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Roche’s first-in-class one-dose antiviral Xofluza has been approved for marketing in the EU to treat influenza in patients aged 12 years or over, and for post-exposure prophylaxis.
Roche’s Phesgo may lower healthcare costs in Europe for treating breast cancer following its approval by European Commission. Other just-approved products nearing the EU market are ViiV’s Vocabria, to be used with Janssen’s Rekambys/Edurant, as a long-acting injectable HIV therapy, and Aimmune’s peanut allergy therapy, Palforzia.
The European Commission has extended the indications for Janssen’s Tremfya to include psoriatic arthritis, and those for BMS’s Opdivo to include gastroesophageal cancer.
Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor Jardiance (empagliflozin) reduces cardiovascular deaths and hospitalizations in certain heart failure patients regardless of whether they have diabetes, and regulatory submissions are expected for the additional indication later this year.
MyoKardia is building up its organization to prepare for commercialization of mavacamten, a potential first-in-class agent for obstructive hypertrophic cardiomyopathy.
The European Commission’s approval of GlaxoSmithKline’s Blenrep is one of the first major fruits of a refocused pipeline and development strategy at the big pharma company.
With the first approval in the bag for its lead product, Idefirix, from the European Commission, Sweden’s Hansa Biopharma is planning to launch the product in Europe using its own medical and commercial organization in core markets.
EU approval came quicker than expected for Vertex’s new triple-combination CFTR drug, Kaftrio.
Licensed from PharmaMar for the US market at the start of the year, Jazz Pharmaceuticals is hoping its new small-cell lung cancer therapy, Zepzelca (lurbinectedin), may have potential for other cancer types and in different combinations.
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