Hold Rating for PTC Therapeutics Amidst Regulatory Hurdles with Translarna
Leerink Partners analyst Joseph Schwartz has maintained their neutral stance on PTCT stock, giving a Hold rating on October 11. Joseph ...
Pharmabiz1d
EMA re-confirms non-renewal of conditional marketing authorisation of Duchenne muscular dystrophy medicine, Translarna
EMA re-confirms non-renewal of conditional marketing authorisation of Duchenne muscular dystrophy medicine, Translarna: Amsterdam, The Netherlands Monday, October 21, 2024, 10:00 ...
The Pharma Letter1d
The week in pharma: action, reaction and insight – week to October 19
Last week’s significant news included Denmark-based CNS drugmaker Lundbeck reaching agreement to acquire US firm Longboard ...
ENDPOINTS NEWS3d
EMA again rec­om­mends against au­tho­riza­tion for PTC Ther­a­peu­tic­s' Translar­na
The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional ...
PharmTech3d
EMA Denies Authorization of Duchenne Muscular Dystrophy Treatment, Again
The agency has reconfirmed its recommendation to not give positive opinion to Translarna (ataluren) after a reexamination of the available data.
FiercePharma3d
EU drug reviewers back Novo Nordisk’s FDA-rejected hemophilia drug, snub PTC’s Translarna again
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...
PTC rebuffed again by EMA; Novartis licenses China-based biotech’s cancer drug
European regulators have for the fourth time issued a negative opinion on PTC's Translarna. Elsewhere, Amylyx read out data ...
PTC: CHMP Maintains Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna
PTC Therapeutics (PTCT) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has ...
PTC Therapeutics: CHMP Again Recommends Against Translarna Renewal
PTC Therapeutics has suffered another setback in its bid to keep its Duchenne muscular dystrophy drug Translarna on the market in Europe. PTC on Friday said the European Medicines Agency's Committee ...
Le Lézard3d
CHMP Maintains Negative Opinion on Translarnatm Reexamination
PTC Therapeutics, Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European ...
CHMP Maintains Negative Opinion on Translarna™ Reexamination
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal ...
The Pharma Letter4d
BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations
The committee also confirmed its previous recommendation to not renew the conditional marketing authorization for PTC Therapeutics (Nasdaq: PTCT) Translarna (ataluren). All the news that moves the ...