-gen brain monitoring devices and expand market reach in Europe and the US.

Restor3d to acquire Conformis for $2.27 per share

restor3d will acquire Conformis for $2.27 per share in cash, pending approval from Conformis’ stockholders and customary closing conditions. The purchase price is a 96% premium to the closing price of Conformis stock on June 22, 2023.

Bio-Techne to Acquire Swiss Spatial Biology Firm Lunaphore

Bio-Techne will acquire Lunaphore in Q1 2024. Lunaphore’s Comet platform analyzes 40 biomarkers/sample, identifying clinically relevant ones and streamlining clinical trials. The acquisition complements Bio-Techne’s spatial biology franchise and accelerates Lunaphore’s penetration into the spatial biology market.

Philips and Biotronik Collaborate to Extend Outpatient Cardiology Lab Care

📈🩺 Philips and BIOTRONIK have joined forces to provide advanced cardiology care outside of hospitals. By combining their expertise and utilizing technology, they hope to enhance patient results and decrease healthcare expenses.

Bausch + Lomb Acquires XIIDRA Eye Drops and Delivery System from Novartis for $2.5B

Bausch + Lomb is acquiring XIIDRA eye drops and a new medicine from Novartis for up to $2.5 billion. This will complement their current dry eye portfolio and boost earnings. 💰 Novartis officials say the deal supports their focus on other medicines. 🙌

Translumina acquires Blue Medical Devices in the Netherlands

Translumina has acquired Blue Medical Devices B.V. a Wellinq Company, a company with patented drug application technology. This acquisition is a big win for Translumina’s sales network, as Blue Medical’s DCB catheters have huge potential. Translumina is a product development and manufacturing company with facilities in India and Germany.

PhaMed Clinical Trials

Gilead touts efficacy of bulevirtide to manage chronic hepatitis D

Gilead Sciences presented new Week 96 results for Hepcludex in treating chronic hepatitis delta infection at the EASL Congress 2023. Bulevirtide, the only approved treatment for HDV in the EU, shows no signs of treatment resistance and has been recommended for full marketing authorization.

PhaMed AI and Innovations

The first fully A.I.-generated drug enters clinical trials in human patients

Insilico Medicine created the first AI-generated drug in clinical trials for idiopathic pulmonary fibrosis. If successful, it will move on to larger studies.

AI with CT may predict chemo efficacy in ovarian cancer

🔍 A study found that a deep-learning model using CT images can predict the success of chemotherapy in ovarian cancer patients, improving personalized treatment and clinical management. 💻

Aisyn introduces Cancer research AI-based solution

Aiosyn has introduced the Aiosyn Mitosis Research, a deep-learning algorithm designed for automated detection of mitosis to support cancer research. This technology will assist researchers in achieving greater consistency and efficiency by using a computational biomarker approach.

AI Plus Mobile App May Help with Smoking Cessation

🚭 Quit Sense, a new AI-powered app, helps smokers quit by curating messages to manage urges. It’s been found to be more effective than NHS online support, with four times as many successful quitters. It could help England’s goal of being smoke-free by 2030. 💪🏼

New high-tech bandage may be the key to healing chronic wounds

Scientists have created a bandage 🩹 with electronics that can heal wounds faster 💨. It delivers antibiotics 💊 and electric currents ⚡️ to promote healing. It records wound details 📝 and releases antibiotics when stimulated. It’s been successful in rodent tests and could help humans next year 🗓️. This could help those with chronic wounds and reduce costs 💰.

App turns smartphone into thermometer

📱🌡️ FeverPhone app from University of Washington uses smartphone sensors to estimate body temperature with 0.41 F error. It tracks health and shares fever results with public health agencies. 🚀 Expanding to more phone models and smartwatches.

FDA Approvals & Recalls

✔ Novel Drugs Approvals:

Ngenla (somatrogon-ghla) Injection

Company: Pfizer.

Date of Approval: June 27, 2023

Treatment for: Pediatric Growth Hormone Deficiency

Rystiggo (rozanolixizumab-noli) Injection

Company: UCB.

Date of Approval: June 26, 2023

Treatment for: Myasthenia Gravis

Litfulo (ritlecitinib) Capsules

Company: Pfizer

Date of Approval: June 23, 2023

Treatment for: Alopecia

❌The FDA recalls:

🚨 PhaMed hasn’t found any drugs/devices 🚫 recalls within the last two weeks.

Thanks for your reading. Please don’t hesitate to share your feedback with us.