Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor(R) Tablets.
Mylan believes that Matrix is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for the product. Matrix filed an ANDA with the U.S. Food and Drug Administration (FDA) in early 2008.
Daiichi Sankyo filed a lawsuit yesterday in the U.S. District Court for the District of New Jersey alleging infringement of the sole patent relating to Azor, which is listed in the "Orange Book" as U.S. Patent No. 5,616,599.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
Wednesday, June 4, 2008
Tuesday, June 3, 2008
Mylan acquires Merck's Central Eastern European generics businesses
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world, has acquired Merck KGaA's Central & Eastern Europe (CEE) generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic.
As announced previously, Mylan exercised its option to acquire these businesses as part of the original, October 2007 agreement in which Mylan acquired Merck KGaA's generics business (Merck Generics) in Western Europe, Asia-Pacific, Africa and North America.
The whole story can be read here.
As announced previously, Mylan exercised its option to acquire these businesses as part of the original, October 2007 agreement in which Mylan acquired Merck KGaA's generics business (Merck Generics) in Western Europe, Asia-Pacific, Africa and North America.
The whole story can be read here.
Lexicon's Drug Candidate for Carcinoid Syndrome Receives Fast Track Status From the FDA
June 3, 2008 -- Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received Fast Track status from the U.S. Food and Drug Administration (FDA) for development of LX1032, an orally-delivered small molecule drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome. LX1032 is one of four programs in human clinical trials as part of Lexicon's 10TO10 program.
The whole story can be read here.
The whole story can be read here.
New Improved Dosing Approved for Pennsaid
Nuvo Research Inc., a Canadian drug development company focused on the research and development of drug products delivered to and through the skin using its topical and transdermal drug delivery technologies, and Paladin Labs Inc., a leading Canadian specialty pharmaceutical company, today announced that Health Canada has approved a new dosing regimen for Pennsaid(R) (topical diclofenac). Paladin sells and markets Pennsaid in Canada, having acquired exclusive Canadian Pennsaid rights from Nuvo in August 2005.
The new dosing regimen of Pennsaid(R) will be 50 drops per knee, 3 times a day, as an alternative to the existing approved dosing regimen of 40 drops per knee, 4 times a day. Pennsaid(R) is now the only topical NSAID approved in Canada with this new improved dosing regimen. Pennsaid had Canadian sales of $10.6 million last year and has been sold in Canada since May 2003.
The whole story can be read here.
The new dosing regimen of Pennsaid(R) will be 50 drops per knee, 3 times a day, as an alternative to the existing approved dosing regimen of 40 drops per knee, 4 times a day. Pennsaid(R) is now the only topical NSAID approved in Canada with this new improved dosing regimen. Pennsaid had Canadian sales of $10.6 million last year and has been sold in Canada since May 2003.
The whole story can be read here.
Advancing Nanoparticle Technology Creating Opportunities for Drug Developers
June 3, 2008--Advances in nanotechnology that enable drugs to be delivered in ways that preserve their efficacy and to precise therapeutic targets are creating a host of opportunities for drug developers. A variety of nanostructures are being investigated as functional drug carriers for a wide range of therapies, most notably cardiovascular medicine, autoimmune diseases, and cancer.
While the concept of nanoparticles in drug delivery is not new, the number of research programs and active drug development projects has escalated as funding to nanotechnology developers has increased. The result is the emergence of a host of novel nanotechnologies tailored to meet the physicochemical requirements of drug developers.
Nanoparticles have already improved the availability and efficacy of some drugs, but the capabilities that evolving technologies possess will leads to a dramatic increase in the number of therapies delivered via nanoparticles. In many cases drugs in nanocrystalline form can be administered in smaller doses because they can be delivered directly to the tissue and in controlled doses related to the patient’s personal requirements.
These findings are contained in a new and comprehensive report: Nanoparticle Drug Delivery: Technologies, Targets and Therapies. The survey concludes that nanoparticle-based drug delivery will gain traction at the expense of traditional drug formulation methods, particularly among emerging biologics.
While the concept of nanoparticles in drug delivery is not new, the number of research programs and active drug development projects has escalated as funding to nanotechnology developers has increased. The result is the emergence of a host of novel nanotechnologies tailored to meet the physicochemical requirements of drug developers.
Nanoparticles have already improved the availability and efficacy of some drugs, but the capabilities that evolving technologies possess will leads to a dramatic increase in the number of therapies delivered via nanoparticles. In many cases drugs in nanocrystalline form can be administered in smaller doses because they can be delivered directly to the tissue and in controlled doses related to the patient’s personal requirements.
These findings are contained in a new and comprehensive report: Nanoparticle Drug Delivery: Technologies, Targets and Therapies. The survey concludes that nanoparticle-based drug delivery will gain traction at the expense of traditional drug formulation methods, particularly among emerging biologics.
Cephalon Files Patent Infringement Lawsuit Against Watson Pharmaceuticals
Cephalon, Inc. today announced that it and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in U.S. District Court in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal tablet) [C-II]. The 6,200,604 and 6,974,590 patents do not expire until 2019. FENTORA was approved by the U.S. Food and Drug Administration (FDA) in September 2006 for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Watson seeking FDA approval for a generic equivalent of fentanyl buccal tablets to be sold in the United States. Watson alleges that the above two FENTORA patents are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.
The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Watson seeking FDA approval for a generic equivalent of fentanyl buccal tablets to be sold in the United States. Watson alleges that the above two FENTORA patents are invalid, unenforceable and/or will not be infringed by Watson's manufacture, use or sale of the product described in its ANDA.
Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Potassium-Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths.
The whole story can be read here.
The whole story can be read here.
Monday, June 2, 2008
ProStrakan Presents Update on Sancuso US Regulatory Review Status
2 June, 2008 -- ProStrakan Group plc (LSE: PSK) announces today that, as a result of continuing discussions with the US Food & Drug Administration (FDA), it believes that there are now no outstanding technical questions from the FDA's review of Sancuso® other than those which will be dealt with in labeling negotiations. Sancuso is ProStrakan's novel, patent-protected transdermal patch for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The whole story can be read here.
The whole story can be read here.
U.S. Patent Office Confirms Second of Four Viread(R) Patents
Jun 2, 2008 - Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Patent & Trademark Office (PTO) has completed the second of four reexamination proceedings and has confirmed the patentability of U.S. Patent No. 5,922,695, which covers the composition of matter for Viread (tenofovir disoproxil fumarate). On May 20, Gilead announced that the U.S. PTO confirmed the patentability of U.S. Patent No. 6,043,230.
The four U.S. PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation (PUBPAT) in March 2007 for U.S. Patents No. 5,922,695; 5,977,089; 5,935,946; and 6,043,230. In its request for the reexaminations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
The whole story can be read here.
The four U.S. PTO review proceedings were initiated July 2007 in response to a challenge issued by the Public Patent Foundation (PUBPAT) in March 2007 for U.S. Patents No. 5,922,695; 5,977,089; 5,935,946; and 6,043,230. In its request for the reexaminations, PUBPAT claimed that prior art existed that would have impacted the issuance of the original patents.
The whole story can be read here.
Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet
Boca Pharmacal, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pamlab's Palgic(R) 4mg Tablet (Carbinoxamine Maleate 4 mg Tablet). The Company plans to launch its product immediately.
The details can be read here.
The details can be read here.
Lannett Company to Launch Amantadine Hydrochloride Soft Gel Capsules, 100 mg
Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, today said that it expects to commence marketing Amantadine Hydrochloride Soft Gel Capsules 100mg, within the next several months. According to Wolters Kluwer, annual sales in 2007 of both the generic and brand product totaled $30 million.
Lannett will receive finished product from Banner Pharmacaps, Inc., under a previously announced supply agreement. Banner received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) last week for Amantadine Hydrochloride Soft Gel Capsules USP 100 mg, the generic equivalent of USL Pharma's Symmetrel(R).
The details can be read here.
Lannett will receive finished product from Banner Pharmacaps, Inc., under a previously announced supply agreement. Banner received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) last week for Amantadine Hydrochloride Soft Gel Capsules USP 100 mg, the generic equivalent of USL Pharma's Symmetrel(R).
The details can be read here.
Banner Pharmacaps Receives FDA Approval for Amantadine Softgel Capsules
Banner Pharmacaps Inc., a leader in the pharmaceutical industry for the development of soft gelatin dosage form technology, announces that the US Food & Drug Administration granted approval for the Company's Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride USP 100 mg soft gelatin capsules on May 29, 2008.
Amantadine is indicated for the prophylaxis and treatment of signs and symptoms of infection in the respiratory tract caused by various strains of influenza A virus. Amantadine is also utilized in the treatment of Parkinson's Disease and drug-induced extrapyramidal reactions.
(Source:www.pharmalive.com)
Amantadine is indicated for the prophylaxis and treatment of signs and symptoms of infection in the respiratory tract caused by various strains of influenza A virus. Amantadine is also utilized in the treatment of Parkinson's Disease and drug-induced extrapyramidal reactions.
(Source:www.pharmalive.com)
Watson Receives Final Approval of Omeprazole Delayed-Release Capsules
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 40mg strength. Watson's marketing exclusivity will begin upon commercial launch. The Company plans to launch its Omeprazole Delayed-Release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities. Watson plans to launch only the 40 mg strength.
The details can be read here.
Watson has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the 40mg strength. Watson's marketing exclusivity will begin upon commercial launch. The Company plans to launch its Omeprazole Delayed-Release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities. Watson plans to launch only the 40 mg strength.
The details can be read here.
Sunday, June 1, 2008
Bristol-Myers to acquire Kosan Biosciences
Bristol-Myers Squibb Company and Kosan Biosciences Inc. announced that the companies have signed a definitive merger agreement providing for the acquisition of Kosan, a cancer therapeutics company, by Bristol-Myers Squibb, for $5.50 per share in cash. The transaction, with a net aggregate purchase price of approximately $190 million after deducting Kosan's projected net cash balance at June 30, 2008, has been unanimously approved by the boards of directors of both companies.
The acquisition of Kosan will enhance Bristol-Myers Squibb's pipeline with compounds in two important classes of anticancer agents: novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
The details can be read here.
The acquisition of Kosan will enhance Bristol-Myers Squibb's pipeline with compounds in two important classes of anticancer agents: novel Hsp90 (heat shock protein 90) inhibitors and epothilones.
The details can be read here.
Boehringer Ingelheim gets EU approval for Actilyse 2mg
Boehringer Ingelheim announced the first approval for Actilyse (alteplase) 2mg within the European Union, which was communicated by the reference member state Germany after successful completion of a mutual recognition procedure.
The new indication is for the thrombolytic treatment of occluded central venous access devices (CVAD), including those used for haemodialysis. This regulatory milestone will result in subsequent approvals of the new indication in the relevant countries of the European Union throughout 2008 onwards.
The whole story can be read here.
The new indication is for the thrombolytic treatment of occluded central venous access devices (CVAD), including those used for haemodialysis. This regulatory milestone will result in subsequent approvals of the new indication in the relevant countries of the European Union throughout 2008 onwards.
The whole story can be read here.
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