Lilly and Boehringer launch Jentadueto

Lilly announced that the company and its partner's Boehringer Ingelheim have launched Jentadueto (linagliptin/metformin) in the US.

The medication was approved in the US earlier this year.

Jantadueto will come in three dosage strengths that can be taken two times a day: 2.5 mg/500 mg, 2.5 mg/850 mg, and 2.5 mg/1000 mg.

The company also announced the that

Promedior's PRM-151 received orphan drug status in the US

Promedior said the company's PRM-151 has been granted orphan drug designation for the treatment of idiopathic pulmonary fibrosis.

PRM-151 is a recombinant form of human Pentraxin-2, which has been shown to be regulating the monocyte-derived cells (such as macrophages and fibrocytes) that control the fibrotic process.  PRM-151 is currently being developed for rare systemic

Fosrenol oral powder has been approved in Europe

Shire announced that the Fosrenol oral powder has been approved in Europe for the management of hyperphosphataemia in chronic renal failure patients on hemodialysis or continuous ambulatory peritoneal dialysis.

The Swedish Medical Products Agency was acting as

Avedro submitted the NDA for Vibex/KXL

Avedro announced that the company has submitted the new drug application for VibeX/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery to the US FDA.

The US FDA has given orphan drug status to VibeX/KXL System in 2011 for the treatment of keratoconus and corneal ectasia following refractive surgery.

VibeX/KXL has received CE Mark in 2010 for corneal collagen cross-linking in 2010 and has been available internationally since.

VibeX/KXL System contains riboflavin ophalthmic solution.

Depomed filed a lawsuit against Actavis, Watson and Incepta

Depomed recently said it has filed a patent infringement lawsuit against three companies who have filed abbreviated new drug applications requesting the FDA's approval to market generic Gralise (gabapentin), Depomend's once-a-day gabapentin product for the management of postherpetic neuralgia. The defendants in the lawsuits comprise of Actavis Elizabeth, Watson Lab, and Incepta Pharmaceuticals.

The company stated in its lawsuit that the company has six patents listed in the Orange Book for Gralise. The last patent will expire in 2024.

Because Depomed has filed a lawsuit within 45 days after receiving the notice, the FDA is not allowed to approve the ANDA of Gralise for 30 months or until the decision has been reached.

The FDA declines to approve the sNDA submitted for Dacogen

Eisai announced that the company has received a complete response letter from the FDA indicating that the Agency can't approve the supplemental new drug application submitted for Dacogen (decitabine) for the treatment of acute myeloid leukemia in adults 65 years of age or older who are not considered candidates for induction therapy.

The Agency said data from the

Mersana entered into a collaborative agreement with Endo

Mersana announced that it has entered into a collaboration agreement with Endo Pharmaceuticals to develop next-generation antibody-drug conjugates using the company's proprietary conjugation technology, Fleximer polymer.

Mersana will receive an upfront payment from

CK-2017357 received orphan drug designation from the EU

Cytokinetics announced that the company's CK-2017357 has received orphan drug designation for the treatment of amyotrophic lateral sclerosis from the European Medicines Agency. The agent has been given orphan drug designation in the US for the same indication.

CK-2017357 is currently being investigated in the phase II clinical trial for the treatment of amyotriphic lateral sclerosis. The agent is also being studied as potential treatment of myasthenia gravis.

CK-2017357 is a skeletal muscle activator developed by Cytokinetics. The company was awarded $2.8M from the National Institute of Neurological Disorders and Strokes in July 2010. The award was given to continue the research and the development of CK-2017357 for the treatment of myasthenia gravis.

A patent interference between Idenix and Pharmasset was declared by the USPTO

Idenix announced that the US Patent and Trademark Office has declared a patent interference between the US Patent Application number 12/131,868 submitted by Idenix and the US Patent No 7,429572 submitted by Pharmasset (now Gilead Sciences). Both applications were

The FDA approved Surfaxin of Discovery lab

Discovery Labs announced that the US FDA has approved the company's Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants at high risk for respiratory distress syndrome.

The company said it anticipates to launch the product commercially in the US in late 2012.

Surfaxin is the first synthetic, peptide-containing

Repligen submitted the marketing authorization application for ScreFlo in Europe

Repligen announced that it has submitted the marketing authorization application to the European Medicines seeking approval to market SecreFlo for the detection of pancreatic duct abnormalities in patients with pancreatitis.

The company said it anticipates to hear back

Millennium of Takeda initiated the phase III trial evaluating MLN8237 in patients with relapsed or refractory peripheral T-cel lymphoma

Takeda announced that Millennium: The Takeda Oncology Company has initiated the phase 3 clinical trial evaluating the company's MLN8237 for the treatment of relapsed or refractory periopheral T-cell lymphoma.

It is a randomized, two-arm, open-label, multi-center, international trial evaluating alisertib against investigator's choice in patients with relapsed or refractory peripheral T-cell lymphoma.

The study primary endpoint is overall response rate and progression-free survival

The study secondary endpoints are safety, complete response rate, overall survival and time to progression.

Alisertib is an orally available, selective Aurora A kinase inhibitor. Aurora A kinase is required for cell division and has been shown to be over-expressed in several types of cancers. The company hopes that alisertib as an Aurora inhibitor can be used to slow down or stop cell division in cancer tissue.

Aegerion seeking approval to market lomitapide in both the US and the EU

Aegerion Pharmaceuticals announced that the company has submitted the New Drug Application to the European Medicine Agency seeking approval to market lomitapide as cholesterol lowering agent when used as an adjunct to low fat diet and other lipid lowering therapies in patients with homozygous familial hypercholesterolemia.

Aegerion plans to initiate clinical development for lomitapide for the treatment of familial chylomicronemia in 2012.

Lomitapide is a small molecule, microsomal

Merck announced update from the FDA for ezetimibe/atorvastatin combination

Merck announced that the US FDA has issued a complete response letter in regard to the NEW Drug Application submitted for ezetimibe and atorvastatin combination product.

In the letter, the US FDA indicated that Merck should review its submission and additional data are needed.

The company said it plans to discuss with the FDA in the near future. With new data regarding the combination product to be available later this year, the

Concert Pharma and Fast Forward collaborate to develop C-21191

Concert Pharmaceuticals entered into a new collaboration with Fast Forward, the National Multiple Sclerosis Society's subsidiary to advance the preclinical development of C-21191, a deuterium-modified subtype-selective GABAa modulator for the potential treatment of spasticity and pain in patients with multiple sclerosis.

Under the terms of the agreement, Fast Forward will provided funding to support the prospective clinical stage development.

The said subtype-selective GABAa modulator is L-838417 which was discovered by Merck. However the main compound does not have a good pharmacokinetic profile despite having a good pharmacologic profile. By using its technology to create deuterium-modified L838417, Concert developed C-21191 which has better drug exposure than the original compound.

The FDA approved quadrivalent flu vaccine

The US FDA has approved the first quadrivalent vaccine containing four strains of the influenza virus, two influenza A strains and two influenza B strains.

FluMist Quadrivalent contains weakened versions of the virus strains and will be administered nasally. 

The most commonly adverse events observed were running or stuffy nose in both children and adults and headache and sorethroat in adults only. 

Quadrivalent will be marketed by MedImmne

Galapagos received milestone payment from Servier

Galapagos announced that the company has received 3.5M Euro from Servier in regard to the positive results of the phase 1 trial evaluating the company's drug candidates for the treatment of osteoarthritis.

In July 2010, both companies entered into an alliance to develop new drug candidates for the treatment of osteoarthritis.  Under the agreement, Galapagos will use its proprietary platform to discover new drug candidates. Servier will have rights to develop, register and

Orally disintegerating film of zolmitriptan has been approved in Europe

APR Applied Pharma Research and Labtec announced that the European Medicine Agency has approved the companies' zolmitriptan oral dispersible film for the management of migraine in Europe.

The companies collaborated with Monosol RX of New Jersey to develop this unique formulation using RapidFilm Technology of APR and Labtec.

The medication will be available in 2 dosage strengths