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Approvals & Launches

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Amicus Piggybacks Off Galafold Commercial Infrastructure For Pombiliti + Opfolda Launch

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

Approvals Launches

Blueprint’s Evolution On Its Path To Financial Sustainability

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.

Launches Business Strategies

What Verona Needs To Make COPD Drug Ensifentrine A Success

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.

Respiratory Business Strategies

Pipeline Watch: Nine Approvals And Nine Phase III Trial Updates

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.

Pipeline Watch Approvals

Jardiance Improves Double-Digit Growth Potential With US Approval In CKD

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.

Approvals Launches

GSK’s Ojjaara Scores Myelofibrosis Nod After Round-The-World Journey

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

Approvals Cancer

Pipeline Watch: Five Approvals And 28 Phase III Updates

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.

Pipeline Watch Approvals

Sun Backs India-First Stroke Drug From Pharmazz

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.

Commercial India

Pipeline Watch: Five Approvals And 20 Phase III Trial Updates

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.

Pipeline Watch Approvals

Schizophrenia, Depression And Neuropathy: What’s Coming In 2024

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

Approvals Neurology

Pipeline Watch: 7 Approvals And 19 Phase III Updates

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.

Pipeline Watch Approvals

Apellis Slashes Costs To Focus On Troubled Syfovre Launch

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

Restructuring Launches

Pipeline Watch: 15 Approvals And 21 Phase III Trial Updates

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.

Pipeline Watch Approvals

Novartis Lauds Long-Term Benefits Of Leqvio At ESC

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.

Cardiovascular Clinical Trials

BMS Broadens Market, De-Risks Long-Term Revenue Potential For Reblozyl

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.

Approvals Launches

Another Phase III Failure For Lenvima Combo, But Lots More Room For Keytruda Growth

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.

Cancer Approvals
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