The Week in Biopharma, Mar 28- Apr 1

CDMO 

• AGC Biologics to Manufacture Peanut Allergy Vax Candidate (Germany)
• Lonza Joins International Pharmaceutical Aerosol Consortium on Regulation & Science (China) 
• Rokote Partners with Exothera to Bring FINCoVac 2.0 to Clinical Phase I/II Trials (Finland/Belgium) 
• CureVac, GSK Initiate Next-Gen COVID Vax Trial (Germany/USA) 
• Rentschler Biopharma and Vetter Unveil Xpert Alliance (Germany) 
• Ten23 Health Expands Swissfillon Manufacturing Site in Switzerland (Switzerland)
• Symbiosis Completes UK Research and Innovation Project (UK) 
• Almac Clinical Technologies Launches OVERSIGHT Trial Data Integrity Monitoring System (USA) 
• Funding from Ontario Government Launches OmniaBio  (Canada) 

CRO 

• Medsir teams with Goldman Sachs-backed Oncoclínicas for Latin American market (Spain/Brazil)
• NAMSA to Acquire European-Based Medanex Clinic to Expand Early-Stage Preclinical Research Capabilities (USA) 

AI 

• Virtualitics AI Platform to Support Computational Biology Research on Long Covid Treatment Options (USA) 
• Symbiance announces the launch of SimpleStats, an application for statistical analysis and reporting of clinical data (USA)  
• Zephyr AI lands $18.5M seed round for data-driven drug discovery (USA)
• Keen Eye and Ultivue Announce Collaborative Agreement to Propel Multiplex and Spatial Analysis in Clinical Research (USA) 
• Insilico Medicine’s AI zeroes in on new drug targets for aging, age-related diseases (China) 

Biopharma 

• Silverback Halts Oncology Programs, Lays Off 27% Of Staff (USA) 

• Phase III Results Set Neurocrine Up for Huntington’s Chorea sNDA (USA) 
• FDA Delays Decision on Merck’s Pediatric Pneumococcal Vaccine (USA) 
• BridgeBio Confirms Layoffs while Other Companies Follow Suit (USA) 
• Origami Brings Protein Degradation to Neurodegenerative Disorders (USA) 
• Altimmune Announces Initiation of 48-week Phase 2 MOMENTUM Trial of Pemvidutide in Obesity (USA)
• Aravive Announces Closing of $10 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules (USA) 
• Anebulo Pharmaceuticals Doses More Than Half of the Subjects in Part A of a Phase 2 Clinical Trial and Provides Guidance on IND Submission (the Netherlands) 
• Alcresta Therapeutics Announces Series of Commercial Milestone Achievements for RELiZORB® (USA) 
• Soleno Therapeutics Announces Closing of Approximately $15 Million Underwritten Public Offering (USA) 
• Pharming Announces Positive Data from Phase II/III Leniolisib Trial Presented at Clinical Immunology Society 2022 Annual Meeting (the Netherlands)
• Relief Therapeutics Announces that its Subsidiary was Issued a Swiss Patent Entitled ‘Vasoactive Intestinal Peptide (VIP) for the Use in the Treatment of Drug-induced Pneumonitis’ (Switzerland) 
• Sage Therapeutics Announces Presentation of Promising Results from the Phase 2 LUMINARY Study of SAGE-718 in Patients with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease (USA) 
• Accord BioPharma Announces U.S. Launch for CAMCEVI™ (Leuprolide) Injection Emulsion for the Treatment of Advanced Prostate Cancer in Adults (USA) 
• Venus Concept Submits FDA 510(k) Related to the Use of its Aime™ Next Generation Robotic Technology for Tissue Excision and Skin Resurfacing (Canada) 
• Tevard Biosciences licenses mRNA Amplifier technology from Johns Hopkins University (USA)
• InflaRx Announces Encouraging Phase III Topline Results from PANAMO Trial of Vilobelimab in Severe COVID-19 Patients (Germany) 
• Northeastern University and Copernicus Therapeutics, Inc. Awarded $14.7 Million NIDA/NIH Grant to Develop a Gene Therapy Approach for Treating Opioid Use Disorder (USA) 
• Ono pulls trigger on deal for multispecific antibody against ‘very challenging’ cancer target (Japan) 
• Sanofi and IGM Biosciences Announce Collaboration Agreement (USA) 
• Zealand Pharma Restructures and Names New CEO (Denmark)
• The Pistoia Alliance Introduces New IDMP Common Core Ontology Project (Global) 
• Safety Concerns Doom Akebia’s Chronic Kidney Disease Drug (USA) 
• Everest Medicines Submits New Drug Application in Hong Kong for Sacituzumab Govitecan in Second-Line Metastatic Triple-Negative Breast Cancer (China) 
• VivoSense Announces Closing of $25M Series A Financing (USA) 
• FDA Clears ReAlta Life Science’s Phase 2 STAR Trial of RLS-0071 in Neonates with Hypoxic-Ischemic Encephalopathy  (USA)
• NanoVibronix Announces PainGuard and UroGuard Approved by Health Canada as Licensed Medical Devices (Canada) 
• VoxNeuro Announces Significant Milestones as it Embarks on its Mission to Become “The Brain Company (Canada) 
• Scenic Biotech and the Barth Syndrome Foundation Announce Partnership to Explore Genetic Modifiers to a Find Tailored Treatment for the Complex Rare Disease ( the Netherlands/USA) 
• Stealth BioTherapeutics Announces New SBT-272 Data and Trial Initiation (USA) 
• Neuron23 Closes $100 Million Series C Financing Round, Nominates Clinical Candidate for Parkinson’s Disease (USA)
• BioVaxys Expands Cancer Vaccine Platform (Canada) 
• PTC Therapeutics Announces Initiation of PIVOT-HD Phase 2 Clinical Trial to Evaluate PTC518 in Patients with Huntington’s Disease (USA) 
• Anixa Biosciences Announces the Initiation of its Ovarian Cancer CAR-T Phase 1 Trial at Moffitt Cancer Center (USA) 
• BillionToOne Closes $125M Series C Funding with Premier Global Investors (USA) 
• nRichDX Launches Revolution Sample Prep™ Service (USA)
• After FDA hold, CytoDyn will appeal for pharma partnerships to save leronlimab (USA) 
• Pfizer Issues Voluntary Recallv of Blood Pressure Tablets Due to High Levels of Nitrosamine (USA) 
• Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in (India) 
• Boehringer Ingelheim Selects Veeva Development Cloud to Deliver Therapies Faster (Germany/USA) 
• Fortis Life Sciences Partners With AccuGenomics to Expand Genomics Portfolio (USA)
• FDA Grants Orphan Drug Designation to Noxopharm for Sarcoma Treatment (Australia) 
• Sangamo Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation (USA) 
• Cybin Announces Successful Completion of In Vivo Preclinical Studies for its Deuterated Psilocybin Analog CYB003 Supporting Advancement into Phase 1/2a Clinical Trial (Canada) 
• ReCor Medical Announces Completion of Enrollment in RADIANCE-II Pivotal Trial of the Paradise™ Ultrasound Renal Denervation System for the Treatment of Uncontrolled Hypertension (USA) 
• VBI Vaccines Announces PreHevbrio™ is Now Available in the United States for the Prevention of Hepatitis B in Adults (USA)
• Vascular Therapies Completes $25 Million Private Financing (USA) 
• Vyant Bio and OrganoTherapeutics Announce Strategic Collaboration to Discover Therapeutics to Treat Parkinson’s Disease (USA/Luxembourg) 
• Eleusis Announces Notice of Allowance for US Patent Application with Claims Covering Lead Drug Candidate ELE-Psilo (USA) 
• Aptevo Therapeutics Announces Monotherapy Patient Received a Transplant in APVO436 Expansion Trial for the Treatment of Acute Myeloid Leukemia (USA) 
• First FDA-Approved Molecular Targeted Therapy for Metastatic Prostate Cancer Now Available at Hoag Family Cancer Institutev (USA)
• ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Virologically Suppressed Adolescents Living With HIV Who Are 12 Years of Age or Older and Weigh at Least 35 kg (USA) 
• Albireo Completes Enrollment in Pivotal Phase 3 ASSERT Study of BylvayTM (odevixibat) in Alagille Syndrome (USA) 
• Brii Bio Announces Strategic Partnership with Sinopharm to Advance Commercialization of Long-Acting COVID-19 Neutralizing Antibody Therapy, Amubarvimab/Romlusevimab Combination, in China (China) 
• RNAimmune Secures $27 Million Series A Round of Financing for Development of mRNA Therapeutics and Vaccines (USA) 
• Biosion licenses BSI-060T (anti-Siglec-15) to Pyxis Oncology (USA/China)
• BioCopy AG presents ValidaTe, a novel ultra-fast screening technology to significantly speed up drug discovery in T-cell therapy (Switzerland) 
• AllCells Opening a New Collection Facility in Houston, Texas (USA) 
• Avera Health, Theralink Partner to Advance Molecular Profiling (USA) 
• Eagle Pharmaceuticals Reaches Agreement to Acquire Acacia Pharma (USA) 
• Innovent Biologics, Lilly Expand Strategic Commercialization Pact (China)
• FDA Greenlights UCB Drug for Severe Form of Epilepsy (USA) 
• FDA Limits Use of GSK & Vir’s COVID-19 Antibody Therapy (USA) 
• Amarin Receives Reimbursement for VAZKEPA® in (Sweden) 
• Neurocrine Biosciences Announces Regulatory Approval of Dysval® (valbenazine) for the Treatment of Tardive Dyskinesia in (Japan) 
• Immorna Biotherapeutics, Inc. Receives IND Clearance to Conduct FIH Study of JCXH-211, the First-in-Class Self-replicating mRNA (USA)
• DelSiTech Enters into an Exclusive Licensing Agreement with Optifye Therapeutics for the Development of a Controlled Release Ophthalmic Eye Drop Product (Finland) 
• Affini-T Therapeutics, a Biotech Company with Roots at Fred Hutch, Raises $175M for Cancer Treatments (USA)