The pharmaceutical business is yet another dynamic venture, present globally and extremely important to research scientists, investors and the entire community at large. As in any other business, the success of any pharma company lies on 2 factors- investment potential and risk taking ability. In addition, the R&D portfolio becomes a huge numerator to ensure successful profit quotient.
So why read Pharma R&D, business news? Because it offers following benefits-
1. Enables investors to take “wise decisions”.
2. Assists Job seekers to realize “where to invest their career”.
3. Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”.
Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news-
So why read Pharma R&D, business news? Because it offers following benefits-
1. Enables investors to take “wise decisions”.
2. Assists Job seekers to realize “where to invest their career”.
3. Helps community to abreast themselves of new medicine introductions, availability of low cost generics and overall to think wise about “how they can control their health care costs”.
Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma business news-
Pfizer's Viagra patent partially rejected.
"Pfizer Inc.'s patent on its impotence drug Viagra [sildenafil citrate] was partially rejected after the US Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed." An agency appeals board "upheld the decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn't cover a new invention." The claim "was key to an infringement suit Pfizer filed in 2002 against Eli Lilly & Co. over its rival Cialis [tadalafil] drug." Now, "Pfizer has until April 12 to seek a rehearing from the PTO's Board of Patent Appeals and Interferences, or appeal to the US Court of Appeals for the Federal Circuit in Washington, which specializes in patent law, according to a letter Lilly lawyer Richard K. Herrmann." Bloomberg News .
Potential kidney transplant drug wins orphan drug designation from FDA.
"Quark Pharmaceuticals Inc.'s potential treatment for kidney transplant patients won orphan drug designation from the Food and Drug Administration." The company "said QPI-1002 is a synthetic small interfering RNA, or siRNA, that blocks expression of a gene called p53 and, as a result, could protect normal cells from injury." QPI-1002 also "is in a Phase I/II study," and "is the first systemic siRNA drug to enter human clinical trials." The San Francisco Business Times.
Lilly, Arkansas settle Zyprexa marketing suit for $18.5 million.
Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly & Co. over off-label marketing of the anti-psychotic drug Zyprexa [olanzapine]." McDaniel had accused Lilly of engaging in "illegal and fraudulent off-label marketing of Zyprexa," alleging that "the company promoted the drug for unapproved use in children." The American Press.
Spending on cancer drugs in UK is 40 percent less than in other European countries.
NHS cancer patients have 40 percent less spent on their medicines than those in other European countries,according to a "report from the centre-right think tank Policy Exchange." The analysis "says cancer currently costs the economy more than £18billion a year, and the figure is expected to rise to almost £25billion over the next decade." The report notes that "spending on cancer medicines is only about 60 percent of that in the EU and other advanced European countries." The UK's Daily Mail.
Roche ordered to pay $25 million in Accutane damages.
Roche Holding AG "must pay $25.16 million in damages to a former user of its Accutane [isotretinoin] drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled." Most of the jurors "agreed that Roche failed to provide an adequate warning, and that the company's failure was a 'proximate cause' of...inflammatory bowel disease" in the plaintiff. The drug maker now "faces almost 1,000 other lawsuits over Accutane." Sales of the drug were halted "in June 2009" over "generic competition and the high cost of defending personal injury lawsuits." Bloomberg News.
India's generic drug industry may attract more interest from larger companies.
India's generic-drug industry has more FDA-approved facilities than any other country outside the US, which is boosting speculation that larger foreign pharmaceutical companies will join the industry. However, the Journal notes that the future of India's generic drug makers is more likely to see intense competition and dwindling margins than high-priced buyouts. The Journal also adds that foreign drug companies have plenty of reason to wait on expensive acquisitions in India for now. The Wall Street Journal.
AstraZeneca purchases RA treatment from Rigel for up to $1.2 billion.
AstraZeneca has signed a deal worth up to $1.2 billion with Rigel for its rheumatoid arthritis drug, called R788, which is "the furthest developed in a new class of oral drugs being tested for treating RA and is designed for patients who do not respond to the older drug, methotrexate." Under the deal, "AstraZeneca will make an up-front payment of $100m to Rigel for its R788 drug, with up to $345m more payable after achieving regulatory and first-sale milestones, plus a potential $800m on further sales-related payments." AstraZeneca will also design a phase III trial to begin later this year. The Daily Telegraph (UK).
Merck may seek approval to sell Gardasil for new uses.
Merck's "Gardasil is about 89 percent effective in blocking cervical cancer, genital warts and lingering HPV infections in women aged 24 to 45." Another new study "shows it is about 77 percent effective in blocking anal cancer and precancerous lesions in homosexual men." The drug maker plans to "seek approval to sell the vaccine for those uses." The American Press.
New Medicare rules may help Affymax grab market share from Amgen.
New Medicare rules "will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or 'bundle,' said Yaron Werber, a Citibank analyst." The move "may push dialysis clinics to use smaller amounts of cheaper drugs, Werber said." The rules could help "Affymax Inc., a 10-year-old company with no marketed products," grab "market share from Amgen Inc.'s $2.6 billion anemia drug Epogen [epoetin alfa] with a treatment in line to be approved next year." The company has yet to announce "a price for its treatment, called Hematide," but the drug is "given only once a month while Epogen is usually administered three times a week." Bloomberg News.
Affymax readies blockbuster alternative to Epogen.
Affymax hopes to get an FDA approval for its experimental anemia treatment Hematide next year, and that could leave the developer perfectly positioned to take advantage of new Medicare rules capping the cost of kidney dialysis at $250. And if Affymax can scoot into the market under the hefty price for Amgen's Epogen, analysts say the new drug could easily squeeze out what has long been the standard of care.
"Pfizer Inc.'s patent on its impotence drug Viagra [sildenafil citrate] was partially rejected after the US Patent and Trademark Office said it wasn't different enough from a Chinese herb known as Horny Goat Weed." An agency appeals board "upheld the decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn't cover a new invention." The claim "was key to an infringement suit Pfizer filed in 2002 against Eli Lilly & Co. over its rival Cialis [tadalafil] drug." Now, "Pfizer has until April 12 to seek a rehearing from the PTO's Board of Patent Appeals and Interferences, or appeal to the US Court of Appeals for the Federal Circuit in Washington, which specializes in patent law, according to a letter Lilly lawyer Richard K. Herrmann." Bloomberg News .
Potential kidney transplant drug wins orphan drug designation from FDA.
"Quark Pharmaceuticals Inc.'s potential treatment for kidney transplant patients won orphan drug designation from the Food and Drug Administration." The company "said QPI-1002 is a synthetic small interfering RNA, or siRNA, that blocks expression of a gene called p53 and, as a result, could protect normal cells from injury." QPI-1002 also "is in a Phase I/II study," and "is the first systemic siRNA drug to enter human clinical trials." The San Francisco Business Times.
Lilly, Arkansas settle Zyprexa marketing suit for $18.5 million.
Arkansas Attorney General Dustin McDaniel on Tuesday announced an $18.5 million settlement of a lawsuit with Eli Lilly & Co. over off-label marketing of the anti-psychotic drug Zyprexa [olanzapine]." McDaniel had accused Lilly of engaging in "illegal and fraudulent off-label marketing of Zyprexa," alleging that "the company promoted the drug for unapproved use in children." The American Press.
Spending on cancer drugs in UK is 40 percent less than in other European countries.
NHS cancer patients have 40 percent less spent on their medicines than those in other European countries,according to a "report from the centre-right think tank Policy Exchange." The analysis "says cancer currently costs the economy more than £18billion a year, and the figure is expected to rise to almost £25billion over the next decade." The report notes that "spending on cancer medicines is only about 60 percent of that in the EU and other advanced European countries." The UK's Daily Mail.
Roche ordered to pay $25 million in Accutane damages.
Roche Holding AG "must pay $25.16 million in damages to a former user of its Accutane [isotretinoin] drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled." Most of the jurors "agreed that Roche failed to provide an adequate warning, and that the company's failure was a 'proximate cause' of...inflammatory bowel disease" in the plaintiff. The drug maker now "faces almost 1,000 other lawsuits over Accutane." Sales of the drug were halted "in June 2009" over "generic competition and the high cost of defending personal injury lawsuits." Bloomberg News.
India's generic drug industry may attract more interest from larger companies.
India's generic-drug industry has more FDA-approved facilities than any other country outside the US, which is boosting speculation that larger foreign pharmaceutical companies will join the industry. However, the Journal notes that the future of India's generic drug makers is more likely to see intense competition and dwindling margins than high-priced buyouts. The Journal also adds that foreign drug companies have plenty of reason to wait on expensive acquisitions in India for now. The Wall Street Journal.
AstraZeneca purchases RA treatment from Rigel for up to $1.2 billion.
AstraZeneca has signed a deal worth up to $1.2 billion with Rigel for its rheumatoid arthritis drug, called R788, which is "the furthest developed in a new class of oral drugs being tested for treating RA and is designed for patients who do not respond to the older drug, methotrexate." Under the deal, "AstraZeneca will make an up-front payment of $100m to Rigel for its R788 drug, with up to $345m more payable after achieving regulatory and first-sale milestones, plus a potential $800m on further sales-related payments." AstraZeneca will also design a phase III trial to begin later this year. The Daily Telegraph (UK).
Merck may seek approval to sell Gardasil for new uses.
Merck's "Gardasil is about 89 percent effective in blocking cervical cancer, genital warts and lingering HPV infections in women aged 24 to 45." Another new study "shows it is about 77 percent effective in blocking anal cancer and precancerous lesions in homosexual men." The drug maker plans to "seek approval to sell the vaccine for those uses." The American Press.
New Medicare rules may help Affymax grab market share from Amgen.
New Medicare rules "will cap fees for kidney dialysis, including the cost of anemia drugs, at about $250 per treatment starting on Jan. 1, 2011, and combine all services under one bill or 'bundle,' said Yaron Werber, a Citibank analyst." The move "may push dialysis clinics to use smaller amounts of cheaper drugs, Werber said." The rules could help "Affymax Inc., a 10-year-old company with no marketed products," grab "market share from Amgen Inc.'s $2.6 billion anemia drug Epogen [epoetin alfa] with a treatment in line to be approved next year." The company has yet to announce "a price for its treatment, called Hematide," but the drug is "given only once a month while Epogen is usually administered three times a week." Bloomberg News.
Affymax readies blockbuster alternative to Epogen.
Affymax hopes to get an FDA approval for its experimental anemia treatment Hematide next year, and that could leave the developer perfectly positioned to take advantage of new Medicare rules capping the cost of kidney dialysis at $250. And if Affymax can scoot into the market under the hefty price for Amgen's Epogen, analysts say the new drug could easily squeeze out what has long been the standard of care.
"When we go under the bundle, everything's going to be about money," specialist Julia Inrig at UT Southwestern Medical Center tells Bloomberg. If Hematide is cheaper to buy and use than Epogen, "its use could significantly increase, and it could potentially drive Epogen out of the market."
Cowen & Co. analyst Phil Nadeau says an approval next year would leave Affymax poised to reap $1.1 billion in blockbuster sales by 2015. Amgen, which currently has the only anemia drugs used in kidney dialysis, charges $8,445 per year for Epogen. And as a synthetic peptide Hematide should be cheaper to make than Epogen.Bloomberg news. http://www.bloomberg.com/apps/news?pid=20601202&sid=a1meTJTyj3g8
Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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