Ono Entered into an Option and Research Collaboration Agreement with Monash University to Discover Anti-GPCR Antibodies

Date: Jan 13, 2023 | Tags: Ono, Monash University, Anti-GPCR Antibodies, Autoimmune, Inflammatory Diseases, Biotech

Penumbra Launches Lightning Flash Thrombectomy System for Blood Clot Removal

Date: Jan 13, 2023 | Tags: Penumbra, Lightning Flash Thrombectomy System, Blood Clot, venous thrombus, pulmonary emboli, Regulatory, MedTech

MediciNova Reports the Completion of Patient Enrollment in the P-II Clinical Trial of MN-166 (ibudilast) for Glioblastoma

Date: Jan 13, 2023 | Tags: Medicinova, MN-166, ibudilast, Glioblastoma, Clinical Trial, P-II

Harbour BioMed Receives the US FDA’s IND Clearance of HBM1020 for the Treatment of Advanced Solid Tumors

Date: Jan 13, 2023 | Tags: Harbour Biomed, HBM1020, Advanced Solid Tumors, Regulatory, US, FDA, IND,

CNS Pharmaceuticals Initiates P-Ib/II Trial of Berubicin for the Treatment of Central Nervous System Lymphoma

Date: Jan 13, 2023 | Tags: CNS Pharmaceuticals, Berubicin, Central Nervous System Lymphoma, Clinical Trial, P-Ib/II Trial

Daiichi Sankyo and AstraZeneca Receive Health Canada’s Approval of Enhertu (trastuzumab deruxtecan) for HER2-Low Metastatic Breast Cancer

Date: Jan 13, 2023 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, trastuzumab deruxtecan, HER2-Low Metastatic Breast Cancer, Regulatory, Health Canada, Approval

Roche’s Xofluza (baloxavir marboxil) Receives EC’s Approval for the Treatment of Influenza in Children Aged ≥1 Year

Date: Jan 12, 2023 | Tags: Roche, Xofluza, baloxavir marboxil, Influenza, Regulatory, EC, Approval

Solid Biosciences Entered into a Research Collaboration with Phlox Therapeutics to Develop New Therapies for Rare Cardiac Diseases

Date: Jan 12, 2023 | Tags: Solid Biosciences, New Therapies, Rare Cardiac Diseases, Duchenne, Friedreich’s Ataxia, Pharma

Cardiovascular Systems, Inc. Reports the First Patient Enrollment of Diamondback 360 Peripheral Orbital Atherectomy System in Japan

Date: Jan 12, 2023 | Tags: Cardiovascular System, Diamondback 360© Peripheral OAS, Study, KAIZEN, Japan, Clinical Trial, MedTech

AstraZeneca and Avillion Receive the US FDA’s Approval of Airsupra (PT027) for the Treatment of Asthma

Date: Jan 12, 2023 | Tags: AstraZeneca, Avillion, Airsupra, albuterol, budesonide, Asthma, Regulatory, US FDA, Approval

Takeda’s Exkivity (mobocertinib) Receives NMPA’s Approval for EGFR Exon20 Insertion+ NSCLC

Date: Jan 12, 2023 | Tags: Takeda, xkivity, mobocertinib, EGFR Exon20 Insertion+ NSCLC, Regulatory, NMPA, Approval

BioNTech to Acquire InstaDeep for ~$683M

Date: Jan 12, 2023 | Tags: BioNtech, InstaDeep, ~$683M, Acquire, cancers, infectious diseases, M&A

Innovent Reports the First Patients Dosing of Mazdutide (IBI362) in the P-III Study (DREAMS-2) for Type 2 Diabetes

Date: Jan 11, 2023 | Tags: Innovent, Mazdutide, IBI362, Type 2 Diabetes, Clinical Trial, P-III, DREAMS-2 Study

Alvotech Reports Initiation of Pharmacokinetic Study for AVT05, a Proposed Biosimilar for Simponi and Simponi Aria

Date: Jan 11, 2023 | Tags: Alvotech, AVT05, Simponi, Simponi Aria, osteoporosis, respiratory illnesses, autoimmune diseases, Biosimilar, Clinical Trial

Exelixis Entered into a License Agreement with Ajinomoto Co. to Discover and Develop Novel Antibody-Drug Conjugates for Cancer

Date: Jan 11, 2023 | Tags: Exelixis, Ajinomoto, Antibody-Drug Conjugates, Cancer, Biotech, AJICAP technology

BioArctic Partner Eisai Reports MAA Submission of Leqembi (lecanemab) to the EMA for Early Alzheimer's Disease

Date: Jan 11, 2023 | Tags: BioArctic, Leqembi, lecanemab, Alzheimer's Disease, Regulatory, EMA, MAA

Arthrex’s ACL TightRope Implant Receives the US FDA’s Clearance for Anterior Cruciate Ligament Reconstruction

Date: Jan 11, 2023 | Tags: Arthrex, ACL TightRope Implant, Anterior Cruciate Ligament Reconstruction, Regulatory, MedTech, US, FDA

AbbVie Collaborated with Anima Biotech to Discover and Develop mRNA Biology Modulators

Date: Jan 11, 2023 | Tags: AbbVie, mRNA Biology Modulators, oncology, immunology, Biotech

Astellas Signed an Exclusive License and Development Agreement with Selecta Biosciences for Xork IgG Protease

Date: Jan 10, 2023 | Tags: Astellas, Selecta Biosciences, AT845, Xork IgG Protease, Pompe disease, Pharma

Ipsen to Acquire Albireo for ~$952M

Date: Jan 10, 2023 | Tags: Ipsen, Albireo, Bylvay, cholestatic liver diseases, progressive familial intrahepatic cholestasis, Acquire, ~$952M, M&A

Lydus Medical’s Vesseal Device Receives the US FDA’s Clearance for Small Arteries

Date: Jan 10, 2023 | Tags: Lydus Medical, Vesseal Device, Small Arteries, Regulatory, MedTech, US, FDA

Genentech Bio Signed a Discovery Collaboration with Kronos Bio to Advance Novel Therapies Against Transcriptional Targets in Oncology

Date: Jan 10, 2023 | Tags: Genentech, Kronos Bio, Novel Therapies, Oncology, Biotech

Arrowhead and Takeda Report P-II Study (SEQUOIA) of Fazirsiran for Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Date: Jan 10, 2023 | Tags: ArFazirsiran, Alpha-1 Antitrypsin Deficiency-Associated Liver Disease, Clinical Trial, P-II, SEQUOIA Study

Neurocrine and Voyager Collaborated to Develop Multiple Gene Therapies for the Treatment of Neurological Diseases

Date: Jan 10, 2023 | Tags: Neurocrine, Voyager, Gene Therapies, Neurological Diseases, Biotech

AstraZeneca to Acquire CinCor Pharma for ~$1.8B

Date: Jan 09, 2023 | Tags: AstraZeneca, Cincor Pharma, baxdrostat, CIN-107, hypertension, M&A, ~$1.8B

Chiesi to Acquire Amryt Pharma for ~$1.48B

Date: Jan 09, 2023 | Tags: Cheisi, Amryt Pharma, epidemolysis bullosa, rare diseases, ~$1.48B, M&A

Phathom Reports P-III Study (PHALCON-NERD-301) Results of Vonoprazan for Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Date: Jan 09, 2023 | Tags: Phathom, Vonoprazan, Symptomatic Non-Erosive Gastroesophageal Reflux Disease, Clinical Trial, P-III, PHALCON-NERD-301 Study

Eisai and Biogen Receive the US FDA’s Accelerated Approval of Leqembi (lecanemab-irmb) for Alzheimer's Disease

Date: Jan 09, 2023 | Tags: Eisai, Biogen, Leqembi, lecanemab-irmb, Alzheimer's Disease, Regulatory, US, FDA, Accelerated Approval, Regulatory

CymaBay Entered into a Collaboration and License Agreement with Kaken to Develop and Commercialize Seladelpar for Primary Biliary Cholangitis in Japan

Date: Jan 09, 2023 | Tags: CymaBay, Kaken, Seladelpar, Primary Biliary Cholangitis, Japan, Pharma

Moderna Entered into a Collaboration and License Agreement with Cytomx to Develop mRNA-Based Conditionally Activated Therapies

Date: Jan 09, 2023 | Tags: Moderna, Cytomx, mRNA-Based Therapies, Oncology, Biotech

Related Post: PharmaShots Weekly Snapshots (January 02 - 06, 2023)