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

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