FDA OKs Cooper contact lens that slows progression of nearsightedness in children
The FDA approves Cooper Companies (NYSE:COO) unit CooperVision’s MiSight contact lens, the first in the U.S. indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 at the start of treatment.
The disposable lens is designed for single use, to be discarded at the end of each day.
Trump set to announce updated hospital/insurer transparency rule today
Hospital operators and health insurers may experience volatility today when the Trump administration releases its updated price transparency rule at 2 pm ET.
On November 3, the White House announced that it was postponing implementation to allow time to include the latter.
Hospital groups vociferously oppose the rule, aimed at driving costs down, citing the “trade secret” nature of negotiated rates with payers
FTC on board with Bristol-Myers/Celgene tie-up on Otezla sale
The U.S. Federal Trade Commission (FTC) says Celgene’s (CELG) divestment of psoriasis med Otezla (apremilast) will settle its charges that its planned merger with Bristol-Myers Squibb (NYSE:BMY) would violate federal antitrust law.
About three months ago, the company announced that it had agreed to sell global rights to Amgen (NASDAQ:AMGN) for $13.4B in cash.
The PDE4 inhibitor accounted for ~12% of Celgene’s Q3 product sales.
FDA OKs Novartis’ crizanlizumab for sickle cell disease
Under Priority Review status, the FDA approves Novartis’ (NVS +0.7%) Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in patients at least 16 years old with sickle cell disease (SCD).
Vaso-occlusive crisis is a painful complication of SCD that arises when microcirculation in obstructed by sickled red blood cells. It is the most common reason for emergency room visits and hospital admissions in these patients.
Crizanlizumab is a humanized monoclonal antibody that binds to a protein on the surface of platelets and endothelium in blood vessels called P-selectin which plays a key role in the vaso-occlusive process.
Roche to acquire Promedior for up to $1.39B
Roche (OTCQX:RHHBY +0.3%) has agreed to acquire Lexington, MA-based Promedior, a clinical-stage developer of therapies for fibrotic diseases, for up to $1.39B.
Specifically, Roche will pay $360M in upfront cash plus up to $1.00B in milestones.
Promedior’s lead candidate is Phase 3-stage PRM-151, a recombinant form of a protein called pentraxin-2, for the potential treatment of idiopathic pulmonary fibrosis and myelofibrosis.
The company say pentraxin-2 acts as an agonist to turn on a fibrosis resolution pathway via regulatory macrophages (type of immune cell) while simultaneously turning off a pathway mediated by pro-inflammatory and pro-fibrotic macrophages.
