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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.
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.
FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
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.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
Upperton Completes New Development of GMP Manufacturing Facility
The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.
Neurogene and Neoleukin Announce Merger
After the completion of the merger, the company is expected to operate under the name “Neurogene Inc."
Vector Laboratories Acquires Quanta BioDesign
Vector Laboratories announced the acquisition of Quanta BioDesign on July 17, 2023, which further expands the former’s portfolio of bioconjugation linkers and dyes, as well as its manufacturing sector, according to the press release.
Westlake Village BioPartners Announces $450 Million Venture Capital Funding Pool
Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.
metabion Expands Oligonucleotide Production Capacity in Germany
German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.
Moving Closer to Dynamic Drug Development through Automated Solutions
There are solutions on the horizon that will help overcome the current bottlenecks and other challenges that are occurring in early drug development.
FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
EMA Aims to Develop Guideline for mRNA Vaccines
EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.
Biosynth Acquires Celares for Growing Conjugate Vaccine Market
The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.
Large Clinical Trial Supports Alzheimer Drug Full Approval
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
Thermo Fisher Scientific Agrees to Acquire CorEvitas
The transaction is expected to be completed by the end of 2023 where CorEvitas will become a part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.
Caribou Biosciences Receives $25 Million Equity Investment from Pfizer
In addition, Caribou will maintain full ownership and control of its pipeline of allogeneic CAR-T and CAR-NK cell therapies.
Camena Bioscience Raises $10 Million to Pursue DNA Synthesis Technology
Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.
Thermo Fisher Scientific Releases Tumoroid Culture Medium Kit
Thermo Fisher Scientific’s new tumoroid culture medium kit is designed to help cancer researchers better model the disease.
