23:44 , Jun 19, 2019 |  BC Extra  |  Company News

Management tracks: Ultragenyx promotes Erik Harris to EVP, COO; plus F-star, Arbutus, Maze and more

Rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) promoted Erik Harris to EVP and chief commercial officer from SVP, head of North American commercial operations. Bispecific antibody company F-star Biotechnology Ltd . (Cambridge, U.K.) said CFO...
23:07 , Apr 29, 2019 |  BC Extra  |  Company News

April 29 Quick Takes: Takeda, Emendo, ViiV, Zynquista, Benlysta and more

Takeda considering value-based pricing in EU  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) is mulling employing a value-based pricing model in Europe for Alofisel darvadstrocel, a stem cell therapy to treat complex perianal fistulas in patients...
22:52 , Apr 26, 2019 |  BC Extra  |  Company News

European regulatory roundup: CHMP opinions and a Portola approval

EMA's CHMP recommended a basket of approvals, including Dovato dolutegravir/lamivudine, Libtayo cemiplimab and two orphan therapies. Also Friday, the European Commission granted conditional approval to Ondexxya andexanet alfa from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) to reverse...
18:55 , Apr 12, 2019 |  BC Week In Review  |  Company News

FDA approves ViiV's two-drug HIV regimen

FDA approved Viiv's Dovato dolutegravir/lamivudine for HIV-1 infection in treatment-naïve adults. The product is a once-daily, single-tablet regimen of dolutegravir and lamivudine that the company plans to launch in 2-3 weeks at a wholesale acquisition...
19:40 , Mar 19, 2019 |  BC Extra  |  Politics & Policy

FDA issues guidances for long-acting PrEP, pediatric HIV drug development

FDA released final versions of two guidances Tuesday aimed at developing drugs for pediatric HIV patients and for pre-exposure prophylaxis (PrEP), which HHS Secretary Alex Azar said was in line with the Trump administration's HIV...
17:44 , Mar 15, 2019 |  BC Week In Review  |  Clinical News

ViiV planning submissions this year for two-drug HIV regimen

ViiV said it plans to submit regulatory applications this year for a once-monthly two-drug regimen comprising cabotegravir and Johnson & Johnson's Edurant rilpivirine to treat HIV-1 infection. ViiV Healthcare Ltd. (Brentford, U.K.) disclosed its plans...
15:48 , Feb 28, 2019 |  BC Innovations  |  Distillery Therapeutics

Neurology; inflammation

INDICATION: Stroke; shock/trauma Patient and mouse studies suggest inhibiting CCR5 could help treat stroke and traumatic brain injury (TBI). In stroke patients, the absence of a loss-of-function mutant CCR5 allele was associated with the severity...
21:58 , Feb 21, 2019 |  BC Extra  |  Preclinical News

Repurposing an HIV target could aid brain injury recovery

Extending CCR5 inhibition beyond treating HIV/AIDS, UCLA researchers showed that blocking CCR5 could promote recovery from stroke and traumatic brain injury (TBI). CC chemokine receptor 5 (CCR5; CD195) is well known for its role in...
00:50 , Jan 5, 2019 |  BC Extra  |  Company News

Flurry of management moves on eve of JPM

More than 30 biopharma companies announced executive changes to kick off the New Year, including Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) and Immunocore Ltd. (Abingdon, U.K.), both of which brought on former AstraZeneca plc (LSE:AZN; NYSE:AZN) executives...
19:25 , Dec 21, 2018 |  BC Week In Review  |  Company News

GSK, Pfizer JV allows both pharmas to focus on innovation

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) took the first step toward splitting up the pharma's consumer healthcare and innovative R&D businesses by agreeing to form a consumer healthcare joint venture with Pfizer Inc. (NYSE:PFE). The British pharma...