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Nicole Watkins

FDA Grants Orphan Drug Designation to Lynparza for Treatment of Pancreatic Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated …

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Cannabics Announces Positive Results for Pilot Study on Treatment of Cancer Anorexia-Cachexia Syndrome

TEL AVIV, Israel and BETHESDA, Maryland, Oct. 16, 2018 /PRNewswire/ —  Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized cannabinoid medicine focused on cancer and its side effects, announced today the results of its pilot study to test the efficacy of Cannabics capsules for the treatment of cancer anorexia-cachexia …

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Scripps Research Translational Institute Collaborates with Seqster To Bring Genetic Risk Scores With Health Data

SAN DIEGO, Oct. 16, 2018 /PRNewswire/ — Seqster, the leading consumer-centric health data management platform empowering employees, members, or patients to collect, own and share all of their health data, today announced a collaboration with Scripps Research Translational Institute (“SRTI”), creators of the MyGeneRank app at the 2018 American Society …

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Gottlieb Makes Statement on FDA’s New Steps to Modernize Drug Development, Improve Efficiency and Promote Innovation of Targeted Therapies

The FDA continues to advance new policies, modernize our programs and advance opportunities for developing more targeted therapies. Using new technology platforms such as cell and gene therapies and small molecule drugs that target the genomic basis of disease, there are more opportunities to intervene in the underlying mechanisms that cause a …

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Alnylam to Initiate Rolling Submission of NDA and Pursue Full Approval for Givosiran for Acute Hepatic Porphyria

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company plans to pursue a full approval based on the complete results of the ENVISION Phase 3 study of givosiran, an investigational RNAi therapeutic targeting …

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Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin®(trastuzumab) …

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FDA Grants Breakthrough Therapy Designation to Loxo Oncology’s Investigational LOXO-292 for RET Fusion-Positive Thyroid Cancer

STAMFORD, Conn., Oct. 15, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid …

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Bristol-Myers Squibb’s Opdivo Fails to Meet Primary Endpoint in Phase 3 Study in Patients with Relapsed Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced topline results from the Phase 3 CheckMate -331 study evaluating Opdivo (nivolumab) versus the current standard of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary endpoint of …

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Bristol-Myers Squibb and Compugen Partner to Evaluate Therapeutic Regimen in Advanced Solid Tumors

NEW YORK & HOLON, Israel–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) and Compugen (NASDAQ: CGEN) today announced the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab), in patients with advanced …

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FDA Grants Orphan Drug Designation to Synspira’s Investigational Cystic Fibrosis Therapy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Synspira, a privately held company developing a new class of inhaled glycopolymer-based therapeutics for the treatment of pulmonary disease, today announced that it has been granted Orphan Designation by the United States Food and Drug Administration (FDA) for poly (acetyl, arginyl) glucosamine (PAAG15A), for the treatment of cystic …

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