19:00 , Feb 7, 2019 |  BC Week In Review  |  Clinical News

Pain Therapeutics chides FDA for 'shambolic' abuse-deterrent regulations

Pain Therapeutics Inc. (NASDAQ:PTIE) said FDA's regulatory procedures for gaining approval of abuse deterrent products lacks predictive pathways for development and commercialization. The company's comments follow a Jan. 31 meeting with FDA to discuss an...
23:18 , Feb 5, 2019 |  BC Extra  |  Company News

Pain Therapeutics chides FDA for 'shambolic' abuse-deterrent regulations

Pain Therapeutics Inc. (NASDAQ:PTIE) said FDA's regulatory procedures for gaining approval of abuse deterrent products lacks predictive pathways for development and commercialization. The company's comments Tuesday follow a Jan. 31 meeting with FDA to discuss...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
18:46 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

FDA issues complete response letter to NDA for Mallinckrodt pain therapy

The SpecGx LLC subsidiary of Mallinckrodt plc (NYSE:MNK) said FDA issued a complete response letter to an NDA for Roxicodone, an immediate-release oral formulation of oxycodone hydrochloride. The company is seeking approval of Roxicodone as...
03:14 , Dec 8, 2018 |  BioCentury  |  Regulation

Path to opioid-free pain relief

To jump-start development of analgesics that can help stem the opioid crisis, companies want FDA’s upcoming guidelines to reduce uncertainty around outcomes that constitute clinically meaningful opioid sparing. But while an advisory panel put some...
01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18 saw investors...
16:45 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency....
18:02 , Aug 29, 2018 |  BC Extra  |  Preclinical News

Bifunctional agonist could treat pain, opioid dependency

A team from Astraea Therapeutics LLC (Mountain View, Calif.) and Wake Forest Baptist Medical Center developed a bifunctional agonist targeting two opioid receptors that could treat pain without opioid-related side effects and reverse opioid dependency....
06:11 , Aug 10, 2018 |  BC Week In Review  |  Clinical News

Pain shifting to AD following fourth Remoxy CRL

Pain Therapeutics Inc. (NASDAQ:PTIE) fell $1.11 (47%) to $1.25 on Aug. 6 after receiving its fourth complete response letter from FDA for pain candidate Remoxy ER oxycodone extended release (PF-00345439). The company does not plan...
18:34 , Aug 6, 2018 |  BC Extra  |  Company News

Pain shifting to AD following fourth Remoxy CRL

Pain Therapeutics Inc. (NASDAQ:PTIE) fell $1.11 (47%) to $1.25 on Monday after receiving its fourth complete response letter from FDA for pain candidate Remoxy ER oxycodone extended release (PF-00345439). The company does not plan to...