The Ahmedabad-based Cadila Pharmaceuticals Ltd is all set to launch two new products for treating pulmonary tuberculosis in adult patients. The products have been developed in collaboration with the Jammu-based Indian Institute of Integrative Medicine (IIIM), it is learnt.
the details can be read here.
Thursday, February 26, 2009
FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India
Feb. 25, 2009--The U.S. FDA today announced that a facility owned by India-based Ranbaxy Laboratories falsified data and test results in approved and pending drug applications. The facility, Paonta Sahib, has been under an FDA Import Alert since September 2008.
the details can be read here.
the details can be read here.
Winston Pharmaceuticals, Inc. Receives Orphan Drug Designation for Novel Patch to Treat Post-Herpetic Neuralgia
Feb 24, 2009 - Winston Pharmaceuticals, Inc. today announced that it has received orphan drug designation from the U.S. FDA for its lead compound, Civamide, a novel TRPV-1 receptor modulator, being developed as a dermal patch for the treatment of post-herpetic neuralgia.
The details can be read here.
The details can be read here.
FDA Approves Apidra SoloSTAR - a Prefilled Disposable Insulin Pen
Sanofi-aventis announced today that the U.S. FDA approved Apidra SoloSTAR (insulin glulisine [rDNA origin] injection), a prefilled disposable pen containing rapid-acting insulin analog Apidra, which is indicated to improve glycemic control in adults and children (4 years and older) with type 1 diabetes or adults with type 2 diabetes.
The details can be read here.
The details can be read here.
FDA Approves Genzyme's Synvisc-One for Osteoarthritis of the Knee
Feb 26, 2009 - Genzyme Corporation today announced that the U.S. FDA has granted marketing approval for Synvisc-One™ (hylan G-F 20), a product intended for the relief of pain associated with osteoarthritis (OA) of the knee.
The details can be read here.
The details can be read here.
European Authorities Approve Larger-Scale Production of Genzyme's Myozyme
Feb 26, 2009 - Genzyme Corporation announced today that the European Commission has approved the production of Myozyme (alglucosidase alfa) at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.
The details can be read here.
The details can be read here.
Alexion's Soliris (eculizumab) Receives Marketing Approval in Australia for All Patients with PNH
Feb 25, 2009 - Alexion Pharmaceuticals, Inc., today announced that the Australian Government's Therapeutic Goods Administration has approved the use of Soliris (eculizumab) for the treatment of all patients in Australia with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris is the first therapy approved in Australia for the treatment of PNH.
the details can be read here.
the details can be read here.
Ark patents novel gene regulation technology as potential successor to RNA silencing
26 February 2009 - Ark Therapeutics Group plc today announces that it has filed a patent application relating to a breakthrough small hairpin RNA (shRNA) based technology that allows both the up- and down-regulation of multiple genes via Ark's existing method of gene delivery.
The details can be read here.
The details can be read here.
On the Heels of Court Ruling Denying Autism-Vaccine Link, U.S. Federal Court Declares MMR Vaccine Caused Autism in a Young Boy
The following release was issued today by the National Autism Association:
Less than two weeks after federal vaccine court ruled against three families claiming vaccines caused autism in their children, writers Robert F Kennedy, JR and David Kirby reported Tuesday on the story of Bailey Banks, a 10-year-old who regressed into autism following the MMR vaccine.
The details can be read here.
Less than two weeks after federal vaccine court ruled against three families claiming vaccines caused autism in their children, writers Robert F Kennedy, JR and David Kirby reported Tuesday on the story of Bailey Banks, a 10-year-old who regressed into autism following the MMR vaccine.
The details can be read here.
Bedford Laboratories to Begin Shipping Sumatriptan Succinate Injection
Bedford Laboratories, a division of Ben Venue Laboratories, Inc., today announced the launch of Sumatriptan Succinate Injection. This product is AP rated and is equivalent to Imitrex(R) by GlaxoSmithKline.
The details can be read here.
The details can be read here.
Mylan's Matrix Receives WHO Approval for First Generic, Heat-Stable Version of HIV Protease Inhibitor
Mylan Inc. today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.
The details can be read here.
The details can be read here.
Tuesday, February 24, 2009
Federal Circuit Affirms Extension of 30-Month Stay Against Teva's Generic Evista
According to the post on Orange Book Blog:
Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if "either party to the action failed to reasonably cooperate in expediting the action."
The details can be read here.
the whole judgement can be read here.
Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within 45 days of receiving a Paragraph IV notice letter. The purpose of the stay is to allow the parties to litigate the patent infringement claims while the ANDA filer pursues FDA approval of its generic drug. Pursuant to 21 U.S.C. § 355(j)(5)(B)(iii), a district court may shorten or lengthen the thirty–month stay if "either party to the action failed to reasonably cooperate in expediting the action."
The details can be read here.
the whole judgement can be read here.
Basilea Pharmaceutica Ltd. (CH) - Zevtera Review Process Delayed in EU
February 24, 2009 - Basilea Pharmaceutica Ltd. announces that the EU Committee for Medicinal Products for Human Use has indicated that the European Commission decision process on Zevtera (ceftobiprole) for the treatment of complicated skin and soft tissue infections is delayed.
the details can be read here.
the details can be read here.
International NGOs voice concern over seizure of Indian generic drugs at EU ports
Several international NGOs have raised a banner of protest against the seizure of Indian drug shipments at the European Union ports on charges of counterfeiting and patents infringement. In separate letters to the heads of the World Health Organization (WHO) and the World Trade Organization (WTO), these organisations have voiced concern over the recent seizures by Dutch customs authorities of Indian generic drugs shipped through the Netherlands en route to Brazil, Colombia and Peru.
The details can be read here.
The details can be read here.
MSD Pharma to launch 13 products in 2 years, enters cardiovascular segment
MSD Pharmaceuticals, the wholly-owned subsidiary of global leader Merck, has entered into the cardiovascular segment with the launch of 'zocor' (simvastatin) and is planning to tap the potentials in the biologicals in the coming years with the target of emerging as one of the top five players in the country by 2015.
The details can be read here.
The details can be read here.
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