Reckitt’s Real Innovation at Mucinex Is the NDA, Not the Twelve Hours
Almost every OTC cold remedy is sold under the monograph system, which confers no protection at all. Reckitt spent a decade filing its way out.
Small Molecule
Indivior’s Holders Take 56.5% and $1 Billion, Supernus Takes the Name, the CEO and the Building
Indivior holders take 56.5% and a billion in cash. Supernus takes the name, the CEO and the building. Equals describes the board seats only.
Revtorpyk Got Its NCCN Category 1 Listing Two Months Before Celcuity Can Sell a Single Vial
The reimbursement case is being built before the product exists. Two gates remain, and a guideline solves neither.
NICE Backed Aficamten the Same Day the MHRA Authorised It, at a Price It Will Not Disclose
Concurrent MHRA and NICE decisions collapse the usual access gap to zero. Then read the conditions, because that is where the guidance lives.
AbbVie Took Two EU Approvals in One Day, Both for Diseases Payers Have Called Cosmetic
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.
A New Antibiotic Reached a Middle-Income Country Six Months After the US
Thailand approved a first-in-class oral antibiotic for gonorrhoea six months after the US, a benchmark for how fast new medicines can reach lower-income markets.
Europe Backs the Cholesterol Class That Failed Four Times
Europe recommended approval for a CETP inhibitor, a class with four prior failures, on LDL-lowering trials. The outcomes trial that decides it has not read out.