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 of...
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 to...
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...
17:40 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

TherapeuticsMD submits NDA for TX-001HR to treat menopause symptoms

TherapeuticsMD Inc. (NYSE-M:TXMD) submitted an NDA to FDA for TX-001HR estradiol/progesterone to treat moderate to severe vasomotor symptoms due to menopause. The candidate is an oral combination capsule of estradiol and progesterone using Symboda technology. TherapeuticsMD...
17:38 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

Agile gets second CRL for Twirla

Agile Therapeutics Inc. (NASDAQ:AGRX) said on Dec. 22, 2017, that FDA issued a second complete response letter for Twirla (AG200-15), a once-weekly transdermal contraceptive patch. Agile said the CRL "identifies deficiencies relating to quality adhesion...
16:51 , Dec 21, 2017 |  BC Innovations  |  Translation in Brief

Replacing the replacements

A Wake Forest team has developed a cell-based hormone replacement therapy that can control the hypothalamic-pituitary-ovarian axis with lower levels of estrogen than standard therapies, and could provide a solution to the side effects of...