BIO, the world’s largest trade association for the biotech industry, has responded to the US Food and Drug Administration's draft guidance on developing human gene therapy products that incorporate genome editing (GE) of human somatic cells.
The developer says it is harnessing parvovirus vectors that can deliver larger gene therapy payloads with enhanced tissue specificity and with minimal neutralizing immunity.
If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.
Pfizer will invest €90.5m ($95m) in French vaccine specialist Valneva, representing 8.1% of Valneva’s share capital. The investment will support the duo’s Lyme disease vaccine partnership.
Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.
Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.
Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.
The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.
Valneva has reached a settlement with the UK government over an abandoned COVID-19 vaccine contract. Meanwhile, the future of its COVID-19 vaccine in the EU could become clearer next week after an EMA committee vote.
San Jose, California-based ParkourSC says it has expanded its digital supply chain operations platform to help pharma companies address supply challenges.
A meeting of the FDA’s vaccines and related biological products advisory committee (VRBPAC) voted Tuesday to recommend that the agency grant Emergency Use Authorization (EUA) for Novavax’ COVID-19 vaccine.
The US Federal Trade Commission (FTC) announced on June 7 that it will examine pharmacy benefit managers’ role at the center of the US pharmaceutical system.
Johnson & Johnson (J&J) has officially informed Emergent BioSolutions Inc of its decision to terminate its agreement with the contract manufacturer in relation to the pharma group’s COVID-19 vaccine.
The US Food and Drug Administration (FDA) has approved GSK’s Priorix (Measles, Mumps and Rubella Vaccine, Live) for individuals 12 months of age and older.
Regeneron Pharmaceuticals will purchase Sanofi's stake in their collaboration on Libtayo (cemiplimab) for an upfront payment of $900m, giving Regeneron exclusive worldwide rights to the medicine.
GSK will acquire Affinivax, a US clinical-stage biopharmaceutical company, for a $2.1bn upfront payment and up to $1.2bn in potential development milestones.
Danish vaccine company Bavarian Nordic has entered several new supply contracts with countries for its smallpox vaccine, with deliveries set to start immediately.
As part of a wider expansion project, Merck commits to expanding an existing facility and building an entirely new one, as part of its strategy to focus on investment in Ireland.
The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.
Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, recently closed a US$37m Series A financing round led by Kineticos Ventures.
Northway Biotech, a contract development and manufacturing organization (CDMO) based out of Vilnius, Lithuania, is set to open a facility in Boston, US.
The World Health Organization (WHO) has today issued an emergency use listing (EUL) for Convidecia, a vaccine manufactured by CanSino Biologics, bringing the total number of COVID-19 vaccines validated by the organisation to 11.
Locus Biosciences says the US$35m in funding it has raised from a mix of old and new investors is further validation of its novel approach to treating bacterial diseases.
South Korean multinational, Lotte Corporation, is to acquire Bristol Myers Squibb's manufacturing facility in East Syracuse, New York. The deal is reportedly worth US$160m.
A survey from Spherix gathered reactions from US neurologists after the US Centers for Medicare & Medicaid Services (CMS) announced its National Coverage Determination for monoclonal antibodies against amyloid for the treatment of Alzheimer’s.
Vaccine company Valneva has received notice from the European Commission of its intent to terminate the Advanced Purchase Agreement for Valneva’s COVID-19 vaccine.
Gerresheimer has enhanced its manufacturing capabilities in India, in an effort to ensure consistent, local supply for pharma and healthcare operations.
Taiwan based CDMO, Bora Pharmaceuticals, says the acquisition of CDMO assets from local player, Eden Biologics, will help it build a presence in large-molecule contract drug development and manufacturing.
The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.
The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.
Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.
Capital investments in Swiss biotech companies reached CHF 3.33bn ($3.53bn) in 2021; while R&D investments increased to a record-high CHF 2.56bn ($2.71bn).
The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.
EU systems need to become more streamlined to help bring novel technologies to market - which would in turn encourage investment and activity in healthcare biotech, says EuropaBio as it publishes key policy recommendations for the sector.
Oramed Pharmaceuticals announced this week that it has enrolled 100% of the patients in the world’s first Phase 3 study of oral insulin under FDA approved protocols.
