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1228 items
8:01 PM, Oct 12, 2018  |  BioCentury | Politics, Policy & Law

COI failure fallout

Jose Baselga resigned as CMO of Memorial Sloan Kettering Cancer Center after being accused of failing to disclose conflicts of interest, upsetting a hornet’s nest on his way out the door that is causing academic...
6:38 PM, Oct 05, 2018  |  BioCentury | Politics, Policy & Law

SUPPORTing FDA’s fight against opioids abuse

Legislation President Donald Trump is expected to sign soon gives FDA powers that are intended to blunt the opioid abuse epidemic and incentivize development of non-addictive pain treatments. The new authorities will give FDA tools...
1:15 PM, Oct 04, 2018  |  BioCentury | Politics, Policy & Law

Research from Mars can fail patients from Venus

Despite rules and directives pushing for clinical trials to include proportional representation of both sexes, some researchers and developers are still behind the curve. FDA, BIO and nonprofit organizations are providing new tools and resources...
7:01 PM, Sep 28, 2018  |  BioCentury | Politics, Policy & Law

PROs in prime time

A recommendation by CMS’s MEDCAC catapults the collection of PRO data to the postmarket setting from their more familiar spot in clinical development. CAR T leaders Novartis AG and Gilead Sciences Inc., however, are not...
5:16 PM, Sep 28, 2018  |  BioCentury | Politics, Policy & Law

Patent law 101

The director of the U.S. Patent and Trademark Office, Andrei Iancu, said last week that a fundamental aspect of patent law that affects life science patents is completely screwed up, and because Congress can’t be...
2:49 PM, Sep 21, 2018  |  BioCentury | Politics, Policy & Law

FDA’s inflection point

Having spent a year at FDA, former Chief Counsel Rebecca Wood sees the agency at an inflection point; it must make dramatic changes in the ways it applies and interprets the law under which it...
1:38 PM, Sep 21, 2018  |  BioCentury | Politics, Policy & Law

Filling the rebate void

HHS’s proposal to eliminate drug rebates should have the intended consequence of increasing transparency into drug pricing in the short term. But the long view is that value-based pricing or alternative co-pay agreements will do...
5:53 PM, Sep 14, 2018  |  BioCentury | Politics, Policy & Law

Debating diagnostics

Instead of perpetuating a decades-old dispute about whether FDA can and should regulate laboratory-derived tests, the agency and test makers have moved on to conversations about how FDA should do so, and from threats of...
8:01 PM, Aug 31, 2018  |  BioCentury | Politics, Policy & Law

A pathway to Biopharma 3.0

As market and social forces continue to tighten around the biopharmaceutical industry, drug companies need to start evolving toward a new business model that both capitalizes on the potential of new technologies and accommodates society’s...
7:58 PM, Aug 31, 2018  |  BioCentury | Politics, Policy & Law

Stepping Through

Once considered obstacles to biomedical product development, regulators around the world have become enablers of the kinds of scientific and economic innovations that will underpin new business models. They are building gateways that could help...