Biopharma News
GSK and Alector Collaborate on Neurodegenerative Disease mAb Candidates
GlaxoSmithKline and Alector have partnered to co-develop two mAbs for a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.
FDA Grants Priority Review for AstraZeneca Asthma Biologic
Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.
Custom Viral Vector Manufacturing Protocols to be Produced by Univercells Technologies and VectorBuilder
Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.
Gyros Protein Technologies and Cygnus Technologies to Develop Impurity Reagent Sets
The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.
Pinteon and Lonza Extend Collaboration for Manufacturing Antibody Therapeutic
The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.
Selexis and KBI Biopharma Partner with Immatics to Advance T-Cell Bispecific Program
Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.
Catalent to Acquire RheinCell Therapeutics
Catalent expands capabilities for stem cell-based therapies with acquisition of RheinCell’s GMP-grade human iPSCs.
AstraZeneca Doses Patients in COVID-19 Variant Vaccine in Trial
The first participants, both previously vaccinated and unvaccinated, receive AstraZeneca’s new COVID-19 variant vaccine AZD2816.
Celularity and Arthrex Announce Distribution Agreement
Arthrex to receive exclusive rights to distribute and commercialize Celularity’s placental-derived biomaterial products for orthopedics and sport medicine in the United States.
Corbus Pharmaceuticals Expands Pipeline with Two New mAbs
Corbus Pharmaceuticals has licensed two integrin-targeting mAbs, expanding its therapeutics pipeline into inflammatory, fibrotic, and metabolic diseases as well as cancer.
Amgen Builds Packaging Facility in Ohio
Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.
AbbVie to Acquire TeneoOne and Lead Asset for Multiple Myeloma Treatment
AbbVie has exercised its right to acquire TeneoOne, along with its lead immunotherapeutic asset for the potential treatment of multiple myeloma.
Amgen’s Aimovig Approved in Japan for Treating Migraine
Amgen’s Aimovig has become the first and only approved treatment in Japan for treating migraine attacks in adults by blocking the CGRP-R.
Lilly's Investigational Alzheimer's Therapeutic Gets Breakthrough Therapy Designation
FDA has granted breakthrough therapy designation to donanemab, Eli Lilly and Co.’s investigational antibody treatment for Alzheimer’s disease.
GSK Announces Consumer Business Demerger
GlaxoSmithKline will focus on vaccines and specialty medicines while spinning off consumer healthcare business.
CureVac Releases Interim Results from COVID-19 Vaccine Candidate Trial
CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.
GSK and iTeos Therapeutics Enter mAb Collaboration
GlaxoSmithKline and iTeos Therapeutics enter into a development and commercialization collaboration worth up to $2.08 billion for a new therapeutic anti-cancer mAb candidate.
Sanofi Facility for Flu Vaccine Licensed by FDA
Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.
Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
Novel Automated Process May Speed Up Development of New Medicines
Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.
New Alzheimer’s Drug Heightens Debate Over FDA Accelerated Approval Process
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
Pfizer and BioNTech COVID-19 Vaccine Authorized in UK and Europe for Adolescents
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for NASH Treatment
FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.
Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb
FDA has granted Janssen breakthrough therapy designation for teclistamab, an investigational bispecific antibody under development for treating relapsed or refractory multiple myeloma.
FDA Grants Accelerated Approval for Biogen’s Alzheimer’s Drug
FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.
Emerson Integrates MTP Process Automation Standard into Control Systems
The Module Type Package standard is now supported in Emerson’s DCS and PLCs.
Moderna and Aldevron Expand Partnership for mRNA Vaccine and Therapeutic Pipeline
Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.
Biogen and Ginkgo Bioworks in $120-Million Deal to Develop Novel Gene Therapy Manufacturing Platform
Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.
Codagenix and Univercells Collaborate on Vaccine Research for Undisclosed Target
Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.
Moderna’s COVID-19 Vaccine Study in Adolescents Has Met its Primary Endpoints
In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.