Fujifilm Corporation is to invest US$1.6bn (€1.4bn) to boost the business of its subsidiary, Fujifilm Diosynth Biotechnologies (FDB), a contract development and manufacturing organization (CDMO).
UK pharma group, Croda International, has inked a deal with the US government in which it will receive up to US$75m to expand its US manufacturing capacity for lipid systems.
People with HIV who began taking antiretroviral therapy (ART) in the early stages of infection achieved a lengthy period of HIV suppression without ART after receiving two broadly neutralizing anti-HIV antibodies (bNAbs), according to a study published...
The antibody drug conjugate market has had a busy few years, as the appetite for acquisitions of ADC-specialists began to grow, with Gilead buying Immunomedics and Merck acquiring VelosBio.
The pharmaceutical company is expanding its alliance with historically Black medical schools to bolster the battle against systemic health disparities.
MSD will supply Keytruda (pembrolizumab) in a phase 1/2a clinical trial for the treatment of patients with solid tumors, as part of an agreement with Transgene and BioInvent.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Construction works on an mRNA manufacturing facility have started in Kigali, Rwanda: as BioNTech works to create a pan-African end-to-end manufacturing network for mRNA-based vaccines.
The industry had over 50 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in both 2020 and 2021, up from an annual total of 29 a decade ago.
VIVEbiotech has completed the latest expansion phase of its lentiviral vector manufacturing capabilities; the development is aimed at alleviating the viral vector bottleneck for advanced therapies.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) made several recommendations for approval of drugs and therapies at its June 2022 meeting.
Merck has doubled its high-potent active pharmaceutical ingredients (HPAPI) production capacity with the expansion of its facility in Verona, Wisconsin, US.
What are the opportunities, challenges and innovation drivers across healthcare? From its 2022 Global Annual Meeting, the DIA tells us the key issues it's keeping its eyes on.
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.
Merck is collaborating with Agilent Technologies to plug what it calls a critical gap within downstream processing for process analytical technologies (PAT).
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.
The Cell and Gene Therapy Catapult (CGT Catapult) and the UK Dementia Research Institute (UK DRI) have announced a collaboration to accelerate clinical development of adeno-associated virus (AAV) based gene therapies for dementia.
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.
The Biotechnology Innovation Organization elected the fresh slate of leaders during the BIO International Convention, taking place in San Diego this week.
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.
Unveiled at the 2022 BIO International Convention, the group's third annual diversity, equity, and inclusion report spotlights improvements both made and needed.
Umoja Biopharma and TreeFrog Therapeutics have formed an alliance to address challenges facing ex vivo allogeneic therapies in immuno-oncology, including issues scaling up production to reach all patients.
San Jose, California-based ParkourSC says it has expanded its digital supply chain operations platform to help pharma companies address supply challenges.
Charles River Laboratories International and ASC Therapeutics have announced plans to manufacture ASC618, a second-generation gene therapy for hemophilia A.
CureVac has acquired Frame Cancer Therapeutics: with the German mRNA specialist planning to draw on Frame’s expertise in antigen identification and validation as it develops mRNA cancer vaccines.
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.
Evonik will build a production facility for pharmaceutical lipids in Indiana: with the new site ‘positioning the group for future growth in novel mRNA-based therapies beyond COVID-19 vaccines’.
CDMO CordenPharma has increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy: with a €10m ($10.7m) investment in new Lipid Nanoparticle (LNP) formulation, development and production areas.
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.