BioSpace News Archive

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• Drug Development

  Denali Therapeutics Announces Advancement and Expansion of Its LRRK2 Inhibitor Clinical Program for Parkinson’s Disease

  Based on a full review of the clinical data from this ongoing study, and additional preclinical data, the FDA has removed the previously imposed partial clinical hold.

  December 21, 2017

   · 

  4 min read
• Drug Development

  Ablynx Announces Positive Data From its Japanese Ethno-Bridging Study of Caplacizumab

  Ablynx today announced that the single and multiple dose Phase I study demonstrated comparable PK of caplacizumab in Japanese and Caucasian subjects.

  December 21, 2017

   · 

  7 min read
• Drug Development

  Gemphire Therapeutics Announces Initiation of its First NASH Proof-of-Concept Clinical Trial and its Differentiated NASH Program

  The program is beginning with a Phase 2a proof-of-conceptclinical trial in adults with FPL.

  December 21, 2017

   · 

  11 min read
• Drug Development

  Motif Bio REVIVE-1 Phase III Study Results with Iclaprim Published in Peer-reviewed Journal, Clinical Infectious Diseases

  The positive topline results from this study were announced in April 2017.

  December 21, 2017

   · 

  9 min read
• Drug Development

  Innovation Pharma Completes Final Patient Visit in Phase IIb Study of Oral Prurisol for Psoriasis

  Innovation Pharma today announces all patient follow-up visits have been completed in its Phase 2b clinical study of oral Prurisol in moderate-to-severe chronic plaque psoriasis.

  December 21, 2017

   · 

  7 min read
• Drug Development

  Altimmune Announces Positive Initial Data from Its HepTcell Phase I Study

  Altimmune today announced it has completed dosing of its HepTcell Phase 1 study in chronic hepatitis B.

  December 21, 2017

   · 

  4 min read
• Drug Development

  Minerva Neurosciences Announces Enrollment of First Patient in Phase IIb Trial Comparing Seltorexant (MIN-202) Versus Quetiapine as Adjunctive Therapy to Antidepressants in Patients With Major Depressive Disorder

  The primary objective of this study is to assess the efficacy of flexibly dosed seltorexant compared to flexibly dosed quetiapine as adjunctive therapy to a baseline antidepressant drug in delaying time to all-cause discontinuation of study drug over a 6-month treatment period.

  December 21, 2017

   · 

  4 min read
• Drug Development

  Merck KGaA Release: FDA Grants Breakthrough Therapy Designation for Avelumab in Combination With INLYTA in Advanced Renal Cell Carcinoma

  Merck KGaA and Pfizer today announced that the FDA has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA for treatment-naive patients with advanced renal cell carcinoma.

  December 21, 2017

   · 

  24 min read
• Biotech Bay

  Advanced Bionics Sound Processors to Become Bluetooth Compatible With Any Cell Phone or TV, Based on Revolutionary New Chip Technology From Sonova

  Advanced Bionics today announces that they will incorporate Sonova’s revolutionary SWORD (Sonova Wireless One Radio Digital) chip and wireless radio technology into their portfolio of solutions.

  December 21, 2017

   · 

  6 min read
• Drug Development

  Basilea Reports That Ceftobiprole Received QIDP Designation From U.S. FDA for the Treatment of Staphylococcus Aureus Bacteremia (SAB)

  Basilea announced today that the U.S. FDA designated its investigational drug ceftobiprole as a QIDP.

  December 21, 2017

   · 

  5 min read