DGAP-Ad-hoc: PAION AG / Key word(s): Miscellaneous
PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION
29-Jan-2021 / 11:20 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO
(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION
- Positive CHMP opinion based on the data from a comprehensive clinical program in procedural sedation in adult patients undergoing bronchoscopy or colonoscopy
- Final decision on MAA expected in the first half of 2021
Karyopharm Receives Positive CHMP Opinion for NEXPOVIO® (selinexor) for the Treatment of Patients with Refractory Multiple Myeloma European Commission Decision Anticipated by April 2021
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NEWTON, Mass., Jan. 29, 2021 /PRNewswire/ Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the conditional approval for NEXPOVIO® (selinexor) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
CHMP Issues Positive Opinion Recommending Ofatumumab in Relapsing Multiple Sclerosis
Genmab A/SJanuary 29, 2021 GMT
Company Announcement
Novartis receives positive CHMP opinion for subcutaneous ofatumumab for adult patients with relapsing forms of multiple sclerosis
Opinion based on Phase 3 ASCLEPIOS I and II studies
Copenhagen, Denmark; January 28, 2021 – Genmab A/S (Nasdaq: GMAB) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Novartis submitted the Marketing Authorization Application for ofatumumab in this indication in January 2020. Ofatumumab is being developed and marke
(2) DJ EQS-News: Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM EQS-News / 28/01/2021 / 10:33 UTC+8 Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM Shanghai and Hong Kong, PRC, January 28, 2021 Antengene Corporation Limited ( Antengene , SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and /or best-in class therapeutics in hematology and oncology, announced that the National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for ATG-010 (Selinexor, XPOVIO(R)), a first-in-class oral selective inhibitor of nuclear export (SINE) compound, for the treatment of patients with relapsed/refractory multiple myeloma ( rrMM). This is the fifth NDA for ATG-010 submitted by Antengene, after the four NDAs recently submitted in Australia, South Korea, Singapore and Hon
PAION AG
ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
DGAP-News: PAION AG / Key word(s): Product Launch
PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
28.01.2021 / 07:06
The issuer is solely responsible for the content of this announcement.
PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
- Approximately 40 million procedures take place annually in the U.S. that require the use of procedural sedation