drug

Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

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Shots: X-Chem to receive an up front and is eligible to receive research, development and regulatory milestone along with royalties on sales of therapies resulting from the collaboration Genentech will lead further development and commercialization of any potential new therapies and retain exclusive rights to… Read More »Genentech Signs an Exclusive License Agreement with X-Chem to Discover Oncology Targets

Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

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Shots: Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs. With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is… Read More »Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

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Shots: The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients Novartis expects to initiate the P-IIb study for… Read More »Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

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Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study… Read More »Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan