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Oncology

DelMar Pharmaceuticals Receives IND Allowance from FDA to Initiate Clinical Trials of VAL-083 for the Treatment of Ovarian Cancer

September 18, 2017 By Stephen Strudwick

VANCOUVER, British Columbia, and MENLO PARK, Calif., Sept. 18, 2017 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, today announced that the U.S. Food and Drug Administration (“FDA”) has allowed an additional Investigational New Drug Application (“IND”) to study its lead […]

General

Sanofi and Amgen, eyeing boost for PCSK9 use, tout benefits for diabetes patients

September 18, 2017 By Stephen Strudwick

The stepped-up focus on cardiovascular risks for diabetes patients isn’t an accident. Drugmakers have conducted enormous trials to gauge those risks—and, in some cases, prove their meds can actually fend them off. But it’s not just diabetes drugs in that spotlight. Just look at two sets of cholesterol drug numbers unveiled a few days ago […]

Oncology

FDA commish cheers on biosimilars as Amgen, Allergan score OK for knockoff of Roche’s Avastin

September 15, 2017 By Stephen Strudwick

Roche now has another big biosimilar rival to contend with. The FDA has OK’d Mvasi, a knockoff of a drug that earned $3 billion in the US — $7 billion worldwide — last year as a mainstay in Roche’s drug portfolio. Amgen and Allergan — which wound up with marketing rights after it emerged on […]

Xtandi drug cleared the Phase III study for non-metastatic, castration resistant prostate cancer.

Oncology

New PhIII data in hand, Pfizer, Astellas hustle ahead in bid to expand US market for Xtandi

September 14, 2017 By Stephen Strudwick

Pfizer just got some badly needed good news for its newly acquired cancer drug Xtandi. After watching sales sink right after it acquired the therapy and all of Medivation for $14 billion, researchers say the drug cleared the Phase III study for non-metastatic, castration resistant prostate cancer. And at least one prominent analyst says that’s […]

Oncology

FDA approves new treatment for adults with relapsed follicular lymphoma

September 14, 2017 By Stephen Strudwick

SILVER SPRING, Md., Sept. 14, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even after […]

General

EASD: Novo Nordisk’s combo Xultophy beat rivals at cutting LDL, blood pressure

September 13, 2017 By Stephen Strudwick

LISBON, PORTUGAL—Novo Nordisk’s combination med Xultophy, which marries its GLP-1 blockbuster Victoza and newest basal insulin Tresiba, became the latest diabetes med to show it could dampen risk factors for cardiovascular disease. The analysis, unveiled Wednesday at the European Association for the Study of Diabetes meeting in Lisbon, showed Xultophy patients had significantly lower systolic […]

Oncology

FDA says Tecentriq won’t lose its bladder cancer nod despite phase 3 failure, Roche reports

September 12, 2017 By Stephen Strudwick

Roche’s immuno-oncology drug Tecentriq took a surprising punch earlier this year when it failed a bladder cancer trial, putting a conditional approval in jeopardy. But the threat of losing FDA approval in bladder cancer has now passed. After recent discussions with the agency, the company expects Tecentriq’s accelerated approval “will be maintained,” a spokeswoman with […]

Events

Top-10 oncology conferences to keep an eye on

September 12, 2017 By Stephen Strudwick

With over 30 years of experience navigating the challenges associated with obtaining, analyzing, and translating complex clinical information for our oncology clients, we like to keep up to date with the latest biotech news and clinical trial data. We recommend you to keep an eye on the outcomes of the following top oncology conferences: ESMO […]

General

Results from the INJOURNEY™ trial investigating Ofev® with add-on pirfenidone provide new insights into this combination treatment for IPF

September 11, 2017 By Stephen Strudwick

– Data from this 12-week study showed that the safety and tolerability profile of Ofev® (nintedanib) with add-on pirfenidone is in keeping with the known profiles of the individual drugs in patients with IPF – Exploratory efficacy analyses suggest a potential benefit of the combination treatment of nintedanib with add-on pirfenidone – Results from INJOURNEY […]

Oncology

BERG Presents Key Clinical Data at ESMO 2017 on BPM 31510 for Advanced Pancreatic Cancer Patients and BPM 31543 for Preventing Hair-Loss in Patients Treated With Chemotherapy

September 11, 2017 By Stephen Strudwick

BOSTON, Sept. 11, 2017 /PRNewswire/ — BERG, a biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced two poster presentations showing promising clinical data that were unveiled at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, from September 8-12: Results from a Phase II study of […]