The signed advance purchase agreements (APA) will make doses available to COVAX starting from this month to help address “immediate and critical gaps” in supply, said the Global Alliance for Vaccines and Immunization (Gavi), which co-leads COVAX alongside the World Health Organization (WHO) and the Coalition for Epidemic Preparedness Innovations (CEPI). The agreements come at
Drugs
The move allows Curia to expand its biologic formulation and fill-finish capabilities; adding to its drug product aseptic formulation development expertise and drug product manufacturing. Founded in 2003 as Integrity Biosolution, Integrity Bio’s focus is on hard-to-formulate biologics and fill-finish of unique therapies in preclinical and clinical development. In a typical year, the organization formulates
Mix and match The idea of mixing and matching vaccine doses – taking one type of vaccine for the first dose but switching to another manufacturer and technology for the second – is being explored by researchers as a way of opening up more doses to more people according to availability of each vaccine type.
The Scottish Medicines Consortium (SMC) published its final advice yesterday recommending ofatumumab for the treatment of RRMS with active disease defined by clinical or imaging features. “Ofatumumab has the potential to reduce relapse rates, slow disease progression and improve quality of life. Offered as a monthly self-injection, this treatment option may minimize the treatment burden
News FDA Alerts Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older July 9, 2021 Audience: Patient, Health Professional, Pharmacy July 9, 2021 — FDA has routinely been using screening methods to monitor the safety of COVID-19 vaccines and to evaluate potential adverse events of interest (AEI)
Univercells Technologies, which provides biomanufacturing technologies for flexible and scalable viral vector production, will work with VectorBuilder’s manufacturing center in Guangzhou to develop and optimize protocols for intensified and continuous viral vector production for cell and gene therapies (CGTs) and vaccine applications. With rapid advances in CGTs in recent years as well as intensified interests
The US Food and Drug Administration (FDA) approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s on June 7, making it the first new treatment approved for the disease since 2003. But the agency has faced criticism from many quarters over the approval. In a letter posted Friday, and announced via Twitter, Woodcock asked the
Founded in 1994, CellGenix produces and markets cell culture components, such as growth factors, cytokines and media in GMP quality for manufacturing cell and gene therapy products. The company is based in Freiburg, Germany; with a sales subsidiary near the biotech hub in Boston, Massachusetts. It employs around 70 people and generated sales of more
The vaccine targets lineages recommended by the WHO for the prevention of influenza: including including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria. The Phase 1/2 randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010, Moderna’s seasonal influenza vaccine candidate in healthy adults 18 years and older
FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes WHIPPANY, N.J.– July 9, 2021 (BUSINESS WIRE)– Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained
Valneva completed recruitment for the vaccine’s Phase 3 trial in April this year and topline data is expected in the summer. The Breakthrough Therapy Designation milestone is in addition to the FDA Fast Track designation (received in December 2018) and the European Medicines Agency’s PRIME designation (received in October 2020). Chikungunya: high morbidity Breakthrough Therapy
Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial First and Only FDA-Approved Therapy for Urothelial Cancer Patients Who Are Cisplatin-Ineligible and Have Previously Received One or More Prior Therapies, Based on Cohort 2 of Pivotal EV-201 Trial TOKYO and BOTHELL, Wash., July 9, 2021 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President
This latest investment package is aimed at accelerating the growth of its subsidiary, FUJIFILM Diosynth Biotechnologies (FDB), a biologics targeted contract manufacturing and development organization (CDMO). This financing brings the total investments made by Fujifilm in that subsidiary since 2011 to US$5.5B (¥600 Billion Yen). This recently announced capital outlay will be used to increase
The company, which is based in the BioPark in Gosselies, Belgium, is looking to address unmet medical needs in orthopedics and other diseases. The EIB financing is to be used to accelerate the clinical development of ALLOB, its allogeneic cell therapy platform, as well as the potential commercialization of its enhanced viscosupplement, JTA-004. EIB loan
July 7, 2021 Audience: Health Professional, Pharmacy July 7, 2021 – The U.S. Food and Drug Administration (FDA) is requiring safety labeling changes to the prescribing information for the class of hydroxyethyl starch products to amend the Boxed Warning to warn about the risk of mortality, kidney injury, and excess bleeding. FDA is also requiring related
WHO endorses IL-6 receptor blockers for COVID-19, Roche engaging with agency on guideline implications Patients with severe and critical COVID-19 often suffer from an overreaction of the immune system and anti-IL-6 receptor monoclonal antibodies – tocilizumab and sarilumab – act to suppress this overreaction, said the World Health Organization (WHO); it said the treatments worked
Novasep performs process development and cGMP bioconjugation of the XB002 ADC at its ADC manufacturing unit on its Le Mans site, in France. The CDMO declined to disclose the duration of the manufacturing agreement with Exelixis. Khalid Shah, senior VP, pharmaceutical operations and supply chain, Exelixis, said Novasep’s ADC process development and manufacturing capabilities were
It is part of an investment directed at boosting supply of vaccines and biotherapeutics on the African continent, helping it gain vaccine sovereignty and access to future treatments. Recipharm, a global contract development and manufacturing organisation headquartered in Stockholm, has signed the MOU with His Majesty the King of Morocco, Mohammed VI; the Moroccan Government;
tezepelumab Treatment for Asthma Tezepelumab Granted Priority Review By U.S. FDA THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. The FDA grants Priority
Keytruda Is Now Approved for the Treatment of Patients With Recurrent or Metastatic or Locally Advanced cSCC That Is Not Curable by Surgery or Radiation KENILWORTH, N.J.–(BUSINESS WIRE) July 6, 2021 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved
Treatment for Prader-Willi Syndrome FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the
The investment follows an agreement, announced in May, which sees the two companies engage in a global research collaboration to develop novel drug candidates using the saRNA platform. This will cover up to five areas selected by Lilly across its key therapeutic focus areas, with Lilly retaining exclusive commercialization rights for any products in the
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