Archive for October 2020
Endo Gains Control of Two Collagenase Therapies in BioSpecifics Purchase
Endo International announced that it will purchase the biopharmaceutical company BioSpecifics Technologies for approximately $540 million giving the company complete control over two promising collagenase-based therapies. Source: Drug Industry Daily
Read MoreAgios Withdraws European Tibsovo AML Submission
Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring an isocitrate dehydrogenase-1 (IDH1) mutation. Source: Drug Industry Daily
Read MoreModerna Could Earn EUA for COVID-19 Vaccine in December, CEO Says
Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected out next month. Source: Drug Industry Daily
Read MoreSinopharm to Supply 1 Billion COVID-19 Vaccine Doses Next Year
China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021. Source: Drug Industry Daily
Read MoreUK Authorizes COVID-19 Human Challenge Trial
The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Source: Drug Industry Daily
Read MoreFDA Cites Nutravail for Data Integrity, Supplier Validation
Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Source: Drug Industry Daily
Read MoreAustralia Invites Comment on Its Planned UDI System
Australia’s Therapeutics Goods Agency (TGA) has issued a new paper on its plan to establish a unique device identification (UDI) system and it wants to hear reactions from device sponsors. Source: The GMP Letter
Read MoreFDA Harmonizes eMDR System With International Codes
The FDA has updated its electronic medical device reporting (eMDR) system to include new fields for summary reports and combination products to harmonize with international reporting codes. Source: The GMP Letter
Read MoreDevicemakers Urged to Use ISO-10993-1 to Assess Biocompatibility
The FDA issued final guidance for devicemakers on the use of the ISO-10993-1 international standard for assessing the biocompatibility risks of devices that come into direct or indirect contact with the human body. Source: The GMP Letter
Read MoreFDA Explains What’s Required in 510(k)s for Blood Glucose Monitoring Systems
In two new guidances, the FDA calls for different types of information in 510(k) premarket submissions for blood glucose monitoring systems for use by healthcare professionals as compared to those for home use by lay-users. Source: The GMP Letter
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