The fixed dose combinations in the categories of analgesics and orthopaedics lead the list of FDCs to be withdrawn from the market following the agreement between the industry and the DCGI over the vexed issue, according to the minutes of the first meeting released recently.
The largest number of number of combinations to be banned or discontinued from the market had aspirin as a component, followed by paracetamol, according to the minutes of the meeting held on July 14, but belatedly released in the second meeting held on October 1.
The details of the Banned and absurd FDC's can be read here.
Tuesday, October 7, 2008
deCODE files IND for Alzheimer's & other cognitive disorders
deCODE genetics announced the filing of an investigational new drug (IND) application for DG071, the company's novel small-molecule modulator of phosphodiesterase 4 (PDE4), with the US Food and Drug Administration (FDA). The compound is being developed as a new and potentially safer means of targeting PDE4 to combat memory loss and cognitive deficits associated with Alzheimer's disease and other disorders in which neural signalling is reduced or impaired.
The details can be read here.
The details can be read here.
MedWatch - Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes
Oct. 7, 2008-FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease.
The details can be read here.
The details can be read here.
Orion comments on new ANDA by Sun Pharma Global, Inc. for generic entacapone in the United States
Oct. 7, 2008-Orion Corporation has been informed that Sun Pharma Global, Inc. has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking authorisation to produce and market a generic version of entacapone (200 mg tablets) in the United States. Entacapone is the active ingredient in Comtan®, a product originated by Orion Corporation for Parkinson's disease and marketed in the United States by its exclusive licensee, Novartis.
The details can be read here.
The details can be read here.
Monday, October 6, 2008
Daiichi Sankyo Propharma to close Osaka plant
Daiichi Sankyo Company, Limited and its subsidiary Daiichi Sankyo Propharma Co, Ltd (hereafter DSPP) have announced the closure of the Osaka plant of DSPP. The Boards of directors of Daiichi Sankyo and DSPP each reached the decision at the meetings held recently.
The whole story can be read here.
The whole story can be read here.
SC appoints Dr P C Chakraborti as technical member to IPAB in Glivec case
The Supreme Court has appointed Dr P C Chakraborti as a new technical member to the Intellectual Property Appellate Board (IPAB) to consider the Novartis appeal against the rejection of the Glivec beta patent by the Indian Patent Office.
The details can be read here.
The details can be read here.
Eli Lilly, Jubilant to set up JV for new drug discovery
Jubilant Organosys and Eli Lilly and Company have entered into an agreement to form an equally-owned joint venture in India that will focus on providing drug development services exclusively to Jubilant- and Lilly-partnered molecules.
The details can be read here.
The details can be read here.
ATryn (antithrombin alfa) BLA Filing Accepted by FDA
OVATION Pharmaceuticals, Inc. announced today that the U.S. FDA has accepted for review the Biologics License Application (BLA) for ATryn (antithrombin alfa). OVATION acquired the exclusive U.S. license to ATryn in August from GTC Biotherapeutics.........
The details can be read here.
The details can be read here.
Oral Cancer Drug Revlimid Receives Marketing Authorization from Health Canada for Treatment of Multiple Myeloma
Celgene International SArl announced that its oral cancer drug REVLIMID (lenalidomide) has received marketing authorization approval from Health Canada for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.
The details can be read here.
The details can be read here.
Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced today that Durezol(TM) (difluprednate ophthalmic emulsion) 0.05% is now commercially available. Durezol, which was approved by the U.S. Food and Drug Administration in June 2008, is a topical ophthalmic corticosteroid indicated for the treatment of inflammation and pain associated with ocular surgery.
The details can be read here.
The details can be read here.
Ariad Announces Favorable Ruling Permitting Immediate Appeal of District Court Findings on NF-(kappa)B Patent in Amgen Litigation
ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) today announced that the U.S. District Court for the District of Delaware granted ARIAD's motion to permit an immediate appeal of the Court's summary judgment ruling of non-infringement by Amgen's drug, Enbrel(R) (etanercept), of seven claims of U.S. Patent No. 6,410,516 (the '516 patent). The Court also cancelled the trial scheduled for November 2008 and administratively closed the case at this time.
The details can be read here.
The details can be read here.
Sunday, October 5, 2008
Impax Laboratories Inc. vs. Aventis Pharmaceuticals Inc. (Riluzole)
October 3, 2008, In an appeal from a District Court's remand decision holding ’940 patent does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ’814 patent, the Federal Circuit affirmed the District Court's finding
the ’940 patent is not an enabling prior art reference and that it does not anticipate claims 1-5 of the ’814 patent.
The whole judgement can be read here.
Other links related to this post are as follows:
http://www.patentdocs.net/patent_docs/2006/12/impax_laborator.html
http://www.orangebookblog.com/2006/12/federal_circuit.html
A breif history of the case.
Impax Laboratories, Inc. (Impax) filed an ANDA with the FDA pursuant to 21 U.S.C. 355(j) seeking approval to market generic riluzole tablets on May 16, 2001. On June 25, 2002, Impax sued Aventis in the district of Delaware for a declaratory judgment that Impax did not infringe, induce infringement of, or contribute to the infringement of the ’814 patent. In its suit, Impax alleged that the ’814 patent was invalid and unenforceable.
After a bench trial, the district court determined that Impax did not prove that the ’814 patent was unenforceable due to inequitable conduct nor show that claims 1-5 were anticipated by prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 333 F. Supp. 2d 265 (D. Del. 2004). On March 16, 2005, the court entered final judgment against Impax.
Impax appealed that decision. This court affirmed-in-part, vacated-in-part, and remanded to the district court. Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1384 (Fed. Cir. 2006). On remand, the trial court examined the asserted prior art, the ’940 patent, for evidence that it enables the use of riluzole to treat ALS and thus qualifies as enabling prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 496 F. Supp. 2d 428, 433 (D. Del. 2007).
In the event that it qualifies as enabling prior art, the trial court also received the opportunity to determine if the disclosure anticipates claims 1-5 of the ’814 patent. Addressing those questions, the district court determined that the ’940 patent does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ’814 patent. Id. Impax timely appealed the district court’s remand decision to this court.
the ’940 patent is not an enabling prior art reference and that it does not anticipate claims 1-5 of the ’814 patent.
The whole judgement can be read here.
Other links related to this post are as follows:
http://www.patentdocs.net/patent_docs/2006/12/impax_laborator.html
http://www.orangebookblog.com/2006/12/federal_circuit.html
A breif history of the case.
Impax Laboratories, Inc. (Impax) filed an ANDA with the FDA pursuant to 21 U.S.C. 355(j) seeking approval to market generic riluzole tablets on May 16, 2001. On June 25, 2002, Impax sued Aventis in the district of Delaware for a declaratory judgment that Impax did not infringe, induce infringement of, or contribute to the infringement of the ’814 patent. In its suit, Impax alleged that the ’814 patent was invalid and unenforceable.
After a bench trial, the district court determined that Impax did not prove that the ’814 patent was unenforceable due to inequitable conduct nor show that claims 1-5 were anticipated by prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 333 F. Supp. 2d 265 (D. Del. 2004). On March 16, 2005, the court entered final judgment against Impax.
Impax appealed that decision. This court affirmed-in-part, vacated-in-part, and remanded to the district court. Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1384 (Fed. Cir. 2006). On remand, the trial court examined the asserted prior art, the ’940 patent, for evidence that it enables the use of riluzole to treat ALS and thus qualifies as enabling prior art. Impax Labs., Inc. v. Aventis Pharms. Inc., 496 F. Supp. 2d 428, 433 (D. Del. 2007).
In the event that it qualifies as enabling prior art, the trial court also received the opportunity to determine if the disclosure anticipates claims 1-5 of the ’814 patent. Addressing those questions, the district court determined that the ’940 patent does not enable a person of ordinary skill in the art to treat ALS with riluzole and therefore does not anticipate claims 1-5 of the ’814 patent. Id. Impax timely appealed the district court’s remand decision to this court.
Advanced Life, Wyeth sign pact for Cethromycin in Asia Pacific region
Advanced Life Sciences Holdings, Inc and Wyeth Pharmaceuticals, a division of Wyeth have signed a development and commercialization agreement for cethromycin in the Asia Pacific region excluding Japan.
The details can be read here.
The details can be read here.
Bayer's rivaroxaban gets marketing approval in Europe
The European Commission has granted marketing approval for Xarelto (rivaroxaban), a novel anticoagulant taken as one tablet, once-daily, for the prevention of venous blood clots in adult patients undergoing elective (planned) hip or knee replacement surgery.
The details can be read here.
The details can be read here.
Cell Therapeutics Submits Supplemental Biologics License Application for Zevalin Use in First-Line Consolidation Therapy
Cell Therapeutics, Inc. today announced that it has submitted a supplemental Biologics License Application with the U.S. FDA for use of Zevalin(R) ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma.
The details can be read here.
The details can be read here.
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