Pharma Business - February 27, 2023
Orion’s Darolutamide receives approval for additional prostate cancer indication in Japan
The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer. The MHLW approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy […]
Biotech Business - February 22, 2023
Hemab Therapeutics raises 135 million USD
Hemab Therapeutics has announced the closing of an oversubscribed Series B financing. The round was led by Access Biotechnology with participation from new investors Deep Track Capital, Avoro Ventures, Invus, Rock Springs Capital, and Maj Invest Equity. All current investors including HealthCap, Novo Holdings, and RA Capital Management also invested. Part of HealthCap’s VIII fund […]
Global report - February 22, 2023
First gene therapy for hemophilia B approved in the EU
The European Commission has granted conditional marketing authorization (CMA) for CSL’s HEMGENIX, the first and only one-time gene therapy for the treatment of severe and moderately severe hemophilia B in adults without a history of Factor IX inhibitors. In the ongoing clinical trial, HEMGENIX reduced the rate of annual bleeds with a single infusion by delivering […]
Agreement - February 20, 2023
Aqilion enters licensing and research collaboration with Merck
Aqilion has announced an exclusive license and strategic research collaboration with Merck to discover, develop and commercialize small molecule inhibitors of the transforming growth factor-β-activated kinase 1 (TAK1) protein. “We are delighted and proud to announce this collaboration with Merck as it validates our business strategy of generating highly innovative discovery projects in combination with […]
Acquisition - February 15, 2023
Biotage acquires Astrea Bioseparations
Biotage has entered into an agreement to acquire Astrea Bioseparations, a high-growth chromatography solutions provider from Gamma Biosciences. The enterprise value for Astrea is approximately 190 million USD, subject to any closing adjustments and potential milestone-based payments, states the company in a press release. “The acquisition represents an excellent strategic fit for Biotage, and it […]
Pharma Business - February 8, 2023
Orexo submits New Drug Application to FDA
Orexo has announced the submission of a New Drug Application to the US Food and Drug Administration for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo’s drug delivery platform amorphOX and contains a high-dose of naloxone. “With the filing of OX124 we are now one […]
