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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 Issues Reminder Over Paxlovid Risks
The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.
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.
Latest Acquisition Sees ProductLife Group Expand its Asia-Pacific Footprint
ProductLife Group has announced its acquisition of Australian company Commercial Eyes.
EMA Given Grant to Support Establishment of African Medicines Agency
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
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.
MHRA’s New International Recognition Procedure
The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.
On the Up and Up
The industry’s M&A activity is on the up and expected to continue to rise in 2024.
Agilent and Incyte Collaborate on Development of CDx in Hematology and Oncology
Agilent Technologies and Incyte have signed an agreement to collaborate on the development of companion diagnostics programs.
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.
Europa Perspectives—Pan-European Challenges and Solutions Post Brexit
An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
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.
Azurity Recalls Zenzedi
The company issued the recall because of a package mislabeling problem.
Sanofi to Aquire Inhibrx for $1.7 Billion
The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.
Getinge Brings Chemistry and Instrument Decontamination Under One Roof
Getinge has announced the inauguration of its new Global Centre of Excellence for Chemistry in the United Kingdom
Pharmapack Report Points to Inhaled Pulmonary and Intranasal Drug Delivery as Areas to Watch
The annual industry report of the Pharmapack Europe event suggests there will be significant innovation in inhaled pulmonary and intranasal drug delivery in 2024.
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.
