00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
18:46 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
22:44 , Aug 21, 2018 |  BC Extra  |  Company News

Allergan uterine fibroids therapy hits regulatory setback

Allergan plc (NYSE:AGN) said FDA issued a complete response letter for its NDA for ulipristal acetate to treat abnormal uterine bleeding in women with uterine fibroids. The company said FDA requested additional information and cited...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
14:43 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

Sellas reports Phase IIb TNBC data for NeuVax combo

Sellas Life Sciences Group Inc. (NASDAQ:SLS) reported interim Phase IIb data showing that NeuVax nelipepimut-S plus Herceptin trastuzumab given in the adjuvant setting significantly improved median disease-free survival (DFS) in triple-negative breast cancer (TNBC) patients...
23:11 , Apr 2, 2018 |  BC Extra  |  Clinical News

Sellas rises on Phase IIb TNBC data

Sellas Life Sciences Group Inc. (NASDAQ:SLS) gained $5.20 (151%) to $8.65 on Monday after reporting interim Phase IIb data showing that NeuVax nelipepimut-S plus Herceptin trastuzumab given in the adjuvant setting significantly improved median disease-free...
18:35 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

FDA extends review for Allergan's ulipristal acetate

Allergan plc (NYSE:AGN) said FDA extended its review of an NDA for ulipristal acetate (Ella, ellaOne, PGL4001) to treat abnormal uterine bleeding in women with uterine fibroids. The company had previously expected a decision from...
20:45 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves AMAG's new Makena formulation

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past. AMAG plans...
22:42 , Feb 15, 2018 |  BC Extra  |  Company News

AMAG gets second FDA approval in two weeks

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past. AMAG jumped...
05:02 , Jan 19, 2018 |  BC Week In Review  |  Company News

Context acquires onapristone from Arno

Cancer company Context Therapeutics (Philadelphia, Pa.) acquired worldwide rights to Apristor onapristone XR from Arno Therapeutics Inc. (Flemington, N.J.) for an undisclosed one-time payment. In December, Arno announced that it would dissolve and turn over...