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Novartis Finalizes Chinook Therapeutics Acquisition in Deal Worth Up to $3.5 Billion
Novartis has completed its acquisition of biopharma company Chinook Therapeutics.
FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
FDA Approves First Oral Treatment for Postpartum Depression
The new drug could be a powerful tool for patients suffering depressive symptoms after birth.
AGC Biologics Completes Expansion at CGT Manufacturing Site in Milan
The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.
Regeneron Pharmaceuticals to Acquire Decibel Therapeutics
The initial collaboration between the two companies began in 2017 with an extension announced in 2021.
Unpacking COVID-19 Pandemic Response
Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.
Sparian Biosciences Awarded Five-Year NIH/NDA Grant for Development of SBS-518
SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).
FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma
The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.
Sartorius and Emerson Collaborate to Expedite New Therapies to Market
The bioreactors can integrate with Emerson’s DeltaV PK Controller in addition to S-Series and M-Series controllers.
FDA Warns that Tydemy May Have Reduced Effectiveness
Lower levels of an active ingredient may result in unexpected pregnancies.
BlueRock Therapeutics and bit.bio Collaborate for Manufacture of Regulatory T cell Based Therapies
BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from this collaboration.
iTolerance and Northway Biotech Form Manufacturing Pact for Fusion Protein
Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.
Waters Launches SEC Columns for Gene Therapy Applications
Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.
Kiefel Launches Modular Form-Fill Seal Machine
Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.
FDA Approves OTC Opioid Overdose Treatment
The nasal-spray drug can be used to reverse the effects of opioid overdose.
Testing Innovative Analytical Waters
Laboratories are focusing on more automated processes while also trying to maintain an efficient, safe, and personalized experience with each analytical test.
A Healthier Tomorrow?
Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.
Phasing Out COVID-19 Regulatory Flexibilities
What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?
New Magic from mRNA
mRNA may be a modality whose chief advances are yet to come.
Supply Chain Securities
Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.
FDA Releases Guidance on Standards Related to Pharmaceutical Quality
The program aims to aid submissions from external stakeholders and FDA staff.
Biogen to Acquire Reata Pharmaceuticals for $7.3 Billion
Biogen’s acquisition of Reata will grant them access to Reata’s FDA-approved treatment for Friedreich’s ataxia.
AstraZeneca and Pfizer Ink $1 Billion Rare Disease Deal
AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.
FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
The guidance document outlines recommendations to limit potential carcinogenic risk.
SCG Therapy Opens Cell Therapy Manufacturing Facility in Singapore
The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.
Congress Leaves Town with Major Drug-Related Bills on Hold
Pandemic, PBM, and other policies on hold during the summer recess.
Biovian Invests €50 Million in Manufacturing Facility in Finland
The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.
Teva Pharmaceuticals and Alvotech Expand Existing Biosimilars Partnership
Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.
Roche and Alnylam Strike $2.8 Billion RNAi Deal
Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.
FDA Approves Novel Demodex Blepharitis Treatment
Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.
