FDA Approves AMGN's 1st Biosimilar, MRNS On Track, All Ears For DRRX, PTIE

(RTTNews) - The FDA on Friday approved Amgen's (AMGN) AMJEVITA, a biosimilar to AbbVie's (ABBV) Humira, across all eligible indications.

AMJEVITA, which is Amgen's first biosimilar to receive the FDA nod, has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.

In July of this year, an FDA advisory panel of outside experts voted 26-0 in favor of recommending approval of AMJEVITA, previously known as ABP 501.

AbbVie's Humira had sales of $14 billion in 2015.

AMGN closed Friday's trading at $174.80, down 0.47%.

Allergan plc (AGN) has added one more to its Natrelle Inspira line of breast implants, following FDA approval of its Natrelle Inspira cohesive breast implant, which are available with both smooth and BIOCELL textured surfaces.

The FDA approval of Natrelle Inspira Cohesive breast implants marks the most recent addition to the broad portfolio of currently available Natrelle products in the U.S.

As you may know, the smooth version of the Natrelle Inspira round gel-filled breast implants with responsive gel was approved by FDA in February 2015, and the textured version of the Natrelle Inspira round gel-filled breast implants with responsive gel were approved by the FDA in June 2015.

The new Natrelle Inspira Cohesive line of breast implants is the latest addition to the category of breast implants commonly referred to as "gummy" implants, designed for women who are interested in increased breast fullness, says the company.

AGN closed Friday's trading at $243.94, up 0.21%.

Shares of BioLineRx Ltd. (BLRX) were up over 26% on Friday, following an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for in-licensing of a novel treatment for various liver failure conditions such as end-stage liver disease and non-alcoholic steatohepatitis.

The novel treatment is to be named BL-1220, and is the second project in-licensed under the framework of the company's strategic collaboration with Novartis Pharma AG.

In December 2014, BioLineRx and Novartis Pharma AG entered into a multi-year strategic collaboration to facilitate development and commercialization of Israeli-sourced drug candidates. Novartis has made an equity investment in BioLineRx of $10 million as per the agreement terms.

BLRX closed Friday's trading at $1.28, up 26.73%.

Remoxy, a long-acting abuse-resistant narcotic analgesic formulation intended to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, awaits FDA decision, which may be announced anytime.

The drug is formulated with Durect Corp.'s (DRRX) SABER technology under a joint development and license agreement entered into between Pain Therapeutics Inc. (PTIE) and Durect in December 2002.

The FDA's decision was originally scheduled for September 25, 2016.

DRRX closed Friday's trading at $1.70, down 2.30%. PTIE closed the day's trading at $2.73, down 4.55%.

Shares of Marinus Pharmaceuticals Inc. (MRNS) have gained over 35% in the last seven trading days in the run-up to the exploratory phase II study results of Ganaxolone, scheduled for this month.

The exploratory phase II clinical trial is evaluating Ganaxolone in females with PCDH19 pediatric epilepsy.

MRNS closed Friday's trading at $2.22, up 26.14%.

Novartis AG's (NVS) biological therapy Ilaris has been granted FDA approval for three new indications, all of which are a part of a group of rare autoinflammatory diseases called Periodic Fever Syndromes.

The three new indications for which Ilaris has been approved are Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).

Ilaris was first approved in the U.S. in June 2009 to treat children and adults with cryopyrin-associated periodic syndrome (CAPS), a serious life-long auto-inflammatory disease. The drug was approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older in May 2013.

In 2015, Ilaris registered sales of $236 million compared to $199 million in 2014.

NVS closed Friday's trading at $81.48, down 0.67%.