PEI – Bulletin on Drug Safety
Bulletin on Drug Safety – Current Issue 3/2022 Published The Bulletin on Drug Safety is a cooperation between the Federal Institute for Drugs and Medical […]
Zerion Pharma and Hovione extend partnership to cover use of the Dispersome® technology platform in nutraceuticals
Hovione and Zerion Pharma A/S (Zerion) today announced an extension of their collaboration on Zerion’s Dispersome® technology into the nutraceutical/dietary supplements field. Many dietary supplements suffer […]
Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine
Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age […]
Novaliq submits New Drug Application seeking approval for first-of-a-kind Dry Eye Disease Treatment CyclASol®
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New […]
Merck has launched the VirusExpress® 293 Adeno-Associated Virus (AAV) Production Platform
Merck Becomes One of the First CDMOs to Provide Full Viral Vector Offering with Launch of VirusExpress® 293 Adeno-Associated Virus Production Platform Merck has launched […]
Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY®
… For Adolescents 12 through 15 Years of Age COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 […]
Pfizer and BioNTech Submit a Variation to EMA
…. for the Vaccination of Children Ages 6 Months to less than 5 Years with COMIRNATY® Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: […]
Statement on Patent Infringement Lawsuit in Germany
BioNTech values and respects valid intellectual property rights. BioNTech’s work is original, and we will vigorously defend it against all allegations of patent infringement. However, […]
Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]
WHO highlights urgent need to transform mental health and mental health care
Report urges mental health decision makers and advocates to step up commitment and action to change attitudes, actions and approaches to mental health, its determinants […]
Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA
Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced […]
PROXIMIE raises $80 million in Series C Funding to accelerate product expansion of full-service connected surgical platform
Funding round led by Advent Life Sciences. New investors include Emerson Collective, SoftBank Vision Fund 2, British Patient Capital, Mubadala and the Minderoo Foundation. Proceeds […]
Merck Announces Collaboration with Agilent Technologies
…to Fill Industry Gap in Process Analytical Technologies for Downstream Processing Merck today announced that it has entered a collaboration with Agilent Technologies to advance […]
Novartis Tafinlar® (dabrafenib) + Mekinist® (trametinib) demonstrates unprecedented efficacy in pediatric patients with BRAF V600 low-grade gliomas in Phase II/III study
Treatment with targeted therapies Tafinlar + Mekinist resulted in 47% ORR versus chemotherapy (11%) and reduced risk of progression or death by 69%, showing significant […]
Antibody Response to Omicron…
and Other Virus Variants Effectively Replenished after 3rd and 4th COVID-19 Vaccination 12 / 2022 Two vaccinations with Comirnaty do not lead to adequate antibody […]