OBR Daily Commentary

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AbbVie Announces Topline Results from Two Phase 3 Studies Investigating Veliparib in Combination with Chemotherapy for the Treatment of Patients with Advanced or Metastatic Squamous Non-Small Cell Lung Cancer and Early-Stage Triple-Negative Breast Cancer

(AbbVie) Apr 19, 2017 - AbbVie, a global biopharmaceutical company, today announced that two Phase 3 studies evaluating veliparib, an investigational, oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor did not meet their primary endpoints.

Howard S. Hochster, MD (Posted: April 27, 2017)

quotesIt is not difficult to imagine that PARP inhibitors, which function through the Homologous Repair pathway, would not add much to standard platinum based therapy in unselected lung cancer and TNBC. What is harder to imagine, is what AbbVie would launch phase 3 trials in unselected patient populations who do not have defined DNA repair defects. We can do better in this era of tumor profiling.quotes

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Supreme Court to Review Biosimilar Battle Between Amgen and Sandoz

(STAT Plus/Pharmalot) Apr 25, 2017 - A hotly anticipated hearing takes place at the US Supreme Court on Wednesday about biosimilars and the eventual decision is expected to have widespread implications for health care costs.

Howard S. Hochster, MD (Posted: April 26, 2017)

quotesFascinating legal wrangling as the Supremes parse the wording of the BPCIA (Biologic Price Competition and Innovation Act). At stake, whether the biosimilar manufacturer must supply the originator company with a copy of their BLA application, and whether an additional 180 day waiting period Is required following actual FDA approval of the biosimilar for the originator to issue patent litigation. This would invalidate notification prior to the formal licensure. Who knew biosimilars could be so exciting and reach SCOTUS ??quotes

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US Supreme Court to Consider Biosimilar Patent Process Next Week

(Regulatory Focus) Apr 20, 2017 - The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA).

Dean Gesme, MD (Posted: April 21, 2017)

quotesThis will only determine how much delay is allowed by the courts and how excessive the legal expenses will be for every new biosimilar to enter the market. If the point is saving money while saving lives, how has our legal system gone so wrong?quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Associate Cancer Center Director, Yale Cancer Center P...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...