Month: October 2018

Biocardia, CellProThera & SlngXpand Collaborates to Develop and Commercialize CD34+

  Shots: SlngXpand will conduct clinical studies of expanded in vitro expanded peripheral blood CD34+ stem cells, CellProThera will fund the clinical studies and to receive exclusive commercialization rights of Biocardia’s Helix Biotherapeutic Delivery System in Singapore Biocardia to get royalties on sales of product from CellProThera. The expanded CD34+ stem cells are processed by […]Read More

Gilead Reports Results of Biktarvy (Bictegravir, Emtricitabine, Tenofovir Alafenamide) in

Shots: The P-III 1490 Study involves assessing of Biktarvy (BIC 50/FTC 200/TAF 25mg tablets) vs dolutegravir and emtricitabine/tenofovir alafenamide (50 mg) (DTG+FTC/TAF) in ratio (1:1) patients with HIV-1 naive to HIV therapy in adults for 96 wks. P-III Study 1490 results: HIV-1 RNA levels less than 50 copies/mL 95%; well-tolerated with low discontinuations @48 wks. […]Read More

AstraZeneca Divests Rights of its Nexium and Vimovo Product to

Shots: AZ will receive an upfront $700M & $115M plus milestone payments up to $90M & $17M for Nexium (esomeprazole) and Vimovo (naproxen/esomeprazole) respectively. Grunenthal to get commercialization rights for Nexium in EU & WW rights for Vimovo (except in the US & Japan) AZ will continue to manufacture and supply Nexium under the long-term […]Read More

Jazz Receives FDA Approval for Xyrem’s (sodium oxybate) sNDA to

Shots: The approval is based on P-II/III EXPRESS study assessing Xyrem vs PBO in patients with narcolepsy with cataplexy aged 7-17 yrs. P-II/III EXPRESS study results: @2 wks. change in weekly number of cataplexy attacks, change in EDS; @47 wks. increment in weekly cataplexy attacks (0.3 vs 12.7); no new safety signals observed published in […]Read More

ProQR Signs Exclusive Worldwide License Agreement with Ionis for IONIS-RHO-2.5

Shots: Ionis Pharmaceuticals will receive an upfront payment in ordinary shares $2.5M, $22.23/share representing 20% premium plus milestones payments and 20% royalties on net sales of QR-1123. ProQR to get WW license rights for Ionis’ IONIS-RHO-2.5 Candidate In 2019, ProQR plans onset of P-I/II trial for QR-1123 in autosomal dominant retinitis pigmentosa (adRP) with awaited […]Read More