PharmaShots Weekly Snapshots (June 26

BioMarin’s Roctavian Receives the US FDA’s Approval for the Treatment of Severe Hemophilia A

Date: Jun 30, 2023 | Tags: BioMarin, Roctavian, Severe Hemophilia A, Regulatory, US FDA, P-III, GENEr8-1

Sanofi and SK Bioscience Report Result of GBP410 in P-II Trial to Treat Pneumococcal Diseases in Infants

Date: Jun 30, 2023 | Tags: Sanofi, SK Biosciences, GBP410, Pneumococcal Diseases, Clinical Trial, P-II

BioNTech and OncoC4 Initiate Pivotal P-III Trial of Gotistobart (BNT316/ONC-392) in Patients with Metastatic Non Small Cell Lung Cancer

Date: Jun 30, 2023 | Tags: Biontech, Oncoc4, Gotistobart, BNT316, ONC-392, NSCLC, ASCO 2023, Preserve-003, FTD, Collaboration, Clinical Trial

Lilly to Acquire Sigilon Therapeutics for Over $300M to Enhance its Cell Therapy Business for the Treatment of Type 1 Diabetes

Date: Jun 30, 2023 | Tags: Lilly, Sigilon Therapeutics, Type 1 Diabetes, Merger & Acquisition, Cell Therapies

BMS Receives the EC Approval for Opdivo (nivolumab) + CT as Neoadjuvant Treatment of Resectable Stage IB to IIIA Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients

Date: Jun 30, 2023 | Tags: BMS, Opdivo, Nivolumab, Chemotherapy, Checkmate –816, P-III, Regulatory

AstraZeneca Reports 4-Year Follow-Up Data for Imfinzi and Imjudo in P-III Trial for the Treatment of Hepatocellular Carcinoma

Date: Jun 30, 2023 | Tags: Astrazeneca, Imfinzi, Imjudo, Hepatocellular Carcinoma, Clinical Trial, P-III, Himalaya

Liquidia and Pharmosa Biopharm Enters into Exclusive Licensing Agreement for $225M to Develop and Commercialize L606 in North America

Date: Jun 29, 2023 | Tags: Liquidia, Pharmosa Biopharma, L606, Sustained-Release Formulation, Treprostinil, PAH, PH-ILD, North America, Pharma

Bayer’s BlueRock Reports the P-I Study Data for Bemdaneprocel (BRT-DA01) Stem Cell Therapy to Treat Parkinson’s Disease

Date: Jun 29, 2023 | Tags: Bayer, Bluerock, Bemdaneprocel, BRT-DA01, Parkinson’s Disease, Clinical Trial, Stem Cell Therapy

Cognition Therapeutics Reports P-II Study (SEQUEL) Results of CT1812 for Mild-to-Moderate Alzheimer’s Disease in Netherlands

Date: Jun 29, 2023 | Tags: Cognition Therapeutics, CT1812, Alzheimer’s Disease, Sequel Study, Netherlands, Quantitative Electroencephalogram, Clinical Trial

Foghorn Therapeutics Reports Discontinuation of P-I Clinical Trial for FHD-286 in Metastatic Uveal Melanoma (mUM)

Date: Jun 29, 2023 | Tags: Foghorn Therapeutics, FHD-286, Metastatic Uveal Melanoma, Clinical Trial, P-I, AML, Decitabine, Cytarabine

CellTrans’ Lantidra Receives the US FDA’s Approval for the Treatment of Type 1 Diabetes

Date: Jun 29, 2023 | Tags: Celltrans, Lantidra, Type 1 Diabetes, Regulatory, US FDA, Approval, Cellular Therapy

K36 Therapeutics Receives $70M Series B Financing to Develop KTX-1001 to Treat Multiple Myeloma

Date: Jun 29, 2023 | Tags: K36 Therapeutics, Nextech Invest, BMS, Atlas Venture, F-Prime Capital, And Eight Roads Ventures, KTX-1001, Multiple Myeloma, Hematological, Solid Tumor, Pharma

Korean MFDS Grants Innovative Medical Device Designation to Kalos Medicals’ DENEX Hypertension Treatment System

Date: Jun 28, 2023 | Tags: Kalos Medicals, Denex Hypertension Treatment System, Hypertension, Korean MFDS, Innovative Medical Device Designation, Medtech

Regeneron and Bayer Receive Complete Response Letter on the BLA for Aflibercept to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, and Diabetic Retinopathy

Date: Jun 28, 2023 | Tags: Regeneron, Bayer, Aflibercept, Age-Related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Regulatory, CRL, BLA, US FDA

Bayer Reports the Initiation of the P-III (QUANTI) Trials for Gadoquatrane as a Contrast Agent for Magnetic Resonance Imaging

Date: Jun 28, 2023 | Tags: Bayer, Gadoquatrane, CNS Disorders, Clinical Trial, P-III, QUANTI, QUANTI CNS, QUANTI OBR, MRI

AstraZeneca’s Xigduo XR Receives the NMPA’s Approval for the Treatment of Type-2 Diabetes

Date: Jun 28, 2023 | Tags: Astrazeneca, Xigduo XR, Dapagliflozin, Metformin Hydrochloride, Type-2 Diabetes, Regulatory, NMPA, Approval

Pfizer Reports the US FDA Acceptance of BLA for Fidanacogene Elaparvovec to Treat Hemophilia B

Date: Jun 28, 2023 | Tags: Pfizer, Fidanacogene Elaparvovec, Hemophilia B, Regulatory, US, FDA, BLA

Genmab and AbbVie Report P-I/II Trial (EPCORE NHL-1) Results of Epcoritamab for the Treatment of Relapsed/Refractory Follicular Lymphoma

Date: Jun 28, 2023 | Tags: Genmab, Abbvie, Epcoritamab, Follicular Lymphoma, Clinical Trial, P-I/II Trial, EPCORE NHL-1

Xentria Entered into an Exclusive Multi-Year License Agreement with Meitheal to Commercialize XTMAB-16 for Pulmonary Sarcoidosis in North America

Date: Jun 27, 2023 | Tags: Xentria, Meitheal, XTMAB-16, Pulmonary Sarcoidosis, North America, Biotech

UCB’s Rystiggo (rozanolixizumab) Receives the US FDA’s Approval for the Treatment of Adults with Generalized Myasthenia Gravis

Date: Jun 27, 2023 | Tags: UCB, Rystiggo, Rozanolixizumab, Generalized Myasthenia Gravis, Regulatory, US, FDA, Approval

Tonix Pharmaceuticals to Acquire Zembrace SymTouch and Tosymra from Upsher-Smith Laboratories for Acute Migraine

Date: Jun 27, 2023 | Tags: Tonix Pharmaceuticals, Upsher-Smith Laboratories, Acute Migraine, Zembrace Symtouch, Tosymra, Acquire, M&A

Sanofi Reports P-IIb Study (STREAM-AD) Results of Amlitelimab for the Treatment of Atopic Dermatitis

Date: Jun 27, 2023 | Tags: Sanofi, Amlitelimab, Atopic Dermatitis, Clinical Trial, P-IIb, STREAM-AD Study

Janssen Reports P-II Trial (UNITY) Results of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn

Date: Jun 27, 2023 | Tags: Janssen, Nipocalimab, Early-Onset Severe Hemolytic Disease, Pregnant Individuals, Fetus, Newborn, Clinical Trial, P-II, Unity Trial

BMS’ Camzyos (mavacamten) Receives EC’s Approval for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy

Date: Jun 27, 2023 | Tags: BMS, Camzyos, Mavacamten, Symptomatic Obstructive Hypertrophic Cardiomyopathy, Regulatory, EC, Approval

Janssen Reports the MAA Submission of Macitentan and Tadalafil to the EMA for the Treatment of Pulmonary Arterial Hypertension

Date: Jun 26, 2023 | Tags: Janssen, Macitentan, Tadalafil, Pulmonary Arterial Hypertension, Clinical Trial, EMA, MAA

GSK Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Daprodustat for Symptomatic Anaemia Associated with Chronic Kidney Disease

Date: Jun 26, 2023 | Tags: GSK, Jesduvroq, Duvroq, Daprodustat, Symptomatic Anaemia, Chronic Kidney Disease, Regulatory, EMA, CHMP, Marketing Authorization

AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Soliris (eculizumab) to Treat Refractory Generalised Myasthenia Gravis

Date: Jun 26, 2023 | Tags: Astrazeneca, Soliris, Eculizumab, Generalised Myasthenia Gravis, Regulatory, EMA, CHMP, Positive Opinion, Marketing Authorization

Sanofi and Sobi Present P-III Study (XTEND-Kids) Results of Altuviiio for Severe Hemophilia A at ISTH 2023

Date: Jun 26, 2023 | Tags: Sanofi, Sobi, Altuviiio, Efanesoctocog Alfa, Severe Hemophilia A, Clinical Trial, P-III, XTEND-Kids Study, ISTH, 2023

Lilly Presented P-II Trial Results of Orforglipron for the Treatments of Adults with Obesity or Overweight at American Diabetes Association

Date: Jun 26, 2023 | Tags: Lilly, Orforglipron, Obesity, Overweight, Clinical Trial, P-II Trial, American Diabetes Association

Pfizer’s Litfulo (Ritlecitinib) Receives the US FDA’s Approval for Adults and Adolescents with Severe Alopecia Areata

Date: Jun 26, 2023 | Tags: Pfizer’s Litfulo, Ritlecitinib, Alopecia Areata, Regulatory, US, FDA, Approval