LONDON – Evox Therapeutics Ltd. has validated its exosome drug delivery technologies in a $882 million deal with Takeda Pharmaceutical Co. Ltd., in which the partners will develop protein replacement and messengerRNA (mRNA) therapies in five rare disease indications. As an indicator of the potential therapeutic power of exosome delivery, the lead program in the collaboration rests on the ability of exosomes to cross the blood-brain barrier and deliver a correct copy of the NPC1 gene, to treat the inherited neurodegenerative disorder, Niemann-Pick type C. Read More
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS. Read More
The stimulus bill passed by the U.S. Senate March 26 on a vote of 96-0 does more than throw $2.2 trillion into the war against COVID-19. “This is not … a stimulus package. It is emergency relief,” Senate Majority Leader Mitch McConnell (R-Ky.) said on the Senate floor before the vote. Read More
Oncopeptides AB remains on track for an NDA filing in the second quarter for its peptide-drug conjugate, melflufen, in relapsed refractory multiple myeloma (RRMM). Read More
During the conference call on earnings in March, CEO Dror Harats told investors that “the most important thing” about VBL Therapeutics Ltd.’s then-upcoming analysis of interim phase III data with gene therapy VB-111 (ofranergene obadenovec) is that it was “designed in a way that will enable us to tell the market if we are at least as good as what we've seen” in the phase II experiment. Read More
Privately held Recode Therapeutics Inc. brought in $80 million through an oversubscribed series A financing with plans to continue its preclinical work in primary ciliary dyskinesia (PCD) and cystic fibrosis (CF). Read More
BEIJING – Suzhou-based Innovent Biologics Inc. has inked a deal with Alector Inc. to obtain the rights of the U.S. biotech’s AL-008, a dual function anti-SIRP-alpha (anti-signal regulatory protein-alpha) antibody, to develop and commercialize it for oncology indications in China. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: BMS, Bolt, Decibel, Healios, Imcheck, Inovio, Ipsen, Ironwood, Medimetriks, Oncopeptides, Otsuka, Qurient, Tolero, Uniqure, VBL. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, APR, Arvelle, Astrazeneca, BMS, Innocoll, Intercept, Jazz, Orphan Technologies, Pear, Recordati, Relief. Read More