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Home » Topics » Regulatory » Phase III

Phase III
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EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 5, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
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EMA validates two filings for Daiichi-Astrazeneca’s ADC

March 4, 2024
By Marian (YoonJee) Chu
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
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Syringe and ampoules

Sanifit seeks benefit in pivotal trial for rare calcification disorder

Feb. 14, 2020
By Michael Fitzhugh
Spain's Sanifit Laboratoris SL, a company developing treatments for calcification disorders, has dosed the first patient in a phase III trial of its lead asset, SNF-472, for the treatment of the rare and sometimes deadly disease calciphylaxis, a calcium accumulation disorder.
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Ritter struggles as its lead candidate fails phase III trial in lactose intolerance

Sep. 16, 2019
By Lee Landenberger
Ritter Pharmaceuticals Inc. is reeling from the phase III failure of its lead candidate, RP-G28, designed for patients with lactose intolerance. RP-G28 failed to demonstrate statistical significance in its primary endpoint as the top-line data showed it had no or little difference on patients compared to placebo. The data also show RP-G28 missed its secondary endpoints, all of which casts a shadow on the company and its pipeline.
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Tocagen shares trounced after phase III brain cancer trial results in 'clear miss'

Sep. 13, 2019
By Michael Fitzhugh
Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents Thursday after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.
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Aveo sees path to potential FDA filing for RCC drug in Tivo-3 study

Sep. 11, 2019
By Michael Fitzhugh
Aveo Oncology Inc. is moving closer to a potential NDA filing for its renal cell carcinoma (RCC) drug, tivozanib, following a recently conducted analysis of the ongoing phase III trial Tivo-3. Updated results evidenced "durable improvements" for study participants, all of whom have refractory metastatic RCC, said primary investigator Brian Rini. Company shares (NASDAQ:AVEO) climbed 30.9% to 92 cents Tuesday as Aveo said it would discuss the data with the FDA, which rejected the company's first attempt at approval in RCC in the summer of 2013.
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Hardly DRP in the bucket, Nuplazid's new indication rates Acadia blockbuster?

Sep. 10, 2019
By Randy Osborne
Good news from San Diego-based Acadia Pharmaceuticals Inc.'s phase III trial with Nuplazid (pimavanserin) in dementia-related psychosis (DRP) had analysts trotting out music metaphors in reports about the study called Harmony, while talking already about would-be sales of the drug, a selective serotonin inverse agonist and antagonist that preferentially targets the 5-HT2A receptor.
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Pharnext shares drop 40% as FDA requests second pivotal trial in CMT

Sep. 3, 2019
By Cormac Sheridan
DUBLIN – Shares in Pharnext SA plunged by more than 40% Friday on news that the FDA requires the company to undertake a second phase III trial of its Charcot-Marie-Tooth disease type 1A (CMT1A) therapy PXT-3003.
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O captain, Mycapssa! Bid by Chiasma nails phase III, oral acromegaly prize won

July 24, 2019
By Randy Osborne
Although the placebo response proved better than expected in Chiasma Inc.'s phase III trial of Mycapssa (octreotide) capsules for acromegaly, "we believe that the response of the patients on Mycapssa is the clinically relevant indicator," said William Ludlam, the Waltham, Mass.-based firm's senior vice president of clinical development and medical affairs.
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Not Accordion to plan, try in PD delivers Intec fizzle; phase III dosing too low?

July 23, 2019
By Randy Osborne
Given how many patients who completed the double-blind portion of the study opted into the extension segment and the quality of pharmacokinetic (PK) data, phase III testing of Intec Pharma Ltd.'s Accordion Pill (AP, carbidopa/levodopa [CD/LD]) against immediate-release CD/LD in Parkinson's disease (PD) seemed likely to ring the statistical significance bell.
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