Biotech Business - November 9, 2021
BerGenBio receives Fast Track designation
BerGenBio has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for bemcentinib in combination with an anti-PD-(L)1 agent as treatment for patients with STK11 altered advanced/metastatic NSCLC patients without actionable mutations. The Fast Track designation will enable BerGenBio to have more frequent interactions with the FDA throughout the drug […]
Biotech Business - November 7, 2021
US-Swedish entrepreneur invests in Intrance Medical Systems
The US-Scandinavian real estate entrepreneur Rutger Arnhult has, via his private company M2 Asset Management AB, agreed to invest in New York based Intrance Medical Systems Inc. “Investing in the life science segment is not new to me. The product has been validated by regulatory agencies in EU and a strategic buyer of the EU […]
Biotech Business - November 6, 2021
Oncopeptides reduces the activity level in the development program of melflufen
Oncopeptides has decided to reduce the activity level in the clinical development program with melflufen (INN melphalan flufenamide) to increase the company’s cash runway and at the same time support the ongoing marketing authorization application process in Europe. This will have implications on the following studies: OCEAN study will continue with long-term follow-up and documentation […]
Biotech Business - October 29, 2021
Abera enters collaboration with American university
Abera Bioscience initiates collaboration with an American university to accelerate the development of a vaccine candidate based on the company’s latest vaccine platform comprising protein bodies. The study will be conducted in vivo and will provide a first indication of applicability outside of the pneumococcal area. The cost profile for protein body-based vaccine formulations is […]
Biotech Business - October 27, 2021
ApoGlyx closes 6 million SEK financing round
ApoGlyx has just closed a 6 million SEK investment round, coming from Almi Invest as well as from Swedish and Danish private investors. This new capital will allow the company to progress its most advanced molecule to mandatory preclinical toxicology testing. Furthermore, ApoGlyx has recently been accepted to Smile Incubator at Medicon Village in Lund. […]
Biotech Business - October 22, 2021
Ultimovacs receives dual FDA Fast Track designation
Ultimovacs has announced that its universal cancer vaccine, UV1, in combination with checkpoint inhibitors has received Fast Track designation from the U.S. FDA in the treatment of unresectable or metastatic melanoma – either as add-on therapy to pembrolizumab or as add-on therapy to ipilimumab. Ultimovacs is currently evaluating UV1 as add-on therapy to ipilimumab and […]
