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Mylan gets US FDA nod for generic version of Mirapex tablets
Mylan Inc's subsidiary Mylan Pharmaceuticals Inc has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Pramipexole Dihydrochloride Tablets, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 1.5 mg, the generic version of Boehringer Ingelheim's Mirapex tablets, a Parkinson's disease treatment.
Pramipexole Dihydrochloride tablets had US sales of approximately US$ 536 million for the 12 months ending June 30, 2010, according to IMS Health. Mylan Pharmaceuticals received final FDA approval for the 0.75 mg strength of Pramipexole Dihydrochloride Tablets on April 9, 2010. All strengths of the product are available for immediate shipment.
Currently, Mylan has 153 ANDAs pending US FDA approval representing $95 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing US$ 24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.
Pramipexole Dihydrochloride tablets had US sales of approximately US$ 536 million for the 12 months ending June 30, 2010, according to IMS Health. Mylan Pharmaceuticals received final FDA approval for the 0.75 mg strength of Pramipexole Dihydrochloride Tablets on April 9, 2010. All strengths of the product are available for immediate shipment.
Currently, Mylan has 153 ANDAs pending US FDA approval representing $95 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing US$ 24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.
Daily Aspirin May Cut Bowel Cancer Risk
According to a study by Oxford University published in the Lancet, taking an aspirin daily may cut certain bowel cancer cases by a quarter and deaths by more than a third in a review of 14,000 patients.Aspirins are already widely used to help protect people against strokes and heart problems, although many healthy middle-aged people do not take them because of the risk of side-effects.They followed up four study groups over a period of 20 years to identify the impact of regular small doses of of the drug - the tablets given for medical reasons are often a quarter of a strength of those used to treat headaches.
"To date, for healthy middle-aged people it has been a fine balance as to whether to take aspirins, but this tips it in my view."There is a small benefit for vascular disease and now we know a big benefit for this cancer. In the future, I am sure it will be shown that aspirin helps prevent other cancers too."
"To date, for healthy middle-aged people it has been a fine balance as to whether to take aspirins, but this tips it in my view."There is a small benefit for vascular disease and now we know a big benefit for this cancer. In the future, I am sure it will be shown that aspirin helps prevent other cancers too."
Adolor Corporation begins phase-2 OIC study of ADL5945
Adolor Corporation has initiation of a phase-2 proof-of-concept (PoC) study of ADL5945 in patients suffering from opioid-induced constipation (OIC)."We are pleased to announce the initiation of our phase-2 proof-of-concept study," said Michael R Dougherty, president and chief executive officer. "We begin this study having just completed a single-ascending dose (SAD) study of ADL5945 in healthy volunteers and a multiple-ascending dose (MAD) study in OIC patients with chronic non-cancer pain. The results were highly encouraging on all fronts: PK profile, tolerability and efficacy. Adolor has a wealth of expertise in this indication, and we look forward to the completion of this trial next summer."
The phase-2 PoC trial will evaluate two doses of ADL5945 (0.10mg and 0.25mg given twice daily) versus placebo in patients with OIC over a four week period. Approximately 120 patients will be enrolled. The primary endpoint of the study will be change from baseline in the weekly average of spontaneous bowel movements (SBMs) during treatment.The recently completed SAD and MAD studies of ADL5945 and ADL7445 enrolled both healthy volunteers and non-cancer pain patients on long-term opioid therapy with OIC. Both compounds were well-tolerated and, in the patients with OIC, produced increases in weekly average SBMs compared to placebo. Notably, the 0.10mg and 0.25mg doses of ADL5945 being tested in the PoC study were successfully evaluated in extended cohorts in the MAD study against placebo. The most commonly reported side effects were dose-dependent gastrointestinal-related effects such as abdominal cramping and nausea. There were no serious adverse events reported.
"The data from this recent trial validate both ADL5945 and ADL7445 for the treatment of OIC in patients with chronic non-cancer pain," said Richard M Mangano, vice president of Clinical Research & Development at Adolor. "The safety and efficacy of these doses of ADL5945 are encouraging and clearly warrant continued clinical development."ADL5945 is a proprietary, peripherally-acting mu opioid receptor antagonist being developed by Adolor for the treatment of OIC.
The phase-2 PoC trial will evaluate two doses of ADL5945 (0.10mg and 0.25mg given twice daily) versus placebo in patients with OIC over a four week period. Approximately 120 patients will be enrolled. The primary endpoint of the study will be change from baseline in the weekly average of spontaneous bowel movements (SBMs) during treatment.The recently completed SAD and MAD studies of ADL5945 and ADL7445 enrolled both healthy volunteers and non-cancer pain patients on long-term opioid therapy with OIC. Both compounds were well-tolerated and, in the patients with OIC, produced increases in weekly average SBMs compared to placebo. Notably, the 0.10mg and 0.25mg doses of ADL5945 being tested in the PoC study were successfully evaluated in extended cohorts in the MAD study against placebo. The most commonly reported side effects were dose-dependent gastrointestinal-related effects such as abdominal cramping and nausea. There were no serious adverse events reported.
"The data from this recent trial validate both ADL5945 and ADL7445 for the treatment of OIC in patients with chronic non-cancer pain," said Richard M Mangano, vice president of Clinical Research & Development at Adolor. "The safety and efficacy of these doses of ADL5945 are encouraging and clearly warrant continued clinical development."ADL5945 is a proprietary, peripherally-acting mu opioid receptor antagonist being developed by Adolor for the treatment of OIC.
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription gastrointestinal and pain management products.
IP can be claimed for standard strengths of dosage forms, not for altered strengths: IPC
In an effort to strictly adhere to the drug regulations and to improve the quality of medicines by having a control on the dose metrics, the Indian Pharmacopoeia Commission (IPC) has clarified to the industry that only the drugs of strengths prescribed in the previous edition of Indian Pharmacopoeia (IP) or recommended by the drug regulatory bodies could claim IP - 2010 standard for dosages.
The additions made in the latest volume of IP are based on usual strength as available in the previous edition of IP or other current pharmacopoeias, usual strength available from the inputs given by the regulatory bodies including the recent updates in dose metrics from the Drug Controller General of India (DCGI) and with the inputs given by industries, clarifies the commission.
The move is expected to indirectly control the dose metrics to improve quality of medicines marketed in India, according to a senior official from IPC. The clarification of IPC that it intends usual strength of medicines when IP standards are concerned, is expected to gradually make the companies stick on to the usual strengths rather than introducing new strengths of medicines which requires clinical investigation to prove the safety and efficacy prior to marketing.
The additions made in the latest volume of IP are based on usual strength as available in the previous edition of IP or other current pharmacopoeias, usual strength available from the inputs given by the regulatory bodies including the recent updates in dose metrics from the Drug Controller General of India (DCGI) and with the inputs given by industries, clarifies the commission.
The move is expected to indirectly control the dose metrics to improve quality of medicines marketed in India, according to a senior official from IPC. The clarification of IPC that it intends usual strength of medicines when IP standards are concerned, is expected to gradually make the companies stick on to the usual strengths rather than introducing new strengths of medicines which requires clinical investigation to prove the safety and efficacy prior to marketing.
Nobel Prize Awarded to Developer of In Vitro Fertilization
It is hard to deny a scientist a Nobel Prize when there are 4 million good reasons.
In the case of Robert Edwards, PhD, who was awarded the 2010 Nobel Prize in medicine or physiology today, the reasons are roughly 4 million people born over the past 32 years due to the therapy he is being honored for — in vitro fertilization (IVF).
The British-born Dr. Edwards worked with the late gynecologist Patrick Steptoe, a British pioneer in laparoscopy, to take IVF from experiment to practical medicine, the Nobel Foundation states in its announcement. On July 25, 1978, the researchers' medical technology bore human fruit when Louise Joy Brown, the daughter of Lesley and John Brown, was the first "test-tube baby" to enter the world.
Dr. Steptoe died in 1988. The Nobel Foundation does not allow individuals to be nominated for a prize posthumously. Dr. Penzias, surgical director at a group practice called Boston IVF, said that if Dr. Steptoe were alive today, he would have shared today's Nobel Prize with Dr. Edwards.
Dr. Edwards is now professor emeritus at the University of Cambridge.
Success Rate of IVF Has Greatly Improved.IVF has made tremendous strides since its inception, according to Dr. Penzias.
In the early 1990s, IVF had a success rate of 10% to 12% per monthly attempt, said Dr. Penzias. Today, the success rate approaches 50%.
When put into the context of repeated monthly attempts, IVF looks even better. "A fertile woman under age 35 having unprotected sex has an 85% chance of getting pregnant within 1 year," said Dr. Penzias. "A woman under age 35 who undergoes 6 IVF attempts has the same odds.
"Once we knew the basic formula for IVF, it set off a worldwide effort to improve the technology."
Likewise, fertility specialists have extended the scope of IVF. "The first class of women treated with IVF had missing or damaged fallopian tubes," said Dr. Penzias. "Now IVF is used for all sorts of infertility problems."
In the case of Robert Edwards, PhD, who was awarded the 2010 Nobel Prize in medicine or physiology today, the reasons are roughly 4 million people born over the past 32 years due to the therapy he is being honored for — in vitro fertilization (IVF).
The British-born Dr. Edwards worked with the late gynecologist Patrick Steptoe, a British pioneer in laparoscopy, to take IVF from experiment to practical medicine, the Nobel Foundation states in its announcement. On July 25, 1978, the researchers' medical technology bore human fruit when Louise Joy Brown, the daughter of Lesley and John Brown, was the first "test-tube baby" to enter the world.
Dr. Steptoe died in 1988. The Nobel Foundation does not allow individuals to be nominated for a prize posthumously. Dr. Penzias, surgical director at a group practice called Boston IVF, said that if Dr. Steptoe were alive today, he would have shared today's Nobel Prize with Dr. Edwards.
Dr. Edwards is now professor emeritus at the University of Cambridge.
Success Rate of IVF Has Greatly Improved.IVF has made tremendous strides since its inception, according to Dr. Penzias.
In the early 1990s, IVF had a success rate of 10% to 12% per monthly attempt, said Dr. Penzias. Today, the success rate approaches 50%.
When put into the context of repeated monthly attempts, IVF looks even better. "A fertile woman under age 35 having unprotected sex has an 85% chance of getting pregnant within 1 year," said Dr. Penzias. "A woman under age 35 who undergoes 6 IVF attempts has the same odds.
"Once we knew the basic formula for IVF, it set off a worldwide effort to improve the technology."
Likewise, fertility specialists have extended the scope of IVF. "The first class of women treated with IVF had missing or damaged fallopian tubes," said Dr. Penzias. "Now IVF is used for all sorts of infertility problems."
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