PharmaShots Weekly Snapshots (August 30 – September 03, 2021)

Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis

Published: Sept 3, 2021 | Tags: Forte, FB-401, P-II, Clinical Trial, Atopic Dermatitis

Novartis Cosentyx (secukinumab) Receives NICE Recommendation for Patients with Plaque Psoriasis

Published: Sept 3, 2021 | Tags: Novartis, Cosentyx, secukinumab, NICE Recommendation, Plaque Psoriasis

Pfizer Initiates P-III RENOIR Trial of RSVpreF Vaccine for the Treatment of Respiratory Syncytial Virus

Published: Sept 3, 2021 | Tags: Pfizer, P-III, RENOIR trial, RSVpreF Vaccine, Respiratory Syncytial Virus

Alexion’s Ultomiris (ravulizumab) Receives EC’s Approval for Expanded Use to Treat Paroxysmal Nocturnal Haemoglobinuria

Published: Sept 3, 2021 | Tags: Alexion, Ultomiris, ravulizumab, EC, Approval, Paroxysmal Nocturnal Haemoglobinuria, EU

Abbott to Acquire Walk Vascular to Bolster its Peripheral Vascular Offerings

Published: Sept 3, 2021 | Tags: Abbott, Walk Vascular, Thrombectomy System, Peripheral Blood Clots

Baxter to Acquire Hillrom for ~$10.5B

Published: Sept 3, 2021 | Tags: Baxter, Acquire, Hillrom, ~$10.5B

Janssen’s Invega Hafyera (paliperidone palmitate) Receives the US FDA’s Approval for the Treatment of Schizophrenia

Published: Sept 2, 2021 | Tags: Janssen, Invega Hafyera, paliperidone palmitate, US, FDA, Approval, Schizophrenia

Astellas Pauses Dosing of AT132 in ASPIRO Clinical Trial for the Treatment of X-linked Myotubular Myopathy

Published: Sept 2, 2021 | Tags: Astellas, Dosing, AT132, ASPIRO Clinical Trial, X-linked Myotubular Myopathy

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Approval for the Treatment of Waldenström’s Macroglobulinemia

Published: Sept 2, 2021 | Tags: BeiGene, Brukinsa, Zanubrutinib, US, FDA, Approval, Waldenström’s Macroglobulinemia

BMS Exercised Its Option to License Evotec’s EVT8683 for the Treatment of Neurodegenerative Disease

Published: Sept 2, 2021 | Tags: BMS, Exercised Its Option, License, Evotec, EVT8683

Takeda’s Pevonedistat Fails to Meet Primary Endpoints in P-III PANTHER Trial as 1L Treatment for Patients with Rare Bone Marrow Cancer

Published: Sept 2, 2021 | Tags: Takeda, Pevonedistat, Azacitidine, P-III, PANTHER Trial, Cancer

AstraZeneca Signs a Multiyear Agreement with Thermo Fisher to Co-Develop NGS-based CDx for Targeted Therapies

Published: Sept 2, 2021 | Tags: AstraZeneca, Thermo Fisher, Co-Develop, NGS-based CDx, Targeted Therapies

Merck and Ridgeback Initiate P-III MOVe-AHEAD Study of Molnupiravir for the Prevention of COVID-19 Infection

Published: Sept 1, 2021 | Tags: Merck, Ridgeback, P-III, MOVe-AHEAD Study, Molnupiravir, COVID-19

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Label Update to Treat Advanced Urothelial Carcinoma

Published: Sept 1, 2021 | Tags: Merck, Keytruda, Pembrolizumab, US, FDA, Approval, Urothelial Carcinoma

Johnson & Johnson Discontinues the P-IIb Imbokodo Trial of HIV Vaccine Regimen for HIV Infection

Published: Sept 1, 2021 | Tags: Johnson & Johnson, P-IIb, Imbokodo Trial, HIV Vaccine Regimen, HIV Infection

Bayer Initiates P-III OASIS Program of Elinzanetant for the Treatment of Vasomotor Symptoms During Menopause

Published: Sept 1, 2021 | Tags: Bayer, P-III, OASIS Program, Elinzanetant, Vasomotor Symptoms, Menopause

AC Immune Report Results of Semorinemab in P-II Lauriet Study for the Treatment of Alzheimer’s Disease

Published: Sept 1, 2021 | Tags: AC Immune, Semorinemab, P-II, Lauriet Study, Alzheimer’s Disease

Novartis Signs an Agreement with NHS to Commercialize Leqvio (inclisiran) for the Treatment of Cardiovascular Disease

Published: Sept 1, 2021 | Tags: Novartis, NHS, Commercialize, Leqvio, inclisiran, Cardiovascular Disease

Boehringer Ingelheim and Eli Lilly Present Results of Jardiance (empagliflozin) in P-III EMPEROR-Preserved Trial for the Treatment of HFpEF at ESC 2021

Published: Aug 31, 2021 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, P-III, EMPEROR-Preserved Trial, HFpEF ESC 2021

Janssen Reports Post-Hoc Analysis of P-III GRIPHON and P-IIIb TRITON Studies of Uptravi (selexipag) for the Treatment of Pulmonary Arterial Hypertension #ESC2021

Published: Aug 31, 2021 | Tags: Janssen, Uptravi, selexipag, P-III, GRIPHON, P-IIIb, TRITON Clinical Trials, Pulmonary Arterial Hypertension

Baxter in Talks to Acquire Hill-Rom for ~$10B

Published: Aug 31, 2021 | Tags: Baxter, Acquire, Hill-Rom, ~$10B

Bone Therapeutics’s JTA-004 Fails to Meet its All Endpoints in P-III Study for Knee Osteoarthritis

Published: Aug 31, 2021 | Tags: Bone Therapeutics, JTA-004, P-III, Study, Knee Osteoarthritis

GSK and SK Bioscience Initiate P-III Study of GBP510 Against AZ/Oxford’s COVID-19 Vaccine

Published: Aug 31, 2021 | Tags: GSK, SK Bioscience, P-III, Study, GBP510, AZ/Oxford’s COVID-19 Vaccine

Abbott Reports Head-to-Head Data for Amplatzer Amulet Against Boston Scientific’s Watchman Device to Treat Atrial Fibrillation #ESC2021

Published: Aug 31, 2021 | Tags: Abbott, Amplatzer Amulet, Boston Scientific, Watchman Device, Atrial Fibrillation, ESC2021

Pfizer Reports Results of Abrocitinib in P-III JADE DARE Study to Treat Atopic Dermatitis

Published: Aug 30, 2021 | Tags: Pfizer, Abrocitinib, P-III, JADE DARE Study, Atopic Dermatitis

SpringWorks Collaborates with Dana-Farber to Evaluate Nirogacestat in Multiple Myeloma

Published: Aug 30, 2021 | Tags: SpringWorks, Dana-Farber, Nirogacestat, Multiple Myeloma

Sanofi and Regeneron’s Dupixent Meets All Endpoints in P-III Study in Children with Atopic Dermatitis

Published: Aug 30, 2021 | Tags: Sanofi, Regeneron, Dupixent, P-III, Study, Atopic Dermatitis

Bio-Thera and Hikma Sign an Exclusive Commercialization and License Agreement for BAT2206 (biosimilar, ustekinumab) in the US

Published: Aug 30, 2021 | Tags: Bio-Thera, Hikma, Exclusive Commercialization, License Agreement, BAT2206, biosimilar, ustekinumab, US

MicroTransponder Receives the US FDA’s Approval for Vivistim System as the First Vagus Nerve Stimulation Implant for Stroke Rehabilitation

Published: Aug 30, 2021 | Tags: MicroTransponder, US, FDA, Approval, Vivistim System, First Vagus Nerve Stimulation Implant, Stroke Rehabilitation

BeiGene Signs a Clinical Trial Agreement with ImmixBio to Evaluate IMX-110 + Tislelizumab in Solid Tumors

Published: Aug 30, 2021 | Tags: BeiGene, ImmixBio, IMX-110, Tislelizumab, Solid Tumors

Related Post: PharmaShots Weekly Snapshots (August 23 – 27, 2021)