Biopure Corporation announced today an update regarding a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) addressing the Company's pending application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)].
The meeting, held on May 29, was attended by Biopure scientific representatives and the pharmaceutical and clinical assessors from the MHRA. The subject of the meeting was manufacturing and quality. The pharmaceutical assessor accepted Biopure's proposed strategies for answering pending questions and provided clarification. The company is confident that it can resolve all of these issues satisfactorily. No new issues were raised.
The whole story can be read here.
Thursday, June 5, 2008
Celgene Europe Limited Withdraws Its Marketing Authorisation Application For Lenalidomide Celgene Europe (Lenalidomide)
June 5, 2008-The European Medicines Agency (Emea) Has Been Formally Notified By Celgene Europe Limited Of Its Decision To Withdraw The Application For A Centralised Marketing Authorisation For Lenalidomide Celgene Europe (Lenalidomide), 5 Mg And 10 Mg Hard Capsules.
Lenalidomide Celgene Europe was intended to be used for the treatment of anaemia due to myelodysplastic syndromes. It was designated as an orphan medicine for use in this condition.
The whole story can be read here.
Lenalidomide Celgene Europe was intended to be used for the treatment of anaemia due to myelodysplastic syndromes. It was designated as an orphan medicine for use in this condition.
The whole story can be read here.
New Drug Application Filing for Levoleucovorin Tablets Completed by Spectrum Pharmaceuticals, Inc.
Jun 5, 2008 - Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) today announced that it has completed its filing with the U.S. Food and Drug Administration (FDA) with the filing of an amendment to the New Drug Application (NDA) for Levoleucovorin Tablets. Levoleucovorin for Injection is indicated after high-dose methotrexate therapy in patients with osteosarcoma, and to diminish the toxicity and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic acid antagonists. LEVOleucovorin is a novel folate analog formulation and the pharmacologically active isomer of calcium leucovorin. Levoleucovorin for Injection is the only commercially available formulation comprised only of the pharmacologically active enantiomer of leucovorin (Levoleucovorin or (6S)-leucovorin).
The Oncology Drug Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate.
The whole story can be read here.
The Oncology Drug Advisory Committee (ODAC) has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate.
The whole story can be read here.
SpePharm Announces the Granting of National Marketing Authorizations for Loramyc in Europe and First Launch in the UK
June 5, 2008 -SpePharm Holding B.V., the specialty pharmaceutical company dedicated to the sales and marketing of innovative hospital and specialists products throughout Europe, today announced the granting of national approvals of Loramyc® in the UK, Denmark, Germany, Belgium, The Netherlands, Luxembourg, Finland and Sweden, as well as in Spain under the trade name Sitamic®. Loramyc® 50mg, a muco-adhesive buccal tablet of miconazole, is indicated for the treatment of oropharyngeal candidiasis (OPC) in immuno-compromised patients. At the same time, Loramyc® has been launched in the UK and will be promoted in the secondary care setting mostly to cancer and HIV/AIDS patients suffering from OPC.
The details can be read here.
The details can be read here.
EMEA Recommends Changes In The Storage Conditions For Neupro (Rotigotine)
June 5, 2008-The European Medicines Agency (EMEA) has recommended the immediate implementation of changes to the product information for neupro (rotigotine), from Schwarz Pharma Ltd, stating that it must be stored in a refrigerator (at a temperature of between 2ºc and 8ºc). The new storage conditions are intended to reduce the possible occurrence of crystallisation of the active substance which has been reported in patches of Neupro.
Neupro is a centrally-authorised medicine used for the treatment of Parkinson’s disease. Its active substance, rotigotine, is a dopamine agonist. Neupro is the only medicine for Parkinson’s disease that is administered as a transdermal patch.
The whole story can be read here.
Neupro is a centrally-authorised medicine used for the treatment of Parkinson’s disease. Its active substance, rotigotine, is a dopamine agonist. Neupro is the only medicine for Parkinson’s disease that is administered as a transdermal patch.
The whole story can be read here.
FDA Broadens US Indication for Once-yearly Reclast As Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
June 5, 2008 - The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast® (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture1.
No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.
The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast.
The details can be read here.
No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.
The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast.
The details can be read here.
Wednesday, June 4, 2008
Novartis to acquire US biotech firm, Protez Pharmaceuticals
Novartis has signed a definitive agreement to acquire Protez Pharmaceuticals along with the rights in North America and Europe to PZ-601, a novel hospital antibiotic in clinical development. This transaction is subject to customary conditions for a transaction of this type.
The agreement with Protez, a privately-held US biotechnology company, based in Malvern, Pennsylvania, also provides Novartis with the company's research expertise.
The whole story can be read here.
The agreement with Protez, a privately-held US biotechnology company, based in Malvern, Pennsylvania, also provides Novartis with the company's research expertise.
The whole story can be read here.
US FDA to revise prescription drug labelling
The US Food and Drug Administration proposed major revisions to the physician labelling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.
According to an US FDA press release, the proposed changes to prescription drug labelling would give health care professionals more comprehensive information for making prescribing decisions and for counselling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
The whole story can be read here.
According to an US FDA press release, the proposed changes to prescription drug labelling would give health care professionals more comprehensive information for making prescribing decisions and for counselling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.
The whole story can be read here.
Biocon inks pact with Safety Syringes of US for novel PFS
Biocon has inked an exclusive pact with US-based Safety Syringes Inc., to introduce ultra safe passive delivery system technology in the form of pre-filled syringes (PFS) for two life saving products, Erypro Safe with EPO (Erythropoitin) for nephrology and Nufil Safe for GCSF (granulocyte-colony stimulating factor ) for cancer patients. The novel drug delivery device is being introduced for the first time in the country. Biocon has incurred expenditure around Rs 10 crore for the research and the clinical trials.
The whole story can be read here.
The whole story can be read here.
Ipca receives US FDA nod for propranolol tablets
Ipca Laboratories has received approval from US Food and Drugs Administration to manufacture propranolol hydrochloride tablets USP 10 mg, 20 mg, 40 mg, 60 mg and 80 mg for the US market.
Total annual market sales for propranolol hydrochloride tablets in US were US$ 24.1 millions (IMS-MAT: December 2007).
According to a company release, this is the first product approval received by lpca for a product manufactured from its Piparia (Silvassa) formulations manufacturing unit after the said unit's pre approval inspection recently by US FDA.
lpca will manufacture this formulation for the US healthcare system from its Piparia (Silvassa) formulations manufacturing unit using lpca's own DMF approved Active Pharmaceutical ingredient (API) - propranolol hydrochloride.
Ipca is a fully integrated pharmaceutical company engaged in the manufacturing and marketing of a range of pharmaceuticals world over. Ipcas exports to over 110 countries across the globe contributed about 50 per cent of the company's income of Rs. 1085 crore in the financial year 2007-08.
source:www.pharmabiz.com
Total annual market sales for propranolol hydrochloride tablets in US were US$ 24.1 millions (IMS-MAT: December 2007).
According to a company release, this is the first product approval received by lpca for a product manufactured from its Piparia (Silvassa) formulations manufacturing unit after the said unit's pre approval inspection recently by US FDA.
lpca will manufacture this formulation for the US healthcare system from its Piparia (Silvassa) formulations manufacturing unit using lpca's own DMF approved Active Pharmaceutical ingredient (API) - propranolol hydrochloride.
Ipca is a fully integrated pharmaceutical company engaged in the manufacturing and marketing of a range of pharmaceuticals world over. Ipcas exports to over 110 countries across the globe contributed about 50 per cent of the company's income of Rs. 1085 crore in the financial year 2007-08.
source:www.pharmabiz.com
Indevus Pharmaceuticals Provides Update on Nebido NDA Status
Indevus Pharmaceuticals, Inc. today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA filing for Nebido(R), the Company expects the FDA to formally request that the Company provide additional safety data prior to approving Nebido. The Company currently believes that an additional study will be required in order to supply the necessary data. The Company expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the Company expects to receive by the original June 27, 2008 PDUFA date.
About NEBIDO
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
The details can be read here.
About NEBIDO
NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.
The details can be read here.
Akorn, Inc. Receives NDA Approvable Letter for Akten Ophthalmic Gel 3.5%
Jun 4, 2008 - Akorn, Inc. (NASDAQ: AKRX) today announced the receipt of an FDA approvable letter for Akten(R) Ophthalmic Gel 3.5%, an ocular topical anesthetic drug product. Our approvable letter identified several minor CMC deficiencies that must be addressed and rectified before final approval is granted. The majority of these items have been addressed in our previous submissions to the FDA. The remaining response will be submitted to the FDA within the next ten days. No additional clinical data is required.
Additionally, prior to approval, product labeling must be finalized. We have received proposed labeling from the FDA and will submit final printed labeling within the next ten days.
We expect Akten(R) to be a significant revenue contributor in the second half of 2008.
Additionally, prior to approval, product labeling must be finalized. We have received proposed labeling from the FDA and will submit final printed labeling within the next ten days.
We expect Akten(R) to be a significant revenue contributor in the second half of 2008.
AstraZeneca Submits an sNDA for Symbicort for the Treatment of Asthma in Children as Young as Age Six
AstraZeneca today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for Symbicort(R) (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.
"Millions of children in the U.S. are affected by asthma(1)," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. "SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone."
The details can be read here.
"Millions of children in the U.S. are affected by asthma(1)," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. "SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone."
The details can be read here.
Antares Receives a Notice of Allowance for U.S. Patent Covering Anturol
Jun 4, 2008 - Antares Pharma, Inc. (AMEX:AIS) a specialty pharmaceutical company, today reported that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance for U. S. patent application 11/120,306 entitled "Permeation Enhancing Compositions For Anticholinergic Agents" related to Antares' Anturol(TM) product for the treatment of overactive bladder. The Notice of Allowance is the USPTO's official communication that the Company's application has successfully completed examination and that a patent will be issued.
Jack E. Stover, President and Chief Executive Officer, commented, "We are pleased to receive this notice of allowance which provides additional protection for our proprietary technology and products and most specifically for Anturol."
The details can be read here
Jack E. Stover, President and Chief Executive Officer, commented, "We are pleased to receive this notice of allowance which provides additional protection for our proprietary technology and products and most specifically for Anturol."
The details can be read here
Javelin Pharmaceuticals, Inc. Announces New Patent Covering PMI-150 (Intranasal Ketamine)
Jun 4, 2008 - Javelin Pharmaceuticals, Inc. (Amex: JAV), a leading developer of specialty prescription medications for pain management was today granted a commercially important patent in the European Union that extends patent protection for Javelin's PMI-150 (intranasal ketamine) drug candidate into 2023. European Patent No. 1 562 566 B1, entitled: "Analgesic Compositions Comprising NMDA Receptor Antagonists and Benzalkonium Chloride," will cover the major EU market countries (G5) as well as an additional 20 Member States of the European Patent Convention. This new patent is the European counterpart to Javelin's U.S. Patent No. 7,273,889 that issued in September, 2007.
"The extension of Javelin's intranasal ketamine patent portfolio in Europe is an important milestone for our company," said Martin Driscoll, Javelin's Chief Executive Officer. "The issuance of this European patent extends the term of commercial exclusivity for Javelin's intranasal ketamine by almost a decade. This extension in the market exclusivity for intranasal ketamine should significantly enhance the potential value of the PMI-150 franchise and further bolster our global partnership discussions."
The details can be read here.
"The extension of Javelin's intranasal ketamine patent portfolio in Europe is an important milestone for our company," said Martin Driscoll, Javelin's Chief Executive Officer. "The issuance of this European patent extends the term of commercial exclusivity for Javelin's intranasal ketamine by almost a decade. This extension in the market exclusivity for intranasal ketamine should significantly enhance the potential value of the PMI-150 franchise and further bolster our global partnership discussions."
The details can be read here.
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