BioCentury | Aug 12, 2020
Deals

Single-asset KaNDy finds $425M exit as Bayer continues to build women’s health portfolio

Bayer’s $425 million takeout of menopause play KaNDy sends a signal to investors that women’s health can deliver a return. Private companies working in the space have long struggled to raise venture money. “Women’s health,...
BioCentury | Feb 26, 2020
Product Development

Subgroup analyses help Vanda hold steady despite Phase III itch miss

Vanda shares Wednesday mostly shrugged off a sharp decline in after-hours trading Tuesday after tradipitant missed the primary endpoint in the Phase III EPIONE trial to treat atopic dermatitis in patients with severe pruritus. Vanda...
BioCentury | Feb 26, 2020
Product Development

Feb. 25 Quick Takes: Vanda’s Phase III miss; plus Iovance; 1st-twoXAR; app for AFib, stroke; ICER-Aetion; new-look Purple Book, and more

Vanda’s itch therapy misses in atopic dermatitis Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares tumbled after market close Tuesday after tradipitant missed the primary endpoint in the Phase III EPIONE trial to treat atopic dermatitis in patients...
BioCentury | Sep 16, 2019
Company News

Sept. 16 Company Quick Takes: FDA accepts Seattle Genetics' BLA; plus Akynzeo, Purdue, Amplyx, Abbott-Sanofi

FDA to review enfortumab vedotin Seattle Genetics Inc. (NASDAQ:SGEN) and partner Astellas Pharma Inc. (JASDAQ:4503) said FDA has accepted a BLA and granted Priority Review to enfortumab vedotin for locally advanced or metastatic urothelial cancer....
BioCentury | Jun 7, 2019
Clinical News

NeRRe hopes to advance cough candidate despite Phase II miss

While NeRRe's orvepitant missed the primary endpoint of the Phase IIb VOLCANO-2 trial, the company believes the trial's patient-reported outcomes support advancement of the refractory chronic cough therapy into Phase III testing. On the trial's...
BioCentury | Jun 3, 2019
Product Development

There are opportunities to eradicate opioid misuse: Investors and innovators should seize them

Eradicating opioid misuse and addiction will take an integrated, holistic approach involving prevention, treatment, and recovery. Crucially, it will also take the help of investors and innovators in biotechnology who understand the challenges and opportunities...
BioCentury | Apr 5, 2019
Clinical News

Astellas' fezolinetant headed for Phase III

Astellas plans to start Phase III testing this year of fezolinetant to treat vasomotor symptoms in postmenopausal women after reporting that the therapy met the four co-primary endpoints in a Phase IIb trial. Astellas Pharma...
BioCentury | Feb 8, 2019
Company News

Vanda sues FDA over 'unnecessary' dog testing requirement

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) filed suit against FDA requesting a federal court lift a partial clinical hold the agency placed on tradipitant after Vanda refused to conduct a nine-month dog toxicity study. In an open...
BioCentury | Feb 6, 2019
Clinical News

Vanda sues FDA over 'unnecessary' dog testing requirement

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) filed suit against FDA requesting a federal court lift a partial clinical hold the agency placed on tradipitant after Vanda refused to conduct a nine-month dog toxicity study. In an open...
BioCentury | Jan 4, 2019
Financial News

Venture roundup: Cabaletta, Thousand Oaks, Sojournix

Autoimmune company Cabaletta Bio Inc. (Radnor, Pa.), CMC services play Thousand Oaks Biopharmaceuticals Inc. (Haimen, China) and women's health company Sojournix Inc. (Waltham, Mass.) each announced venture rounds of at least $44 million on Jan....
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