The Week in Biopharma, Feb 28-Mar 4

Contract Development and Manufacturing Organizations (CDMO) 

• IDT Biologika, Exothera Collaborate to Accelerate Scale-Up of Viral Vaccines (USA) 
• Cambrex Expands Biopharmaceutical Testing Services Biz (USA) 
• Forge Biologics, Ray Therapeutics Enter Gene Therapy Mfg. Pact (USA)
• Thermo Fischer Scientific and Symphogen Extend Collaboration (USA) 
• TFF Pharma, Catalent Enter Dry Powder Development and Manufacturing Agreement (USA) 
• WuXi STA Passes First EMA Drug Pre-Approval Inspection at Wuxi City Site (China) 
• BIO-CAT Microbials Invests $35 Million in State-of-the-Art Virginia Fermentation Facility (USA) 
• Evonik Increases Capacity for Plant-derived Cholesterol (Germany) 
• Aceto Acquires Biotron and Talus Mineral (USA) 
• INCOG Biopharma Reaches Another Expansion Milestone (USA) 
• Sterling Pharma Solutions Acquires Novartis Facility (Ireland) 
• CordenPharma Increases Lipid Manufacturing Capacity (France) 
• Actym Therapeutics and Wacker Biotech Sign Manufacturing Contract for Actym’s Lead Candidate for the Treatment of Solid Tumors (USA/ the Netherlands) 

Contract Research Organizations (CRO) 

• 1nHealth, ObvioHealth team to aid firms struggling with decentralized trials (USA) 
• Biognosys Launches Expanded Suite of Proteomics Platforms to Support Drug Research and Development (Switzerland) 

AI 

• FDA clears Gleamer’s X-ray AI for spotting broken bones (France) 

Biopharma 

• Element Biosciences Partners with Genoox (USA) 
• AbbVie Acquires Syndesi for $130M Upfront (USA) 
• IQVIA, Argenx Partner to Accelerate Clinical Development of VYVGART (USA) 
• CureVac Launches Company Designed to Advance the RNA Printer (Germany) 
• Valneva COVID Vax Authorized by the Bahraini NHRA (Bahrain) 
• Touchlight, Versamebv Enter Development, Manufacturing Pipeline Pact (UK) 
• Biocon Biologics to Acquire Viatris’ Biosimilars Assets in $3.3B Deal (USA) 
• Quanterix links up with Eli Lilly for Alzheimer’s blood biomarker testing collaboration (USA) 
• LevitasBiov Unveils LeviPrep and LeviSelect Product Lines (USA) 
• Dragonfly Therapeutics Announces Achievement of Phase 1 Clinical Development Milestone for IL-12 Investigational Immunotherapy Program with Bristol Myers Squibb (USA) 
• Varana Capital leads $17 Million Round in Stämm Biotechv, Joining Draper Associates and Other Current and New Investors (Argentina) 
• Mission Bio Announces its First Single-Cell Tapestri Center of Excellence for Solid Tumor Research (USA) 
• NeuroSense Therapeuticsv Granted Key Patent for its ALS Drug PrimeC in Australia (Australia) 
• RedHill Announces Positive Phase 2 Study Results with Oral RHB-107 in Non-Hospitalized COVID-19 (Israel) 
• Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers (USA) 
• Saol Therapeutics and GeneDx, Inc.v Collaborate to Detect Patients with Rare Mitochondrial Disease (USA) 
• Kintor Pharma Announces First Patient Dosing in Phase II Clinical Trial of KX-826 for Treatment of Androgenic Alopecia Patients in the US (USA) 
• Emalex Biosciences Expands CNS Platform to Advance Treatment for Restless Legs Syndrome with Augmentation (USA) 
• ValGenesis and ZeeDimension Partner to Deliver Best-in-Class Digital Validation Solutions for Pharmaceutical Companies in the Middle East (USA/Dubai) 
• DURECT Corporation Doses First European Patient in Phase 2b AHFIRM Study of Larsucosterol(DUR-928) in Severe Alcohol-Associated Hepatitis (USA) 
• Lifebit and Boehringer Ingelheimv announce partnership to capture transformational value of health data (UK) 
• FDA slaps hold on Finch’s C. diff med to get info on COVID-19 screening for donor-derived therapy (USA) 
• SAB’s shares drop 45% after NIH ditches COVID-19 trial due to waning hospitalizations (USA) 
• Facing omicron ‘curveball,’ Inovio seeks endpoint switch amid fear it will strike out against original goal (USA) 
• Novartis backs Epsilogen’s bid to turn ‘Cinderella antibody’ into new class of cancer drug (USA) 
• Sanofi picks a ‘safe’ bet for Adagene’s antibody tech in $2.5B biobucks tie up (France/China) 
• Flagship unveils Vesalius with $75M to bankroll ambitious target of treating 90% of human illnesses (USA) 
• UT Austin scientists design safer Cas9 with improved CRISPR gene editing accuracy (USA) 
• Palm-sized PCR testmaker Visby ropes in $100M for tenfold production boost (USA) 
• FDA approves J&J’s allergy-fighting contact lens infused with an antihistamine (USA) 
• Embark discovers mutation associated with breed-specific hearing loss, in first-ever canine health discovery using commercial testing genetic data (USA) 
• Prescient Healthcare Group Acquires Strategic North (UK) 
• Elgan Pharma Announces Positive Results from its Phase III Study of ELGN-GI in Preterm Infants for Treatment of Intestinal Malabsorption (Israel) 
• Months after IPO, Stevanato Italian vial company lands BARDA investment as government looks to shore up pandemic preparedness (USA) 
• Domainex Purchases Over $1.3 Million Worth of New Waters Equipment (UK) 
• IASO Bio’s Nanjing Mfg. Facility Licensed for CAR-T Cell Therapies (China) 
• BMS Executes Lease for World-Class R&D Building at Alexandria Point (USA) 
• Helsinn Group, BridgeBio Amend Strategic Infigratinib Collaboration (USA) 
• Synairgen’s NIH-sponsored COVID-19 trial paused a day after SAB study nixed completely (UK) 
• Foresite Labs’ new $173M fund to bankroll fewer startups but ‘big ideas’ fueled by data (USA) 
• Atlas lands $450M fund to build fresh batch of biotechs (USA) 
• Genome and Company announces Clinical Trial Collaboration with MSD to evaluate ‘GEN-001’ in combination of KEYTRUDA® (pembrolizumab) in phase 2 clinical trial in biliary tract cancer patients (South Korea) 
• InxMed Raised $50 million in Series B Financing to Advance Innovative Therapies to Drug-resistance Cancers (China) 
• Circa Scientific has Received FDA Clearance for New Esophageal Temperature Probe that Is Visible on 3D Cardiac Mapping Systems (USA) 
• uLab™ Completes $20 Million Financing From CareCapital (USA) 
• AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug (USA) 
• Inhibrx Receives FDA Orphan-Drug Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency (USA) 
• New York State Approves SQI Diagnostics’ EXACT COVID-19 Antibody Assay (USA) 
• Claudin18.2 CAR T Cells (CT041) Receives Approval to Initiate a Confirmatory Phase II Clinical Trial for advanced GC/GEJ in China (China) 
• Cystic Fibrosis Foundation Invests in Felix Biotechnology as They Advance New Therapies Targeting Chronic Infections in Cystic Fibrosis (USA) 
• NephroSant Publishes Real-World Evidence Showing Potential to Improve the Detection of Early Rejection Events with Qsant (USA) 
• BioLineRx Announces Additional Positive Results from Pharmacoeconomic Study Comparing Motixafortide + G-CSF to Plerixafor + G-CSF in Stem Cell Mobilization (Israel) 
• Priothera – FDA and EMA Grant Orphan Drug Designation to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) (Ireland) 
• Nonprofit Civica goes after insulin prices in a big way, prepping for $30 vials by 2024 (USA) 
• Aerami Therapeutics Holdings, Inc. and FoxWayne Enterprises Acquisition Corp. Mutually Agree to Terminate Business Combination Agreement (USA) 
• Aravax Pty Ltd announces opening of IND for Phase 2 clinical trials of PVX108, a next-generation immunotherapy for the treatment of peanut allergy (Australia) 
• In German-only announcement, Bayer invests $1.5B into native country manufacturing Germany 
• Ocugen Ends Week on Low as FDA Rejects Covaxin EUA for Kids (USA) 
• Lannett Announces Receipt of Notice of Non-Compliance from NYSE (USA) 
• Altamira Therapeutics and Nuance Pharma Enter into Exclusive Licensing and Distribution Agreement for Bentrio in China and Additional Asian Markets (China) 
• 111, Inc. Reaches Strategic Partnership on Direct Supply with Beilin Pharmaceutical to Blaze New Trails in Digital Development of Chinese Patent Medicine (China) 
• Eyenovia Strengthens Balance Sheet with a $15 Million Institutional Capital Investment from Armistice Capital Master Fund Ltd. (USA) 
• Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations (Canada) 
• LANNETT Announces sale of liquid drug manufacturing plant and other assets for $10.5 million (USA) 
• Evofem Completes Enrollment in EVOGUARD Phase 3 Clinical Trial of EVO100 for Prevention of Chlamydia and Gonorrhea in Women (USA) 
• Junshi Biosciences and Coherus Announce Positive Results from Phase 3 Esophageal Cancer Study of Toripalimab Published in Cancer Cell (China/USA) 
• Amryt’s shares tumble as FDA stiff-arms skin treatment, a month after EU delay revealed (UK) 
• Huadong buys into Heidelberg, signs nearly $1B deal to gain access to four cancer assets (Germany) 
• FDA sticks a fork in Reata’s treatment for chronic kidney (USA) 
• Deaths in Keytruda combo study spur Celyad to pause trial of off-the-shelf CAR-T cell therapy (Belgium) 
• Medicago and GlaxoSmithKline (GSK) Plant-based COVID-19 vaccine approved in Canada (Canada) 
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• Innovent Biologics and AnHeart Therapeutics Receive NMPA Breakthrough Designation for Taletrectinib in ROS1-Positive Non-Small Cell Lung Cancer (USA/China) 
• Freenome Launches the Vallania Study for the Early Detection of Multiple Cancers (USA) 
• Seelos Therapeuticsv Announces Dosing of the First Participants in a Registrational Phase II/III Trial of SLS-005 in Amyotrophic Lateral Sclerosis on the HEALEY ALS Platform (USA) 
• Phase II Clinical Study at Weill Cornell Medical Center Investigating Paxalisib in Combination with Metformin and a Ketogenic Diet Enrolls First Patient (Australia) 
• Novavaxv Announces Extended Durability of Protection Against Infection and Disease in United Kingdom COVID-19 Vaccine Phase 3 Clinical Trial (USA) 
• Lyra Therapeutics Announces First Patient Dosed in Pivotal ENLIGHTEN I Clinical Trial of LYR-210 in Chronic Rhinosinusitis Patients (USA) 
• AbbVie Seeks New Indication for IMBRUVICA® (ibrutinib) in Pediatric Patients with Chronic Graft Versus Host Disease (cGVHD) (USA)