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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.
Fundraising in the life sciences sector has been booming even as firms in many other industries are struggling to stay in business. Goodwin’s David Mardle is upbeat about the sector’s ongoing prospects – although M&A deals are currently proving tricky to complete.
Novartis will not start to compete in the increasingly crowded US multiple sclerosis marketplace with ofatumumab this month, as regulators extend the review process for the B-cell depleting therapy until September.
EU Approvals: Takeda advances its targeted ALK-positive NSCLC tyrosine kinase inhibitor into early lines of therapy, while Bayer and Finland’s Orion gain clearance for their androgen receptor inhibitor for prostate cancer.
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