Breaking News

VectivBio Announces Successful Opening of US IND for Apraglutide for Acute Graft-Versus-Host Disease

STARGAZE, a Phase 2, randomized, double-blind study, will assess the safety, tolerability, pharmacokinetic profile and efficacy of apraglutide in patients with steroid-refractory aGVHD. Dosing of the first patient is expected in 1Q 2022. Interim data read out is anticipated for 2H 2022.

UCB to License its AI Technology to ImageBiopsy Lab

Currently more than two-thirds of vertebral fractures are undiagnosed. Identifying them systematically has proven to be challenging for all clinicians. ImageBiopsy Lab will integrate UCB's...

LumiraDx receives approval for its COVID-19 Antigen Test for use in India

Test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of COVID-19

New Acquisitions & Mergers

Biotage Acquires ATDBio

The acquisition of ATDBio adds important platform solutions to Biotage within DNA and RNA oligonucleotide synthesis and purification.

KSL Biomedical, Inc. Announces Expansion to Canada with Acquisition of Pulse Scientific

Pulse Scientific is located on the shores of Lake Ontario between Toronto and Niagara Falls in Burlington, Ontario

Growth / Development

Sequential Skin Raise US $1.65M in Oversubscribed Seed Round

This latest investment brings the total venture funding raised by Sequential Skin to US $2.15M in 2021.

NeuroBo Pharmaceuticals Closes $14 Million Registered Direct Offering

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering

Clinical Trials

Active Biotech and NeoTX: 1st Patient Enrolled in the Phase IIa Clinical Trial of Naptumomab Estafenatox in Combination with Docetaxel in Patients with Advanced...

“We are very pleased that NeoTX takes the next step in the development of Naptumomab in NSCLC, a disease with a high unmet medical need, and are excited to follow the progress of the trial.” says Helén Tuvesson, CEO, Active Biotech AB.

Pulmotect Reports Positive Topline Results from Randomized, Placebo Controlled Phase-2 Trial of PUL-042 Against COVID-19

Statistically significant reduction in time to the improvement of respiratory symptoms. Fewer hospitalizations and intensive care admissions.

Executives on the Move

Opus Genetics Announces 2 Key Leadership Appointments

Opus Genetics, a patient-focused gene therapy company developing treatments for orphan inherited retinal diseases, today announced two key appointments to its founding executive team. Ash Jayagopal, Ph.D., has joined the company as Chief Scientific Officer (CSO) and Joe Schachle has joined as Chief Operating...

Mike Hicks Appointed Chief Technology Officer of ValGenesis

Before joining ValGenesis, Mike served as the Chief Product & Technology Officer of Intelex Technologies and currently serves as a growth advisor for multiple startups.

BioMarin New Hires

Consistent with BioMarin's regular planning, Dr. Bernstein will succeed Geoff Nichol M.B. Ch.B., MBA, FRACP, who has served for almost five years making significant contributions to the Company's clinical development program including three product approvals.  Dr. Nichol will remain at the Company to assist with the transition and to serve in an advisory capacity on late stage clinical programs. 

FDA Cleared Devices & News

Stealth BioTherapeutics Receives Refusal to File Letter from the FDA

Elamipretide was previously granted rare pediatric designation, fast track designation, and orphan drug designation by the FDA, and orphan drug designation by the European Medicines Agency (EMA), for the treatment of Barth syndrome. 

OpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

The Acuitas® AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens.

Pharma