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Regulatory

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Shots: The approval is based on P-II Brigatinib-2001 (J-ALTA) assessing Alunbrig in 72 Japanese patients with ALK+ NSCLC and P-III AP26113-13-301 (ALTA-1L) study assessing Alunbrig (180mg, qd with seven-day lead-in at 90mg, qd) vs crizotinib

Biotech

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement MTPA to commercialize Exservan in the US

Regulatory

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Shots: The approval is based on pivotal phase III ATLAS and FLAIR study assessing Cabenuva in 1,100+ HIV-1 adults to replace the current ARV regimen in those who were virologically suppressed (HIV-1 RNA less than

Clinical Trials

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Shots: The P-III BLAZE-2 COVID-19 prevention trial involves assessing bamlanivimab (4,200mg) vs PBO in residents and staff at skilled nursing and assisted living facilities. The 965 &132 COVID-19 negative & positive participants were included in

Biotech

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Shots: MiNA to receive $267.6M in up front, exclusivity fee on first neurological target and will be eligible to receive research, development, regulatory and commercial milestones along with royalties Servier will lead pre/ clinical development

M&A MedTech

Boston Scientific to Acquire Preventice for ~$1.2B

Shots: Boston Scientific to acquire Preventice for ~$1.2B including $925M as up front, up to an additional $300M as commercial milestones. However, Boston Scientific has built up a 22% stake in Preventice, which is expected

Regulatory

Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification Result: 2.0 mg dose achieved significant and superior reduction

Regulatory

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for 24wks. The anticipated PDUFA date is May’2021 Results: Over 24wks.

MedTech

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Shots: Qiagen’s QIAstat-Dx and NeuMoDx tests remain accurate & effective in detecting SARS-CoV-2 infections The company started cross-checking variants in May’2020 & assessed the tests against genetic mutations of the virus uploaded to the GISAID