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 previously guided that it planned to file a Biologics License…

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 wholly-owned subsidiary of SFJ Pharmaceuticals, LP., II (Location: California, the…

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 thyroid cancer (RR-DTC). The preliminary safety analyses showed that the…

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 12, 2015 Approval Granted Two Months Ahead of FDA Priority…

- 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 12, 2015 - Approval Granted Two Months Ahead…

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 growth factor receptor (EGFR)-activating mutations.  “Lung cancer remains the leading…

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 the European Union (EU) for the first-line treatment of adult…

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 Administration approval of gemtuzumab ozogamicin (Mylotarg®). After four decades of…

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 INO-VATE ALL (NCT01564784), a randomized (1:1), open label, international, multicenter…

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 approval in May 2000 as monotherapy for older patients with…

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 of subjects in the study who achieved the primary endpoint,…

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 treatment with lenvatinib (marketed as Lenvima®) resulted in a statistically…

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 a major effect on PhaseBio’s stock this morning. The agreement…

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) — PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on…

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, a Crestwood, Ky.-based clinical-stage biopharmaceutical company, said it has partnered…

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 16 in the Phase 3 PEGASUS study 85% of patients…

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 12.1 g/dL compared to an increase from 8.7 g/dL to…

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) of the China National Medical Products Administration (NMPA) in collaboration…

WALTHAM, Mass. and STOCKHOLM, Sweden, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of Aspaveli® (pegcetacoplan) for the treatment…

  PHILADELPHIA and SAN FRANCISCO, 11 May 2023: SERB Pharmaceuticals, a global specialty pharmaceutical company, and SFJ Pharmaceuticals, a global drug development company, announce that SERB has acquired exclusive US rights to the ticagrelor reversal agent bentracimab from SFJ. Bentracimab is a novel, monoclonal antibody fragment designed to reverse the antiplatelet activity of ticagrelor. Ticagrelor, marketed by…

  Pleasanton, CA and Philadelphia, PA, Aug. 02, 2024 (GLOBE NEWSWIRE) -- SFJ Pharmaceuticals, (SFJ), Sponsor of the bentracimab Biologics License Application (BLA), and SERB Pharmaceuticals (SERB), who acquired exclusive US rights to bentracimab from SFJ and will commercialize bentracimab in the United States, announced today that the US Food and Drug Administration (FDA) has…

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 means of 3.8 g/dL of hemoglobin at week 16Safety profile…

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 Lenvima® (lenvatinib mesylate) indicated for the treatment of adult patients…

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 Drug Administration (FDA) has approved VIZIMPRO® (dacomitinib), a kinase…

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 (mCRC) in combination with Erbitux® and chemotherapy Clinical program will…

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 (EGFR)-activating mutations. “Lung cancer remains the leading cause of cancer-related…

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 the development and commercialization of novel therapies for cardiopulmonary diseases,…

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 the treatment of multiple rare diseases including paroxysmal nocturnal hemoglobinuria…

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 the U.S. Food and Drug Administration (FDA) has approved BESPONSA®…

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

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

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

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 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and…

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 indications WALTHAM Mass., and CRESTWOOD, Ky., February 28, 2019 (GLOBE…

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 a financing and co-development collaboration with SFJ Pharmaceuticals to support the development…