Category Archives: Public Policy

Latest From Public Policy

BIO Participating in IDSA Stakeholder Group on Antimicrobial Resistance

MRSA

BIO will be participating in a newly formed partnership which will work collaboratively to inform federal policy and find ways to better combat the growing crisis of antimicrobial resistance. Launched yesterday by the Infectious Diseases Society of America (IDSA), which also released foundation principles for the group, the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR) will hold its inaugural meeting in Philadelphia next month on October 9th. BIO joins more than 75 other national organizations Read More >

Health, Public Policy  |  1 Comment  |  Email This Post
Tags: , , , ,

BIO Submits Amicus Briefs in Braintree v. Novel, Gilead v. Natco, and Bristol-Myers Squibb v. Teva Pharmaceuticals

scientist-eyedropper

BIO has submitted briefs in three recent cases which could significantly impair drug and biotechnology efforts, urging reconsideration and review from both the Supreme Court and the U.S. Court of Appeals for the Federal Circuit. BIO, in conjunction with PhRMA, submitted an amicus brief to the Supreme Court in Braintree v. Novel, arguing that the majority’s decision creates an unpredictable climate for patent claims. Vacating the prior claim construction precedent which had repeatedly interpreted “a” Read More >

Patently BIOtech  |  Leave a comment  |  Email This Post
Tags: , , ,

PTO Patent Examinations in the wake of Mayo and Myriad

stopped-media-115x76

Biotech patent applicants are finding themselves in uncharted waters.   After the Supreme Court’s decisions in Mayo Collaborative Svs. v. Prometheus Labs and Ass’n for Molecular Pathology v. Myriad Genetics, companies have been trying to understand how these decisions will impact the industry. A recent study supported by BIO, in collaboration with Bloomberg BNA and the law firm of Robins, Kaplan, Miller & Ciresi analyzed how Mayo and Myriad have changed patent eligibility for biotechnology. Read More >

Patently BIOtech  |  Leave a comment  |  Email This Post
Tags: , , , , , , , , , , , , , , , , , , , , ,

Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems

FDA115x76

In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee Act (PDUFA). This program ensures that FDA has the ability to hire additional reviewers to expedite the drug review process by having industry pay “user fees.” Recently, attention has been given to a flawed study in the August 2014 issue of Health Affairs, which has some critics claiming that PDUFA fees are biasing FDA review decisions. The study looked at Read More >

Health, Public Policy  |  Leave a comment  |  Email This Post
Tags: , , , ,

Delivering on Biotech’s Promise to Treat Anthrax, Smallpox, Ebola

Jim Greenwood

Thanks to federal biodefense programs that partner with industry to develop and stockpile medical countermeasures, each year America is better equipped to respond to potential biological, chemical, nuclear and radiological threats, BIO president and CEO Jim Greenwood says in a Roll Call op-ed published today. With recent anthrax and smallpox incidents at CDC and NIH labs,  which fortunately did not lead to any human exposure,  it’s worth taking a look at how we might respond Read More >

Jim's Corner  |  Leave a comment  |  Email This Post
Tags: , , , , , , ,