Bio/Pharma News
MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization
Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.
Moderna Files Suit Against Pfizer and BioNTech
Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.
Alcon to Purchase Aerie Pharmaceuticals for $770 Million
Aerie to be purchased by Alcon after recently bringing two glaucoma drugs to market.
European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
ProBioGen Executes Master Service Agreement with NextPoint Therapeutics
ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.
Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products
Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer
The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.
UK Approves First Bivalent COVID-19 Booster Vaccine
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
Moderna and European Commission Amend COVID-19 Vaccine Agreement
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.
FDA Approves Roche’s Influenza Treatment for Use in Young Children
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
Merck Enters Alzheimer’s Collaboration with Cerevance
Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.
Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion
Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics is expected to strengthen its sickle cell disease portfolio.
Sartorius to Acquire Albumedix for £415 Million
Sartorius’ £415 million (US$429 million) acquisition of Albumedix is intended to bolster its portfolio with recombinant albumin-based solutions.
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.
FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Sanofi and Innovent Enter Oncology Collaboration
Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.
Amgen Will Acquire Chemocentryx in $4 Billion Deal
Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).
EC Approves Additional Indication for Lynparza as Adjuvant Treatment in Breast Cancer
The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.
La Jolla Institute for Immunology Acquires Carterra LSA Platform
La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.
Ipsen Strikes Deal Worth Up to $1.59 Billion With Marengo Therapeutics
Ipsen and Marengo Therapeutics will collaborate to advance two precision immuno-oncology candidates.
Oregon Freeze Dry Opens $7.5 Million Biopharma Facility
The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.
Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity
Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.
WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant
WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.
Discovery Life Sciences Acquires AllCells
Discovery Life Sciences’ acquisition of AllCells is intended to bolster its cell and gene therapy products and services.
AstraZeneca to Acquire TeneoTwo in Deal Worth Up to $1.26 Billion
AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.
Merck and Orion Announce Global Collaboration for Oncology Drug
Merck, known as MSD outside the United States and Canada, and Orion Corporation are collaborating to develop and commercialize a treatment for metastatic castration-resistant prostate cancer.
Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
TFF Pharmaceuticals Expands R&D Operations with New Facility
TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.
Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children
Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.