PharmaShots Weekly Snapshots (October 11 – 15, 2021)

Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Published: 15 Oct, 2021 | Tags: Bristol Myers Squibb, Zeposia, ozanimod, CHMP, Positive Opinion, Adult Patients with Moderately to Severely Active Ulcerative Colitis

Gan & Lee Completes P-III Studies of GL-GLA for Patients with T1D & T2D

Published: 15 Oct, 2021 | Tags: Gan & Lee, P-III, GL-GLA, T1D, T2D

Exelixis In-Licenses Second Anti-Cancer Compound from Aurigene Following the US FDA’s Acceptance of IND for P-I Study of XL114 in Non-Hodgkin’s Lymphoma

Published: 15 Oct, 2021 | Tags: Exelixis, Aurigene, US, FDA, Acceptance, IND, P-I Study, XL114, Non-Hodgkin’s Lymphoma

Hologic to Acquire Bolder Surgical for $160M

Published: 15 Oct, 2021 | Tags: Hologic, Acquire, Bolder Surgical, $160M, NovaSure, MyoSure tissue removal devices, Acessa laparoscopic radiofrequency ablation system

AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III HIMALAYA Study for 1L Treatment of Unresectable Liver Cancer

Published: 15 Oct, 2021 | Tags: AstraZeneca, Imfinzi, Tremelimumab, P-III, HIMALAYA Study, 1L, Treatment, Unresectable Liver Cancer

Lilly Presents Updated Data of Verzenio (abemaciclib) in P-III monarchE Trial Presented at ESMO and Published in the Annals of Oncology

Published: 15 Oct, 2021 | Tags: Lilly, Verzenio, abemaciclib, P-III, monarchE Trial, ESMO, Annals of Oncology

Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19

Published: 14 Oct, 2021 | Tags: Regeneron, US, FDA, Acceptance, Priority Review, REGEN-COV, COVID-19

Asieris Receives NMPA’s IND Approval to Evaluate APL-1202 + Tislelizumab as Neoadjuvant Therapy for MIBC Patients

Published: 14 Oct, 2021 | Tags: Asieris, NMPA, IND Approval, APL-1202, Tislelizumab, Neoadjuvant Therapy, MIBC

Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema

Published: 14 Oct, 2021 | Tags: Novartis, US, FDA, EMA, Beovu, Diabetic Macular Edema

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Second Indication in Cervical Cancer

Published: 14 Oct, 2021 | Tags: Merck, Keytruda, pembrolizumab, US, FDA, Approval, Second Indication, Cervical Cancer

Turning Point and EQRx Collaborate to Evaluate Elzovantinib + Aumolertinib in Patients with EGFR Mutant Met-Amplified Advanced NSCLC

Published: 14 Oct, 2021 | Tags: Turning Point, Elzovantinib, Aumolertinib, NSCLC

PharmaTher’s Ketamine Receives the US FDA’s Orphan Drug Designation for Complex Regional Pain Syndrome

Published: 14 Oct, 2021 | Tags: PharmaTher, Ketamine, US, FDA, Orphan Drug Designation,  Complex Regional Pain Syndrome

Eli Lilly’s Verzenio (abemaciclib) Receives the US FDA’s Approval for People with HR+ HER2- High Risk Early Breast Cancer

Published: 13 Oct, 2021 | Tags: Eli Lilly, Verzenio, abemaciclib, US, FDA, Approval, HR+, HER2-, High Risk Early Breast Cancer

Sanofi’s Sarclisa Combination Regimen Receives Health Canada’s Approval for Multiple Myeloma

Published: 13 Oct, 2021 | Tags: Sanofi, Sarclisa, Combination Regimen, Health Canada, Approval, Multiple Myeloma

Sanofi Presents Results of Tolebrutinib in a P-IIb LTS for Relapsing Forms of Multiple Sclerosis at ECTRIMS 2021

Published: 13 Oct, 2021 | Tags: Sanofi, Tolebrutinib, P-IIb, LTS, Relapsing Forms of Multiple Sclerosis, ECTRIMS 2021

Ultimovacs Reports Results of 24-month Follow-up Study of UV1 + Pembrolizumab for 1L Treatment of Metastatic Malignant Melanoma

Published: 13 Oct, 2021 | Tags: Ultimovacs, UV1, Pembrolizumab, Metastatic Malignant Melanoma

Spark Signs an Exclusive Global Licensing Agreement with CombiGene for CG01 to Treat Focal Epilepsy

Published: 13 Oct, 2021 | Tags: Spark, CombiGene, CG01, Focal Epilepsy, develop, manufacture, commercialize

Takeda Signs an Exclusive License Agreement with Poseida for Novel Non-Viral In Vivo Gene Therapies

Published: 13 Oct, 2021 | Tags: Takeda, License Agreement, Poseida, Non-Viral In Vivo Gene Therapies

Sutro Signs an Option Agreement with BioNova to Develop and Commercialize STRO-001 for Hematologic Cancers in Greater China

Published: 12 Oct, 2021 | Tags: BioNova, Greater China, Hematologic Cancers, Option Agreement, STRO-001, Sutro

The US FDA Lifts the Clinical Hold of Protagonist’s Rusfertide Clinical Development Program

Published: 12 Oct, 2021 | Tags: Clinical Hold, FDA, Protagonist, Rusfertide Clinical Development Program, US

AbCellera Enters into a Collaboration and License Agreement with Salipro to Boost Therapeutic Antibodies

Published: 12 Oct, 2021 | Tags: AbCellera, Salipro, Therapeutic Antibodies

Sarepta Presents the New Analyses and Functional Data of SRP-9001 in Multiple Studies for the Treatment of DMD at SRP-9001 Micro-dystrophin Day

Published: 12 Oct, 2021 | Tags: DMD, Multiple studies, Sarepta, SRP-9001, SRP-9001 Micro-dystrophin Day

Pacira to Acquire Flexion for ~427M

Published: 12 Oct, 2021 | Tags: ~427M, Acquire, Flexion, Pacira

AstraZeneca’s AZD7442 Meet its Primary Endpoints in P-III TACKLE Trial for the Treatment of COVID-19

Published: 12 Oct, 2021 | Tags: AstraZeneca, AZD7442, COVID-19, P-III, TACKLE Trial

Supernus to Acquire Adamas for ~$450M

Published: 11 Oct, 2021 | Tags: ~$450M, Acquire, Adamas, Supernus

Merck and Ridgeback Report EUA Submission to the US FDA for Molnupiravir to Treat COVID-19

Published: 11 Oct, 2021 | Tags: COVID-19, EUA, FDA, Merck, Molnupiravir, Ridgeback, US

Regenxbio Presents Results of RGX-314 in P-II ALTITUDE Trial for the Treatment of Diabetic Retinopathy at ASRS Annual Meeting

Published: 11 Oct, 2021 | Tags: ALTITUDE Trial, ASRS Annual Meeting, Diabetic Retinopathy, P-II, Regenxbio, RGX-314

Turning Point Presents Results of Repotrectinib in P-I/II TRIDENT-1 Study for the Treatment of Solid Tumors at AACR-NCI-EORTC 2021

Published: 11 Oct, 2021 | Tags: AACR-NCI-EORTC 2021, P-I/II, Repotrectinib, Solid Tumors, TRIDENT-1 Study, Turning Point

Genentech’s Gantenerumab Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Alzheimer’s Disease

Published: 11 Oct, 2021 | Tags: Alzheimer’s Disease, Breakthrough Therapy Designation, FDA, Gantenerumab, Genentech, US

Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis

Published: 11 Oct, 2021 | Tags: FDA, Janssen, Juvenile Psoriatic Arthritis, sBLA, Stelara, US, ustekinumab

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