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PharmaShots Weekly Snapshots (October 03 - 07, 2022)

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PharmaShots Weekly Snapshots (October 03 - 07, 2022)

PharmaShots Weekly Snapshots (October 03 - 07, 2022)

Opiant Reports the Completion of Patient Enrolment in P-II Study for OPNT002 to Treat Alcohol Use Disorder

Published: Oct 7, 2022| Tags: Opiant, OPNT002, Alcohol Use Disorder, Clinical Trial, P-II, naltrexone, WHO

Alnylam Reports the US FDA’s Acceptance of sNDA Application Filed for Oxlumo to Treat Advanced Primary Hyperoxaluria

Published: Oct 7, 2022| Tags: Alnylam, Oxlumo, Advanced Primary Hyperoxaluria, Regulatory, P-III, ILLUMINATE-A, ILLUMINATE-B, US, FDA, EMA

Merck and Ridgeback Report Results for Lagevrio in P-II Studies for the Treatment of COVID-19

Published: Oct 7, 2022 | Tags: Merck, Ridgeback, Lagevrio, COVID-19, Clinical Trial, P-II, PANORAMIC, Clalit, Tg RasH2

Abbott Reports New (FLASH-UK) Trial Results of FreeStyle Libre 2 System for Type 1 Diabetes and Sub-Optimal Glycemic Control

Published: Oct 7, 2022 | Tags: Abbott, FreeStyle Libre 2 System, Type 1 Diabetes, Sub-Optimal Glycemic Control, Clinical Trial, NEJM

Sanofi Entered into a Co-Promotion Service Agreement with Provention Bio to Commercialize Teplizumab for Type 1 Diabetes

Published: Oct 7, 2022 | Tags: Sanofi, Provention Bio, Teplizumab, Type 1 Diabetes, Pharma, Co-Promotion Service Agreement

Boehringer Ingelheim Entered into a Collaboration and License Agreement with Surrozen to Develop SZN-413 for the Treatment of Retinal Diseases

Published: Oct 7, 2022 | Tags: Boehringer Ingelheim, Surrozen, SZN-413, Retinal Diseases, Pharma, SWAP technology

Eli Lilly’s Tirzepatide Receives the US FDA’s Fast Track Designation for the Treatment of Obesity

Published: Oct 6, 2022 | Tags: Eli Lilly, Tirzepatide, Obesity, Regulatory, US, FDA, Fast Track Designation

NewAmsterdam Pharma Initiates P-II Dose-Finding Study of Obicetrapib for the Treatment of Dyslipidemia

Published: Oct 6, 2022 | Tags: NewAmsterdam Pharma, Obicetrapib, Dyslipidemia, Clinical Trial, P-II, Dose-Finding Study

Glenmark Launches Lobeglitazone (thiazolidinedione lobeglitazone) for Uncontrolled Type 2 Diabetes in India

Published: Oct 6, 2022 | Tags: Glenmark, Lobeglitazone, thiazolidinedione lobeglitazone, Uncontrolled Type 2 Diabetes, Regulatory, India

Roche’s CDx Test Receives the US FDA’s Approval for HER2 Low Metastatic Breast Cancer

Published: Oct 6, 2022 | Tags: Roche, CDx Test, PATHWAY, anti-HER2/neu (4B5) Rabbit monoclonal primary Ab, Enhertu, HER2 Low Metastatic Breast Cancer, US, FDA, Approval, Regulatory, MedTech 

Takeda Reports the US FDA’s Acceptance of sBLA for Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years

Published: Oct 6, 2022 | Tags: Takeda, Takhzyro, lanadelumab-flyo, Hereditary Angioedema, regulatory, US, FDA, sBLA 

GSK Reports P-II (PERLA) Trial Results of Jemperli (dostarlimab) for Metastatic Non-Squamous Non-Small Cell Lung Cancer

Published: Oct 6, 2022 | Tags: GSK, Jemperli, dostarlimab, Metastatic Non-Squamous, Non-Small Cell Lung Cancer, Clinical Trial, P-II PERLA Trial

NextCure Reports Initiation of NC410 + Keytruda in P-Ib/II Clinical Trial for Immune Checkpoint Refractory or Naïve Solid Tumors

Published: Oct 5, 2022 | Tags: NextCure, NC410, Keytruda, Immune Checkpoint Refractory, Naïve Solid Tumors, Clinical Trial, P-Ib/II Clinical Trial 

Oxford BioTherapeutics Outlicenses Novel Antibody to Genmab for Immuno-Oncology

Published: Oct 5, 2022 | Tags: Oxford BioTherapeutics, Genmab, OBT076, Immuno-Oncology, Outlicenses, Biotech

Exelixis Expands 2021 Clinical Trial Collaboration and Supply Agreement with BMS for XL092 as Fixed Dose Combination in P-Ib (STELLAR-002) Trial for Advanced Solid Tumors

Published: Oct 5, 2022 | Tags: Exelixis, BMS, XL092, nivolumab, ipilimumab, Advanced Solid Tumors, Pharma, P-Ib, STELLAR-002, Trial

Ascletis Reports First Patient Dosing in the P-II Clinical Trial of ASC41 for Liver Biopsy-Proven Non-Alcoholic Steatohepatitis

Published: Oct 5, 2022 | Tags: Ascletis, ASC41, Liver Biopsy-Proven, Non-Alcoholic Steatohepatitis, Clinical Trial, P-II Clinical Trial

SyntheX Entered into a Research Collaboration with BMS to Discover and Develop Targeted Protein Degradation Therapies

Published: Oct 5, 2022 | Tags: SyntheX, BMS, Targeted Protein Degradation Therapies, ToRNeDO molecular glue discovery platform, Pharma

Pfizer In-Licenses Voyager Therapeutics' AAV Capsid for Rare Neurologic Disease Target

Published: Oct 5, 2022 | Tags: Pfizer, In-Licenses, Voyager Therapeutics, AAV Capsid, Rare Neurologic Disease, TRACERTM capsid discovery platform, pharma

Sanofi Entered into an Exclusive License Agreement with miRecule to Advance Antibody-RNA Conjugate for Facioscapulohumeral Muscular Dystrophy

Published: Oct 4, 2022 | Tags: Sanofi, miRecule, Antibody-RNA Conjugate, Facioscapulohumeral Muscular Dystrophy, NANOBODY technology, Biotech

Astellas Expands its 2021 Agreement with Pantherna to generate mRNA-Based Regenerative Medicine Programs

Published: Oct 4, 2022 | Tags: Astellas, 2021, Agreement, Pantherna, mRNA-Based Regenerative Medicine Programs, Pharma

Amneal Launches Alymsys (biosimilar, bevacizumab) in the US

Published: Oct 4, 2022 | Tags: Amneal, mAbxience, Alymsys, biosimilar, bevacizumab, US, Launches, Regulatory

Biogen and Denali Report the Initiation of P-III (LIGHTHOUSE) Study for BIIB122 to Treat Parkinson’s Disease Associated with LRRK2 Pathogenic Mutations

Published: Oct 4, 2022 | Tags: Biogen, Denali, BIIB122, Parkinson’s Disease, LRRK2 Pathogenic Mutations, Clinical Trial, P-III (LIGHTHOUSE) Study

REGENXBIO Reports Interim P-II (AAVIATE) and P-I/IIa Long-term Follow-up Study of RGX-314 for Wet AMD

Published: Oct 4, 2022 | Tags: REGENXBIO, RGX-314, Wet AMD, Clinical Trial, P-II, AAVIATE, P-I/IIa, Long-term Follow-up

Estrella to Go Public via TradeUP SPAC Merger for ~$398.5M

Published: Oct 4, 2022 | Tags: Estrella, Public, TradeUP, SPAC Merger, EB103, EB104, solid tumors, ~$398.5M, M&A

Alexion to Acquire LogicBio Therapeutics for ~$68M

Published: Oct 3, 2022 | Tags: Alexion, LogicBio Therapeutics, ~$68M, Acquire, GeneRid, M&A

Axsome Reports (SHARP) Study Results of Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Obstructive Sleep Apnea

Published: Oct 3, 2022 | Tags: Axsome, Sunosi, solriamfetol, Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Clinical Trial, SHARP Study

Incyte to Acquire Medicxi-backed Villaris Therapeutics for Auremolimab

Published: Oct 3, 2022 | Tags: Incyte, Medicxi-backed Villaris Therapeutics, Auremolimab, Acquire, vitiligo, VM6, M&A

Solid Biosciences to Acquire AavantiBio for Gene Therapy Programs

Published: Oct 3, 2022 | Tags: Solid Biosciences, AavantiBio, Gene Therapy Programs, SGT-003, Duchenne, AVB-202, Friedreich’s ataxia, AVB-401, BAG3 mediated dilated cardiomyopathy, cardiac diseases, Acquire, $215M, M&A 

Janssen Presents P-I/II (MGT009) and P-I Study Results of Two Gene Therapy Programs for X-Linked Retinitis Pigmentosa and Dry AMD at AAO 2022

Published: Oct 3, 2022 | Tags: Janssen, botaretigene sparoparvovec, JNJ-1887, Linked Retinitis Pigmentosa, Dry AMD, P-I/II MGT009, P-I Study, Clinical Trial, AAO, 2022

Apellis Presents 24-Month P-III (OAKS) Post Hoc Results of Pegcetacoplan for the Treatment of Geographic Atrophy at AAO 2022

Published: Oct 3, 2022 | Tags: Apellis, Pegcetacoplan, Geographic Atrophy, Clinical Trial, 24-Month, P-III OAKS, AAO, 2022

Related Post: PharmaShots Weekly Snapshots (September 26 - 30, 2022)


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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