May 13, 2008 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that it has received Notices of Allowance from the U.S. Patent and Trademark Office for patent applications numbered 11/252,966 and 11/349,043, covering claims for various organic arsenic compounds, including purified crystalline darinaparsin, glycolic arsenicals, and the oral pharmaceutical composition of an organic arsenic compound, and their use in the treatment of cancer. A notice of allowance signifies that the applicant is entitled to a patent under the law.
Darinaparsin is currently being tested in a variety of phase II studies for the treatment of leukemia, lymphoma, myeloma and liver cancer. The drug is being studied both as an intravenous agent and in oral form.
The details can be read here.
Tuesday, May 13, 2008
Monday, May 12, 2008
Supreme court declines to hear Apotex Appeal
The U.S Supreme court declined to hear Apotex's request for a rehearing on patent litigation with Abott Laboratories over the epilepsy drug Depakote (Divalproex Sodium) and in result ending the decade long litigation in Abott's favour.
Abott filed a petition for writ of certiorari in January 2008, after losing the case in October 2007 and having his request for a rehearing denied in the US court of Appeals for Federal Circuit.
The Federal circuit decision can be read here.
Abott filed a petition for writ of certiorari in January 2008, after losing the case in October 2007 and having his request for a rehearing denied in the US court of Appeals for Federal Circuit.
The Federal circuit decision can be read here.
BiPar expands phase 2 trials of ovarian cancer drug
BiPar Sciences, Inc. has announced the expansion of phase II clinical trial programmes for its lead product, BSI-201, in ovarian cancer. This is the third major clinical trial of BSI-201 that BiPar has launched in the past six months, expanding on on-going trials in breast and brain cancer.
The company is evaluating BSI-201, the first poly ADP-ribose polymerase (PARP) inhibitor in its DNA repair portfolio, as a monotherapy for patients whose ovarian cancer is linked to a hereditary genetic defect. Clinicians at Memorial Sloan-Kettering Cancer Center will enrol patients who have a mutation in their BRCA1 or BRCA2 genes.
The details can be read here.
The company is evaluating BSI-201, the first poly ADP-ribose polymerase (PARP) inhibitor in its DNA repair portfolio, as a monotherapy for patients whose ovarian cancer is linked to a hereditary genetic defect. Clinicians at Memorial Sloan-Kettering Cancer Center will enrol patients who have a mutation in their BRCA1 or BRCA2 genes.
The details can be read here.
Ranbaxy inks pact with Merck for anti-infective drug discovery
Ranbaxy Laboratories Ltd. and Merck & Co., Inc have signed a strategic Product Development Agreement for a drug discovery and clinical development collaboration for new products, in the anti-infective field.
Ranbaxy and Merck will work together to develop clinically validated anti-bacterial and anti-fungal drug candidates. Ranbaxy will carry-out drug discovery and clinical development through phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates thereafter.
The details can be read here.
Ranbaxy and Merck will work together to develop clinically validated anti-bacterial and anti-fungal drug candidates. Ranbaxy will carry-out drug discovery and clinical development through phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates thereafter.
The details can be read here.
FDA Approves Taclonex Scalp- Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
May 12, 2008 -- Warner Chilcott and LEO Pharma announced today that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Taclonex Scalp(R) (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension. LEO Pharma submitted the NDA for Taclonex Scalp(R) to the FDA in July 2007. Taclonex Scalp(R) is a topical suspension containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of moderate to severe psoriasis vulgaris of the scalp in adults. Taclonex Scalp(R) is called Xamiol(R) outside the United States.
The details can be read here.
The details can be read here.
GlaxoSmithKline Receives Authorisation in Europe for Oral Hycamtin for the Treatment of Relapsed Small Cell Lung Cancer
April 12, 2008-GlaxoSmithKline (GSK) announced that oral Hycamtin® (topotecan hard capsules) have received approval from the European Commission for the treatment of relapsed SCLC. Specifically, topotecan hard capsules are indicated as monotherapy for the treatment of adult patients with relapsed SCLC (PS0-2 ) for whom re-treatment with the first-line regimen is not considered appropriate.
Topotecan is already available as an intravenous (IV) injection and the approval of topotecan hard capsules provides physicians and patients with another convenient option.
“The approval of topotecan hard capsules is welcome news for patients and their physicians. Small cell lung cancer is a very aggressive disease and there are limited treatment options after relapse,” said Dr. Mary O'Brien, Head of the Lung Cancer Unit at The Royal Marsden Hospital, Surrey, UK. “Topotecan not only improves symptoms and extends the lives of patients, but as it is in capsule form treatment can be started without delay.”
“The European approval of topotecan as an oral formulation is good news for patients with relapsed small cell lung cancer across Europe. Topotecan hard capsules provide physicians and patients with an alternative, effective treatment, with the added convenience of being administered orally,” said Eddie Gray, President, Pharmaceuticals Europe, GlaxoSmithKline. “The approval of topotecan capsules continues to underscore GSK’s commitment to the research and development of therapies to address the unmet medical needs of cancer patients around the world.”
The details can be read here.
Topotecan is already available as an intravenous (IV) injection and the approval of topotecan hard capsules provides physicians and patients with another convenient option.
“The approval of topotecan hard capsules is welcome news for patients and their physicians. Small cell lung cancer is a very aggressive disease and there are limited treatment options after relapse,” said Dr. Mary O'Brien, Head of the Lung Cancer Unit at The Royal Marsden Hospital, Surrey, UK. “Topotecan not only improves symptoms and extends the lives of patients, but as it is in capsule form treatment can be started without delay.”
“The European approval of topotecan as an oral formulation is good news for patients with relapsed small cell lung cancer across Europe. Topotecan hard capsules provide physicians and patients with an alternative, effective treatment, with the added convenience of being administered orally,” said Eddie Gray, President, Pharmaceuticals Europe, GlaxoSmithKline. “The approval of topotecan capsules continues to underscore GSK’s commitment to the research and development of therapies to address the unmet medical needs of cancer patients around the world.”
The details can be read here.
FDA Approves First Generic Ropinirole
May 9, 2008-The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.
"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.
The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.
The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.
The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.
(Source: www.pharmalive.com)
Ropinirole hydrochloride tablets have been approved in the following dosages: 0.25 milligram, 0.5 milligram, 1 milligram, 2 milligram, 3 milligram, and 4 milligram.
"This generic drug approval is an example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary J. Buehler, director of the FDA's Office of Generic Drugs.
The following companies have received approval to market ropinirole hydrochloride tablets: Roxane Laboratories Inc., Teva Pharmaceuticals USA, Par Pharmaceuticals Inc., and Mylan Pharmaceuticals Inc.
The labeling of the generic versions of ropinirole hydrochloride may differ from that of Requip because some uses of the drug are protected by patents. In addition to treating Restless Legs Syndrome, Requip is also FDA-approved to treat symptoms of Parkinson's disease. The generic products are not approved for treatment of Parkinson's disease because this indication is protected by patent. Manufacturers of the generic drugs may seek approval for that use once the patent for the Parkinson's disease indication expires later this month.
The generic ropinirole hydrochloride tablets will have the same safety warnings as Requip, cautioning about patient reports of falling asleep while engaged in activities of daily living, including while driving. Although many of these patients reported sleepiness while on the drug, some patients perceived that they had no warning signs and believed that they were alert immediately prior to falling asleep. Some of these events have been reported as late as one year after the start of treatment.
(Source: www.pharmalive.com)
Sunday, May 11, 2008
Actemra improves symptoms in rheumatoid arthritis: Roche
Roche announced that Actemra (tocilizumab) can significantly inhibit structural damage to joints in patients with rheumatoid arthritis (RA), a critical measure of effectiveness of an RA treatment. Actemra also improved the patients' physical function after one year of therapy, leading to a better quality of life.
Results from the Lithe1 trial showed that a greater proportion of patients treated with Actemra in combination with a commonly used RA drug called methotrexate (MTX) benefited from a significant inhibition of structural damage during 12 months of therapy, compared to patients treated with MTX alone. This is critical to patients because damage in the joints caused by the disease leads to the disability and pain associated with RA.
Additionally, Actemra improved the patients ability to perform normal daily activities, as assessed by Health Assessment Questionnaire (HAQ) scores.
In the Lithe study, Actemra was generally well tolerated and the overall safety profile after 12 months of treatment was consistent with previously reported six month trial data.
The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available. New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA.
"The Lithe data further shows the potential of Actemra as an effective and well tolerated treatment for patients suffering from the debilitating effects of RA" said William M Burns, CEO Roche Pharmaceuticals Division. "By demonstrating an inhibition of joint damage and improving physical function, Actemra not only positively impacts the disease, but also helps patients to improve the quality of their lives".
The Lithe study is the fifth global phase III trial on Actemra to successfully meet its primary endpoints in patients with moderate to severe RA. First-year data from this two-year trial will be submitted for presentation at upcoming international scientific meetings.
Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.
(Source: www.pharmabiz.com)
Results from the Lithe1 trial showed that a greater proportion of patients treated with Actemra in combination with a commonly used RA drug called methotrexate (MTX) benefited from a significant inhibition of structural damage during 12 months of therapy, compared to patients treated with MTX alone. This is critical to patients because damage in the joints caused by the disease leads to the disability and pain associated with RA.
Additionally, Actemra improved the patients ability to perform normal daily activities, as assessed by Health Assessment Questionnaire (HAQ) scores.
In the Lithe study, Actemra was generally well tolerated and the overall safety profile after 12 months of treatment was consistent with previously reported six month trial data.
The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available. New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA.
"The Lithe data further shows the potential of Actemra as an effective and well tolerated treatment for patients suffering from the debilitating effects of RA" said William M Burns, CEO Roche Pharmaceuticals Division. "By demonstrating an inhibition of joint damage and improving physical function, Actemra not only positively impacts the disease, but also helps patients to improve the quality of their lives".
The Lithe study is the fifth global phase III trial on Actemra to successfully meet its primary endpoints in patients with moderate to severe RA. First-year data from this two-year trial will be submitted for presentation at upcoming international scientific meetings.
Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.
(Source: www.pharmabiz.com)
Merck secures 2 patents in India, to pursue more
US-based Merck has received patent approval from the Indian Patent Office for two of its upcoming drugs for dyslipidemia and obesity. The two new patented drugs are in final stages of trial and are yet to receive the Drug Controller General of India’s (DCGI) approval.
The details can be read here.
The details can be read here.
Friday, May 9, 2008
Jubilant acquires Speciality Molecules to strengthen Pyridine portfolio
Jubilant Organosys Ltd., an integrated pharmaceutical company which is also the largest custom research and manufacturing services company in India, has acquired Speciality Molecules Pvt. Ltd., a niche manufacturer of Speciality Intermediates with manufacturing facilities located in Ambernath, near Mumbai. The purchase consideration to acquire 100 per cent stake is Rs 199.5 million on a debt free, cash free basis.
The acquired company is engaged in the business of developing, manufacturing and selling of specialty intermediates, which include primarily pyridine derivatives that are used in pharmaceuticals and other life science industry. The acquisition will be accretive to Jubilant's earnings from the date of acquisition and will strengthen Jubilant's ability to provide comprehensive offering of pyridine derivatives to the customers in life science industry.
According to Shyam S Bhartia, chairman and MD and Hari S Bhartia, Co-chairman and managing director of Jubilant Organosys, the acquisition of Speciality Molecules is yet another step in strengthening our global leadership position in pyridine derivatives. This acquisition will further strengthen Jubilant's Halogenation capabilities as we plan to sell and also use these speciality intermediates for various life science derivatives which will help us to offer products based on a common platform at very competitive prices to our global customers who are sector leaders in the pharma and agrochemicals business".
The acquired company is engaged in the business of developing, manufacturing and selling of specialty intermediates, which include primarily pyridine derivatives that are used in pharmaceuticals and other life science industry. The acquisition will be accretive to Jubilant's earnings from the date of acquisition and will strengthen Jubilant's ability to provide comprehensive offering of pyridine derivatives to the customers in life science industry.
According to Shyam S Bhartia, chairman and MD and Hari S Bhartia, Co-chairman and managing director of Jubilant Organosys, the acquisition of Speciality Molecules is yet another step in strengthening our global leadership position in pyridine derivatives. This acquisition will further strengthen Jubilant's Halogenation capabilities as we plan to sell and also use these speciality intermediates for various life science derivatives which will help us to offer products based on a common platform at very competitive prices to our global customers who are sector leaders in the pharma and agrochemicals business".
Adolor Provides Regulatory Update on Entereg (alvimopan)
May 9, 2008 - Adolor Corporation (Nasdaq:ADLR) announced today that the U.S. Food and Drug Administration (FDA) has communicated to the company that it will not be issuing an action letter on the NDA for Entereg(R) (alvimopan) for postoperative ileus by May 10, 2008, the scheduled PDUFA date. The FDA did not provide a specific date, but informed the company that it expects to issue the action letter shortly.
Adolor is seeking marketing approval of Entereg for the proposed indication to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
Adolor is seeking marketing approval of Entereg for the proposed indication to accelerate upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
USFDA Approves Abilify for Add-On Treatment to Lithium or Valproate
May 8, 2008 - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved updated labeling for Abilify(R) (aripiprazole) as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults. ABILIFY has been approved as monotherapy for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004.
In addition to this new indication, the FDA also approved a new recommended starting and target dose of 15 mg daily for ABILIFY monotherapy in the treatment of Bipolar I Disorder in adults.
The details can be read here.
In addition to this new indication, the FDA also approved a new recommended starting and target dose of 15 mg daily for ABILIFY monotherapy in the treatment of Bipolar I Disorder in adults.
The details can be read here.
Astellas Mycamine Licensed for Use in Europe
May 9, 2008– The European Medicines Agency (EMEA) has announced the marketing authorisation of Mycamine®, Astellas Pharma Europe’s treatment for invasive candidiasis, oesophageal candidiasis and prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation. Mycamine® will initially be available in the U.K and across the European market shortly after this.
Professor David Denning of The University of Manchester said of the announcement; “The approval of micafungin is very good news for patients with life-threatening fungal infections in Europe. The Company has conducted a number of large, high quality clinical studies in Candida infections with impressive results. Particularly welcome are the indications for fungal infections in children and babies, often a neglected group in the early drug approval process.”
The efficacy and safety of Mycamine® have been demonstrated in a clinical development programme including more than 3,500 patients in 16 clinical trials. The trials included nearly 300 children. Mycamine® was launched in Japan in 2002 and in the US three years ago. In these two major markets more than 350,000 patients have been treated with the product.
“We are delighted that Mycamine® is now licensed for use in Europe.” said Alan Houston, MBBS, MRCP, FFPM, Senior Vice President, Research and Development, Astellas Pharma Europe. “It means that doctors will now have a new option to treat both their adult and paediatric – including neonatal – patients with.”
Recognising the increasing need for new products to fight the growing epidemic caused by healthcare associated infections, Astellas is committed to building a strong anti-infectives franchise. This is reflected by its extensive clinical trial programme which has been very positively received by key opinion leaders in the area.
(Source: www.pharmalive.com)
Professor David Denning of The University of Manchester said of the announcement; “The approval of micafungin is very good news for patients with life-threatening fungal infections in Europe. The Company has conducted a number of large, high quality clinical studies in Candida infections with impressive results. Particularly welcome are the indications for fungal infections in children and babies, often a neglected group in the early drug approval process.”
The efficacy and safety of Mycamine® have been demonstrated in a clinical development programme including more than 3,500 patients in 16 clinical trials. The trials included nearly 300 children. Mycamine® was launched in Japan in 2002 and in the US three years ago. In these two major markets more than 350,000 patients have been treated with the product.
“We are delighted that Mycamine® is now licensed for use in Europe.” said Alan Houston, MBBS, MRCP, FFPM, Senior Vice President, Research and Development, Astellas Pharma Europe. “It means that doctors will now have a new option to treat both their adult and paediatric – including neonatal – patients with.”
Recognising the increasing need for new products to fight the growing epidemic caused by healthcare associated infections, Astellas is committed to building a strong anti-infectives franchise. This is reflected by its extensive clinical trial programme which has been very positively received by key opinion leaders in the area.
(Source: www.pharmalive.com)
Spectrum Pharmaceuticals Announces Sale of Injectable Generic Drugs to Sagent Pharmaceuticals, Inc.
May 9, 2008-Spectrum Pharmaceuticals, Inc., (NasdaqGM:SPPI) announced today that it has sold its abbreviated new drug applications (ANDAs) for its injectable generic drugs, ondansetron, carboplatin, fludarabine, and mitoxantrone, to Sagent Pharmaceuticals, Inc.
"The sale of these non-core assets provides additional non-dilutive funding which will be used to further fund the advancement of our late stage clinical programs," said Rajesh C. Shrotriya, MD, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals.
"This transaction allows us to quickly add these important near-term products to our pipeline of more than 200 products," said Jeffrey M. Yordon, CEO, founder and chairman of the board of Sagent Pharmaceuticals. "Our extensive global development network will enable us to accelerate commercialization of these products at a comparatively low cost."
"The sale of these non-core assets provides additional non-dilutive funding which will be used to further fund the advancement of our late stage clinical programs," said Rajesh C. Shrotriya, MD, Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals.
"This transaction allows us to quickly add these important near-term products to our pipeline of more than 200 products," said Jeffrey M. Yordon, CEO, founder and chairman of the board of Sagent Pharmaceuticals. "Our extensive global development network will enable us to accelerate commercialization of these products at a comparatively low cost."
Schweizerhall: Impending Approval of Clopidogrel from Cimex in Germany
The decentralized approval procedure of clopidogrel developed by Cimex AG (original product: Plavix® / Iscover® by Bristol-Myers Squibb / Sanofi-Aventis) has successfully been completed.
“Clopidogrel developed by Cimex is the first alternative of this valuable medication available in Germany. We expect shortly a positive ruling from the German authorization agency for medicines and we plan to launch clopidogrel throughout the European Union in cooperation with marketing partners. A first license agreement with a major generics company was already concluded and the signing of a contract with another generics provider is imminent. We expect first sales already in the current quarter”, said Luzi A. von Bidder, Chairman of Schweizerhall Holding AG.
The details can be read here.
“Clopidogrel developed by Cimex is the first alternative of this valuable medication available in Germany. We expect shortly a positive ruling from the German authorization agency for medicines and we plan to launch clopidogrel throughout the European Union in cooperation with marketing partners. A first license agreement with a major generics company was already concluded and the signing of a contract with another generics provider is imminent. We expect first sales already in the current quarter”, said Luzi A. von Bidder, Chairman of Schweizerhall Holding AG.
The details can be read here.
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