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PharmaShots Weekly Snapshots (October 11 - 15, 2021)

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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

Related Post: PharmaShots Weekly Snapshots (October 04 - 08, 2021)


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This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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