DVAX Moves On, GSK Gets FDA Nod, HART-Warming, ZGNX Gains On Favorable Ruling

(RTTNews) - AbbVie (ABBV) has initiated a global phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer.

The trial is designed to recruit approximately 900 patients, and the primary efficacy outcome of the trial is overall survival.

ABBV closed Tuesday's trading at $47.86, up 2.20%.

Akebia Therapeutics Inc. (AKBA) has completed enrollment in its ongoing 200-patient phase 2b study of AKB-6548 for the treatment of anemia associated with chronic kidney disease in patients who are not dependent on dialysis. The study results are expected to be announced in the fourth quarter of 2014.

AKBA closed Tuesday's trading 5.30% higher at $22.26.

Dynavax Technologies Corp. (DVAX) has initiated a new phase III clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine to address the concerns raised by FDA in the Complete Response Letter for HEPLISAV-B. The company was issued a Complete Response Letter for HEPLISAV-B by the regulatory agency in February, 2013.

The new phase III study is expected to be fully enrolled by the end of 2014 with follow-up to be completed by the fourth quarter of 2015.

DVAX closed Tuesday's trading at $1.45, down 3.33%.

GlaxoSmithKline plc (GSK) has received FDA approval for Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The company expects to launch Tanzeum in the U.S. in the third quarter of 2014. The drug was approved by EMA under the brand name Eperzan last month.

GSK closed Tuesday's trading at $52.32, up 0.93%.

Harvard Apparatus Regenerative Technology Inc. (HART) said that a research team led by Paolo Macchiarini at Karolinska Institutet in Sweden has successfully transplanted a regenerated esophagus into a rat using a bioreactor developed by the company.

This research is slated to be presented at the American Association for Thoracic Surgery Annual Meeting 2014 to be held April 26-30 at the Metro Toronto Convention Centre in Toronto, Canada.

HART closed Tuesday's trading 5.79% higher at $8.96.

Mylan Inc. (MYL) and its partner Famy Care Ltd. have entered into a settlement and license agreement with Actavis plc (ACT) to settle all outstanding patent litigation related to Mylan's filing of an Abbreviated New Drug Application with FDA for generic version of Generess FE, indicated for the prevention of pregnancy.

As per the agreement terms, Actavis will grant Mylan a license to market its generic version of Generess beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015.

MYL closed Tuesday's trading at $46.23, up 0.43%.

Zogenix Inc. (ZGNX) rose more than 10 percent in extended trading on Tuesday to $2.59 following the Court's order preventing the implementation of the Governor's order that blocked access to Zohydro ER on Constitutional grounds.

The Court's order will become effective on April 22, 2014.

Zohydro ER is an oral, novel extended-release formulation of hydrocodone without acetaminophen, approved for the management of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid therapy for an extended period of time.

To combat the growing opioid addiction epidemic in Massachusetts, Governor Deval Patrick announced several actions last month, one of which was the immediate ban of Zohydro until adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.

Claiming the Governor's executive order improper, Zogenix took legal action in Federal Court earlier this month to block the Massachusetts ban on Zohydro.

Commenting on the Court's favorable ruling, Roger Hawley, chief executive officer of Zogenix said, "We invite concerned officials to engage with us to discuss fair and appropriate safeguards for pain medications like Zohydro ER rather than seeking to ban or restrict one specific treatment."