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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.
EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies
Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.
MilliporeSigma Expands Production Facility for Cell Culture Media
MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.
AbbVie Expands Collaboration with Calibr to Advance Clinical Assets
The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.
Update on Storm Damage to Pfizer Facility in North Carolina
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.
EMA Extends OPEN Framework to More Medicines
The framework is now expanded beyond COVID-19 vaccines and treatments.
EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
Sanofi and Recludix Enter STAT6 Inhibitor Partnership Worth More Than $1.3 Billion
Sanofi and Recludix Pharma’s deal centers on developing treatments for various immunological and inflammatory diseases.
WuXi Sta Launches High Potency Manufacturing Line in Wuxi City Location
WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.
Crossbow Therapeutics Debuts with $80 Million in Series A Financing to Advance Antibody Therapeutics
Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.
Bristol Myers Squibb and Evotec Extend Neuroscience Pact
Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.
Sandoz Spin-off Gets Green Light from Novartis Board
The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.
Pfizer and Flagship Pioneering Enter Innovation Partnership
The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.
Sanofi and Scribe Therapeutics Expands Genomics Collaboration
The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.
Novartis Acquires DTx Pharma in Deal Worth Up to $1 Billion
Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
