PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19

Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19

Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM

Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR Trial, Treatment, Pulmonary Arterial Hypertension

Revance Presents Results of DaxibotulinumtoxinA for Injection in P-III ASPEN-1 Trial for the Treatment of Cervical Dystonia at AAN2021

Published: Apr 2, 2021 | Tags: Revance, Presents, Results, DaxibotulinumtoxinA, Injection, P-III ASPEN-1 Trial, Treatment, Cervical Dystonia

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib Trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma

Published: Apr 2, 2021 | Tags: Janssen and SpringWorks, Reports, Dosing, First, Patient, P-Ib Trial, Nirogacestat, Teclistamab, Treat, Relapsed or Refractory Multiple Myeloma

Kite Reports Submission of sBLA to the US FDA for Tecartus in Adult Patients with R/R Acute Lymphoblastic Leukemia

Published: Apr 2, 2021 | Tags: Kite, Reports, Submission, sBLA, US, FDA, Tecartus, Adult, Patients, R/R Acute Lymphoblastic Leukemia

BeyondSpring Submits NDA to the US FDA and China NMPA for Plinabulin to Prevent CT-Induced Neutropenia

Published: Apr 2, 2021 | Tags: BeyondSpring, Submits, NDA, US, FDA, China, NMPA, Plinabulin, Prevent, CT-Induced Neutropenia

Alnylam Report Results of Lumasiran in P-III ILLUMINATE-A Study for Primary Hyperoxaluria Type 1, Published in NEJM

Published: Apr 1, 2021 | Tags: Alnylam, Report, Results, Lumasiran, P-III ILLUMINATE-A Study, Primary Hyperoxaluria Type 1

Sanofi’s Sarclisa (isatuximab-irfc) + Carfilzomib and Dexamethasone Receives the US FDA’s Approval for the Treatment of R/R Multiple Myeloma

Published: Apr 1, 2021 | Tags: Sanofi, Sarclisa (isatuximab-irfc), Carfilzomib, Dexamethasone, Receives, US, FDA, Approval, Treatment, R/R Multiple Myeloma

ADQ to Acquire Amoun Pharmaceutical from Bausch Health for ~$740M

Published: Apr 1, 2021 | Tags: ADQ, Acquire, Amoun Pharmaceutical, Bausch Health, ~$740M

Amryt Reports NDA Submission for Oleogel-S10 (filsuvez) to Treat Cutaneous Manifestations of Junctional and Dystrophic Epidermolysis Bullosa

Published: Apr 1, 2021 | Tags: Amryt, Reports, NDA, Submission, Oleogel-S10 (filsuvez), Treat, Cutaneous, Manifestations, Junctional, Dystrophic Epidermolysis Bullosa

BioXcel Report Results of BXCL501 in P-Ib/II RELEASE Study for the Treatment of Opioid Withdrawal Symptoms

Published: Apr 1, 2021 | Tags: BioXcel, Report, Results, BXCL501, P-Ib/II RELEASE Study, Treatment, Opioid Withdrawal Symptoms

BridgeBio Collaborates with Helsinn to Co- Develop and Commercialize Infigratinib in Oncology

Published: Apr 1, 2021 | Tags: BridgeBio, Collaborates, Helsinn, Co- Develop, Commercialize, Infigratinib, Oncology

Roche Launches Elecsys Epstein-Barr Virus (EBV) Immunoassay Panel to Identify EBV Infection Staging

Published: Mar 31, 2021 | Tags: Roche, Launches, Elecsys Epstein-Barr Virus (EBV) Immunoassay Panel, Identify, EBV Infection Staging

Amgen to Acquire Rodeo Therapeutics for ~$721M

Published: Mar 31, 2021 | Tags: Amgen, Acquire, Rodeo Therapeutics, ~$721M

Ipsen’s Cabometyx + Opdivo Receive EC’s Approval as a 1L Treatment for Patients with Advanced Renal Cell Carcinoma

Published: Mar 31, 2021 | Tags: Ipsen, Cabometyx, Opdivo, Receive, EC, Approval, 1L, Treatment, Patients, Advanced, Renal Cell Carcinoma

AbbVie Reports the US FDA’s Acceptance of NDA for Atogepant as a Preventive Treatment for Migraine

Published: Mar 31, 2021 | Tags: AbbVie, Reports, US, FDA, Acceptance, NDA, Atogepant, Preventive, Treatment, Migraine

Merck to Acquire Alydia Health for ~$240M on Behalf of its Planned Spinoff of Organon

Published: Mar 31, 2021 | Tags: Merck, Acquire, Alydia Health, ~$240M, Behalf, Planned, Spinoff, Organon

Novartis In-Licenses Fibroblast Activation Protein (FAP) to Expand its Oncology Radioligand Pipeline

Published: Mar 31, 2021 | Tags: Novartis, In-Licenses, Fibroblast Activation Protein (FAP), Expand, Oncology, Radioligand, Pipeline

Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

Published: Mar 30, 2021 | Tags: Novartis, Kesimpta (ofatumumab), Receives, EC, Approval, Adult, Patients, Relapsing Multiple Sclerosis

Cerecor Signs a Worldwide License Agreement with Kyowa Kirin for CERC-00

Published: Mar 30, 2021 | Tags: Cerecor, Signs, Worldwide, License Agreement, Kyowa Kirin, CERC-00

Eli Lilly along with VIR and GSK Report Results of Bamlanivimab + VIR-7831 in P-II BLAZE-4 Study for Low-Risk Adults with COVID

Published: Mar 30, 2021 | Tags: Eli Lilly, VIR and GSK, Report, Results, Bamlanivimab, VIR-7831, P-II BLAZE-4 Study, Low-Risk, Adults, COVID

Medtronic’s Harmony Transcatheter Pulmonary Valve Receives the US FDA’s Approval for Patients with Congenital Heart Disease

Published: Mar 30, 2021 | Tags: Medtronic, Harmony Transcatheter Pulmonary Valve, Receives, US, FDA, Approval, Patients, Congenital Heart Disease

Roche and PTC’s Evrysdi (risdiplam) Receive the EC’s Approval as First and Only at Home Treatment For Spinal Muscular Atrophy

Published: Mar 30, 2021 | Tags: Roche and PTC, Evrysdi (risdiplam), Receive, EC, Approval, First, Only, Home, Treatment, Spinal Muscular Atrophy

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Published: Mar 30, 2021 | Tags: Samsung Bioepis, Expand, Footprints, Launch, Hadlima (biosimilar, adalimumab), Australia, Canada

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Published: Mar 29, 2021 | Tags: Roche, Tecentriq, Receives, CHMP, Positive Opinion, 1L, Treatment, Metastatic, Non-Small Cell Lung Cancer

Qiagen’s NeuMoDx Multiplex Test Receives the US FDA’s EUA and Expands its COVID-19 Portfolio

Published: Mar 29, 2021 | Tags: Qiagen, NeuMoDx Multiplex Test, Receives, US, FDA, EUA, Expands, COVID-19, Portfolio

GSK and VIR Report EUA Submission to the US FDA for VIR-7831 to Treat COVID-19

Published: Mar 29, 2021 | Tags: GSK and VIR, Report, EUA, Submission, US, FDA, VIR-7831, Treat, COVID-19

Helius Medical’s PoNS Receives the US FDA’s Approval to Improve Gait in Multiple Sclerosis Patients

Published: Mar 29, 2021 | Tags: Helius Medical, PoNS, Receives, US, FDA, Approval, Improve, Gait, Multiple Sclerosis Patients

GSK’s Benlysta (belimumab) Receives CHMP’s Opinion Recommending its Approval for Active Lupus Nephritis

Published: Mar 29, 2021 | Tags: GSK, Benlysta (belimumab), Receives, CHMP, Opinion, Recommending, Approval, Active, Lupus Nephritis

BMS and bluebird bio’s Abecma (idecabtagene vicleucel) Receive the US FDA’s Approval as the First Anti-BCMA CAR T Cell Therapy for R/R Multiple Myeloma

Published: Mar 29, 2021 | Tags: BMS and bluebird bio, Abecma (idecabtagene vicleucel), Receive, US, FDA, Approval, First, Anti-BCMA, CAR T Cell Therapy, R/R Multiple Myeloma

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