Approvals & Launches

The company anticipates potential sales in excess of $1bn for the late-onset Pompe disease drug by the end of the decade.

Chief operating officer Christina Rossi talked to Scrip about the company’s new blockbuster-sized commercial opportunity for Ayvakit and the company’s next phase: financial sustainability.

Getting on the best reimbursement pathway in the US will be vital for the UK company as it moves closer to approval and taking on the established players in the chronic obstructive pulmonary disease arena.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Boehringer expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.

The US FDA approved the JAK inhibitor momelotinib for myelofibrosis with anemia, with an analyst forecasting peak sales of more than $425m.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Sun debuts Pharmazz Inc’s new stroke drug sovateltide in India at under $20/ vial.  The selective endothelin-B receptor agonist, which can be administered up to 24 hours post cerebral ischemic stroke, is also being studied in Alzheimer’s disease.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The following four neurological products are likely to reach market next year. Carving out sales will be an entirely different problem. 

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The blockbuster-tipped eye therapy Syfovre has hit safety doubts and Apellis is streamlining to give more support to the drug’s global launch.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Putting aside access issues for Leqvio, Novartis has presented data showing that the small interfering RNA directed PCSK9 twice-a-year injection provides consistent low-density lipoprotein cholesterol reduction over six years and more.

As a first-line treatment for anemia in patients with myelodysplastic syndromes, Reblozyl is approved for indications that will account for 75%-80% of the $4bn-plus in sales Bristol has forecast by 2029.

The combination of Keytruda plus Eisai’s Lenvima combination may be reaching the limit of its potential, but the US giant’s blockbuster PD-1 therapy has plenty more opportunities to maintain its growth for the next five years.