Friday, March 23, 2012

Abbott decides on the new name of spin-off company

Abbott announced that the company has decided to name its spin-off as AbbVie which will function as an independent research-based pharmaceutical company. The company expects AbbVie will come live by the end of 2012.

Late last year, Abbott has announced that it would divide the current company into two publicly traded companies. One will remain as Abbott who will be the diversified medical products including branded generic pharmaceutical, devices, diagnostics, and nutritional businesses. The other will be a research-based company.

The company explains the meaning behind the new name: "AbbVie is a combination of two words:"Abb"short for Abbote and "vie" stands for the latin root "vi" meaning life.

I will reserve my comment for this name...

LINX Reflux Management System of Torax has been approved in the US


The FDA has approved LINX Reflux Management System of Torax Medical based in St. Paul, Minn for the management of gastroesophageal reflux disease in patients who continue to have chronic symptoms despite the use of maximal medical therapy for the treatment. .

The system is a sterile, single-use, surgically placed device composed of a series of titanium beads, each with a magnetic core. The beads are connected together with independent titanium wires and form a ring shape. The device is to be implanted at the lower

Elite entered into an agreement with a private company

Elite Pharmaceuticals announced that it has signed an agreement with a private hong kong company to develop a prescription medicine in the US.

Under the terms of the agreement, the private hong-kong based company will provide the company the product's formulation. Elite will be in charge of the developmental program for the product.  The private company will be responsible for the filing of the new drug application for the finished product developed by Elite.

Once approved, Elite will retain certain rights to the manufacturing of the final product and will be eligible to receive milestone payments for the development work.

Thursday, March 22, 2012

Tarsa signed contract manufacturing agreement with QS Pharma

Tarsa therapeutics announced that it has entered into a commercial agreement with QS Pharma.

Under the terms of the agreement, QS Pharma will manufacture the bulk material of Ostora oral recombinant salmon calcitonin tablet in its manufacturing

Wednesday, March 21, 2012

The FDA approved Watson's ANDA for ibandronate

Watson announced that the USFDA has approved the company's abbreviated new drug application for ibandronate 150 mg tablet which is currently marketed as BONIVA by Roche.  Boniva has been approved for the prevention and treatment of osteoporosis in women

Tuesday, March 20, 2012

Ampio to continue the development of Optina following positive interim data

Ampio Pharmaceutical announces that the company will plan to meet with the USFDA in order to initiate the US resignation studies for Optina for the treatment of diabetic macular edema after the company has completed the planned interview review of the first 50% of patients enrolled in the Optina's trial for diabetic macular edema.

The Optina's trial is conducted at St. Michael

Alnylam initiates the phase I trial evaluating ALN-TTR02

Alnylam announced that the company has initiated the phase I trial evaluating its ALN-TTR02 for the treatment of TTR-mediated amyloidosis in the UK.

The study plans to evaluate the safety and tolerability of ALN-TTR02 in healthy volunteers. It will also evaluate the clinical activity of the compound based

Visudyne of QLT Inc received orphan drug designation

QLT Inc announced that the company's Visudyne (verteporfin) has been granted orphan drug designation for the potential treatment of chronic or recurrent serious chorioretinopathy from the USFDA.

Visudyne is a two-step procedure involving administration of verteporfin into patient's arm intravenously. However, the drug is not activated then. In order to activate the drug, a non-thermal laser light is shone into patient's eye. Once activated, the drug can act to

Watson announced that Abbott has filed a lawsuit against the company

Watson announced that Abbott Laboratories and Abbott Respiratory have filed a lawsuit against Watson on March 16, 2012 in regard to the abbreviated new drug application submitted for generic Niaspan (niacin extended-release tablet 500 mg and 1000 mg) to the USFDA.

Abbott said Niaspan is still a patent protected product being covered by patent nos 6,080,428 and 6,0469,035.

The lawsuit will prevent the FDA from approving the ANDA filed by Watson for up to 30 months starting from the date it receives the notice or until the companies enter into the final solution before the court whichever is sooner.

Based in IMS Health data, the 12-month US sales of Niaspan were estimated to be $1.2 B.

Monday, March 19, 2012

Takeda and Pronova presented data evaluating TAK-085 for the treatment of hyperlipidemia

Takeda and Pronova BioPharma announced results from a phase 3 trial evaluating TAK-085 (omega-3-acid ethylesters 90) in Japan for the treatment of Hyperlipidemia.

The trail is a randomized, double-blind, controlled multicenter study evaluating TAK-085 for the treatment of hypergtriglyceridemia. The trial enrolled

Anthera to cut 45% of its workforce

Anthera announced that it is to cute 45% of its headcount after the company announced a halt on the phase VISTA-16 clinical study following recommendation made by the Independent Data Safety Monitoring Board.  The move is to reduce operating expense in order to allow

Sunday, March 18, 2012

Alcon acquires ex-US rights for ocrliplasmin from ThromboGenics

Alcon announced that it has acquired ex-US rights for ocrliplasmin from ThromboGenics for the treatment of symptomatic vitreomacular adhesion.

Under the terms of the agreement, ThromboGenics will receive approximately $100M from Alcon as upfront payment. ThromboGenics is also eligible to receive