PharmaShots Weekly Snapshots (September 13 -17, 2021)

Coave Signs an Exclusive License Agreement with Théa to Co-Development and Commercialize CTx-PDE6b for PDE6b Associated Retinitis Pigmentosa in EU

Published: Sept 17, 2021 | Tags: Coave, Théa, CTx-PDE6b, PDE6b, Retinitis Pigmentosa, EU

Coherus and Junshi Present Interim Results of Toripalimab in P-III JUPITER-06 Trial as 1L Treatment for Advanced Esophageal Squamous Cell Carcinoma at ESMO 2021

Published: Sept 17, 2021 | Tags: Coherus, Junshi, Toripalimab, P-III, JUPITER-06 Trial, Esophageal Squamous Cell Carcinoma, ESMO 2021

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Active Ulcerative Colitis

Published: Sept 17, 2021 | Tags: AbbVie, US, FDA, EMA, Rinvoq, upadacitinib, Active Ulcerative Colitis

Biogen Reports Mixed Results of Vixotrigine (BIIB074) in P-II CONVEY Study for the Treatment of Small Fiber Neuropathy

Published: Sept 17, 2021 | Tags: Biogen, Vixotrigine, BIIB074, P-II, CONVEY Study, Small Fiber Neuropathy

Clarus Signs an Exclusive WW License Agreement with McGill University to Develop and Commercialize its Technology for Rare Conditions Due to Coenzyme-Q10 Deficiencies

Published: Sept 17, 2021 | Tags: Clarus, McGill University, Technology, Rare Conditions, Coenzyme-Q10 Deficiencies

Boehringer Ingelheim Enters into a Clinical Collaboration with Amgen to Evaluate BI 1701963 + Lumakras (sotorasib) for Locally Advanced or Metastatic NSCLC

Published: Sept 17, 2021 | Tags: Boehringer Ingelheim, Amgen, BI 1701963, Lumakras, sotorasib, NSCLC

BMS Reports Five-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -214 for the Treatment of Advanced or Metastatic Renal Cell Carcinoma

Published: Sept 16, 2021 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, P-III, CheckMate -214, Renal Cell Carcinoma

Amgen Presents Results of Lumakras (sotorasib) + Vectibix (panitumumab) in P-Ib/II CodeBreaK 101 study for KRAS G12C-Mutated Colorectal Cancer at ESMO21 2021

Published: Sept 16, 2021 | Tags: Amgen, Lumakras, sotorasib, Vectibix, panitumumab, P-Ib/II, CodeBreaK 101 Study, KRAS G12C-Mutated, Colorectal Cancer, ESMO21 2021

BioCryst’s Orladeyo (berotralstat) Receives NICE Recommendation as First Oral Therapy to Prevent HAE Attacks in the UK

Published: Sept 16, 2021 | Tags: BioCryst, Orladeyo, berotralstat, NICE Recommendation, HAE Attacks, UK

Merck Enters into a Clinical Collaboration with Hookipa to Evaluate Keytruda (pembrolizumab) + HB-200 as 1L Treatment of Advanced Head and Neck Cancers

Published: Sept 16, 2021 | Tags: Merck, Hookipa, Keytruda, pembrolizumab, HB-200, Advanced, Head and Neck Cancers

Biogen to Initiate P-IIIb ASCEND Study Evaluating Higher Doses of Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy

 Published: Sept 16, 2021 | Tags: Biogen, P-IIIb, ASCEND Study, Spinraza, nusinersen, Spinal Muscular Atrophy

Takeda’s Exkivity (mobocertinib) Receives the US FDA’s Approval as the First Oral Therapy for EGFR Exon20 Insertion+ NSCLC

Published: Sept 16, 2021 | Tags: Takeda, Exkivity, mobocertinib, US, FDA, Approval, EGFR Exon20 Insertion+ NSCLC

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma\

Published: Sept 15, 2021 | Tags: BeiGene, Brukinsa, zanubrutinib, US, FDA, Accelerated Approval, R/R, Marginal Zone Lymphoma

MSD Enters into a Clinical Collaboration with IO to Evaluate IO102-IO103 + Keytruda as 1L Treatment of Metastatic Melanoma

Published: Sept 15, 2021 | Tags: MSD, IO, IO102, IO103, Keytruda, Metastatic Melanoma

AbCellera Acquires TetraGenetics to Enhance its Capabilities for Developing Antibodies

Published: Sept 15, 2021 | Tags: AbCellera, Acquires, TetraGenetics, Antibody

Roche Collaborates with Temedica to Launch Brisa App for the Treatment of Multiple Sclerosis

Published: Sept 15, 2021 | Tags: Roche, Temedica, Brisa App, Multiple Sclerosis

RedHill’s Opaganib (ABC294640) Fails to Meet its Primary Endpoints in P-II/III Study for the Treatment of Severe COVID-19

Published: Sept 15, 2021 | Tags: RedHill, Opaganib, ABC294640, P-II/III, Study, COVID-19

Ginkgo Going Public with ~1.63B in Proceed Via Soaring Eagle SPAC Merger

Published: Sept 15, 2021 | Tags: Ginkgo, Going Public, ~1.63B, Soaring Eagle, SPAC Merger

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Published: Sept 14, 2021 | Tags: Amgen, Lumakras, sotorasib, Health Canada, Approval, KRAS G12C-Mutated, Non-Small Cell Lung Cancer

ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

Published: Sept 14, 2021 | Tags: ONO, BMS, sBLA, Opdivo, nivolumab, Yervoy, ipilimumab, ESCC, Japan

Everest Signs a License Agreement with Providence to Advance mRNA Vaccines

Published: Sept 14, 2021 | Tags: Everest, Providence, mRNA Vaccines

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021

Published: Sept 14, 2021 | Tags: Coherus, Junshi, Toripalimab, P-III, CHOICE-01 Trial, Non-Small Cell Lung Cancer, WCLC 2021

AzurRx Signs a Reverse Triangular Merger Agreement to Acquire First Wave Bio for ~$229M

Published: Sept 14, 2021 | Tags: AzurRx, Reverse Triangular Merger Agreement, Acquire, First Wave Bio, $229M

Nuformix Signs an Exclusive WW License Agreement with Oxilio to Develop NXP001 for Oncology Disease

Published: Sept 14, 2021 | Tags: Nuformix, Oxilio, NXP001, Oncology Disease

BMS Reports Three-Year Data of Opdivo (nivolumab) + Yervoy (ipilimumab) in P-III CheckMate -743 Trial for 1L Treatment of Unresectable Malignant Pleural Mesothelioma

Published: Sept 13, 2021 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, P-III, CheckMate -743 Trial, Malignant Pleural Mesothelioma

AbbVie Collaborates with Regenxbio to Develop and Commercialize RGX-314 for the Treatment of Retinal Diseases

Published: Sept 13, 2021 | Tags: AbbVie, Regenxbio, RGX-314, Retinal Diseases

Hutchmed’s Amdizalisib (HMPL-689) Receives Breakthrough Therapy Designation for the Treatment of R/R Follicular Lymphoma in China

Published: Sept 13, 2021 | Tags: Hutchmed, Amdizalisib, HMPL-689, Breakthrough Therapy Designation, R/R Follicular Lymphoma, China

ZOLL to Acquire Itamar for ~$538M

Published: Sept 13, 2021 | Tags: ZOLL, Acquire, Itamar, ~$538M

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021

Published: Sept 13, 2021 | Tags: AstraZeneca, Imfinzi, durvalumab, Tremelimumab, P-III, POSEIDON Study, Stage IV, Non-Small Cell Lung Cancer, WCLC 2021

BeiGene and Novartis Report the US FDA’s Acceptance of BLA for Tislelizumab to Treat Esophageal Squamous Cell Carcinoma

Published: Sept 13, 2021 | Tags: BeiGene, US, FDA, BLA, Tislelizumab, Esophageal Squamous Cell Carcinoma

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