Category - Developments

Developments

Zogenix reaches agreement with FDA for FINTEPLA NDA resubmission

Following a Type A meeting with the FDA, Zogenix (NASDAQ:ZGNX) reported that it plans to resubmit its NDA for FINTEPLA for the treatment of seizures associated with Dravet syndrome.

June 27, 2019

Developments

Dova Pharma gets FDA sNDA approval for thrombocytopenia drug

Dova Pharmaceuticals (NASDAQ:DOVA) reported that the FDA approved DOPTELET’s supplemental NDA, expanding its use to include the treatment of adults with chronic immune thrombocytopenia (ITP) who have not responded to...

June 27, 2019

Developments

Aridis Pharma gets orphan drug designation for CF drug

Aridis Pharmaceuticals (NASDAQ:ARDS) received FDA orphan drug designation for AR-501 for the treatment of lung infections in patients with cystic fibrosis (CF).

June 27, 2019

Developments

Novavax confirms accelerated approval pathway for NanoFlu

Novavax (NASDAQ:NVAX) reported that the FDA recently made the accelerated approval pathway available for NanoFlu, and that Novavax will be pursuing that pathway for licensure of the vaccine.

June 27, 2019

Developments

Zenabis joining Shoppers Drug Mart and TruTrace medical cannabis verification pilot

Zenabis Global (TSX:ZENA) will use TruTrace Technologies’ (CSE:TTT; OTC:BKKSF) StrainSecure platform to collect, register, manage, track and publish verified testing data of its cannabis plant DNA and strains, and...

June 27, 2019

Developments

ContraVir submits IND for CRV431 for NASH

ContraVir Pharmaceuticals (NASDAQ:CTRV) filed an IND with the FDA for CRV431 for the treatment of non-alcoholic steatohepatitis (NASH).

June 27, 2019

Developments

Titan Pharma, Molteni receive European regulatory okay for Probuphine

The European Commission approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Sixmo, the brand name for its Probuphine implant in the European Union.

June 26, 2019

Developments

Dare Bioscience completes trial recruitment for Ovaprene contraceptive

Dare Bioscience (NASDAQ:DARE) completed patient recruitment for a postcoital test (PCT) trial of Ovaprene, a self-administered, hormone-free, contraceptive intravaginal ring.

June 26, 2019

Developments

Inovio Pharma completes enrollment for HPV-related cervical pre-cancer trial

Inovio Pharmaceuticals (NASDAQ:INO) reached target enrollment of 198 women for its pivotal Phase 3 trial for VGX-3100 for the treatment of cervical dysplasia caused by human papillomavirus (HPV).

June 26, 2019

Developments

Canopy Growth acquires KeyLeaf Life Sciences to support extraction needs

Canopy Growth (TSX:WEED; NYSE:CGC) acquired Saskatoon-based bio-product extractor, KeyLeaf Life Sciences.

June 26, 2019

Category - Developments

Zogenix reaches agreement with FDA for FINTEPLA NDA resubmission

Dova Pharma gets FDA sNDA approval for thrombocytopenia drug

Aridis Pharma gets orphan drug designation for CF drug

Novavax confirms accelerated approval pathway for NanoFlu

Zenabis joining Shoppers Drug Mart and TruTrace medical cannabis verification pilot

ContraVir submits IND for CRV431 for NASH

Titan Pharma, Molteni receive European regulatory okay for Probuphine

Dare Bioscience completes trial recruitment for Ovaprene contraceptive

Inovio Pharma completes enrollment for HPV-related cervical pre-cancer trial

Canopy Growth acquires KeyLeaf Life Sciences to support extraction needs

General

More