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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.
FDA Approves First Nonprescription Daily Oral Contraceptive
Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.
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.
Perfecting the Pitch: Learning to Attract Investor Funding
Start-ups are plagued with common issues that dramatically decrease their odds of achieving investor funding.
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.
INTERPHEX 2023 Honors Packaging Innovations
Parenteral packaging and handling advancements receive awards.
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
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.
Eurofins Genomics Blue Heron Launches In-Vitro Transcription mRNA Synthesis Service
Eurofins Genomics Blue Heron’s novel mRNA synthesis service is designed for customizable applications.
Europe Phases Out COVID-19 Flexible Regulations
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.
COVID-19 Vaccine, Nuvaxovid, Gains EU Approval
Full Marketing Authorization has been granted for Novavax’s COVID-19 vaccine by the European Commission.
Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene
Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.
Meletios Therapeutics’ Efforts in Antiviral Field Gains Recognition from Bpifrance
Meletios Therapeutics has been awarded with funding worth €1.2 million (US$1.3 million) from Bpifrance’s Deeptech development program.
Syngene Adds Biologics Drug Substance Manufacturing Capacity with Facility Acquisition
Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
New Deal on the Horizon
The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.
Innovation Idolatry
If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.
Drug Pricing’s Static Changes
The debate surrounding drug pricing changes rages on.
Frontrunner in Therapies for Complement-Mediated Diseases
A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.
Donaldson Company Acquires Univercells Technologies for €136 Million
Donaldson Company’s €136 million (US$148 million) acquisition of Univercells is designed to broaden its portfolio of biomanufacturing solutions.
FDA Approves UCB Generalized Myasthenia Gravis Treatment
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.