🔬 This Week's Roundup: Gene Therapy, Psilocybin, and More!

FDA approvals for hemophilia & alopecia, EU approvals for Pompe disease & HCM, new obesity trials & intriguing clinical studies!

The Weekly Roundup newsletter curates the top five - deals, pipeline, funding, and news from the past week.

The complete list is available here: Industry Updates

🤝Deals and Collaborations

1️⃣ Bio-Techne acquires Lunaphore to enhance immunology, immuno-oncology, and neuroscience research, driving scientific breakthroughs and therapeutic advancements. //Read more

2️⃣ Shionogi acquires Qpex Biopharma to bolster infectious disease innovation, expand the antimicrobial pipeline, and enhance R&D expertise. //Read more

3️⃣ Baudax Bio acquires TeraImmune, adding TI-168, a novel autologous FVIII TCR-Treg cell therapy for Hemophilia A patients, to its portfolio. //Read more

4️⃣ Lilly acquires Emergence Therapeutics, advancing next-gen Nectin-4-targeting ADC technology to reduce side effects and improve cancer treatment. //Read more

5️⃣ Lilly to acquire Sigilon Therapeutics for $300M, strengthening their partnership aimed at discovering a functional cure for Type 1 diabetes. //Read more

⏫ Pipeline and Approvals

1️⃣ Gastroenterology: Eli Lilly's mirikizumab, a breakthrough IL-23p19 targeted therapy for ulcerative colitis, receives MHRA marketing authorization in Great Britain following successful LUCENT-1 and LUCENT-2 Phase III trials. //Explore further

2️⃣ Dermatology: FDA approves Pfizer's Litfulo (ritlecitinib), the first oral treatment for severe alopecia areata in individuals aged 12 and older, targeting JAK3 and TEC family of kinases. //Explore further

3️⃣ Cardiology: Bristol Myers Squibb's Camzyos (mavacamten) receives European Commission approval as the first and only allosteric, reversible cardiac myosin inhibitor for treating symptomatic obstructive hypertrophic cardiomyopathy (HCM) in EU member states. //Explore further

4️⃣ Genetic disorders: Amicus Therapeutics' Opfolda® (miglustat) receives European Commission approval for use with Pombiliti® (cipaglucosidase alfa) as a long-term enzyme replacement therapy for adults with late-onset Pompe disease. //Explore further

5️⃣ Genetic disorders: BioMarin Pharmaceutical's ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) receives FDA approval as the first gene therapy for adults with severe hemophilia A without antibodies to AAV5. The one-time, single-dose infusion aims to transform treatment and increase bleed control. //Explore further

💰 Funding

1️⃣ Lion TCR raises $40M to fund global Phase Ib/II trial of their HBV-specific T cell receptor therapy for liver cancer. //Learn more

2️⃣ Luminopia secures $16M to fund the commercial rollout of their VR-based lazy eye treatment, targeting vision loss in children. //Learn more

3️⃣ Actimed Therapeutics raises £5M to progress Phase 2b/3 IMPACT program for cancer cachexia treatment in non-small cell lung cancer and colorectal cancer. //Learn more

4️⃣ Exeliom Biosciences raises €24M in Series A extension to fund Phase 1/2 clinical studies of EXL01 for immuno-oncology and recurrent C. difficile infection, starting in 1H 2024. //Learn more

5️⃣ Astraveus raises €16.5M to develop its Lakhesys platform for cell and gene therapy manufacturing, advancing technology and expanding the team. //Learn more

📰 Interesting News

1️⃣ 10 key clinical trials in H2 2023: Duchenne gene therapy, lung cancer, obesity, and heart disease studies among those generating high anticipation. //Find out more

2️⃣ 9 awaited FDA decisions in H2 2023: potential milestones in Alzheimer's disease, depression, sickle cell disease, advanced melanoma, following H1 2023 breakthroughs in SOD1 ALS, Rett Syndrome, and Friedreich's ataxia. //Find out more

3️⃣ Six upcoming obesity trials in the next 12 months, focusing on advancements in GLP-1 targeting drugs and dual/triple-agonist medications. //Find out more

4️⃣ Australia approves psilocybin and MDMA for therapeutic use in hospitals or clinics with two psychotherapists monitoring patients for six to eight hours. //Find out more

5️⃣ 10 non-bench biotech careers: Regulatory Affairs Specialist, Clinical Research Associate, Technical Writer, Business Development Manager, Medical Science Liaison, Project Manager, Business Systems Analyst, Quality Assurance Specialist, Medical Affairs Manager, and Medical Sales Representative. //Find out more