Tags : Alexion

Weekly Snapshot

PharmaShots Weekly Snapshots (July 26 – 30, 2021)

Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, Evrysdi, risdiplam, FIREFISH Study, Type 1 SMA, NEJM BeiGene Reports Results of Brukinsa (zanubrutinib) in P-III SEQUOIA Trial for the Treatment of Chronic Lymphocytic Leukemia Published: July 30, 2021 | […]Read More

Regulatory

Alexion’s Ultomiris (ravulizumab) Receives CHMP’s Positive Opinion Recommending its Approval

Shots: The CHMP’s positive opinion is based on a P-III study assessing Ultomiris and showed effectiveness in completing C5 complement inhibition @26wks. for children & adolescents aged ≤18yrs. with PNH The study demonstrated that there is no reported treatment-related sAEs, and no patients discontinued treatment during the primary evaluation period or experienced breakthrough hemolysis The […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe […]Read More

Top 20

Top 20 Biopharma Deal Terminations of 2020 Based on Total

The biopharma industry saw numerous deal terminations in 2020. Clinical and regulatory results, change in control limitations, and strategic reprioritizations were among the most common reasons for deal termination. Sanofi and Hanmi’s agreement in 2015 ranked first under which Hanmi regained WW rights to its protein/peptide discovery technology, lapscovery. The second position goes to the […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, […]Read More

M&A

AstraZeneca to Acquire Alexion for $39B

Shots: Alexion to receive $60M in cash and 2.1243 ADSs (each ADS represents ½ ordinary share of AstraZeneca) for each Alexion share. The deal values Alexion at $175/ share with a 45% premium to the closing price on Dec 11, 2020 Alexion will own ~15% of the combined company. The acquisition will bolster AstraZeneca’s footprints […]Read More

Regulatory

Alexion’s Ultomiris (ravulizumab) Receives the CHMP’s Positive Opinion for its

Shots: The CHMP has adopted a positive opinion recommending marketing authorization in the EU for a new 100 mg/mL (IV) advanced formulation of Ultomiris (ravulizumab). The positive opinion is based on CMC submission and a supplementary clinical data set showing that the safety, PK, and immunogenicity following administration of Ultomiris (10mg/mL & 100mg/mL) were comparable […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2020

The second quarter of 2020 has ended with big approvals in pharma and biotech industry. Moving with the latest approval of Roche’s Phesgo and Enspryng & Zogenix’s Fintepla. Highlights of the quarter is COVID-19 as the development of vaccines and drugs were on peak. Celltrion evaluated Remsima (biosimilar, infliximab) against COVID-19 in the UK. The […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (May 04-08, 2020)

1.Fitbit Launches Heart Study to Validate its Wearable Technology for Identifying Atrial Fibrillation Published: May 06, 2020 | Tags: Fitbit, Launches, Heart Study, Validate, Wearable Technology, Identifying, Atrial Fibrillation 2.  Celltrion Launches Remsima SC (biosimilar, infliximab) for the Treatment of Autoimmune Diseases in the Netherlands Published: May 07, 2020 | Tags: Celltrion, Launches, Remsima SC, biosimilar, […]Read More