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Research & Development

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Roche Hit By Surprising Tecentriq Miss In TNBC

Tecentriq is the only checkpoint inhibitor to get approval for first-line TNBC but failure in a second study for that indication will encourage rival Merck & Co with Keytruda nearing approval.

Clinical Trials Companies ImmunoOncology

Clinical Trials

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Latest From Clinical Trials

Catalyst's Firdapse Expansion To Myasthenia Gravis In Doubt, LEMS Launch Disrupted By COVID-19

Sales & Earnings Clinical Trials

First Clinical Safety Study Starts For Newron's Evenamide

Following safety issues raised by the US FDA, no toxicity concerns have emerged in preclinical studies of Newron’s candidate schizophrenia therapy, evenamide, and a clinical safety study has started to evaluate its CNS effects.

Clinical Trials Neurology

Coronavirus Update: Japan Makes Moves On Vaccine Manufacturing

Takeda has linked up with COVID-19 vaccine frontrunner Novavax, while Daiichi Sankyo has been selected by Japan’s Ministry of Health, Labour and Welfare as an official participant under the first round of a national government initiative to build production capacity.

Coronavirus COVID-19 Clinical Trials

Q&A: BIO CEO Michelle McMurry-Heath Outlines Diversity Goals

Expanding on difficult conversations during the recent BIO Digital meeting, the group aims to take actions that will increase diversity and inclusion in health care, science and industry.

Clinical Trials Human Capital

Seres Aims To File C. Diff Microbiome Drug On Single Pivotal Trial

Competing with several other firms to bring the first microbiome-derived therapy to market, Seres says the magnitude of its Phase III efficacy compared to placebo may enough for registrational filing.

Clinical Trials Drug Approval Standards

Roche’s Etrolizumab Failure ‘Removes Big Pipeline Opportunity’

Roche’s etrolizumab missed primary endpoints in its Phase III study program evaluating it as maintenance therapy in moderately to severely active ulcerative colitis, a new therapeutic area for the firm.

Clinical Trials Companies
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Approvals

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Latest From Approvals

Russia Approves First COVID-19 Vaccine

The Russian ministry of health has raised eyebrows by approving a vaccine against SARS-CoV-2 just weeks after its first clinical trials in 76 volunteers. Phase III confirmatory studies await for the adenovirus-based product but a mass vaccination plan is slated to begin in October. 

Coronavirus COVID-19 Approvals

Roche’s Evrysdi Approved For SMA, Priced Below Competitors

Risdiplam’s efficacy across two clinical trials and oral dosing made it a credible threat before its US FDA approval, but its weight-based pricing falls below Biogen’s Spinraza and Novartis’s Zolgensma. 

Approvals Launches

Pipeline Watch: Phase III Readouts For Seladelpar, Fasinumab And Carbetocin

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

Hope For Price Flexibility After India Pretomanid Go-Ahead

Mylan gets approval in India for pretomanid as part of a combination regimen with bedaquiline and linezolid, providing new hope to patients with drug-resistant tuberculosis. Volume changes may provide opportunities to tweak prices.

Policy & Regulation India

GSK’s Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning

US FDA-approved belantamab mafodotin is indicated for heavily pre-treated multiple myeloma and has a list price of $23,900 per month. Its REMS could limit initial uptake, but response rates have been encouraging.

Approvals Launches

Morphosys/Incyte’s Monjuvi Wins Early US FDA Approval In Second-Line DLBCL

Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.

Approvals Cancer
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