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Research & Development

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More Surufatinib Cheer For Chi-Med As Second NET Trial Stopped Early

Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.

Cancer Clinical Trials China

Clinical Trials

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Latest From Clinical Trials

Kissei Discussing Rovatirelin Path After Mixed Phase III Results

Japanese firm in discussions with regulator as high-need novel therapy for spinocerebellar degeneration misses endpoint but shows promise in pooled analysis.

Japan Clinical Trials

Genentech’s SMA Type 1 Data Strengthen Case Backing Risdiplam Approval

With top-line data showing efficacy in type 1 SMA patients, risdiplam may be able to obtain a label that would address significantly more patients than Novartis’ Zolgensma. Final efficacy data will show how drug’s efficacy compares to Biogen’s Spinraza.

Clinical Trials Business Strategies

HanAll Advancing Novel Dry Eye Contender Despite Mixed Top-Line

HanAll and Daewoong remain upbeat on dry eye candidate HL036 and are gearing up for a second Phase III US study despite the first missing its primary endpoint in just-released top-line results.

Ophthalmic Clinical Trials

More Surufatinib Cheer For Chi-Med As Second NET Trial Stopped Early

Chi-Med’s surufatinib has come up trumps in a second trial in neuroendocrine tumors, after the monitoring committee recommended an early halt following achievement of its PFS target in the pancreatic setting.

Cancer Clinical Trials

J.P. Morgan Stockwatch: No Substitute For M&A

Stock market reaction to the first day’s news from the 38th J.P. Morgan Healthcare conference in San Francisco was negative, probably because expectations for a continuation of December’s bumper M&A bonanza were too high.

 

M & A Advisory Committees

Korean Pharma Highlights R&D Progress, 2020 Strategy At JPM

Among the Korean firms presenting at J.P. Morgan, Hanmi laid out its strategy for obesity and other core pipeline assets, Celltrion focused on its expanding biosimilar pipeline and China plans and LG Chem unveiled new R&D progress.

South Korea Business Strategies
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Approvals

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Latest From Approvals

JT Gains World-First Topical JAK Inhibitor Approval

Latest new drug approvals in Japan include the first anywhere for a topical JAK inhibitor and also a marketing clearance for a new contender in the large prostate cancer space.
Japan Approvals

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Approvals Business Strategies

J&J's Stelara Gets Europe OK For Pediatric Psoriasis

The European Commission has backed J&J's blockbuster to treat children with psoriasis but the drug has fallen foul of NICE for ulcerative colitis.

Immune Disorders EU

Horizon Sees Blockbuster Future For Tepezza After US Approval

Once a pariah because of its price gouging, the new approval represents a change of tack from Horizon.

Approvals Commercial

Novartis MS Drug Mayzent Gets Europe OK

Mayzent is the first oral treatment specifically indicated for patients with secondary-progressive multiple sclerosis and while it is expected to be a blockbuster, the company tells Scrip that educational programs for physicians are a priority.

Neurology Approvals

Pipeline Watch: Phase III Starts With EB-101, Tavapadon, Ziresovir

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
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