Archives: Press Releases

FDA ACCEPTS DUPIXENT® (DUPILUMAB) FOR REVIEW IN CHILDREN WITH MODERATE-TO-SEVERE

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma […]Read More

BLINCYTO® (Blinatumomab) Demonstrated Significantly Prolonged Event-Free Survival Compared With Consolidation

THOUSAND OAKS, Calif., March 2, 2021 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of […]Read More

Vir Biotechnology and GSK Provide Update on NIH-Sponsored ACTIV-3 Trial

SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) — Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met […]Read More

Tempest Therapeutics Announces Clinical Collaboration with Roche to Advance TPST-1120

SOUTH SAN FRANCISCO, Calif., March 03, 2021 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapeutics that combine both precision and immune-mediated mechanisms, today announced a clinical collaboration agreement with F. Hoffmann-La Roche Ltd. The collaboration will evaluate TPST-1120, Tempest’s small molecule PPAR⍺ antagonist, in combination with atezolizumab (Tecentriq®) and bevacizumab (Avastin®) […]Read More

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment

NEW YORK–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE: PFE) supplemental New Drug Application (sNDA) for LORBRENA® (lorlatinib), expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected […]Read More

Takeda Secures Global Rights from Ovid Therapeutics to Develop and

Osaka, Japan, and New York, March 3, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) and Ovid Therapeutics Inc. (NASDAQ: OVID) (“Ovid”), a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, today announced that Takeda has entered into an exclusive agreement under which Takeda will secure global rights at […]Read More

Boston Scientific Announces Agreement To Acquire Lumenis LTD. Surgical Business

MARLBOROUGH, Mass., March 3, 2021 /PRNewswire/ — Boston Scientific (NYSE: BSX) today announced that it has entered into a definitive agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire the global surgical business of Lumenis LTD., a privately-held company that develops and commercializes energy-based medical solutions, for an upfront cash payment of $1.07 billion, subject to closing […]Read More

Veru Receives FDA Agreement to Advance VERU-111 into Phase 3

MIAMI, March 01, 2021 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company, today announced that the FDA agreed in an End of Phase 2 meeting, to advance VERU-111 into a Phase 3 registration clinical study based on the clinically meaningful benefits observed with VERU-111 treatment in the recently completed double-blind, randomized, placebo-controlled […]Read More

Junshi Biosciences and AstraZeneca Announce Strategic Collaboration to Commercialize Toripalimab

SHANGHAI, China, March 01, 2021 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the Company has entered into an exclusive promotion agreement with AstraZeneca Pharmaceutical Co., Ltd. (“AstraZeneca Pharmaceutical” or the “Promoter”), pursuant to which Junshi […]Read More

Hologic Acquires European Molecular Diagnostic Company Diagenode for Approximately $159

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, announced today that it has acquired Diagenode, a privately held, European developer and manufacturer of molecular diagnostic assays and epigenetics products, for approximately $159 million (130 million euros), subject to working capital and other customary closing adjustments. “Our businesses are highly complementary, and […]Read More