Teva Provides Update on Generic Prevacid Litigation

Nov 7, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a March 31, 2008 decision by the District Court, which had found TAP Pharmaceutical Products Inc.'s U.S. Patent No. 4,628,098 valid and enforceable. As a result of today's decision, Teva expects to market its generic version of TAP's Prevacid(R) (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg no later than November 10, 2009, when the patent is otherwise set to expire.

The details can be read here.

Daiichi Sankyo completes Ranbaxy acquisition

MUMBAI: Japanese drugmaker Daaichi Sankyo Company has completed the acquisition of Ranbaxy Laboratories, with the final transfer of the promoters’ stake. As a result of this acquisition of shares, the Singh family has ceased to be the promoters of the co mpany and Daiichi Sankyo has become the promoter of the company with effect from November 7.

Daiichi now holds 63.92 per cent stake in Ranbaxy, the companies said in a statement to the Bombay Stock Exchange on Friday.

Supreme court of Canada upholds clopidogrel patent

The Supreme Court of Canada has rejected an attempt by a Toronto-based generic drug maker to prevent brand-name pharmaceutical companies from patenting specific parts of previously patented medicines.

The court ruled unanimously against Apotex Inc. and in favour of France's Sanofi-Synthelabo over a challenge involving the blood-thinner clopidogrel bisulphate. The compound is marketed as Plavix, one of the world's top-selling drugs.

The whole judgement can be read here.

US FDA recalls mislabelled ReliOn insulin syringes

The US Food and Drug Administration announced that the agency is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabelling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycaemia, serious health consequences, and even death.

The details can be read here.

Glenmark Generics launches Perindopril tablets in UK

Glenmark Generics Limited has announced that its European subsidiary has launched its first product in Western Europe via initiation of sales of Perindopril tablets in the United Kingdom.Perindopril Erbumine, an ACE inhibitor indicated for symptomatic heart failure is being manufactured at the Glenmark Generics' plant in Goa, India.

The details can be read here.

Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal

SALVAT announced today the submission of the response to the FDA Approvable Letter for CETRAXAL(R) (Ciprofloxacin 0.2% Otic Solution in Single Dose Containers). In an Approvable Letter received on April 6, 2006, the FDA requested additional data with respect to chemistry, manufacturing, and controls.

The details can be read here.

FDA Approves Ranexa for First Line Anti Anginal Use

CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa(R) (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes.

The details can be read here.

Benitec Limited (ASX:BLT) Double-Stranded Patent Granted in Singapore

Benitec Limited today announced that a key patent focused on producing Double-Stranded Nucleic Acid constructs for therapeutic and related applications of RNA interference (RNAi) had been granted in Singapore.

The details can be read here.

Santarus Prevails on Claims Disputed by Par Pharmaceutical at Markman Hearing

Nov 5, 2008 - Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company, today announced that Chief Judge Gregory M. Sleet of the U.S. District Court for the District of Delaware has ruled in favor of Santarus and the University of Missouri following the Markman hearing held November 5, 2008. "Markman" hearings, also known as claim construction hearings, are held to resolve any disputes concerning the meaning of asserted patent claims prior to trial.
The details can be read here.

Par Pharmaceutical Begins Shipment of Sumatriptan Injection

Par Pharmaceutical Companies, Inc. today announced that it will begin shipping generic versions of Imitrex(R) Injection (sumatriptan succinate injection) 4mg and 6mg starter kits and 4mg and 6mg prefilled syringe cartridges to the trade immediately. In addition, Par anticipates launching the 6mg vials early next year.

The details can be read here.

NicOx says naproxcinod has an edge over naproxen for hypertension

NicOx SA announced positive top-line results from a 118 patient Ambulatory Blood Pressure Monitoring (ABPM) trial (the 111 study), which compared the 24-hour blood pressure profile of escalating doses of naproxcinod and naproxen in osteoarthritis (OA) patients with controlled hypertension.

The details can be read here.

US FDA clears Salix's mesalamine pills for ulcerative colitis

Salix Pharmaceuticals, Ltd. announced that the US Food and Drug Administration (FDA) has granted marketing approval for Apriso (mesalamine) extended-release capsules 0.375 g.

The details can be read here.

Antares Announces Additional Regulatory Approvals in Europe and Australia for Its Needle-Free Injection Device

Nov 5, 2008 - Antares Pharma, Inc. today announced that it's license partner, Ferring Pharmaceuticals has received additional regulatory approvals in Europe and Australia for use of Antares' needle-free injection devices with it's human growth hormone (hGH), Zomacton.

The details can be read here.

Keppra XR Offers Convenient Dosing For People With Partial Onset Seizures

UCB announced today that Keppra XR(TM) offers convenient dosing for people with epilepsy. Keppra XR(TM) was approved by the U.S. Food and Drug Administration (FDA) in September 2008 for use as an add-on to other antiepileptic treatments for people with partial-onset seizures who are 16 years of age and older.

The details can be read here.

Through the Eye of a Needle - Labcyte Awarded U. S. Patent Describing the Acoustic Transfer of Droplets into Small Openings

Nov 5, 2008 - Labcyte Inc., the pioneer in 'touchless' acoustic transfer of liquids, announces the issuance of U.S. Patent 7,405,395 which exploits the unique advantages of using sound to move liquids. This patent describes the acoustic transfer of fluid droplets into openings less than 300 microns in diameter. "We have exquisite capabilities for directing a droplet exactly to where we want it," said Chief Technical Officer, Richard Ellson. "We can easily direct a droplet of almost any liquid into an extremely small opening or lay it onto a complex surface such as a stent. We have been able to position droplets with better than 10 micron accuracy.

The details can be read here.