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Approvals & Launches

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Wet AMD Market Snapshot: A High-Growth Market Poised For Change

Regeneron's Eylea and Roche's Lucentis currently dominate the treatment market for wet-AMD and diabetic eye disease, but biosimilar ranibizumab and new brand launches are on the horizon.

Ophthalmic Market Intelligence

Pipeline Watch: Phase III Readouts In NSCLC, Ovarian Cancer And More

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

Pipeline Watch: Phase III Readouts In Asthma, NASH And More

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

Biogen Says Physician Debate About Aduhelm More ‘Pervasive’ Than Anticipated

CEO Michel Vounatsos and US president Alisha Alaimo outlined plans to overcome the Alzheimer’s drug’s launch challenges and hinted at lower sales expectations at a Morgan Stanley investor event.

Launches Reimbursement

JW Therapeutics Wins China’s Second CAR-T Approval

The approval of China's second CAR-T therapy has come amid reimbursement challenges, despite the pricing of its direct competitor being much lower than in the US. Chinese developers are pinning their hopes on rapid domestic market expansion via commercial insurance tie-ups as other CAR-Ts move through local development.

China Approvals

Pipeline Watch: Phase III Readouts In NSCLC, CKD And 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.

Pipeline Watch Approvals

Stock Watch: The Biotech Departure Lane From Europe

It is not only gene therapy companies that have found European payers hard to convince of the value of their products. Amarin’s proposed European pricing may lead to another US company exit.

Pricing Strategies Reimbursement

Anthos CEO On When Big Promo Efforts Are Needed, Telehealth's Acute Care Promise

Anthos Therapeutics’ CEO and ex-head of global commercial operations at Novartis Pharma, John Glasspool, tells Scrip there’s no "automatic premise" that the large promotional launch model is broken. He also outlines how teleconsultation is taking medicine back to its roots and "where it can be" as well, with patients less likely to get white coat syndrome. 

Commercial Digital Health

Five Hematology Drug Launches To Look Out For In 2022

In a series of articles, Scrip takes a look at some of the key novel products expected to reach the market in 2022 in a cross-section of therapy areas. Here, with input from Biomedtracker, are five new hematology products that could make their market debuts (or return) next year.

Approvals Companies

Pipeline Watch: Phase III Readouts in Wilson Disease, Parkinson's Disease And COVID-19

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

Amneal’s IPX-203 Increases ‘Good’ ON Time For Parkinson’s Patients

The proprietary carbidopa/levodopa formulation increased good ON time with fewer doses versus immediate-release levodopa. A post-hoc analysis also showed 1.55 hours more ON time per dose. 

Clinical Trials Strategy

Ascendis Will Take On Daily Genotropin With Weekly Skytrofa

Ascendis’s growth hormone deficiency drug Skytrofa will offer a convenience advantage as a weekly injectable. But the label does not clearly delineate superiority shown in a Phase III trial.

Approvals Pricing Strategies
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