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Hello, PhaMed TransBrief subscribers and newcomers. Here’s the fourth issue with great news, job opportunities, and large pharma collaborations.

Invest just five minutes of your time and discover something great! 🕑 Check out this brief that’s sure to catch your interest. 💡

Top PhaMed Stories

WHO downgrades COVID pandemic, says it’s no longer emergency

World Health Organization now classifies COVID-19 as no longer an emergency 🙌, showing that efforts to control it are working. We must still follow guidelines and stay vigilant to keep ourselves and others healthy 🤝💪.

Pharma Game Changers

1️⃣ Sandoz and Just-Evotec Biologics announce multi-year biosimilar partnership ➡Source

Sandoz and Just – Evotec Biologics have partnered to develop and manufacture multiple biosimilar candidates, expanding Sandoz’s pipeline from 15 to around 24 candidates.

Sandoz partners with Just-Evotec Biologics to access their drug development platform and manufacturing tech. They plan to deliver biosimilars to patients worldwide. 💰🌍

2️⃣ Fusion Pharmaceuticals unveils Radiopharmaceutical manufacturing facility ➡ Source

Fusion Pharmaceuticals has opened a new facility to support its pipeline of targeted alpha therapies. The 27,000 sq ft facility will produce over 100,000 doses of TATs annually. It will be fully operational by 2024 and support the research, development, and production of next-gen radiopharmaceuticals for cancer treatment.

3️⃣ Eisai’s cancer drug Halaven at the center of a $2B pact with BlissBio, like its Bristol Myers ADC deal ➡ Source

Eisai Co., Ltd. will pay up to $2B to co-develop an antibody-drug conjugate with @Bliss Biopharmaceutical 🧬. The ADC, BB-1701, uses Eisai’s Halaven to treat breast 🎀, lung, and solid tumors expressing HER2.

If successful 🎉, Eisai could gain ex-Greater China rights and pay sales royalties to BlissBio 💸.

4️⃣ Wacker Purchases ADL BioPharma ➡ Source

WACKER has acquired ADL BioPharma, a CMO for over €100m 💰, which means their fermentation capacities have expanded by 2,000 m3 and added recovery and purification process capacities 🧪.

Wacker is committed to growing their customer relationships in the food 🍔, pharmaceutical 💊, and consumer goods industries.

This acquisition is a big step towards reaching their goal of generating one billion euros in sales by 2030.

5️⃣ Thermo Fisher, and Pfizer team up on global access to cancer DNA testing ➡ Source

Thermo Fisher Scientific and Pfizer are partnering to bring DNA 🧬 testing for lung and breast cancer patients to over 30 countries. 🏥 They aim to make rapid genomic screening more accessible and affordable by introducing it to local labs and educating healthcare providers. 💪 The partnership may also expand to cover other forms of cancer and more countries in the future. 🌟

PhaMed Clinical Trials

1️⃣ Alzheimer’s drug donanemab: what promising trial means for treatments ➡ Source

An MRI scan shows shrinkage around the front and sides of the brain of a person with early-onset Alzheimer's disease. Credit: Zephyr/SPL
An MRI scan shows shrinkage around the front and sides of the brain of a person with early-onset Alzheimer’s disease. Credit: Zephyr/SPL

A new experimental drug called donanemab has been shown to reduce cognitive decline in patients with Alzheimer’s disease, according to a press release from pharmaceutical company Eli Lilly and Company.

Donanemab, a drug that targets the accumulation of amyloid protein in the brain, has been shown to slow mental decline by 35% in a trial. However, the drug carries a high risk of side effects, including amyloid-related imaging abnormalities. Longer-term studies are needed to assess its safety and effectiveness.

2️⃣ TILT Biotherapeutics doses first patient in cancer trial ➡ Source

A phase 1 dose-escalation trial will evaluate the combination of igrelimogene litadenorepvec (TILT-123) and avelumab in treating squamous cell carcinoma of the head and neck (SCCHN) and melanoma in patients with advanced solid tumors that are refractory to or progressing after anti-PD(L)1.

The trial is part of TILT Biotherapeutics Ltd‘s agreement with Merck KGaA, Darmstadt, Germany and Pfizer, and is taking place in Helsinki, Finland, with plans to open a US site in Q3 2023. TILT-123, the biotech’s lead product, is a chimeric serotype adenovirus armed with two human cytokines that can be delivered intravenously or intratumorally to boost the patient’s systemic immune response to better enable it to find and destroy cancer cells.

PhaMed AI

Surgalign launches Holo AI Insights for neurovascular research ➡ Source

Surgalign has just released Holo AI Insights, an amazing platform that uses AI to analyze medical images automatically. Surgalign partnered with Brian Jankowitz, MD, for the launch.

It can even conduct volumetric analysis of vascular structures on MRI, making the process more efficient! 🤖 Plus, it’s perfect for longitudinal comparisons. 📈

The best part? It’s integrated with Surgalign’s Holo Portal spine system. 🙌

PhaMed HR

Join China Pharmaceutical University Seeking Talents Worldwide for Exciting Opportunities APPLY NOW

China Pharmaceutical University is seeking candidates in various fields, including Pharmacy, Traditional Chinese Pharmacy, Life Sciences, Chemistry, and Medicine. Chemical Biology, Systems Biology, Basic Medicine, Synthetic Biology, Artificial Intelligence and Big Data, Biostatistics, and Bioinformatics are prioritized.

It closes on 7 July 2023.

FDA Approvals & Recalls

✔ Novel Drugs Approvals

1) Elfabrio (pegunigalsidase alfa-iwxj) Injection

Company: Protalix Biotherapeutics

Date of Approval: May 9, 2023

Treatment for: Fabry Disease

2) Veozah (fezolinetant) Tablets

Company: Astellas Pharma US

Date of Approval: May 12, 2023

Treatment for: Menopausal Disorders, Hot Flashes

❌The FDA recalls: 

1) Walnut.

Company: BearCare, Inc

Date of Recall: 05/12/2023

Product Description: Wearable Smart Thermometer

Recall Reason: Potential for injuries, including skin burns & irritation

2) Pilot

Company: SD Biosensor, Inc.

Date of Recall: 05/05/2023

Product Description: COVID-19 At-Home Test

Recall Reason: Due to microbial contamination in the liquid buffer solution.

🎁Download your copy of Q9(R1) Quality Risk Management Guidance for Industry by FDA (This guidance offers risk management principles for pharmaceutical quality and replaces an earlier draft guidance issued on June 15, 2022.)

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