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Nicole Watkins

Cleveland Diagnostics’ Novel Prostate Cancer Diagnostic Test Granted Breakthrough Device Designation from the FDA

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the early detection of cancers, announced today that it has received FDA Breakthrough Device Designation for the IsoPSA® Assay, a novel prostate cancer diagnostic test. Published studies from multicenter prospective clinical trials suggest that the non-invasive, blood-based …

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Alexion to Acquire Achillion Pharmaceuticals for $930 Million

BOSTON & BLUE BELL, Pa.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) today announced that they have entered into a definitive agreement for Alexion to acquire Achillion, a clinical-stage biopharmaceutical company focused on the development of oral small molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, …

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Results from STELLAR Trial of Tumor Treating Fields with Chemotherapy in Malignant Pleural Mesothelioma Published in The Lancet Oncology

ST. HELIER, Jersey–(BUSINESS WIRE)–Novocure (NASDAQ: NVCR) today announced that results from the STELLAR trial were published in The Lancet Oncology. The STELLAR trial was a prospective, single-arm trial including 80 patients that studied the use of Tumor Treating Fields, delivered via the NovoTTF-100L System, in combination with pemetrexed plus cisplatin/carboplatin as …

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ViiV Submits sNDA to the FDA for Use of Dovato in Virologically Suppressed Adults with HIV-1

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Dovato (dolutegravir and lamivudine) as a switch treatment for …

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Phase 3 Trial of Lilly’s Investigational Pancreatic Cancer Drug Fails to Meet its Primary Endpoint of Overall Survival

INDIANAPOLIS, Oct. 16, 2019 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced top-line results from its Phase 3 SEQUOIA trial evaluating pegilodecakin plus FOLFOX (folinic acid, 5-FU, oxaliplatin) compared to FOLFOX alone in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing …

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Incyte’s Jakafi Meets Primary Endpoint in its Phase 3 Trial in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced positive results from the Novartis-sponsored pivotal Phase 3 REACH2 study evaluating ruxolitinib (Jakafi®) in patients with steroid-refractory acute graft-versus-host disease (GVHD). The study met its primary endpoint of improving overall response rate (ORR) at Day 28 with ruxolitinib treatment compared to best available …

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Final Results of Cannabics’ Pilot Study of its Controlled Released Capsules for Treatment of Cancer Anorexia-Cachexia Syndrome Published

TEL AVIV, Israel and BETHESDA, Maryland, Oct. 16, 2019 /PRNewswire/ — Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today that the final results of its pilot study to test the efficacy of Cannabics’ Dosage-Controlled capsules for the treatment …

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HitGen Enters into DNA-Encoded Library Based Drug Discovery Research Collaboration with Galapagos NV

CHENGDU, China–(BUSINESS WIRE)–HitGen Inc. today announced that it has entered into a drug discovery research collaboration with Galapagos NV to identify potential small molecule leads against targets of interest to Galapagos NV. In this collaboration, HitGen will apply its technology platform, based on DNA-encoded library design, synthesis and interrogation, to …

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Ipsen and Blueprint Medicines Enter Exclusive Global License Agreement for Development of BLU-782 for Fibrodysplasia Ossificans Progressiva

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) and Blueprint Medicines Corporation (NASDAQ: BPMC) today announced Ipsen, through its subsidiary Clementia Pharmaceuticals, and Blueprint Medicines have entered into an exclusive, worldwide license agreement for the development and commercialization of BLU-782, an oral, highly selective investigational ALK2 inhibitor …

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FDA Approves Secuado Transdermal System, the First and Only Transdermal Patch for Adults with Schizophrenia

MIAMI & JERSEY CITY, N.J.–(BUSINESS WIRE)–Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced the U.S. Food and Drug Administration (FDA) has approved SECUADO ® (asenapine) transdermal system, the first-and-only transdermal patch formulation for the treatment of adults with schizophrenia.1 “As people living with schizophrenia cycle through treatments …

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