Hutchmed Reports the US FDA's Acceptance of Surufatinib's NDA for Advanced Neuroendocrine Tumors

Published: July 2, 2021 | Tags: Hutchmed, US, FDA, Surufatinib, NDA, Advanced Neuroendocrine Tumors

Denovo In-Licenses Lundbeck's Idalopirdine for Alzheimer's Disease and Other Indications

Published: July 2, 2021 | Tags: Denovo, Lundbeck, Idalopirdine, Alzheimer's Disease, DB109

Zydus Seeks EUA for ZyCoV-D Against COVID-19 in India

Published: July 2, 2021 | Tags: Zydus, EUA, ZyCoV-D, COVID-19, India

Almirall and Kaken Enter into a License Agreement for the Development and Commercialization of Efinaconazole in Europe

Published: July 2, 2021 | Tags: Almirall, Kaken, License Agreement, Efinaconazole, Europe

The US FDA Approves FoundationOne CDx for Alunbrig (brigatinib) in Patients with ALK+ NSCLC

Published: July 2, 2021 | Tags: US, FDA, Approves, FoundationOne CDx, Alunbrig, brigatinib, ALK+ NSCLC

Nestle and Seres Collaborate to Jointly Commercialize SER-109 for Recurrent Clostridioides difficile Infection

Published: July 2, 2021 | Tags: Nestle, Seres, Commercialize, SER-109, Recurrent Clostridioides difficile Infection,   microbiome therapeutic

Orchard Collaborates with Pharming to Develop and Commercialize OTL-105 for Hereditary Angioedema

Published: July 1, 2021 | Tags: Orchard Therapeutics, Pharming, Develop, Commercialize, OTL-105, Hereditary Angioedema

Jazz's Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Receives the US FDA's Approval for Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Published: July 1, 2021 | Tags: Jazz Pharmaceuticals, Rylaze, asparaginase erwinia chrysanthemi, US, FDA, Approval, Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma

Abbott's XIENCE Stent Receives the US FDA's Approval for Shortest Blood Thinner Course in Patients with High Bleeding Risk

Published: July 1, 2021 | Tags: Abbott, XIENCE Stent, US, FDA, Approval, Shortest Blood Thinner Course, High Bleeding Risk

LEXEO Therapeutics' LX2006 Receives the US FDA's Rare Pediatric Disease Designation and Orphan Drug Designation to Treat Friedreich Ataxia

Published: July 1, 2021 | Tags: LEXEO Therapeutics, LX2006, Rare Pediatric Disease Designation, Orphan Drug Designation, Friedreich Ataxia

STADA and Xbrane's Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

Published: July 1, 2021 | Tags: STADA, Xbranen, Xlucane, biosimilar, ranibizumab, P-III, Xplore Clinical Trial

Apellis and Beam Sign a Five-Year Research Collaboration to Discover Novel Therapies for Complement-Driven Diseases

Published: July 1, 2021 | Tags: Apellis, Beam Therapeutics, Five-Year Research Collaboration, Novel Therapies, Complement-Driven Diseases

Formycon and Bioeq Report MAA Submission to EMA for FYB201 (biosimilar, ranibizumab)

Published: June 30, 2021 | Tags: Formycon, Bioeq, MAA, EMA, FYB201, biosimilar, ranibizumab

Vivoryon and Simcere Sign a License Agreement for N3pE Amyloid-Targeting Medicines to Treat Alzheimer's Disease in Greater China

Published: June 30, 2021 | Tags: Vivoryon, Simcere, License Agreement, N3pE Amyloid-Targeting Medicines, Alzheimer Disease, Greater China

Arbutus and Antios Enter into a Clinical Collaboration to Evaluate AB-729 + ATI-2173 for Chronic Hepatitis B Virus Infection

Published: June 30, 2021 | Tags: Arbutus Biopharma, Antios Therapeutics, AB-729, ATI-2173, Chronic Hepatitis B Virus Infection

AbbVie Report Results of Rinvoq (upadacitinib) in P-III Maintenance Study for the Treatment of Ulcerative Colitis

Published: June 30, 2021 | Tags: AbbVie, Rinvoq, upadacitinib, P-III, Maintenance Study, Ulcerative Colitis

BMS Opdivo (nivolumab) + Yervoy (ipilimumab) Receive EC's Approval for dMMR or MSI-H mCRC After Prior Chemotherapy

Published: June 30, 2021 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, EC, Approval, dMMR, MSI-H mCRC

Medtronic Launches its First App-Based Research Study to Manage Atrial Fibrillation Disease Burden

Published: June 30, 2021 | Tags: Medtronic, Launches, App-Based Research Study, Atrial Fibrillation Disease Burden

Sanofi Reports Results of Soliqua (insulin glargine and lixisenatide) in SoliMix Study for the Treatment of Type 2 Diabetes

Published: June 29, 2021 | Tags: Sanofi, Soliqua, insulin glargine, lixisenatide, SoliMix Study, Type 2 Diabetes

Medtronic Presents Real-World Data of InPen Smart Insulin Pen for Controlling Blood Sugar Levels at ADA2021

Published: June 29, 2021 | Tags: Medtronic, Real-World Data, InPen Smart Insulin Pen, Controlling Blood Sugar Levels, ADA2021

AstraZeneca's Vaxzevria (AZD1222) Delivers Strong Immune Responses in COV001 and COV002 Trials Against COVID-19

Published: June 29, 2021 | Tags: AstraZeneca, Vaxzevria, AZD1222, COV001, COV002 Trials, COVID-19

Teva Signs an Exclusive Commercialization Agreement with Bioeq for FYB201 (biosimilar, ranibizumab)

Published: June 29, 2021 | Tags: Teva, Commercialization Agreement, Bioeq, FYB201, biosimilar, ranibizumab

Innovent's Tyvyt (sintilimab) + Byvasda (biosimilar, bevacizumab) Receive the NMPA's Approval as 1L Therapy for Hepatocellular Carcinoma

Published: June 29, 2021 | Tags: Innovent, Tyvyt, sintilimab injection, Byvasda, biosimilar, bevacizumab, NMPA, Approval, Hepatocellular Carcinoma

Gilead Reports Submission of NDA to the US FDA for Lenacapavir to Treat HIV-1 in People with Limited Therapy Options

Published: June 29, 2021 | Tags: Gilead, NDA, US, FDA, Lenacapavir, HIV

Samsung Bioepis and Biogen Receive the CHMP's Positive Opinion Recommending Approval of Byooviz (biosimilar, ranibizumab) for Retinal Vascular Disorders

Published: June 28, 2021 | Tags: Samsung Bioepis, Biogen, CHMP, Approval, Byooviz, biosimilar, ranibizumab, Retinal Vascular Disorders

AstraZeneca's Forxiga (dapagliflozin) Receives CHMP's Recommendation for Approval to Treat Chronic Kidney Disease in EU

Published: June 28, 2021 | Tags: AstraZeneca, Forxiga, dapagliflozin, CHMP, Recommendation, Approval, Chronic Kidney Disease in EU

Roche's Enspryng Receives EC's Approval as First Home Subcutaneous Treatment for NMOSD

Published: June 28, 2021 | Tags: Roche, Enspryng, satralizumab, EC, Approval, NMOSD

Lilly Presents the Results of Tirzepatide in SURPASS-1 Trial for Type-2 Diabetes at ADA2021

Published: June 28, 2021 | Tags: Lilly, Tirzepatide, SURPASS-1 Monotherapy Trial, Type-2 Diabetes, ADA2021, The Lancet

Mirati's Adagrasib (MRTX849) Receives the US FDA's Breakthrough Therapy Designation for Advanced Non-Small Cell Lung Cancer

Published: June 28, 2021 | Tags: Mirati Therapeutics, Adagrasib, MRTX849, US, FDA, Breakthrough Therapy Designation, Advanced Non-Small Cell Lung Cancer

AstraZeneca Reports First Patient Vaccinating in P-II/III D7220C00001 Trial for AZD2816 to Prevent COVID-19

Published: June 28, 2021 | Tags: AstraZeneca, P-II/III, D7220C00001 Trial, COVID-19 Variant Vaccine, AZD2816, COVID-19

Related Post: PharmaShots Weekly Snapshots (June 21 - 25, 2021)