Pharma companies who choose to take advantage of the EMA’s Prime scheme, which is designed to streamline and accelerate the development and approval process for priority drugs, will now be able to meet with the agency about a year before they file for approval.
A $10 million pot of seed money has catapulted Ctrl Therapeutics Inc. into existence, enabling it to advance an immunotherapy approach in which tumor cells are extracted from the bloodstream rather than the tumor itself. By targeting circulating tumor-reactive lymphocytes (cTRLs) in the blood, the company’s cell therapy platform – which originated at the University of Toronto – is designed to address the challenges of existing cell therapy technologies.
Merck & Co. Inc. has seen promise in Proxygen GmbH’s molecular glue degrader technology, agreeing to pay the drug discovery company up to $2.55 billion if specified research, development and commercial milestones are met.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
Scorpion Therapeutics Inc. has out-licensed two of its small-molecule EGFR inhibitors to Pierre Fabre SA in exchange for a $65 million up-front fee and could also earn up to $553 million in potential milestone payments, plus royalties on net sales.
Biontech SE has tapped into two of Duality Biologics Co. Ltd.’s antibody-drug conjugate candidates (ADCs), paying Duality $170 million up front and agreeing on development, regulatory and commercial milestone fees of $1.5 billion or more.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
The role of G protein-coupled receptor 35 (GPR35) in gastrointestinal (GI) diseases has been genetically validated for some time, with several pharmaceutical companies advancing programs designed to tackle the target; however, most of these efforts to date have focused on increasing GPR35 activity. ThirtyFiveBio’s approach is different: The newly founded virtual biotech company believes that antagonizing the target and thereby blocking unwanted GPR35 signaling may be a more appropriate way to address GI conditions, including digestive tract cancers.
Boehringer Ingelheim GmbH has agreed to pay Covant Therapeutics Inc. $10 million for exclusive rights to the latter’s ADAR1-targeting immuno-oncology program. Under the terms of the exclusive research collaboration and worldwide licensing agreement, newly unveiled drug discovery company Covant will carry out the preclinical work in creating an ADAR1 small-molecule inhibitor, with Boehringer offering its scientific expertise to help advance the program into the clinic.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
