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Approvals

Chiesi Committed To Becoming A Major Player In Rare Diseases

The Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.

Rare Diseases Metabolic Disorders Approvals
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Ultragenyx Gets Second Drug Approval; Crysvita With Kyowa Hakko Kirin

Ultragenyx already has a sales team in place to market its second commercial drug Crysvita (burosumab) – partnered with Kyowa Hakko Kirin – following its April 17 FDA approval for the treatment of pediatric and adult patients with x-linked hypophosphatemia (XLH).

Approvals Launches

Rigel Readies Tavalisse For Late-May Launch After FDA Approval

Rigel has its first US FDA approval for Tavalisse (fostamatinib) and plans to launch the drug for adults with immune thrombocytopenia (ITP) in late May, after working on the drug's development for more than a decade across multiple indications.

Approvals Immune Disorders

Pipeline Watch: Phase III Top-Line Results With Upadacitinib, Keytruda And Cosentyx

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events 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

Pacira Sees Big Opportunity In Exparel's Narrow Nerve Block Indication

Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.

Approvals Advertising, Marketing & Sales

FDA Tells RegeneRx It Needs 3rd Phase III Trial On RGN-259 For Dry Eye Syndrome

The FDA is requiring an additional RGN-259 Phase III trial to further show efficacy in both signs and symptoms of dry eye in a larger patient population.

Analysis Approvals

Roche Seen Offering NICE Further Price Cut For MS Drug Ocrevus

UK HTA provisionally tells Roche price for supplying MS blockbuster Ocrevus to the NHS not good enough – 'try again'.

Approvals Commercial
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