BioCentury | May 6, 2020
Product Development

May 5 Quick Takes: Data propel Adverum, TG, Akebia stocks; plus Tolmar, SRI-Exscientia, Sino-GeoVax

TG’s combo meets Phase III leukemia endpoint  TG Therapeutics Inc. (NASDAQ:TGTX) climbed $4.23 (34%) to $16.69 on Tuesday after CD20 inhibitor ublituximab plus PI3Kδ inhibitor umbralisib met the primary endpoint of progression-free survival (PFS) in...
BC Extra | Nov 19, 2019
Clinical News

Big gain for Myovant as oral prostate cancer therapy heads for submission

Myovant shares more than doubled in value Tuesday after the company revealed Phase III data showing its oral GnRH receptor antagonist relugolix led to sustained testosterone suppression in 96.7% of prostate cancer patients in Phase...
BC Week In Review | Feb 15, 2019
Clinical News

Xtandi reduces radiographic PFS by 61% in metastatic hormone-sensitive prostate cancer

Astellas Pharma Inc. (Tokyo:4503) and Pfizer Inc. (NYSE:PFE) reported that Xtandi enzalutamide plus androgen deprivation therapy (ADT) reduced the risk of radiographic progression or death, the primary endpoint, by 61% vs. ADT alone in the...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
BC Week In Review | Aug 31, 2018
Clinical News

Pfizer, Astellas speed up Phase III trials of Xtandi in hormone-sensitive prostate cancer

Astellas Pharma Inc. (Tokyo:4503) and Pfizer Inc. (NYSE:PFE) amended the Phase III ARCHES and EMBARK trials of Xtandi enzalutamide to treat hormone-sensitive prostate cancer and now expect to complete both trials sooner than previously guided....
BC Week In Review | Feb 9, 2018
Clinical News

Pfizer, Astellas report detailed data for Xtandi in non-metastatic CRPC

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) reported detailed data from the Phase III PROSPER trial to treat non-metastatic castration-resistant prostate cancer (CRPC) showing that once-daily 160 mg oral Xtandi enzalutamide plus androgen deprivation...
BC Extra | Feb 8, 2018
Politics & Policy

FDA facilitating generic versions of complex drugs

FDA released new guidance documents Thursday that are intended to facilitate generic competition for “complex,” hard-to-copy drugs. It issued product-specific guidance on 19 complex medicines, including six that have no generic competition. The drugs are...
BC Extra | Feb 5, 2018
Clinical News

Pfizer, Astellas report detailed data for Xtandi in non-metastatic CRPC

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) reported detailed data from the Phase III PROSPER trial to treat non-metastatic castration-resistant prostate cancer showing that Xtandi enzalutamide plus androgen deprivation therapy led to median metastasis-free...
BC Week In Review | Sep 15, 2017
Clinical News

Xtandi meets in Phase III for non-metastatic CRPC

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) reported top-line data from the Phase III PROSPER trial in about 1,400 patients with non-metastatic castration-resistant prostate cancer (CRPC) showing that once-daily 160 mg oral Xtandi enzalutamide...
BC Extra | Sep 14, 2017
Clinical News

Xtandi meets in Phase III for non-metastatic CRPC

Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (Tokyo:4503) said Xtandi enzalutamide plus androgen deprivation therapy met the primary endpoint of improving metastasis-free survival (MFS) compared to androgen deprivation therapy alone in the Phase III PROSPER...
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