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ImaginAb Announces License and Supply Agreement with Pfizer for CD8 ImmunoPET Technology

The Pharma Data

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. ImaginAb will receive license fees and payments for manufacturing and other support. View original content to download multimedia: [link]. LOS ANGELES , Jan. SOURCE ImaginAb, Inc.

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ACEP Applauds Removal of X-waiver, Expanding Medication-assisted Treatment for Opioid Use Disorder

The Pharma Data

Department of Health and Human Services’ (HHS) decision to effectively remove the “X-waiver” requirement for physicians, expanding their ability to utilize medication-assisted treatment (MAT) for patients struggling with opioid use disorder (OUD). View original content to download multimedia: [link]. Source link.

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Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

The Pharma Data

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

Disease 52
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Innovation Pharmaceuticals’ Brilacidin for the Treatment of COVID-19 Receives FDA Fast Track DesignationPhase 2 clinical trial of Brilacidin for COVID-19 anticipated to commence this month

The Pharma Data

Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of Brilacidin as a potential treatment for COVID-19. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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Harbour BioMed’s Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis

The Pharma Data

HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). Harbour BioMed also licenses the platforms to companies and academic institutions.

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BioInvent and Cantargia sign manufacturing agreement for monoclonal antibody CAN10

The Pharma Data

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

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Corlieve Therapeutics SAS Closes Seed Financing to Develop Therapies for Severe Neurological Conditions

The Pharma Data

Corlieve’s lead program employs a novel AAV gene therapy approach for the treatment of refractory temporal lobe epilepsy (TLE), the most commonly diagnosed focal epilepsy in humans. In addition, Corlieve has licensed REGENXBIO’s NAV AAV9 technology for the TLE program. View original content to download multimedia: [link].