Apellis, CHMP
Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy,
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan In Geographic Atrophy, Stock Down
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the
Apellis: CHMP Once Again Recommends Against Syfovre
The CHMP initially adopted a negative opinion in January after finding it was unable to establish a positive balance of benefits and risks for Syfovre, but Apellis sought a re-examination and was able to submit new data in support of its application following an unrelated court ruling in Europe.
Apellis Pharmaceuticals declines afters CHMP's third negative opinion on Syfovre
European regulators on Friday upheld its negative opinion on Apellis Pharmaceuticals' (NASDAQ:APLS) proposed treatment for its eye disease therapy for the third time this year. Apellis reported that the Committee for Medicinal Products for Human Use,
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the profound impact this medicine has had for GA patients in the U.
Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult pati…
HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...
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NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk A/S NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) ...
AbbVie Gets CHMP Backing for Elahere in Ovarian Cancer
Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...
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Pfizer/BioNTech Get CHMP Nod for Omicron KP.2 EU Vaccine
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing ...
Medindia17h
Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
HANSIZHUANG (serplulimab) is the world's first anti-PD-1 mAb for first-line treatment of ES-  SCLC   - HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 ...
Medscape1d
Hympavzi Approved in Europe for Severe Hemophilia A and B
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of ...
Merck Receives Positive EU CHMP Opinions for KEYTRUDA® (pembrolizumab) Regimens as Treatment for Patients With Two Types of Gynecologic Cancers
Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced ...
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Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents
COPENHAGEN, Denmark I 19, 2024 I Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has adopted the Committee for ...