Court Report

As per the court report published on patentdocs.net.

Sepracor Inc. and University of Massachusetts v. Pharmaceutical Associates, Inc.
3:08-cv-04718; filed September 19. 2008 in the District Court of New Jersey

Infringement of U.S. Patent Nos. 7,214,683 ("Compositions of Descarboethoxyloratadine," issued May 8, 2007) and 7,214,684 ("Methods for the Treatment of Allergic Rhinitis," issued May 8, 2007), licensed to Schering-Plough........,
View the complaint here.

Bayer Schering Pharma AG et al. v. Sandoz, Inc. et al.
1:08-cv-08112; filed September 18, 2008 in the Southern District of New York

Infringement of U.S. Patent No. 5,569,652 ("Dihydrospirorenone as an antiandrogen," issued October 29, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture ......
View the complaint here.

View the details here.

Actavis to market BSV's anti-infective generic formulation in Europe, SA & Turkey

Bharat Serums and Vaccines Limited (BSV), one of the top ten Indian biopharmaceutical companies, has entered into an exclusive licensing , manufacturing and supply agreement with Actavis for marketing one of BSV's anti-infective generic formulations.

The details can be read here.

Eli Lilly Sues Teva Again Over Gemzar ANDA

Eli Lilly & Co. has filed another infringement complaint against Teva Pharmaceuticals USA Inc. in the U.S. District Court for the Southern District of Indiana, over efforts to make a generic version of Lilly's cancer treatment Gemzar.

The details can be read here.

Debiopharm seeks European approval for Decapeptyl for prostate cancer

Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announces the filing of an application with the European Agencies for the approval of its new 6-month formulation of Decapeptyl (triptorelin pamoate 22.5 mg), a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer.

The details can be read here.

Orchid ties-up with Merck to develop anti-infective drugs

Orchid Chemicals and Pharmaceuticals and Merck & Co, Inc have entered into research collaboration and license agreement focused on the discovery, development and commercialization of novel agents for the treatment of bacterial and fungal infections.

The details can be read here.

ImClone begins patient enrolment in phase-2 study of breast cancer drug

ImClone Systems Incorporated, a global leader in the development and commercialization of novel antibodies to treat cancer, announced that its disease-directed randomized phase-2 clinical trial of IMC-A12, ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in women with advanced breast cancer has commenced patient enrolment.

The details can be read here.

Morphotek, Pivotal Biosciences enter monoclonal antibodies development pact

Morphotek, Inc, a subsidiary of Eisai Corporation of North America, and Pivotal BioSciences, Inc, a privately held Los Angeles-based biotechnology company developing oncology products, have entered into an agreement in which Morphotek will access Pivotal BioSciences' LEC platform technology, developed by Dr Alan Epstein, for the development of therapeutic monoclonal antibodies.

The detailc can be read here.

Sagent Pharma acquires Infusive Technologies

Sagent Pharmaceuticals, Inc, a privately-held specialty pharmaceutical company, announced the acquisition of Infusive Technologies' proprietary, patented, multi-chamber, sequential dose syringe technology.

The details can be read here.

New Life for Old Antibiotics – Senate Passes Bill Creating New Exclusivity Provisions; House Passage is Expected Very Soon

According to a blog post on fdalawblog...
Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.” Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics.

The details can be read here.

New drug promising in HCV infection: SciClone

SciClone Pharmaceuticals, Inc announced promising results from its proof-of-concept phase-2 clinical trial using its proprietary, immunomodulatory compound SCV-07 as a sole agent administered to patients chronically infected with the hepatitis C virus (HCV).

The details can be read here.

ProStrakan's cancer pain drug gets UK MHRA marketing nod

ProStrakan Group plc, the international specialty pharmaceutical company, announces that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a marketing authorisation for Abstral (for breakthrough cancer pain).

The details can be read here.

Roche completes acquisition of Arius

Roche announced that it has completed the acquisition of cent per cent of the issued and outstanding shares and warrants of Arius Research. On September 19th, the Ontario Superior Court, Canada, approved the plan of arrangement previously approved by the security holders and announced ....

The details can be read here.

Indevus and FDA Agree on Path Forward for Nebido

Indevus Pharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for NEBIDO(R) in the first quarter of calendar 2009. ...

The details can be read here.

Merck KGaA’s Kuvan Recommended for European Approval

Merck KGaA and its Merck Serono division announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for Kuvan® (sapropterin dihydrochloride) as an oral treatment for hyperphenylalaninemia (HPA) in patients with phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.

The details can be read here.

Zypadhera Receives Positive Opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Maintenance Treatment of Schizophrenia

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Zypadhera (olanzapine powder and solvent for prolonged release suspension for injection, also known as olanzapine long-acting injection) for maintenance treatment of adult patients with schizophrenia sufficiently stabilized during acute treatment with oral olanzapine, Eli Lilly and Company (LLY) announced today.

The details can be read here.