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Alcami Adds Solid-State Characterization Capabilities to North Carolina Laboratory
The dedicated solid-state research and development suite is designed to promote discovery of novel polymorph, salt, and cocrystal forms.
Pfizer to Supply up to 6 Million PAXLOVID Treatment Courses for Low-and-Middle-Income Countries
Pfizer is set to supply global fund up to 6 million treatment courses of its COVID-19 oral treatment, PAXLOVID, for low-and-middle-income countries.
EC Approves Vabysmo for Two Leading Causes of Vision Loss
EC has approved Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss.
Roquette Acquires Indian Excipient Manufacturer
Roquette’s acquisition of Crest Cellulose is designed to reinforce its presence in India and other countries in Asia.
Congress Slated to Reauthorize User Fees Without FDA “Improvements”
Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.
FDA and NIH Enter Rare Neurodegenerative Diseases Partnership
The Public-Private Partnership for Rare Neurodegenerative Diseases will work to enhance understanding and develop treatments for rare neurodegenerative diseases.
FDA Approves Bluebird Bio’s $3 Million CALD Treatment
FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.
Lonza Expands HPAPI Multipurpose Suite
Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.
Boehringer Ingelheim Adopts Virtuosi VR Education Platform
Boehringer Ingelheim will use Virtuosi to train employees at three aseptic sites across its network.
Clinical Trial Modernization Raises FDA Compliance Issues
Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.
CytoReason Announces Expanded Collaboration Deal with Pfizer
CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.
EC Approves Lupkynis for Treatment of Active Lupus Nephritis
Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.
Civica to Invest $27.8 Million in New Testing Facility
Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.
Novo Nordisk and Microsoft Collaborate to Accelerate Drug Discovery and Development
Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.
Ensysce Biosciences and Quotient Sciences Announce Partnership
Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.
EMA Recommends Approval of Enjaymo
EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.
Advanced Biopharma Manufacturing Key to White House Cancer Moonshot
The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
Emergence Therapeutics to License Synaffix ADC Technology Platform in Deal Worth Up to $360 Million
Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.
MilliporeSigma to Invest €130 Million in French Manufacturing Facility
MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.
WHO Grants Prequalification to GSK’s Malaria Vaccine
WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.
FDA In Limbo as User Fee Renewal Stuck on Capitol Hill
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
Salipro Biotech Obtains Patents in US and China for Direct Extraction of Membrane Proteins and Library Generation
Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.
Charles River and Cure AP-4 Announce Manufacturing Collaboration
Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.
Avance Clinical Acquires C3 Research Associates
Avance Clinical’s acquisition of C3 Research Associates expands its CRO services to North America.
ElevateBio and the University of Pittsburgh Announce Creation of Pitt BioForge BioManufacturing Center
In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.
Roche to Acquire Good Therapeutics for $250 Million
Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.
SIRIO Enhances Company Strategy with Addition of Lonza’s Sara Lesina
SIRIO is enhancing its strategy for small and medium nutrition brands as Lonza’s Sara Lesina joins as GM in Europe.
Lynparza Approved in Great Britain
Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
FDA Approves Novel ASMD Treatment from Sanofi
Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.
Lonza and Touchlight Enter mRNA Collaboration
Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.