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Albireo Pharma, Inc.: Albireo Receives Positive CHMP Opinion for Bylvay (odevixibat) for Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)

- Bylvay has the potential to become first approved drug to treat all forms of PFIC - - CHMP opinion is based on the PEDFIC Phase 3 studies - - PEDFIC 1 met the bile acid (P=0.003) and pruritus ....

United States , City Of , United Kingdom , Colleen Alabiso , Richard Thompson , Hans Vitzthum , Ron Cooper , Lisa Rivero , Albireo Pharma Inc , Lifesci Advisors , European Commission , Pediatric Committee , Resource Network , United States Or European Union , Exchange Commission , Committee For Medicinal Products Human , European Union , European Medicines Agency , Committee For Medicinal Products Human Use , Access Program , Medicinal Products , Human Use , Chief Executive Officer , Molecular Hepatology , College London , Priority Review ,

Rhythm Pharmaceuticals, Inc.: Rhythm Pharmaceuticals Receives Positive CHMP Opinion for Setmelanotide for Treatment of Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency

European Commission decision anticipated in JulyBOSTON, May 21, 2021 (GLOBE NEWSWIRE) Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company committed to transforming ....

United States , France General , Adam Daley , Hannah Deresiewicz , David Meeker , David Connolly , Stern Investor Relations Inc , European Commission , Drug Administration , Rhythm Pharmaceuticals , Exchange Commission , Rhythm Pharmaceuticals Inc , Nutriomics Laboratory , Berry Company Public Relations , Corporate Communications , European Medicines Agency , Committee For Medicinal Products Human Use , Medicinal Products , Human Use , Sorbonne Universit , Chief Executive Officer , Data Supporting Positive , Pivotal Data , About Rhythm , Rhythm Engine , Sexual Arousal ,

Boehringer Ingelheim: CHMP issues positive opinion for Jardiance (empagliflozin) for the treatment of adults with heart failure with reduced ejection fraction

The positive opinion is based on the EMPEROR-Reduced trial, which showed a significant 25 percent reduction in the combined relative risk of cardiovascular death or hospitalization for heart failure ....

Faiez Zannad , Waheed Jamal , Greg Kueterman , Stefanie Molkenthin , Eli Lilly , Jeff Emmick , Product Development , University Of Lorraine , European Medicines Agency , European Commission , Boehringer Ingelheim , Committee For Medicinal Products Human Use , Medicinal Products , Human Use , Emeritus Professor , Marketing Authorisation , Corporate Vice President , Cardiometabolic Medicine , Vice President , Communication Manager , வீத் ஜமால் , எலி லில்லி , ஜெஃப் எம்மிக்க் , ப்ராடக்ட் வளர்ச்சி , பல்கலைக்கழகம் ஆஃப் லோரெய்ன் , ஐரோப்பிய தரகு ,

Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze

Janssen Gets Two Positive CHMP Opinions For Darzalex Subcutaneous Formulation Utilizing Enhanze
NEW BRUNSWICK (dpa-AFX) - Janssen Pharmaceutica received two positive opinions from the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA recommending to broaden the existing marketing authorization for the DARZALEX or daratumumab subcutaneous formulation, which uses ENHANZE technology, in two new indications, Halozyme Therapeutics Inc. (HALO) said in a statement.
One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone, for the treatment of adult patients with newly diagnosed systemic light chain amyloidosis.
The second recommendation is for the use of daratumumab subcutaneous in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalido ....

Janssen Pharmaceutica , Committee For Medicinal Products Human , European Medicines Agency , Halozyme Therapeutics Inc , Medicinal Products , Human Use , Halozyme Therapeutics , குழு க்கு மருத்துவ ப்ராடக்ட்ஸ் மனிதன் , மருத்துவ ப்ராடக்ட்ஸ் , மனிதன் பயன்பாடு ,

DGAP-News: SphingoTec Accelerates Growth with Direct Sales

DGAP-News: SphingoTec Accelerates Growth with Direct Sales
vom 20.05.2021, 10:00 Uhr
Bild: pixabay.com
SphingoTec Accelerates Growth with Direct Sales
20.05.2021 / 10:00
The issuer is solely responsible for the content of this announcement.
SphingoTec to expand the commercialization strategy by establishing a sales division and appointing new head of sales
Tailored diagnostic solutions for point of care use
Innovative proprietary biomarkers and standard parameters available on the fully automated Nexus IB10 platform
Hennigsdorf/Berlin, Germany, May 20, 2021 - Diagnostics company SphingoTec GmbH ( SphingoTec ) announces an expansion of its go-to-market strategy to scale its sales in Germany by creating a direct sales force for its integrated diagnostic solutions. SphingoTec will sell directly to healthcare providers its Nexus IB10 point of care platform together with a broad portfolio of assays. The rapid tests include commonly used parameters ....

San Diego , United States , Andreas Bergmann , Sphingotec Gmbh , Steffen Hohmann , Sphingotec Gmb , Ruxandra Lenz , Corporate Action Strategic Company Decision , Nexus Dx Inc , Distribution Services , Strategic Company Decision , Tec Accelerates Growth , Direct Sales , Dipeptidyl Peptidase , Tec Gmbh , Manager Marketing , Corporate News , Regulatory Announcements , Dgap News , Action Strategic , சான் டியாகோ , ஒன்றுபட்டது மாநிலங்களில் , ஆண்ட்ரியாஸ் பெர்க்மேன் , நெக்ஸஸ் ட்க்ஸ் இன்க் , விநியோகம் சேவைகள் , மூலோபாய நிறுவனம் முடிவு ,