Category - Developments

Developments

EMA accepts Novaliq’s CyclASol for regulatory review in DED

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) from Novaliq GmbH for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new...

August 24, 2023

Developments

Tarsier Pharma misses endpoint in Phase 3 uveitis trial

Closely-held Tarsier Pharma of Israel did not reach the primary endpoint in the non-infectious anterior uveitis TRS4VISION trial with its TRS01 eye drops. However, a post hoc analysis of the data demonstrates the much...

August 23, 2023

Developments

Relmada doses first patient in Phase 3 trial for MDD

Relmada Therapeutics (NASDAQ:RLMD) announced dosing the first patient in the Relight Phase 3, randomized, double-blind, placebo-controlled trial evaluating REL-1017 as an adjunctive treatment of major depressive...

August 23, 2023

Developments

LEO Pharma to acquire Timber Pharmaceuticals

LEO US Holding, a wholly-owned subsidiary of LEO Pharma A/S, entered into a definitive agreement to acquire Timber Pharmaceuticals (NYSEA:TMBR) in a total transaction value of up to $36-million. Timber is eligible to...

August 21, 2023

Developments

Anebulo gets FDA nod for Phase 3 in acute cannabinoid intoxication

The FDA provided positive feedback to Anebulo Pharmaceuticals (NASDAQ:ANEB) for its Phase 3 program of ANEB-001 in patients suffering from acute cannabinoid intoxication (ACI) and substance abuse.

August 21, 2023

Developments

MindBio receives first LSD batch for home psychedelic clinical trials

MindBio Therapeutics (CSE:MBIO; Frankfurt:WF6) received its first batch of MB22001 ready for take-home use in Phase 2 psychedelic microdosing clinical trials. MB22001 is a proprietary titratable form of lysergic acid...

August 18, 2023

Developments

Reviva completes Phase 3 enrollment for brilaroxazine in schizophrenia

Reviva Pharmaceuticals (NASDAQ:RVPH) completed enrollment in the pivotal Phase 3 RECOVER study, evaluating brilaroxazine for schizophrenia, with 402 patients enrolled across 40 sites in the U.S., Europe, and Asia. “We...

August 17, 2023

Developments

Minghui enrolls first patient in Phase 3 trial for atopic dermatitis

Closely-held Minghui Pharmaceutical enrolled the first patient in the Phase 3 clinical study for MH004 cream targeting mild-to-moderate atopic dermatitis, a prevalent skin condition. The randomized, double-blind, and...

August 17, 2023

Developments

Keystone Dental Holdings to combine with Check-Cap

Closely-held Keystone Dental Holdings agreed to a definitive business combination with Check-Cap (NASDAQ:CHEK), with stockholders of Keystone becoming majority holders of the combined company. If completed, the business...

August 17, 2023

Developments

Eyenovia acquires U.S. rights for ocular asset from Formosa Pharmaceuticals

Eyenovia (NASDAQ:EYEN) entered an agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) to acquire the exclusive U.S. rights to distribute and sell Formosa’s APP13007 (clobetasol propionate ophthalmic...

August 16, 2023

Category - Developments

EMA accepts Novaliq’s CyclASol for regulatory review in DED

Tarsier Pharma misses endpoint in Phase 3 uveitis trial

Relmada doses first patient in Phase 3 trial for MDD

LEO Pharma to acquire Timber Pharmaceuticals

Anebulo gets FDA nod for Phase 3 in acute cannabinoid intoxication

MindBio receives first LSD batch for home psychedelic clinical trials

Reviva completes Phase 3 enrollment for brilaroxazine in schizophrenia

Minghui enrolls first patient in Phase 3 trial for atopic dermatitis

Keystone Dental Holdings to combine with Check-Cap

Eyenovia acquires U.S. rights for ocular asset from Formosa Pharmaceuticals

General

More