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Approvals & Launches

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Pipeline Watch - ADD Meeting Dominates Phase III Readouts

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

Pharming’s Portfolio Grows As Ultra-Rare Disease Drug Joenja Is Approved

The first ever approval for ultra-rare immunodeficiency disease APDS gives Pharming its second product on the market but patient diagnosis will be a major challenge.

Commercial Companies

Cidara’s Novel Antifungal Approved For Antimicrobial-Resistant C. Auris Infections

Cidara’s US commercial partner Melinta will launch the novel echinocandin this summer, announcing pricing shortly before rollout. Limited indication follows recommendation of FDA advisory panel.

Approvals Business Strategies

Incyte’s US Approval For PD-1 Inhibitor Zynyz In MCC Draws Muted Response

The US firm’s Zynyz has won accelerated approval for the treatment of first-line Merkel cell carcinoma, bouncing back from a prior regulatory setback, but its third-to-market status leaves it with the crumbs under the table in this orphan indication.

Approvals Companies

Pipeline Watch: Eight Approvals And 12 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

Acadia’s Daybue Gets First Approval In Rett Syndrome

Daybue is the first drug approved to treat the rare neurodevelopmental disorder Rett syndrome, despite high clinical trial incidence of diarrhea. Product labeling includes clinician guidance for the side effect.

Approvals Rare Diseases

Pipeline Watch: ACC Meeting Dominates Clinical Updates Plus Four New Approvals

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 Clinical Trials

Pfizer’s Blockbuster Migraine Portfolio Plan On Track With Zavzpret Approval

Pfizer plans to build on the momentum gained for its oral drug Nurtec ODT, now the leading CGRP inhibitor, with the intranasal Zavzpret, which will be priced in line with the rest of the class. 

Approvals Launches

Aldeyra All Set For Double Date With The FDA

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

Ophthalmic Drug Review

Ferring Reflects On Fruitful 2022 As Filing Costs Hit Profits

While reproductive medicine and maternal health remains the mainstay for the Swiss group, Ferring president Per Falk says the approvals of the microbiome treatment Rebyota and bladder cancer gene therapy Adstiladrin represent "important avenues for exploration and growth."

Sales & Earnings Business Strategies

Weight Watchers Weighs In On Obesity Drugs, Offering Valuable Validation

WW International’s decision to move into pharmaceutical weight management could build commercial momentum for Novo Nordisk’s Wegovy and Lilly’s Mounjaro.

Advertising, Marketing & Sales Launches

Esperion Preps Nexletol/Nexlizet To Be ‘Clear Next Step’ After Statins

The company plans to ramp up its commercial infrastructure later this year, ahead of a labeling update based on positive cardiovascular outcomes trial data.

Cardiovascular Clinical Trials
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