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Europa Perspectives—Pan-European Challenges and Solutions Post Brexit
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
BioVaxys Acquires Full Portfolio of Former IMV
BioVaxys has acquired the full portfolio of discovery, preclinical, and clinical development-stage assets of the former IMV.
Nelson Labs Creates Center of Excellence for Parenteral and Ophthalmic Drug Manufacturing
The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
Samsung Biologics Partners with LegoChem Biosciences on ADCs
Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.
EMA Accepts Three Organizations into ATMP Pilot Program
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
Novartis to Acquire MorphoSys for Roughly $2.9 Billion
Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.
FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
Purolite and Repligen Launch New Affinity Resin
Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.
Quantum-Si Launches Platform Enhancements for Protein Sequencer
The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.
Biovian and 3P Biopharmaceuticals Combine to Form 3PBIOVIAN
The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.
Novo Holdings to Acquire Catalent in Deal Valued at $16.5 billion
Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.
AbbVie Gains Nod from NICE for Tepkinly
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
Lonza and Oxford Nanopore Partner on mRNA Analytics
Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.
EMA Given Grant to Support Establishment of African Medicines Agency
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition
With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.
FDA Issues Guidance on CAR-T Cell Product Development
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
FDA Give Guidance on Human Genome Editing in Gene Therapies
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
IMU Biosciences Raises Millions in Series A Funding Round
IMU Biosciences has secured £11.5 million in its Series A financing round.
Sanofi to Aquire Inhibrx for $1.7 Billion
The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.
Winners of the 2024 Pharmapack Europe Awards are Announced
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
Takeda’s Subcutaneous Immunoglobulin Receives FDA Approval for Maintenance Therapy of Rare Neuromuscular Disorder
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.
KBI Biopharma and Argonaut Manufacturing Services Team Up on Drug Substance and Drug Product Manufacturing Solutions
Under a new alliance, KBI Biopharma and Argonaut Manufacturing Services will combine their strengths to offer end-to-end biopharma development and CGMP manufacturing solutions.
Abzena Launches New Cell Line Development Platforms
Abzena has launched its AbZelect platforms, designed for improving cell line development.
EMA Looks Back at Medicines Approved in 2023
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
Novartis Acquires Calypso Biotech for up to $425 Million
The acquisition will give Novartis full rights to CALY-002, Calypso’s lead product candidate.
CDER Approved 55 Novel Drugs in 2023
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
Charles River Launches Off-the-Shelf Rep/Cap Plasmids for AAV Vector Manufacturing
Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.
Bora Pharmaceuticals Fuels Global Expansion with Acquisition in US
The acquisition marks a pivotal expansion for the company into the US market.
EMA Starts Safety Review of CAR T-Cell Medicines
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
