Table of Contents

Today is special for launching our first newsletter for the #pharma industry.

In this newsletter, we will cover various topics that are relevant and exciting for professionals in pharma. Here’s what you can expect in your PhaMed TransBrief:

Latest industry news: Stay up-to-date with the most recent developments and breakthroughs in the pharma world.

Research highligtings: We’ll spotlight significant research studies and their potential implications for the industry.

Expert insights: Get exclusive opinions and analysis from industry leaders and subject matter experts.

The FDA approvals and recalls: Be updated on the most recent approvals and recalls of drugs and medical devices from the FDA.

Let’s get right to it to save your time and help you grow.

Top Reports:

1️⃣ EMA Mid-Point Regulatory Science Strategy Report Highlights Progress in Precision Medicine:

The European Medicines Agency (EMA) has released a mid-term report on its Regulatory Science Strategy (RSS) to 2025, which outlines a five-year plan to advance regulatory science. The report highlights progress in precision medicine development, innovation in clinical trials, real-world data, and health technology assessment. The EMA plans to advance the Regulatory Science Strategy to 2025 and the broader European medicines agencies network strategy to 2025. A final report on the regulatory science strategy will be published in 2026. ➡ Spend more time on the Source.

2️⃣ White House unveils bold goals for US biomanufacturing efforts:

White House unveils ambitious biomanufacturing goals in a 64-page report, aiming for more robust supply chains and increased domestic production. Goals include producing 25% of small-molecule drug APIs in the US within five years and implementing R&D initiatives. ➡ Spend more time on the Source.

Pharma Game Changers:

1️⃣ Merck’s Biomanufacturing Optimization Leads to Significant Production Gains:

Merck has increased its biomanufacturing productivity and predictability using data analytics and operations research, leading to $200 million in extra revenue. Partnerships formed with researchers at the Eindhoven University of Technology enabled Merck to optimize their bioreactors, with plans to transfer the lessons learned to their human biomanufacturing facilities. A bleed-feed process optimization was used to increase batch yields by 82%. Prediction models are also being developed for real-time inferences for continuous biomanufacturing. ➡ Spend more time on the Source.

2️⃣ UPS Healthcare opens its first dedicated facility in Germany:

UPS Healthcare has opened its first dedicated healthcare logistics facility in Giessen, Germany, which has created up to 150 new jobs and comes with 30,000 pallet positions that support storage from -20C to 25C. The facility also produces more than 850,000 kWh of electricity annually and is strategically located for access to growing European healthcare markets. Healthcare’s investments in Germany will double its presence in healthcare facilities in 2023. The facility will also support Hospital & Pharmacy distribution across Germany. Recently, the company has launched a service that can prioritize and track critical shipments within 3 meters of their location anywhere in UPS’s global network. ➡ Spend more time on the Source.

3️⃣ Curia + Corning = New Programs

Curia, a contract research, development, and manufacturing organization, has announced a collaboration with Corning Incorporated to advance biopharmaceutical continuous-flow development and manufacturing programs. The partnership will include the installation of Corning’s G1 production system, which supports higher-quality active pharmaceutical ingredient-chemical production using inherently safer flow-chemistry technology. This marks the first global installation of Corning’s G1 production system to enhance intermediate and active pharmaceutical ingredient production using continuous flow technology. ➡ Spend more time on the Source.

4️⃣ Takeda to build a $739.98m plasma therapy manufacturing site:

Takeda will invest £600m to build a manufacturing facility in Osaka, Japan, for plasma-derived therapies. The new plant, set to be the largest in Japan, will have a plasma fractionation capacity of more than two million liters per year and add incremental capacity to Takeda’s global manufacturing network. The Osaka site will increase the capacity of Takeda’s current plasma manufacturing area in Narita almost five-fold. Takeda’s existing site will continue to operate until at least the end of the decade, with the new facility expected to be operational around 2030. ➡ Spend more time on the Source.

Pharma ⚕ in the Age of ChatGPT 🤖

1️⃣ Robotic Gripper Helps Clean Up Hazardous Liquid Spills

Mechanical engineers at Colorado State University have developed a soft robotic gripper that can handle individual droplets to remotely clean biofluid spills. The robotic manipulator is sensitive enough to pick up individual liquid droplets and minimize human spill exposure. The soft robot grippers are inexpensive, lightweight, and capable of precise, lossless liquid cleanup work. ➡ Spend more time on the Source.

2️⃣ Biologists Say Deep Learning Is Revolutionizing Pace of Innovation

The fascination with generative AI exploded late last November with the release of OpenAI’s text-writing tool, ChatGPT, and the Meta AI atlas.

Professor David Baker uses deep learning to design proteins for use in a range of ways, including developing drugs and vaccines. His lab has spun out 17 companies and three to four more are expected to emerge this year alone. ➡ Spend more time on the Source.

FDA Approvals and Recalls

🆗 The FDA has approved the following drugsThe FDA has approved the following drugs within the last two weeks. Includes newly approved drugs and new indications for drugs already approved.

1️⃣ Joenja (leniolisib) Tablets

Company: Pharming Group N.V.

Date of Approval: March 24, 2023

Treatment for: Activated Phosphoinositide 3-Kinase Delta Syndrome

Joenja (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

2️⃣ Zynyz (retifanlimab-dlwr) Injection

Company: Incyte Corporation

Date of Approval: March 22, 2023

Treatment for: Merkel Cell Carcinoma

Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody for treating Merkel cell carcinoma.

3️⃣ Rezzayo (rezafungin) Powder for Injection

Company: Cidara Therapeutics, Inc.

Date of Approval: March 22, 2023

Treatment for: That’sidemia, Systemic Candidiasis

Rezzayo (rezafungin) is an echinocandin antifungal used to treat candidemia and invasive candidiasis.

⚠ The FDA has recalled the following drugsThe FDA has recalled the following drugs within the last two weeks.

1️⃣ Camber

Company: Camber Pharmaceuticals Inc

Date of Recall: March 31, 2023

Product Description: Device & Drug Safety/Microbial Contamination/Bacillus cereus

Recall Reason: Potential Bacillus cereus Contamination

2️⃣ Midwest Cleaning Solutions, Clean Pro Supply

Company: JARMAN’S MIDWEST CLEANING SYSTEM INC

Date of Recall: March 28, 2023

Product Description: Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution

Recall Reason: Due to Presence of Methanol

3️⃣ Ascend Laboratories

Company: Ascend Laboratories, LLC

Date of Recall: March 22, 2023

Product Description: Dabigatran Etexilate Capsules, USP

Recall Reason: Detection of N-nitroso-dabigatran (NDAB) Impurity

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