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Hello PhaMed Readers,

We want to start this issue with a sincere apology. We know you’ve been eagerly waiting for issue 8 of our newsletter, and we deeply regret that it has arrived later than expected.

Unexpected challenges disrupted our usual publishing schedule, and we are truly sorry. Your patience, understanding, and unwavering support have been immensely appreciated.

Now, let’s dive into all the exciting content we’ve prepared for you in this issue. It will be worth the wait. Remember, good things often come to those who wait, and we hope that holds true as you explore this issue of PhaMed. 🎉

Thank you once again for your understanding and continued support. ❤️

PhaMed Top Stories

Another HIV Patient Possibly Cured with Stem Cell Transplant— But this case is unique, researchers say

A man with HIV underwent a stem cell transplant for cancer treatment, but unlike previous cases, his donor stem cells did not have the mutation that confers resistance to HIV. He has been off antiretroviral medication for 20 months without detectable HIV levels. The patient had a difficult recovery but has achieved longer durable HIV remission than in previous cases. However, he will need to be monitored closely over the next months to years. This is a promising development in the quest for a cure for HIV.

Pfizer limits the distribution of some drugs from a North Carolina plant damaged by tornado

Tornado damages Pfizer facility in Rocky Mount, NC., July 19, 2023. ABC Affiliate WTVD | via Reuters
Tornado damages Pfizer facility in Rocky Mount, NC., July 19, 2023. ABC Affiliate WTVD | via Reuters
  • Pfizer is limiting the distribution of some drugs manufactured at its plant in Rocky Mount, North Carolina, after the facility was struck by a tornado last month, the company said in a letter to hospitals.The letter listed 12 drugs that Pfizer will only distribute through emergency orders “due to their high medical need,” effective “immediately and until further notice.”
  • According to a database from the American Society Of Health-System Pharmacists Inc, some injections on the list were already in short supply as of late last month.

PhaMed Game Changers

BioNTech acquires tech company InstaDeep for $549m

BioNTech SE has acquired UK-based technology provider InstaDeep Ltd for €500m ($549m) in cash after collaborating since 2019 and investing in a Series B funding round in January 2022. The deal will help BioNTech establish expertise in AI-powered drug discovery and develop advanced vaccines for high unmet medical needs. InstaDeep will become BioNTech’s global subsidiary in the UK, adding 290 specialists in AI, bioengineering, data science, ML, and software development. InstaDeep will continue to offer services to global customers while supporting BioNTech’s research partners’ network and expanding its talent hubs in the Middle East, the US, Europe, and Africa.

STERIS Completes the Acquisition of Surgical Instrumentation Assets from BD

STERIS has acquired surgical and laparoscopic instrumentation and sterilization container assets from BD, expanding its Healthcare segment. Lazard and Thompson Hine LLP provided financial and legal counsel.

Biogen to acquire rare disease drugmaker Reata for $7.3B

Biogen is acquiring Reata Pharmaceuticals, Inc. for $7.3 billion, gaining access to the newly approved Skyclarys drug for Friedreich’s ataxia. The move is seen as a strategic asset with the potential for significant sales. Investors have urged Biogen to be more active in deals.

Spinal Stabilization Technologies signs merger agreement with BlueRiver

SPINAL STABILIZATION TECHNOLOGIES, LTD is merging with BlueRiver Acquisition Corp. to list on a stock exchange in 2023 or 2024. The $302 million merger will be used for commercial expansion and an FDA trial for PerQdisc, a surgical solution for lower back pain—spinal plans to enter the augmented discectomy and degenerative disc disease markets.

Roche and Alnylam Strike $2.8 Billion RNAi Deal

Alnylam Pharmaceuticals and Roche will develop and sell zilebesiran, an RNAi therapy for hypertension. Alnylam will get $310M upfront and up to $2.8B depending on milestones. Zilebesiran showed sustained blood pressure reduction in Phase I. Roche will sell it outside the US, and both companies will sell it in the US.

Chembio acquires Qualigen’s FastPack diagnostics business

Chembio Diagnostics, Inc. bought Qualigen Therapeutics‘ FastPack testing system. The deal lets Qualigen focus on its drug pipeline while FastPack expands its diagnostics market.

Teleflex to expand urology portfolio with $600M acquisition

Teleflex to acquire Palette Life Sciences to expand the urology portfolio and protect healthy tissue during prostate cancer treatment. The acquisition is expected to boost growth rate and gross margin but may be dilutive to earnings per share in 2023 and 2024—potential for future acquisitions.

Augmedics to acquire digital health assets from Surgalign auction

Augmedics acquires digital health assets of Surgalign and HoloSurgical Inc. (NASDAQ:SRGA) for $900k, pending court approval. This will strengthen their portfolio with IP and other assets. Surgalign also sold hardware and biologics assets to Xtant Medical for $5m. their ongoing passion to develop the best solutions to help drive better patient outcomes.”

PhaMed AI and Innovations

Scientists train artificial intelligence to mimic the gaze of radiologists reading images

Cardiff University / Prifysgol Caerdydd researchers have trained an AI to mimic radiologists’ gaze when reading mammograms. The system can accurately predict which areas radiologists focus on, helping improve diagnostics and alleviate radiologist shortages in the UK.

Digital Platform Designed to Bring Visibility to Drug Supply Chain

National Association of Boards of Pharmacy and IBM Consulting are launching Pulse in the summer of 2023, a digital platform to prevent counterfeit prescription drugs and ensure compliance with the Drug Supply Chain Security Act. It will facilitate communication between manufacturers, wholesalers, pharmacies, and regulators.

Groundbreaking AI brain surgery helps NY quadriplegic man regain movement

Thanks to a groundbreaking surgery, a quadriplegic man has regained feeling and movement in his arm and hand years after an accident left him paralyzed. With the help of AI, five microchips were implanted in his brain to reconnect it with his spinal cord and the rest of his body. His ability to move has improved dramatically, giving hope to the 100 million people worldwide with paralysis.

3D-printed COVID-19 breath test takes two breaths and one minute

Researchers at Washington University in St. Louis have created a 3D-printed COVID-19 breath test that can detect the virus within a minute from just one or two breaths. The test could be used for quick diagnosis or to screen people in shared spaces. The technology could also be modified to detect other viruses.

Machine learning based on LLMs predicts protein-drug binding

Massachusetts Institute of Technology researchers have developed a simple method called ConPlex to predict protein-drug binding. It uses protein sequences and basic drug descriptions and is fast and accurate. ConPlex is available online for finding new drugs or repurposing existing ones for other diseases.

Pen, gel system can promote wound healing

Chinese researchers have created a 3D-printing pen and gel that promotes healing by exposing wounds to immune-system vesicles. The PAINT system accelerates the healing process by promoting vascular regeneration and can be used in clinical settings for various cuts.

PhaMed Research

Rewiring cancer drivers to activate apoptosis

Researchers have discovered natural pathways in our bodies that can kill cancer cells, but sometimes they don’t work properly. They have found a way to activate these pathways using special molecules called TCIPs. TCIP1 has been effective at killing cancer cells, even those resistant to chemotherapy and with certain genetic mutations. This research could also have applications in treating other diseases and disorders.

FDA Approvals & Recalls

✔ Novel Drugs Approvals:

Drug Name Active Ingredient Approval Date FDA-Approved use on approval date
Izervay avacincaptad pegol 8/4/2023 To treat geographic atrophy secondary to age-related macular degeneration
Zurzuvae zuranolone 8/4/2023 To treat postpartum depression
Xdemvy lotilaner 7/25/2023 To treat Demodex blepharitis
Vanflyta quizartinib 7/20/2023 To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria
Beyfortus nirsevimab-alip 7/17/2023 To prevent respiratory syncytial virus (RSV) lower respiratory tract disease

❌The FDA recalls:

Date Brand Name Description Type Recall Reason Company
07/31/2023 Lupin Pharmaceuticals, Inc. Tydemy oral contraceptive Drugs Out-of-Specification Results Lupin Pharmaceuticals, Inc.
07/07/2023 Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Drugs Failure to deliver the recommended dose Cipla
08/04/2023 Dräger Carina Sub-Acute Care Ventilators Medical Devices Product Safety/Potential Foreign Material Drägerwerk AG & Co. KGaA
SIGMA Spectrum and Spectrum IQ Infusion pumps Medical Devices Due to an increase in reported false upstream occlusion alarms following the software upgrades. Baxter International Inc.


PhaMed Language Matters

Consent document translation expense hinders inclusive clinical trial enrolment

Translation costs for consent documents deter non-industry-sponsored cancer clinical trials from including patients with limited English proficiency. These patients are often underrepresented in such studies and sign consent forms in a language other than their primary language. Investigators may refrain from offering translated consent documents due to the costs. Providing translated consent documents could increase the inclusion of these patients in clinical trials.

Don’t let language barriers stand in the way of advancing cancer research. 🚫💬 Our expert Arabic translation services can help you save money on consent document translation and make it easier for Arabic-speaking patients to participate in clinical trials. 📝💉 Act now and make a difference in the fight against cancer. 🔥🥊 Contact us to get started! 📞💻

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