BioCentury | Feb 1, 2020
Company News

Any chance left for safer opioids?

...morphine. “That turned out to be wrong in a big way,” said Katz. More recently, OxyCodone...
BioCentury | Jan 14, 2020
Company News

Amid need for new pain options, FDA panel rebuffs Nektar’s ‘safer’ opioid

...showing that supratherapeutic doses of oxycodegol have similar potential for abuse as supratherapeutic doses of oxycodone...
...trial’s 1200 mg oxycodegol arm and 33 of 60 (55%) patients in the 40 mg oxycodone...
...dose combination of tramadol and celecoxib from Esteve S.A. and an extended-release oral formulation of oxycodone...
BioCentury | Jan 8, 2020
Politics, Policy & Law

Over 200 biopharma leaders endorse commitment to patients and the public

Dismayed by their industry’s abysmal reputation, leaders of small and medium-sized biotechs are taking rebuilding public trust into their own hands. Led by six CEOs, executives representing over 150 companies have signed an open letter...
BioCentury | Nov 8, 2019
Product Development

NIDA pushes for translational solutions to opioid crisis

One outcome of the flood of attention to the opioid crisis is that it is starting to sway the perception of addiction towards the concept it is a disease, suffered by patients, rather than a...
BioCentury | Sep 21, 2019
Politics, Policy & Law

Congress won’t adopt Pelosi’s price controls, but it may revamp Medicare Part D

...drugs from Canada. Trump’s interest in a drug pricing “win” is balanced by a strong aversion...
...support for legislation that falls far short of the changes his party has demanded. The aversion...
BioCentury | Sep 4, 2019
Company News

Sept. 4 Company Quick Takes: Boehringer licenses Lupin MEK inhibitor; plus BMS-BioMotiv, KemPharm-GPC, Lilly, Nektar and Intellipharmaceutics

...may be delayed due to the postponement of FDA advisory committee meetings for opioid analgesics. Oxycodone...
...PDUFA date of Aug. 28. Targets: IL-17A - Interleukin-17A; KRAS - K-Ras BioCentury Staff KP415 KP484 NKTR-181 oxycodone er (rexista oxycodone...
BioCentury | Aug 23, 2019
Politics & Policy

Aug. 23 P&P Quick Takes: FDA meetings on pediatric safety of OxyContin, Singulair; a vaccine meeting on Chikungunya

...studies and data considerations for pediatric labeling for opioids, including pediatric-focused safety reviews for OxyContin oxycodone...
BioCentury | May 30, 2019
Product Development

CAR T developers plan steps to reach more indications

...Ts would make a substantial difference, said the stakeholders, because the tension between inherent risk aversion...
BioCentury | May 29, 2019
Product Development

Why Novartis’ Jay Bradner thinks CAR T needs disruptive innovation

...about the need for quicker iteration and small-scale human trials, and agreement that the risk aversion...
BioCentury | May 17, 2019
Politics & Policy

Friends, Parker Institute call for more flexibility in early T cell therapy development

...Institute, at which a who’s who of cancer cell therapy pioneers praised FDA and said risk-aversion...
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