In the News

PhaseBio Pharmaceuticals and SFJ Pharmaceuticals® Announce Approval of IND Application in China for Bentracimab

MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that the Investigational New Drug (IND) application for bentracimab submitted to the Center for Drug Evaluation (CDE)... ...

Apellis and Sobi Report Positive Top-line Results from the Phase 3 PRINCE Study of EMPAVELI™ (pegcetacoplan) in Treatment-naïve Patients with PNH

EMPAVELI demonstrated statistical superiority on the co-primary endpoints of hemoglobin stabilization (p<0.0001) and reduction in lactate dehydrogenase (LDH) (p<0.0001) compared to standard of care, which did not include complement inhibitors, at Week 26 Mean hemoglobin levels in the EMPAVELI group increased from 9.4 g/dL to... ...

Apellis Announces U.S. Food and Drug Administration (FDA) Approval of EMPAVELI™ (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)

EMPAVELI, the first targeted C3 therapy, is approved for use in adults with PNH who are: Treatment naïve Switching from C5 inhibitor Soliris® (eculizumab) Switching from C5 inhibitor Ultomiris® (ravulizumab) EMPAVELI was superior to Soliris for the change from baseline in hemoglobin level at Week... ...

Nektar Announces Collaboration with SFJ Pharmaceuticals® for Bempegaldesleukin in Head and Neck Cancer

Nektar to receive up to $150 million in development funding through a novel financing collaboration agreement.   SAN FRANCISCO, Feb. 17, 2021 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cancer and auto-immune disease, today announced... ...

PhaseBio Announces Financing and Co-Development Collaboration with SFJ Pharmaceuticals® for PB2452

MALVERN, Pa. and SAN DIEGO, Jan. 10, 2020 (GLOBE NEWSWIRE) — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage ...

SFJ Pharmaceuticals® partner, Apellis, enters Strategic Collaboration with Sobi to Develop and Commercialize Pegcetacoplan in Hematologic Indications outside the U.S.

PLEASANTON, Calif., Oct. 27, 2020 /PRNewswire/ — SFJ Pharmaceuticals® (“SFJ”) is pleased to note that its partner Apellis Pharmaceuticals Inc. ...

SFJ Pharmaceuticals® partner, Apellis, enters Strategic Collaboration with Sobi to Develop and Commercialize Pegcetacoplan in Hematologic Indications outside the U.S.

PLEASANTON, Calif., Oct. 27, 2020 /PRNewswire/ — SFJ Pharmaceuticals® (“SFJ”) is pleased to note that its partner Apellis Pharmaceuticals Inc. (“Apellis”) (Waltham, MA) and Swedish Orphan Biovitrum AB (“Sobi™”) (Stockholm, Sweden) today announced a strategic collaboration to accelerate the advancement of systemic pegcetacoplan, a targeted C3 therapy, for... ...

PhaseBio Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Recent Business Highlights

Recently Initiated PB2452 Phase 3 Trial for the Reversal of the Antiplatelet Effects of Ticagrelor Received FDA Breakthrough Therapy Designation and EMA PRIME Designation for PB2452 Secured PB2452 Financing and Co-Development Collaboration with SFJ Pharmaceuticals® MALVERN, Pa. and SAN DIEGO, March 30, 2020 (GLOBE NEWSWIRE)... ...

PHAS Stock Rockets 25% on Collaboration With SFJ Pharma

In a development that would come as a major boost to PHAS stock, PhaseBio Pharmaceuticals Inc (NASDAQ:PHAS) announced that it has reached a major agreement with SFJ Pharmaceuticals. Important Collaboration The company announced today that it reached a collaboration and financing agreement with SFJ, which has had... ...

PhaseBio Announces Financing and Co-Development Collaboration with SFJ Pharmaceuticals® for PB2452

PhaseBio Announces Financing and Co-Development Collaboration with SFJ Pharmaceuticals® for PB2452 PDF Version PhaseBio to receive up to $120 million in development funding PhaseBio retains exclusive worldwide commercial rights to PB2452 MALVERN, Pa. and SAN DIEGO, Jan. 10, 2020 (GLOBE NEWSWIRE) — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on... ...

Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2)

News Release Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2) Compared to Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) January 7, 2020 Pegcetacoplan met the primary endpoint in the PEGASUS study, demonstrating superiority to eculizumab (p<0.0001) with an improvement in adjusted... ...

Apellis Reports Positive Top-line Results from Phase 3 Head-to-Head Study of Pegcetacoplan (APL-2)

WALTHAM, Mass., Jan. 07, 2020 (GLOBE NEWSWIRE) —  Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company ...

VIZIMPRO® (dacomitinib) Receives Marketing Authorization in European Union (EU)

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor... ...

VIZIMPRO® (DACOMITINIB) RECEIVES MARKETING AUTHORIZATION IN EUROPEAN UNION (EU) FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH EGFR-MUTATED NON-SMALL CELL LUNG CANCER

Wednesday, April 03, 2019 – 05:42am EDT Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal... ...

Apellis Pharmaceuticals Announces Collaboration with SFJ Pharmaceuticals®

Apellis Pharmaceuticals Announces Collaboration with SFJ Pharmaceuticals® for APL-2 in Hematologic Indications Apellis to receive up to $120 million in upfront and near-term milestone payments, with the potential for additional payments subject to mutual agreement Apellis retains exclusive worldwide commercial rights to APL-2 in all... ...

Apellis lands as much as $250M in financing from drug development company

By Chris Larson  –  Reporter, Louisville Business First Feb 28, 2019 Apellis Pharmaceuticals Inc. has reached a deal with a globally oriented drug development company that could give Apellis as much as $250 million in financing through what Apellis calls “a novel, risk-sharing collaboration.” Apellis,... ...

PFIZER RECEIVES POSITIVE CHMP OPINION FOR VIZIMPRO® (DACOMITINIB) FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WITH EGFR-ACTIVATING MUTATIONS

Friday, February 01, 2019 – 04:17am EST   NEW YORK–(BUSINESS WIRE)–Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in... ...

Momenta Pharmaceuticals Provides Update on US Regulatory Strategy for M923, Proposed Biosimilar to HUMIRA®

CAMBRIDGE, Mass., Dec. 03, 2018 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company with a validated scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases, today announced a revised regulatory strategy in the United States for M923, Momenta’s proposed biosimilar to HUMIRA. Momenta had... ...

Annuals of Oncology – 10-20-2018 – Axitinib

Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial Background: The ATLAS trial compared axitinib versus placebo in patients with locoregional renal cell carcinoma (RCC) at risk of recurrence after nephrectomy. Patients and methods: In... ...

Eisai Launches Anticancer Agent Lenvima®

Eisai Launches Anticancer Agent Lenvima® (Lenvatinib Mesylate) In United Kingdom Indicated For Advanced Thyroid Cancer Refractory To Radioactive Iodine Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has launched its in-house developed novel anticancer agent... ...

VIZIMPRO FDA Approval Press Release ED

U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer Approval Supported by Data from Phase 3 Head-to-Head Study vs. Gefitinib NEW YORK, N.Y., September 27 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and... ...

Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non–Small-Cell Lung Cancer and EGFR-Activating Mutations

Purpose ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-naïve patients with advanced non–small-cell lung cancer (NSCLC) and activating mutations in EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is... ...

Abituzumab in Metastatic Colorectal Cancer

Merck KGaA, Darmstadt, Germany to Develop Abituzumab in Metastatic Colorectal Cancer with SFJ Pharmaceuticals Group Agreement enables Merck KGaA, Darmstadt, Germany, to further develop abituzumab through a novel risk-sharing collaboration agreement SFJ Pharmaceuticals Group to develop abituzumab as a first-line treatment for metastatic colorectal cancer... ...

Inotuzumab ozogamicin (InO) treatment in patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL): Analysis from INO-VATE by bone marrow blast percentage (BMB%)

Background:InO is a calicheamicin-conjugated antibody targeting CD22 on ALL blast cells. Here we report outcomes in R/R ALL patients (pts) receiving InO or standard of care chemotherapy (SC) in the phase 3 INO-VATE trial according to baseline BMB%, an indicator of disease burden.   Methods:Adults... ...

Dacomitinib (daco) versus gefitinib (gef) for first-line treatment of advanced NSCLC (ARCHER 1050): Final overall survival (OS) analysis

Background:In the ongoing phase 3 ARCHER 1050 study, first-line treatment with daco significantly improved the primary endpoint of progression-free survival, duration of response, and time to treatment failure vs gef in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer... ...

FDA Approves Gemtuzumab Ozogamicin for AML

WEDNESDAY, NOVEMBER 1, 2017   The U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for two patient populations: adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) and children ≥2 years old with relapsed or refractory CD33-positive AML.   GO originally received accelerated... ...

Mylortarg received FDA approval

PFIZER RECEIVES FDA APPROVAL FOR MYLOTARG™ (GEMTUZUMAB OZOGAMICIN) ONLY APPROVED ANTIBODY-DRUG CONJUGATE FOR NEWLY DIAGNOSED AND RELAPSED OR REFRACTORY CD33-POSITIVE ACUTE MYELOID LEUKEMIA REINTRODUCTION OF MYLOTARG SUPPORTED BY CONTINUED RESEARCH BY THE AML COMMUNITY DEMONSTRATING FAVORABLE RISK:BENEFIT PROFILE Friday, September 1, 2017 – 11:38am EDT... ...

FDA APPROVAL OF AML THERAPY IS A SIGNIFICANT ADVANCE FOR BLOOD CANCER PATIENTS

Rye Brook, N.Y. (September 1, 2017) – The steady march of progress in new treatments for patients with acute myeloid leukemia (AML), one of the most deadly blood cancers which takes more than 10,000 lives in the U.S. each year, continues today with the U.S. Food & Drug... ...

Defining Radioiodine-Refractory Differentiated Thyroid Cancer: Efficacy and Safety of Lenvatinib by Radioiodine-Refractory Criteria in the SELECT Trial

Background: While there is a clear consensus for defining radioiodine-refractory differentiated thyroid cancer (RR-DTC), it is unknown whether these criteria are equally valid for determining when radioiodine (RAI) therapy is no longer beneficial and systemic treatment should be considered. Lenvatinib, a multikinase inhibitor, significantly prolonged progression-free... ...

LENVATINIB SIGNIFICANTLY IMPROVED OVERALL SURVIVAL IN OLDER PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE-REFRACTORY DIFFERENTIATED THYROID CANCER ACCORDING TO RESULTS OF SUBANALYSIS OF PHASE 3 SELECT TRIAL

First kinase inhibitor to show improvement in overall survival in any patient group with RAI-R DTC Data published in the Journal of Clinical Oncology WOODCLIFF LAKE, N.J., Aug. 28, 2017 /PRNewswire/ — Eisai Inc. announced data from a prespecified subgroup analysis, which was published in the Journal of Clinical Oncology, showing... ...

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL

On Aug. 17, 2017, the U.S. Food and Drug Administration approved inotuzumab ozogamicin (BESPONSA, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).   The approval was based on data from... ...

BESPONSA FDA Approval Release

PFIZER RECEIVES U.S. FDA APPROVAL FOR BESPONSA® (INOTUZUMAB OZOGAMICIN) August 17, 2017 BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia NEW YORK–(BUSINESS WIRE)– Pfizer Inc. (NYSE:PFE) today announced that... ...

Momenta Pharmaceuticals Announces Positive Top-Line Phase 3 Results for M923, a Proposed HUMIRA® (adalimumab) Biosimilar

CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion... ...

Inotuzumab ozogamicin (InO) for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) in the phase III INO-VATE trial: Efficacy and safety by prior therapy

Background:InO, an anti-CD22 antibody-calicheamicin conjugate, showed superior response vs standard care for R/R ALL in the phase III INO-VATE trial. Herein, effects of prior therapy on response and toxicities were assessed in patients (pts) receiving InO.    Methods:Per protocol, intent-to-treat analyses of complete remission /CR... ...

FDA Approves Eisai’s LENVIMA (lenvatinib) for the Treatment of Patients with Locally Recurrent or Metastatic, Progressive, Radioactive Iodine-Refractory Differentiated Thyroid Cancer

– New Therapy Demonstrated a Dramatic Improvement in Progression-Free Survival and a Statistically Significant Overall Response Rate in Some Patients with RAI-Refractory Differentiated Thyroid Cancer – File Submission and Approval Based on Data from Phase 3 SELECT Study Published in New England Journal of Medicine... ...

FDA APPROVES EISAI’S LENVIMA™ (LENVATINIB) FOR THE TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE-REFRACTORY DIFFERENTIATED THYROID CANCER

New Therapy Demonstrated a Dramatic Improvement in Progression-Free Survival and a Statistically Significant Overall Response Rate in Some Patients with RAI-Refractory Differentiated Thyroid Cancer File Submission and Approval Based on Data from Phase 3 SELECT Study Published in New England Journal of Medicine on February... ...

PHASE 3 TRIAL SHOWS LENVATINIB MEETS PRIMARY ENDPOINT OF PROGRESSION FREE SURVIVAL IN RADIOIODINE-REFRACTORY DIFFERENTIATED THYROID CANCER

WOODCLIFF LAKE, N.J., Feb. 2, 2014 /PRNewswire/ –Eisai Inc. announced today that the Phase 3 SELECT trial (Study 303) of investigational agent lenvatinib met its primary endpoint. Compared to placebo, lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with radioiodine-refractory differentiated... ...

EISAI TO ACCELERATE LATE-STAGE CLINICAL DEVELOPMENT OF NEW DRUGS BY EFFECTIVELY LEVERAGING EXTERNAL RESOURCES

Enters Collaborative Development Agreement with SFJ Pharmaceuticals for Anticancer Agent E7080 (lenvatinib) Tokyo, Japan, September 7, 2011 — Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that it has entered into a collaborative development agreement with SFJ Pharma Ltd. (“SFJ”), a... ...