PFE, SUPN Get FDA Nod, SNY Will Have To Wait Till Nov., Xenetic On The Move

(RTTNews) - Alere Inc. (ALR) has received 510(k) marketing clearance from the FDA for its Alere i RSV test for the detection of RSV infection in children and adults. The test will be available for use in hospitals in time for the 2016-2017 respiratory season.

The Alere i molecular platform was initially cleared for marketing by the FDA for the detection and differentiation of influenza A and B virus in June 2014, and for Strep A in March 2015.

In its first quarter ended March 31, 2016, Alere's revenue was $578 million, a 6% decrease compared to $613 million in the prior year period. Global influenza sales were $27 million during the first quarter of 2016, including U.S. influenza sales of $20 million, of which $12 million was Alere i sales.

Commenting on the Q1 results, Namal Nawana, CEO of Alere said that Alere i has continued to grow its market presence, generating record revenue during the first quarter of 2016.

ALR closed Friday's trading at $40.47, up 0.65%.

The FDA has approved Pfizer Inc.'s (PFE) Troxyca ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

In June of this year, an FDA panel voted 9 to 6 in favor of approval of Troxyca ER, formerly known as ALO-02.

PFE closed Friday's trading at $34.98, down 0.60%.

The FDA review time for Sanofi's (SNY) New Drug Application for iGlarLixi for the treatment of adults with type 2 diabetes has been extended by three months, following which the regulatory decision is now expected at the end of November 2016.

IGlarLixi is a once-daily, fixed-ratio combination of Adlyxin and Lantus. Adlyxin was approved in the U.S. as recently as last month while Lantus received FDA approval as far back as 2000.

On 25 May 2016, an FDA panel voted 12 to 2 recommending approval of IGlarLixi.

SNY closed Friday's trading at $39.67, down 0.23%.

Supernus Pharmaceuticals Inc. (SUPN) on Friday received tentative approval from the FDA for its Supplemental New Drug Application requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults.

The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity which expires March 28, 2017. Final approval may not be made effective until this exclusivity period has expired, the company said.

The FDA has also granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients 6 years and older, rather than 10 years and older.

Trokendi XR was first approved in 2013 for the treatment of epilepsy. The drug raked in sales of $110.3 million for full year 2015, an increase of 70% from 2014.

SUPN closed Friday's trading at $22.13, up 0.18%.

Xenetic Biosciences Inc. (XBIO.OB) has been allowed by the FDA to initiate a phase II clinical study of its drug candidate Virexxa in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy.

The primary objective of the study is to assess the anti-tumor activity of Virexxa. Secondary objectives include assessment of additional efficacy, pharmacokinetic and safety/tolerability parameters, the company noted.

XBIO.OB closed Friday's trading at $4.65, down 1.06%.