Archived News Headlines

We have been archiving all OBR daily news stories since March 2008. Use the box below to search our archives for specific articles and content. Please note: we do not "host" news articles on our website. When a media source removes an article from their website the link becomes inactive, and you will only be able to see the date, title, first sentence and media source that published the article.

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).

Save the Dates: ASCO Quality Reporting Webinars Scheduled May 15, June 19, July 10

(ASCO in Action) Apr 18, 2017 - The Quality Payment Program (QPP), established by the Medicare Access and CHIP Reauthorization Act, launched in January 2017 and is being implemented in oncology practices across the country.

Eight Noteworthy FDA Actions

(Healio) Apr 21, 2017 - The FDA announced several decisions related to hematology and oncology therapies and devices in the past month.

In the Debate Over Rising Drug Prices, Both Drugmakers And PBMs Claim Innocence

(CNBC.com) Apr 19, 2017 - The battle over rising drug prices has become a full-blown he-said-she-said. Drug companies have pointed the finger at middlemen in the health-care system, saying they not only benefit from rising drug prices but contribute to their increases.

Grail Initiates Massive Multicenter Breast Cancer Study

(MedCity News) Apr 20, 2017 - Illumina spin-out Grail announced a new multicenter clinical study on Thursday and, true to form, it’s a large-scale endeavor.

FDA Wants Researchers to Rethink Patient Eligibility Criteria

(AJMC.com) Apr 20, 2017 - Although the purpose of eligibility criteria is to protect patients from unnecessary harm, define the study population, and allow researchers to collect safety and efficacy data for a specific population, unnecessary restriction may not capture the heterogeneity of real-world patients.

H3, Foundation Medicine Extend Precision Oncology Collaboration

(Genetic Engineering & Biotechnology News) Apr 20, 2017 - Eisai subsidiary H3 Biomedicine said today it has extended its more than 2-year-old collaboration with Foundation Medicine to discover and develop precision medicines in oncology.

FDA Expands Warnings on Codeine and Tramadol for Children

(Wall Street Journal) Apr 20, 2017 - The agency says the medicines carry serious risks, including slowed breathing or death.

Opinion: AACR’s March On Washington

(The Hill) Apr 21, 2017 - The foundation of the United States was not laid in the gloomy age of scientific drought but at an epoch when fostering innovation was better understood and more clearly defined. This is when the United States came into existence as a nation.

Gene Therapy 1.0 Is a Flop, but Biotech Isn’t Worried

(STAT Plus) Apr 21, 2017 - The Western world’s first gene therapy is soon to become but a footnote in biotech history, doomed by minuscule demand and a colossal price. But its failure has hardly dampened the enthusiasm of the scientists and biotech companies betting that gene therapy’s best days are ahead.