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  • Pharma and Biotech Weekly Roundup: FDA Approves InflaRx's COVID-19 Treatment, Tally Raises $10M to Fight Aging, and More!

Pharma and Biotech Weekly Roundup: FDA Approves InflaRx's COVID-19 Treatment, Tally Raises $10M to Fight Aging, and More!

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 NanoViricides signs a license agreement that includes clinical evaluation of its COVID-19 drug candidates. Under this Agreement, Karveer has the right to commercialize the Company's COVID drugs NV-CoV-2 and NV-CoV-2-R in India. To enable commercialization, Karveer has undertaken Clinical Development and Evaluation and is sponsoring these two drugs in India for this purpose.

2️⃣ Bright Green announces decision to complete Alterola Biotech acquisition. Alterola Biotech is a U.K.-based pharmaceutical company focused on developing cannabinoid and cannabinoid-like medicines and products.

3️⃣ Longboard Pharma selects Societal CDMO to support the clinical development of LP352. Societal CDMO will provide technology transfer and analytical method validation activities to support Longboard’s lead asset, LP352, a 5-HT2C receptor superagonist.

4️⃣ Rxilient Biotech, Junshi Biosciences formed JV to develop and commercialize toripalimab in Southeast Asia. Joint venture to develop and commercialize toripalimab in Thailand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, and Vietnam.

5️⃣ Cognizant and Microsoft collaborate to bring Microsoft Cloud-based technology solutions to the healthcare market. Cognizant and Microsoft will build an integration roadmap between Cognizant's TriZetto healthcare products with Microsoft Cloud for Healthcare. The companies will also collaborate to develop and run Cognizant's current and future healthcare SaaS solutions on Microsoft Azure.

⏫ Pipeline and Approvals

1️⃣ Neurology: EMA committee recommends approval of TG Therapeutics' Briumvi (ublituximab-xiiy) to treat relapsing forms of multiple sclerosis in adults.

2️⃣ Ophthalmology: EMA committee recommends marketing approval for Ultomiris (ravulizumab) to treat adults with neuromyelitis optica spectrum disorder.

3️⃣ Covid: InflaRx receives FDA Emergency use authorization for Gohibic (vilobelimab) for treatment of critically ill COVID-19 Patients.

4️⃣ Oncology: Bristol Myers Squibb's B cell lymphoma drug receives EU approval.

5️⃣ Rare disorder: Kissei Pharmaceutical rolled out Tavalisse (fostamatinib), an oral spleen tyrosine kinase (SYK) inhibitor for the treatment of chronic immune thrombocytopenic purpura (ITP) in Japan.

💰 Funding

1️⃣ Adcendo raises $34mn to fund ADC treatments for sarcoma. The round will bankroll the development of Adcendo’s pipeline of antibody-drug conjugates (ADCs) for the treatment of solid tumors.

2️⃣ Mosaic Therapeutics closes $28mn series A financing. Oncology specialist Mosaic Therapeutics Ltd will use a $28m financing to push its preclinical pipeline of targeted oncology therapies for biomarker-stratified populations to IND-enabling studies

3️⃣ Phlow reaps $36mn in series B fundraising to boost CDMO program. The company has earmarked the bulk of the funds to support the growth of its manufacturing operations—dubbed cdmoX—in order to meet market demands for customized services

4️⃣ Biostage announces $6mn financing to advance clinical trial. The funds will be used to accelerate the clinical development of Biostage’s lead product candidate, the Biostage Esophageal Implant.

5️⃣ A Pedro Pascal-backed biotech startup just raised $10mn to fight aging. Tally does a test to determine a client’s biological age, which may be different from their chronological age, and then creates personalized recommendations.

📰 Interesting News

1️⃣ FDA issues draft guidance for AI/ML-enabled devices. AI/ML training data should be representative of the target population's age, disease, ethnicity, gender, geographic distribution, and race; and information about training data should be communicated to device users.

2️⃣ Cancer vaccines: 10 biotech companies that have changed the game. Aston Sci, BioNtech, Dendreon, Elicio Therapeutics, Immunomic Therapeutics, Imugene, Scancell, Takis, Ultimovacs, and VacV Biotherapeutics are 10 companies listed in this article and making progress in the field of vaccine development for cancer.

3️⃣ Men and women have different obesity drivers, pointing to the need for tailored interventions. A new study finds sex-specific brain signals that appear to confirm that different drivers lead men and women to develop obesity. The study combined data from several modes of MRI with patients' clinical features and personal histories to identify sex-specific mechanisms in the brain underlying obesity.

4️⃣ Cancer and heart disease vaccines ‘ready by end of the decade’. A leading pharmaceutical firm said it is confident that jabs for cancer, cardiovascular and autoimmune diseases, and other conditions will be ready by 2030.

5️⃣ A new test analyzing DNA changes could improve 10-year diabetes risk predictions. The test was developed by researchers at the University of Edinburgh who published a study Thursday in the journal Nature Aging that describes how taking DNA methylation into account can augment current diabetes risk-scoring systems.