Healthcare Roundup – FDA OKs new formulation of Regeneron and Sanofi’s Dupixent, COVID blows keep coming – Phillies close training facilities
FDA OKs new formulation of Regeneron and Sanofi’s Dupixent
Regeneron Pharmaceuticals (REGN +2.7%) and collaboration partner Sanofi (SNY +1.5%) announce the FDA nod for a 300 mg single-dose prefilled pen formulation of Dupixent (dupilumab) for certain patients at least 12 years old with atopic dermatitis, asthma or chronic rhinosinusitis with nasal polyposis.
The product will be commercially available in the U.S. next quarter.
COVID blows keep coming – Phillies close training facilities
The MLB’s Philadelphia Phillies confirms that five players and three staff members at the club’s Clearwater, FL facility have tested positive for COVID-19, with the first confirmed case coming this past Tuesday.
Twenty players (both major and minor leaguers) and twelve staff members are in the process of being tested.
The club declines to say how this news might affect plans for a 2020 season.
This report comes on top of Apple closing some stores in four states where COVID cases are back on the rise. Also, the WHO says the pandemic is accelerating after a record number of new cases yesterday.
Johnson & Johnson drops skin-whitening creams amid environment over race issues
Responding to the current global debate over racial inequality, Johnson & Johnson (JNJ +0.5%) has decided to stop selling its skin-whitening creams used primarily by women in the Middle East and Asia.
Its line-up of Clean & Clear Fairness products sold in India and its Neutrogena Fine Fairness line sold in Asia and the Middle East will be discontinued, although some may remain on retailers’ shelves for a time until inventories run out.
Unilever (UL +2.1%), Procter & Gamble (PG +0.6%) and L’Oreal (OTCPK:LRLCF +2.1%) sell similar products. None have commented yet on their respective plans according to Reuters.
Dosing underway in study of COVID-19 vaccine with Dynavax adjuvant
The first participants have been dosed in a Phase 1 clinical trial evaluating Clover Biopharmaceuticals’ S-Trimer COVID-19 vaccine candidate, SCB-2019, that contains Dynavax’s (NASDAQ:DVAX) CpG 1018 adjuvant.
The study will assess safety, reactogenicity and immunogenicity of SCB-2019 alone, in combination with the CpG 1018 adjuvant combined with alum and in combination with a different adjuvant at multiple dose levels in 150 adult healthy and elderly participants.
Based on preclinical results demonstrating the ability of CpG 1018-adjuvanted SCB-2019 to elicit neutralizing antibodies in multiple animal species, the collaboration, announced on March 24, has been expanded to include clinical supply of CpG 1018 to Clover.
Preliminary safety and immunogenicity results are expected in August 2020.
DVAX up 6% premarket on light volume.
MediPharm Labs Australia inks new supply deal with Vivo Cannabis
MediPharm Labs’ (OTCQX:MEDIF) Australian subsidiary has entered into an agreement to supply pharmaceutical-quality (GMP certified), formulated cannabis oil products to VIVO Cannabis (OTCQB:VVCIF) unit, Beacon Medical Australia Pty. Ltd. for further distribution under its own branding.
The agreement has an initial term of one year, subject to renewal.
MediPharm Labs Australia has also received a large shipment of 35,000 GMP units of formulated finished products and a large volume of bulk oil from its Barrie, Ontario facility to support commencement of sales revenue.