BC Week In Review | Nov 3, 2014
Company News

Pain Therapeutics Inc., King deal

Pfizer Inc. (NYSE:PFE, New York, N.Y.) terminated a deal to develop and commercialize Remoxy oxycodone and will return rights to the compound to Pain. Pfizer made the decision after completing an internal review of top-line...
BC Week In Review | Oct 20, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

FDA approved an sNDA from Pfizer to update the label of Embeda morphine/naltrexone to include a claim indicating that the pain drug has properties that are expected to reduce abuse via the oral and intranasal...
BC Extra | Oct 18, 2014
Company News

FDA approves abuse-deterrent labeling for Embeda

FDA approved expanded labeling for Embeda morphine sulfate/ naltrexone hydrochloride extended-release capsules from Pfizer Inc. (NYSE:PFE) to include data from abuse-deterrent studies. Embeda is indicated to treat pain severe enough to require daily, around-the-clock, long-term...
BC Week In Review | Aug 11, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

Pfizer disclosed in its 2Q14 earnings that FDA delayed by 3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone to include data from abuse-deterrent studies. The PDUFA date...
BC Week In Review | Aug 11, 2014
Clinical News

Morphine/naltrexone regulatory update

Pfizer disclosed in its 2Q14 earnings that FDA delayed by 3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone to include data from abuse-deterrent studies. The PDUFA date...
BC Week In Review | Jun 30, 2014
Clinical News

Oxycodone-naltrexone: Additional Phase III data

Additional data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that a greater proportion of patients receiving ALO-02 achieved a >=30% reduction (57.5% vs....
BC Week In Review | Jun 30, 2014
Clinical News

Oxycodone-naltrexone: Clinical trial data

Pfizer reported data from 2 abuse potential studies with ALO-02 at the American Pain Society meeting in Tampa. A double-blind, placebo- and active-controlled, 6-way crossover abuse potential trial in 41 healthy, non-dependent recreational opioid users...
BC Week In Review | Apr 21, 2014
Company News

Acura, Pfizer deal

Pfizer returned rights to Oxecta oxycodone to Acura after the biotech terminated a 2007 deal granting the pharma North American rights to the pain drug and Acura's Aversion abuse-deterrent technology. On a conference call discussing...
BC Week In Review | Jan 27, 2014
Clinical News

Oxycodone-naltrexone: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that ALO-02 met the primary endpoint of improving mean daily average pain NRS scores...
BC Extra | Jan 24, 2014
Clinical News

Pfizer's ALO-02 meets in Phase III pain trial

Pfizer Inc. (NYSE:PFE) said ALO-02 met the primary endpoint of improving pain scores from baseline to the final two weeks of the 12-week treatment period vs. placebo in a Phase III trial to treat moderate...
Items per page:
1 - 10 of 285
BC Week In Review | Nov 3, 2014
Company News

Pain Therapeutics Inc., King deal

Pfizer Inc. (NYSE:PFE, New York, N.Y.) terminated a deal to develop and commercialize Remoxy oxycodone and will return rights to the compound to Pain. Pfizer made the decision after completing an internal review of top-line...
BC Week In Review | Oct 20, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

FDA approved an sNDA from Pfizer to update the label of Embeda morphine/naltrexone to include a claim indicating that the pain drug has properties that are expected to reduce abuse via the oral and intranasal...
BC Extra | Oct 18, 2014
Company News

FDA approves abuse-deterrent labeling for Embeda

FDA approved expanded labeling for Embeda morphine sulfate/ naltrexone hydrochloride extended-release capsules from Pfizer Inc. (NYSE:PFE) to include data from abuse-deterrent studies. Embeda is indicated to treat pain severe enough to require daily, around-the-clock, long-term...
BC Week In Review | Aug 11, 2014
Clinical News

Embeda morphine/naltrexone regulatory update

Pfizer disclosed in its 2Q14 earnings that FDA delayed by 3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone to include data from abuse-deterrent studies. The PDUFA date...
BC Week In Review | Aug 11, 2014
Clinical News

Morphine/naltrexone regulatory update

Pfizer disclosed in its 2Q14 earnings that FDA delayed by 3 months the PDUFA date for an sNDA seeking to expand the label of Embeda morphine/naltrexone to include data from abuse-deterrent studies. The PDUFA date...
BC Week In Review | Jun 30, 2014
Clinical News

Oxycodone-naltrexone: Additional Phase III data

Additional data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that a greater proportion of patients receiving ALO-02 achieved a >=30% reduction (57.5% vs....
BC Week In Review | Jun 30, 2014
Clinical News

Oxycodone-naltrexone: Clinical trial data

Pfizer reported data from 2 abuse potential studies with ALO-02 at the American Pain Society meeting in Tampa. A double-blind, placebo- and active-controlled, 6-way crossover abuse potential trial in 41 healthy, non-dependent recreational opioid users...
BC Week In Review | Apr 21, 2014
Company News

Acura, Pfizer deal

Pfizer returned rights to Oxecta oxycodone to Acura after the biotech terminated a 2007 deal granting the pharma North American rights to the pain drug and Acura's Aversion abuse-deterrent technology. On a conference call discussing...
BC Week In Review | Jan 27, 2014
Clinical News

Oxycodone-naltrexone: Phase III data

Top-line data from a double-blind, U.S. Phase III trial in 281 patients with moderate to severe chronic low back pain showed that ALO-02 met the primary endpoint of improving mean daily average pain NRS scores...
BC Extra | Jan 24, 2014
Clinical News

Pfizer's ALO-02 meets in Phase III pain trial

Pfizer Inc. (NYSE:PFE) said ALO-02 met the primary endpoint of improving pain scores from baseline to the final two weeks of the 12-week treatment period vs. placebo in a Phase III trial to treat moderate...
Items per page:
1 - 10 of 285