Category - Developments

Developments Markets

Mayo Clinic listed on TULSA center locator page, indicating Profound Medical’s first sale to a teaching hospital

The Mayo Clinic has just been listed as a new TULSA-PRO site, representing the first sale of the system to a teaching hospital by the technology’s developer, Profound Medical Profound Medical (TSX:PRN; NASDAQ:PROF)...

July 9, 2020

Developments

FDA approves Osmotica Pharma’s Upneeq for blepharoptosis

The FDA approved Osmotica Pharmaceuticals’ (NASDAQ:OSMT) Upneeq for the treatment of acquired blepharoptosis, an abnormal drooping of the upper eyelid that can limit field of vision. Acquired blepharoptosis is often...

July 9, 2020

Developments

Crinetics Pharma’s paltusotine gets FDA orphan drug designation for acromegaly

The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) paltusotine orphan drug designation for the treatment of acromegaly, a disease usually caused by a benign growth hormone-secreting tumor in the brain’s pituitary...

July 8, 2020

Developments

AnaptysBio imsidolimab gets FDA orphan drug designation for pustular psoriasis

The FDA granted AnaptysBio’s (NASDAQ:ANAB) imsidolimab orphan drug designation for the treatment of generalized pustular psoriasis (GPP). GPP is a rare, chronic, life-threatening disease characterized by the development...

July 8, 2020

Developments

Ziopharm doses first patient in Phase 1/2 pediatric brain tumor trial

Ziopharm Oncology (NASDAQ:ZIOP) dosed the first patient in its Phase 1/2 trial evaluating controlled IL-12 for the treatment of diffuse intrinsic pontine glioma (DIPG). Ziopharm’s controlled IL-12 is a gene therapy...

July 8, 2020

Developments

Outlook Therapeutics completes enrollment in pivotal retinal disease trial

Outlook Therapeutics (NASDAQ:OTLK) completed patient enrollment in its pivotal clinical trial evaluating LYTENAVA, an ophthalmic formulation of bevacizumab, for use in retinal indications. Formerly known as ONS-5010...

July 7, 2020

Developments

IntelGenx in feasibility pact with Cybin for fast-acting, orally-dissolving psilocybin film

IntelGenx (TSXV:IGX; OTCQB:IGXT) inked a feasibility agreement with Cybin for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin. Cybin is Canada’s premier mushroom...

July 7, 2020

Developments

Hepion Pharma posts preclinical data supporting two-pronged approach treating COVID-19 with CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that its anti-fibrotic drug candidate, CRV431, was efficacious in two distinct preclinical research models related to COVID-19 disease. CRV431 demonstrated strong anti...

July 7, 2020

Developments

Soliton files 510(k) for RAP device approval to reduce cellulite

Soliton (NASDAQ:SOLY) filed for 510(k) premarket clearance with the FDA of its second generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance of cellulite. The 510(k) filing is based on results...

July 1, 2020

Developments

Luminal BioSciences provides guidance on milestones; begins collecting plasma from COVID-19 recovered donors

Liminal BioSciences (NASDAQ, TSX:LMNL) provided a guidance update on the timing of certain expected key milestones for 2020. The company withdrew guidance in May because of the COVID-19 pandemic. In a statement, Kenneth...

July 1, 2020

Category - Developments

Mayo Clinic listed on TULSA center locator page, indicating Profound Medical’s first sale to a teaching hospital

FDA approves Osmotica Pharma’s Upneeq for blepharoptosis

Crinetics Pharma’s paltusotine gets FDA orphan drug designation for acromegaly

AnaptysBio imsidolimab gets FDA orphan drug designation for pustular psoriasis

Ziopharm doses first patient in Phase 1/2 pediatric brain tumor trial

Outlook Therapeutics completes enrollment in pivotal retinal disease trial

IntelGenx in feasibility pact with Cybin for fast-acting, orally-dissolving psilocybin film

Hepion Pharma posts preclinical data supporting two-pronged approach treating COVID-19 with CRV431

Soliton files 510(k) for RAP device approval to reduce cellulite

Luminal BioSciences provides guidance on milestones; begins collecting plasma from COVID-19 recovered donors

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