Impax Pharmaceuticals (the branded product division of Impax Lab) announced that the new drug application filed for IPX006 for the treatment of Idiopathic Parkinson's disease has been accepted by the FDA. The NDA was submitted in December 2011. The PDUFA date has been set to
A pharmaceutical news and commentary post
Saturday, February 25, 2012
Glenmark recalled seven lots of birth control pills
Glenmark announced that it is recalling seven lots of birth control pills containing norgestimate and ethinyl estradiol in the following dosages: 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg due to possible out of sequence tablets.
In the press release, the company said packet with
In the press release, the company said packet with
Friday, February 24, 2012
Xencor entered into a collaboration agreement with Boehringer Ingelheim
Boehringer Ingelheim entered into a collaboration agreement with Xencor to develop, manufacture and supply biosuperior monoclonal antibodies. Xencor has developed its proprietary antibody engineering technology called Xtend which can increase the half-life of antibodies.
Under the terms of the collaboration agreement, Boehringer Ingelheim will be responsible for all the manufacturing and product supply from preclinical through phase 1 development. Xencor will be in charge of conducting preclinical and clinical studies as well as retaining all development and commercial rights to products developed under the agreement. Once the phase 1 studies have been completed, Boehringer Ingelheim will have certain manufacturing rights to supply clinical and commercial material to Xencor.
Xencor intends to conduct phase 1 trial using its lead anti-TNF antibody engineered using the company's Xtend technology in 2013.
Xencor is a private company located in Monvoriva, CA. The company has dedicated its sources to develop protein therapeutics. The company has developed two superior protein drug candidates: XmAB antibody therapeutics and XPro protein therapeutics. The company currently has a couple of drug candidates in the clinical: XmAb5871 targeting CD32b and CD19 for the treatment of autoimmune diseases and XmAb2513 targeting CD30 for the treatment of Hodgkin's lymphoma.
Under the terms of the collaboration agreement, Boehringer Ingelheim will be responsible for all the manufacturing and product supply from preclinical through phase 1 development. Xencor will be in charge of conducting preclinical and clinical studies as well as retaining all development and commercial rights to products developed under the agreement. Once the phase 1 studies have been completed, Boehringer Ingelheim will have certain manufacturing rights to supply clinical and commercial material to Xencor.
Xencor intends to conduct phase 1 trial using its lead anti-TNF antibody engineered using the company's Xtend technology in 2013.
Xencor is a private company located in Monvoriva, CA. The company has dedicated its sources to develop protein therapeutics. The company has developed two superior protein drug candidates: XmAB antibody therapeutics and XPro protein therapeutics. The company currently has a couple of drug candidates in the clinical: XmAb5871 targeting CD32b and CD19 for the treatment of autoimmune diseases and XmAb2513 targeting CD30 for the treatment of Hodgkin's lymphoma.
Mylan received tentative approval to market pediatric version of Epzicom
Mylan announced that the company has received tentative approval to market the pediatric version of Epzicom (combination of abacavir and lamivudine tablet) under the President's Emergency Plan for AIDS Relief (PEPFAR). The company has already tentative approval for the adult-strength of generic Epzicom on March 30, 2009. It has also received approval from the World Health Organization under their Prequalification of Medicines program to market the therapy in certain developing countries outside the US.
EPZICOM is currently marketed by Viiv Healthcare that has been approved for the treatment of HHIV in adult patients.Epzicom is currently as abacavir 600 mg and lamivudine 300 mg.
Mylan has conducted clinical and pharmacokinetic studies evaluating the combination of abacavir 60 mg and lamivudine 30 mg in pediatric patients whose age range from 3 months to 13 years of age.
EPZICOM is currently marketed by Viiv Healthcare that has been approved for the treatment of HHIV in adult patients.Epzicom is currently as abacavir 600 mg and lamivudine 300 mg.
Mylan has conducted clinical and pharmacokinetic studies evaluating the combination of abacavir 60 mg and lamivudine 30 mg in pediatric patients whose age range from 3 months to 13 years of age.
Thursday, February 23, 2012
Auxilium entered into a collaboration agreement with Actelion
Auxilium Pharmaceuticals entered into a collaboration agreement with Actelion for the development, pply, and commercialization of Xiaflex (collagenase clostridium histolyticum) in Canada, Australia, Brazil and Mexico.
Under the terms of the agreement, Actelion will have exclusive rights for two potential indications: the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. Actelion will be responsible for the regulatory and commercialization activities of Xiaflex in these countries. Actelion plans to file application for approval of Xiaflex for the treatment
Under the terms of the agreement, Actelion will have exclusive rights for two potential indications: the treatment of Dupuytren's contracture and Peyronie's disease in Canada, Australia, Brazil and Mexico. Actelion will be responsible for the regulatory and commercialization activities of Xiaflex in these countries. Actelion plans to file application for approval of Xiaflex for the treatment
Qnexa was recommended for approval
What happens to be the biggest story of the day and also..one of the biggest stock jump recently belongs to the weight-loss drug Qnexa.
After numerous set back, the FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Qnexa for approval in the US for the treatment of obesity in adults.
Based on the news release, the committee considers the benefit profile of Qnexa outweight the risk which include an increase in risk of stroke and heart disease.
Qnexa is a combination product of phentermine and topiramate that are formulated in a proprietary, oral, controlled-release formulation. The agents work to decrease appetite and increase satiety.
The PDUFA date has been set to be on April 17, 2012. So set your clock! However, despite the recommendation, the FDA is still an authority who will decide whether Qnexa should be available in the market.
Vivus open with an 88% jump in its stock price going from around $10 a share to over 1$ and reaches its 52-week high at over 21 per share. The company's stock is currently being traded on the NASDAQ as VVUS
After numerous set back, the FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Qnexa for approval in the US for the treatment of obesity in adults.
Based on the news release, the committee considers the benefit profile of Qnexa outweight the risk which include an increase in risk of stroke and heart disease.
Qnexa is a combination product of phentermine and topiramate that are formulated in a proprietary, oral, controlled-release formulation. The agents work to decrease appetite and increase satiety.
The PDUFA date has been set to be on April 17, 2012. So set your clock! However, despite the recommendation, the FDA is still an authority who will decide whether Qnexa should be available in the market.
Vivus open with an 88% jump in its stock price going from around $10 a share to over 1$ and reaches its 52-week high at over 21 per share. The company's stock is currently being traded on the NASDAQ as VVUS
Levadex earned additional patent protection
MAP Pharmaceuticals announced that the company has obtained additional US Patent for Methods of achieving rapid treatment of migraine based on the pharmacokinetic profile of dihydroergotamine. The company utilizes its proprietary TEMPO inhaler to administer dihydroergotamine to achieve the pharmacokinetic profiles that can lead to rapid efficacy while minimizing side effects that are often seen in migraine therapy.
The newly issued patent will last until 2028.
Levadex or dihydroergotamine inhaler is currently not approved in the US or other countries. The company however has submitted a new drug application to the US FDA. MAP entered into a collaboration agreement with Allergen to co-promote the product to neurologists and pain specialists in the US and Canada.
The newly issued patent will last until 2028.
Levadex or dihydroergotamine inhaler is currently not approved in the US or other countries. The company however has submitted a new drug application to the US FDA. MAP entered into a collaboration agreement with Allergen to co-promote the product to neurologists and pain specialists in the US and Canada.
Wednesday, February 22, 2012
Repligen's Secreflo has been granted priority review with set PDUFA date
Repligen announced that the FDA has granted priority review to the company's NDA submitted for SecreFlo for the improved detection of pancreatic duct abnormalities in patients with pancreatitis. The PDUFA goal date has been set to be on June 21, 2012.
ScecreFlo is a synthetic version of the natural hormone secretin which is produced in the small intestine and plays an important role in digestion. Scecretin can stimulates the pancreas to release digestive juices into the pancreatic ducts that can be filled and emptied into the
ScecreFlo is a synthetic version of the natural hormone secretin which is produced in the small intestine and plays an important role in digestion. Scecretin can stimulates the pancreas to release digestive juices into the pancreatic ducts that can be filled and emptied into the
AstraZeneca's Caprelsa is now approved in Europe
AstraZeneca announced that the company's Caprelsa (vandetanib) has been approved in Europe for the treatment of aggressive and symptomatic medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
The approval came after the Committee for Medicinal Products for Human Use recommended the approval of Caprelsa on November 17, 2011.
The approval came after the European Commission reviewed the data from the phase III program that included the ZETA study which is a double-blind trial evaluating the agent
The approval came after the Committee for Medicinal Products for Human Use recommended the approval of Caprelsa on November 17, 2011.
The approval came after the European Commission reviewed the data from the phase III program that included the ZETA study which is a double-blind trial evaluating the agent
Arno Therapeutics entered into an agreement with Invivis
Arno Therapeutics announced earlier that the company has entered into an exclusive worldwide licensing agreement to develop an investigational oncology product, onapristone, with Invivis Pharmaceuticals, a privately held company.
Onapristone is an anti-progestin hormone blocker that has been shown to have anti-tumor activity against breast cancer.
Arno Therapeutics also intends to develop a company diagnostic test to detect biomarkers that can be used to identify patients who can be benefit from onapristone treatment.
Under the terms of the agreement, Arno will make milestone payment to Invivis based on certain research, clinical and regulatory development. In addition, Invivis will receive royalties based on net sales of licensed products. In a separate agreement, Invivis will provide Arno certain clinical development support services.
Onapristone is an anti-progestin hormone blocker that has been shown to have anti-tumor activity against breast cancer.
Arno Therapeutics also intends to develop a company diagnostic test to detect biomarkers that can be used to identify patients who can be benefit from onapristone treatment.
Under the terms of the agreement, Arno will make milestone payment to Invivis based on certain research, clinical and regulatory development. In addition, Invivis will receive royalties based on net sales of licensed products. In a separate agreement, Invivis will provide Arno certain clinical development support services.
Tuesday, February 21, 2012
Acella adds another ANDA to its portfolio
Acella Pharmaceuticals announced that it has filed an abbreviated new drug application with the US FDA for a product that can be used in the upper respiratory therapeutic area. This will be the fifth ANDA that Acella filed and all of which are currently waiting for approval from the FDA.
Acella Pharmaceutical was founded in 2007. The company develops, markets and sells and distribute specialty pharmaceutical and other products in the following therapeutic areas: dermatology, women's health, pediatrics and others.
Acella Pharmaceutical was founded in 2007. The company develops, markets and sells and distribute specialty pharmaceutical and other products in the following therapeutic areas: dermatology, women's health, pediatrics and others.
Bayer released positive results from the GALILEO and COPERNICUS trials
Bayer released positive one year results from the phase III trials evaluating aflibercept injection (VEGF Trap-Eye) for the treatment of macular edema due to central retinal vein occlusion.
Due to the encouraging results of the trial, Regeneron has already submitted a supplemental Biologics License Application in the US which has been granted an action date of September 23, 2012. Bayer intends to file a marketing authorization application Europe in the
Due to the encouraging results of the trial, Regeneron has already submitted a supplemental Biologics License Application in the US which has been granted an action date of September 23, 2012. Bayer intends to file a marketing authorization application Europe in the
Takeda announced top-line results of the phase 3 GEMINI trial
Takeda announced the top-line results of the phase 3 trial evaluating vedolizumab in patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, the GEMINI I trial with positive results.
The GEMINI I is a randomized, placebo-controlled, double-blind phase IIItrial evaluating vedolizumab against placebo in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy. The trial was conducted in more than 34 countries at more than 210 sites.
The study comprised of two phases: the induction phase and
The GEMINI I is a randomized, placebo-controlled, double-blind phase IIItrial evaluating vedolizumab against placebo in 895 patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy. The trial was conducted in more than 34 countries at more than 210 sites.
The study comprised of two phases: the induction phase and
Monday, February 20, 2012
Corcept's Korlym (mifepristone) got approved in the US for Cushing's syndrome
Corcept announced that the FDA has approved the company's Korlym (mifepristone) 300 mg tablet once-daily oral medication to contorl hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery.
The approval came after the FDA reviewed the results of an uncontrolled, open-label, multicenter, 24-week phase III study evaluating Korlym in 50 patients who had endogenous Cushing's syndrome and were either not eligible for or had relapse from surgery and were either glucose intolerant or had hypertension. The results showed that
The approval came after the FDA reviewed the results of an uncontrolled, open-label, multicenter, 24-week phase III study evaluating Korlym in 50 patients who had endogenous Cushing's syndrome and were either not eligible for or had relapse from surgery and were either glucose intolerant or had hypertension. The results showed that
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