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Hello, PhaMed TransBrief‘s Friends. 👋 We curated some of the most exciting stuff in the #pharma industry within the last fourteen days. 💊💉 Invest only 4 minutes of your time to look at this brief. 👀🕑

PhaMed Top Stories

Don’t delay reforms to prepare for next pandemic, World Health Organization chief says

 

Pharma Game Changers

(1) Novartis to buy Avrobio gene therapy for $88M, leaving rest of the biotech on the shelf (Source)

Novartis 💰 paid $87.5 million 💵 for Avrobio’s gene therapy candidate AVR-RD-04 for cystinosis. Avrobio sold it due to financial pressures. Novartis gains exclusive license to use certain IP. 🤝

(2) Meiji Seika Pharma, Adcock Ingram Pharma Complete Construction of New Manufacturing Facility (Source)

Adcock Ingram opened a new manufacturing facility in India with a large production capacity to supply pharmaceuticals globally. Meiji Seika Pharma plans to expand their CMO/CDMO business with reliable products.

(3) Johnson & Johnson venture arm names new resident company (Source)

Ceramedix, a biotherapeutics company, has been named a resident company by Johnson & Johnson Innovation. They will join JLABS to create antibody-based drugs targeting diseases involving the microvasculature.

(4) Biotech company expands antibody research, production facilities in Vancouver with government cash boost (Source)

AbCellera Biologics 🧬 is expanding in Vancouver 🏙️ with a $700 million 💰 project, backed by $401 million 💵 in government funding. They’ll focus on antibody therapies for cancer 🩸 and autoimmune diseases 🦠, building on the success of their COVID-19 treatment 💉, Bamlanivimab. They’ll also create 400 new jobs 💼.

PhaMed AI

(1) TeraRecon integrates Bot Image’s PCa diagnosis into Eureka AI platform (Source)

TeraRecon, Inc.‘s Eureka Clinical AI | Formerly known as EnvoyAI platform has integrated Bot Image‘s ProstatID AI and MRI post-processing software for prostate cancer.

The integration provides advanced AI and deep learning technology for precise identification and diagnosis of prostate cancer through bpMRI and AI, reducing false positives. ProstatID is suitable for monitoring disease progression and available to all healthcare providers in the TeraRecon AI partner ecosystem.

(2) New superbug-killing antibiotic discovered using AI (Source)

🔬 Researchers in Canada and the US have found a new antibiotic, abaucin, using AI. 💊 This drug has been proven to kill a dangerous superbug in lab tests. 🤖 AI can greatly speed up drug discovery, making it a revolutionary force in science and medicine.

PhaMed Clinical Trials

(1) SILDENAFIL VS. TADALAFIL FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA: A SINGLE-ARM SELF-CONTROLLED CLINICAL TRIAL. (Source)

CONTRIBUTORS: Mazyar Menachem Zahir, Mohammad Samzadeh, Amirhossein Poopak, Alireza Khoshdel, Arash Armin

A study compared sildenafil and tadalafil for treating benign prostatic hyperplasia (BPH). Both drugs improved PVR, IPSS, and IPSS-QoL index significantly. Sildenafil was more effective in reducing PVR and improving IPSS-QoL index. Age affected responsiveness to therapy in both drugs, with a more prominent role in sildenafil. Considering the better improvement with sildenafil, it can be a suitable alternative for tadalafil in BPH treatment, especially in younger patients without contraindications.

(2) Sanofi drug, acquired from a startup, shows early potential in MS (Source)

Sanofi’s experimental multiple sclerosis drug, frexalimab, showed promising results in a mid-stage trial, significantly reducing brain lesions and disease burden in patients. The drug was well-tolerated with mild side effects reported. Sanofi plans to begin pivotal testing in 2024. The drug was licensed by biotech startup ImmuNext and works by blocking a signaling protein without lowering lymphocyte counts. Study investigator Gavin Giovannoni called the drug’s target “pivotal in the pathogenesis of MS.”

(3) Pfizer’s hemophilia therapy reduces bleeding in late-stage study (Source)

Pfizer’s experimental hemophilia therapy, marstacimab, has shown superiority to current standard-of-care treatments in reducing bleeding rates in patients. In a late-stage study, it demonstrated a 92% reduction in bleeding in severe hemophilia A and moderately severe to severe hemophilia B patients. The therapy is an anti-tissue factor pathway inhibitor and could potentially help initiate blood clotting. Pfizer is also developing at least two other hemophilia therapies.

(4) Could this be the beginning of the end for fall flu shots? (Source)

🌡️The National Institutes of Health is testing a universal flu vaccine using mRNA tech. It could cover all strains, eliminating the need for annual shots.💉 The vaccine is faster and more effective💪, and could help fight future pandemics.🦠

FDA Approvals & Recalls

✔ Novel Drugs Approvals

1) Miebo (perfluorohexyloctane)

Company: Bausch & Lomb Inc.

Date of Approval: May 18, 2023

Treatment for: Dry Eye Disease

2) Epkinly (epcoritamab-bysp)

Company: AbbVie

Date of Approval: May 19, 2023

Treatment for: Diffuse Large B-Cell Lymphoma

3) Xacduro (sulbactam and durlobactam )

Company: Innoviva, Inc.

Date of Approval: May 23, 2023

Treatment for: Acinetobacter Pneumonia

4) Paxlovid (nirmatrelvir and ritonavir)

Company: Pfizer Inc.

Date of Approval: May 25, 2023

Treatment for: COVID-19

5) Posluma (flotufolastat F 18)

Company: Blue Earth Diagnostics

Date of Approval: May 25, 2023

Treatment for: Positron Emission Tomography Imaging, Diagnosis and Investigation

6) Inpefa (sotagliflozin) Tablets

Company: Lexicon Pharmaceuticals, Inc.

Date of Approval: May 26, 2023

Treatment for: Heart Failure

❌The FDA recalls:

G-SUPRESS DX

Company: NOVIS PR LLC

Date of Recall: 05/12/2023

Product Description: Cough Suppressant, expectorant, nasal decongestant pediatric drops

Recall Reason: Device & Drug Safety/Mislabeling (Packaging may contain incorrect product)

🎁📑Download the FDA’s guidance on adjusting for covariates in randomized trials

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