Pieris Pharmaceuticals Inc. is banking $20 million up front and could receive up to $1.4 billion more in preclinical, clinical and commercial milestones from a multi-program collaboration and license agreement in respiratory disease and ophthalmology with Genentech. Read More
Provention Bio Inc.’s diabetes candidate, teplizumab, is heading into a May 27 advisory committee meeting with a skinnier label than originally planned, which could signal a smoother path to approval. The positive briefing document the FDA put out Tuesday also suggested an approval path for what could be the first disease-modifying treatment available for type 1 diabetes (T1D). Read More
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17. Read More
The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap. Read More
San Diego-based Biotheryx Inc. has raised $92 million in series E financing led by Farallon Capital Management to advance multiple molecular glues, proteolysis-targeting chimeras and monovalent degraders toward the clinic. Its first molecular glue program, BTX-1188, is expected to enter the clinic by the end of this year. Read More
Vectivbio Holding AG’s IPO last month shone light on short bowel syndrome (SBS), where the company has advanced the glucagon-like peptide-2 analogue apraglutide to the phase III stage. The company aims to show an advantage over same-class Gattex (teduglutide) from Takeda Pharmaceuticals Co. Ltd., cleared by the FDA in December 2012 for adults with SBS and in May 2018 for children at least 1 year of age. Read More
HONG KONG – Mitoimmune Therapeutics Inc., a company that earlier this year completed a ?27.5 billion (US$24.41 million) series B financing led by Korea Development Bank, has received investigational new drug approval in the U.S. for MIT-001, its anti-inflammatory and anti-necrotic agent, moving the company a step closer to entering the clinic. Read More
With a number of Medicare coverage policies in flux, the U.S. Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator, closing out one more critical remaining position for the Biden administration at the Department of Health and Human Services. Still unannounced is the administration’s nominee to lead the FDA, an omission that becomes more conspicuous with each passing day. Read More
Global regulatory activity in 2021 has risen by 25% over this time last year, but the proportion of the activity associated with COVID-19 has dropped in recent months. Read More
The Institute for Clinical and Economic Review (ICER) will turn its magnifying glass on insurance companies as it evaluates how 15 of the largest U.S. payers cover 28 cost-effective prescription drugs. Read More
New hires and promotions in the biopharma industry, including: Abeona, Acelyrin, Adare, Aicuris, Antengene, Atyr, Auravax, Coya, Decibel, Innoskel, IO Biotech, Longeveron, Lytix, Nucleome, Praxis, Turning Point, Vectivbio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Eyenovia, Flugen, Incyte, Innovent, Moderna, Moleculin, Nordic Nanovector, Oncopeptides, RDIF, Sobi, Tavanta, Telix, Tiziana. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Ascletis, Asklepios, Idorsia, Janssen, Optimus, Pharmather, Provention, Sandoz, Scholar Rock, TG, Therapeuticsmd, TLC. Read More
