Shares of Takeda Pharmaceutical, Japan’s largest drugmaker, fell on Monday after it said it expects a delay until March 2012 or later in U.S. approval of its key diabetes drug SYR-322 [ID:nSP468416].
Takeda said on Saturday it expects a delay in approval of the drug, which the stock market expected, after U.S. regulators repeated on Friday their request made originally in March for an additional study and more safety data from Takeda on the drug.Takeda reiterated it was still discussing with U.S. regulators details of an additional study on cardiovascular risks.
Analysts said the delay in approval of the successor to Takeda’s top-selling drug Actos by around two and a half years from the previously targeted deadline of Friday was generally expected after the regulators’ request in March.
Takeda shares fell 1.6 percent to 3,730 yen, underperforming sector rivals such as Astellas Pharma (4503.T), which dipped 0.6 percent, and Daiichi Sankyo (4568.T), which fell 0.5 percent.
reuters.com
Pharmaceutical Process Equipment
Tuesday, 30 June 2009
Tuesday, 23 June 2009
Manufacturers avoid worst.
The pharmaceutical industry has headed off the threat of more onerous imposed cost savings by stepping up to the plate on healthcare reform in the all-important U.S. market.
A weekend deal, announced by President Barack Obama, offering some $80 billion in prescription discounts over 10 years to help elderly Americans afford drugs will crimp profits, but the figure is a less than initially feared.
"Negotiations began with government asking for $130 billion, so $80 billion would represent a relatively benign outcome," said Savvas Neophytou, an analyst at Panmure Gordon. What's more, the plan agreed with Senate Finance Committee Chairman Max Baucus, with the backing of the Obama administration, means concessions will be funnelled in an area that could generate additional sales volume.
Drugmakers have agreed to provide a 50 percent discount for those elderly and disabled Americans in the Medicare health insurance program who face a gap in coverage after their drug costs reach a certain level, known as the "doughnut hole".
"Roughly 20-25 percent of Medicare D patients reach the doughnut hole, and the majority of them either stop or switch their medications," Deutsche Bank analyst Barbara Ryan said in a research note.
"Therefore, pharma may be providing discounts for branded drugs which will primarily represent incremental demand."
guardian.co.uk
A weekend deal, announced by President Barack Obama, offering some $80 billion in prescription discounts over 10 years to help elderly Americans afford drugs will crimp profits, but the figure is a less than initially feared.
"Negotiations began with government asking for $130 billion, so $80 billion would represent a relatively benign outcome," said Savvas Neophytou, an analyst at Panmure Gordon. What's more, the plan agreed with Senate Finance Committee Chairman Max Baucus, with the backing of the Obama administration, means concessions will be funnelled in an area that could generate additional sales volume.
Drugmakers have agreed to provide a 50 percent discount for those elderly and disabled Americans in the Medicare health insurance program who face a gap in coverage after their drug costs reach a certain level, known as the "doughnut hole".
"Roughly 20-25 percent of Medicare D patients reach the doughnut hole, and the majority of them either stop or switch their medications," Deutsche Bank analyst Barbara Ryan said in a research note.
"Therefore, pharma may be providing discounts for branded drugs which will primarily represent incremental demand."
guardian.co.uk
Monday, 22 June 2009
Obama To Formally Announce Medicare Drug Cuts Today.
The pharmaceutical industry agreed Saturday to reduce Medicare drug costs as part of health overhaul in an apparent effort to stave off potentially more-burdensome givebacks under the Democrats’ health-overhaul plan. Today, President Barack Obama will make a formal announcement about the deal.
The Wall Street Journal reports: “Drug makers on Saturday outlined a proposal to forgo $80 billion in revenue over a decade, largely by covering more of the cost of brand-name prescription drugs under the federal government program for seniors. It would make up part of the $313 billion in government health-spending cuts that President Barack Obama has proposed over a decade to help pay for the overhaul plan.
The agreement is the latest in a series of cost-cutting deals the government has made with insurance companies, doctors, hospitals and medical-device manufacturers as it seeks to find ways to pay for proposed changes to the health-care system, including expanding insurance coverage to 46 million uninsured Americans.”
kaiserhealthnews.org
The Wall Street Journal reports: “Drug makers on Saturday outlined a proposal to forgo $80 billion in revenue over a decade, largely by covering more of the cost of brand-name prescription drugs under the federal government program for seniors. It would make up part of the $313 billion in government health-spending cuts that President Barack Obama has proposed over a decade to help pay for the overhaul plan.
The agreement is the latest in a series of cost-cutting deals the government has made with insurance companies, doctors, hospitals and medical-device manufacturers as it seeks to find ways to pay for proposed changes to the health-care system, including expanding insurance coverage to 46 million uninsured Americans.”
kaiserhealthnews.org
Friday, 19 June 2009
The swine flu threat
As media coverage dwindled, the swine flu threat faded from the minds of most Americans, despite warnings that we weren't out of the woods yet. Many believed that the virus could return with a vengeance come flu season, but it appears that even those predictions may have been optimistic. On Wednesday, the WHO announced that 74 countries had reported 27,737 cases of H1N1, including 141 deaths. About half of the confirmed cases are in the U.S. In Australia, the number of reported cases has tripled in the last week, drawing the attention of the WHO as it evaluated the severity of the threat.
Pharmaceuticals in Focus
As perverse as it sounds, this latest development is good news for some. Pharmaceutical manufacturers have continued work on vaccines behind the scenes despite the apparent abatement of the threat. With the elevation of the pandemic alert level from 5 to 6, many pharmaceutical companies are likely to be flooded with requests (and funding) for vaccine development and testing. And as the likelihood of a worst-case scenario (a full-blown global outbreak) increases, so does the potential for a huge payday for vaccine manufacturers.
Pharmaceuticals in Focus
As perverse as it sounds, this latest development is good news for some. Pharmaceutical manufacturers have continued work on vaccines behind the scenes despite the apparent abatement of the threat. With the elevation of the pandemic alert level from 5 to 6, many pharmaceutical companies are likely to be flooded with requests (and funding) for vaccine development and testing. And as the likelihood of a worst-case scenario (a full-blown global outbreak) increases, so does the potential for a huge payday for vaccine manufacturers.
Thursday, 18 June 2009
Britain pledges £485 Million to global vaccine project.
Britain will invest almost $500 million in an international scheme to encourage pharmaceutical firms to develop vaccines against some of the common diseases which plague poorer nations.
The Advance Market Commitment, a pilot project launched on the sidelines of the G8 finance ministers meeting this weekend, guarantees to buy vaccines at fixed prices once they have been developed, giving drug companies an incentive to produce them.
"The UK is pleased to support this initiative ... which should ensure a sustainable and affordable supply of vaccines well into the future," said British finance minister Alistair Darling.
Britain, Italy, Canada, Russia, Norway and the Bill and Melinda Gates Foundation are investing a total of $1.5 billion in the project, which is being run by the World Bank, UNICEF, the World Health Organization and the international vaccine agency GAVI alliance.
Pharmaceutical firms who sign up will be tasked with developing vaccines to fight pneumococcal diseases, which claim up to 1.6 million lives each year -- most of them children.
Firms that participate will also make legally binding commitments to supply the vaccines at lower and sustainable prices after the donor funds are spent.
The AMC scheme aims to prevent more than 7 million deaths by 2030.
The Advance Market Commitment, a pilot project launched on the sidelines of the G8 finance ministers meeting this weekend, guarantees to buy vaccines at fixed prices once they have been developed, giving drug companies an incentive to produce them.
"The UK is pleased to support this initiative ... which should ensure a sustainable and affordable supply of vaccines well into the future," said British finance minister Alistair Darling.
Britain, Italy, Canada, Russia, Norway and the Bill and Melinda Gates Foundation are investing a total of $1.5 billion in the project, which is being run by the World Bank, UNICEF, the World Health Organization and the international vaccine agency GAVI alliance.
Pharmaceutical firms who sign up will be tasked with developing vaccines to fight pneumococcal diseases, which claim up to 1.6 million lives each year -- most of them children.
Firms that participate will also make legally binding commitments to supply the vaccines at lower and sustainable prices after the donor funds are spent.
The AMC scheme aims to prevent more than 7 million deaths by 2030.
Wednesday, 17 June 2009
Scottish woman is first Briton to die from swine flu
A patient suffering from swine flu has died in hospital in Scotland, becoming the first person outside the Americas to have been killed by the virus.
The Scottish government disclosed that the patient, thought to be from the Paisley area and one of 10 Scots in hospital with the H1N1 virus, had underlying health problems.
Last night the victim was locally identified as a 38-year-old woman from Glasgow, who had prematurely given birth to a baby in recent days. She had been in intensive care at the Royal Alexandra hospital in Paisley, where a large number of those infected with the H1N1 virus have been treated. Health officials said earlier today that nearly 500 people in Scotland had been diagnosed with the virus, with a majority in the Greater Glasgow and Clyde area.
The Scottish government released a statement shortly before 8pm tonight, stating: "With regret, we can confirm that one of the patients who had been in hospital and had been confirmed as suffering from the H1N1 virus, has died today. At the family's request, to allow them time to come to terms with their loss, no further details will be released tonight."
Nicola Sturgeon, the Scottish health secretary, said: "I'd like to express my condolences to the patient's family and friends," she said. "This is a tragedy for those concerned and they have my heartfelt sympathy. Tragic though today's death is, I would like to emphasise that the vast majority of those who have H1N1 are suffering from relatively mild symptoms."
The Scottish government disclosed that the patient, thought to be from the Paisley area and one of 10 Scots in hospital with the H1N1 virus, had underlying health problems.
Last night the victim was locally identified as a 38-year-old woman from Glasgow, who had prematurely given birth to a baby in recent days. She had been in intensive care at the Royal Alexandra hospital in Paisley, where a large number of those infected with the H1N1 virus have been treated. Health officials said earlier today that nearly 500 people in Scotland had been diagnosed with the virus, with a majority in the Greater Glasgow and Clyde area.
The Scottish government released a statement shortly before 8pm tonight, stating: "With regret, we can confirm that one of the patients who had been in hospital and had been confirmed as suffering from the H1N1 virus, has died today. At the family's request, to allow them time to come to terms with their loss, no further details will be released tonight."
Nicola Sturgeon, the Scottish health secretary, said: "I'd like to express my condolences to the patient's family and friends," she said. "This is a tragedy for those concerned and they have my heartfelt sympathy. Tragic though today's death is, I would like to emphasise that the vast majority of those who have H1N1 are suffering from relatively mild symptoms."
Tuesday, 16 June 2009
Hospitals oppose Obama’s Medicare, Medicaid cuts
Obama said high health care costs hurt the entire economy and contribute to the nearly 50 million people who lack coverage. His address focused on payments to Medicare and Medicaid, which cover millions of elderly and low-income people and involve thousands of doctors, hospitals, nursing homes and other institutions.
He proposed cutting $313 billion from the programs over 10 years. That’s in addition to the $635 billion “down payment” in tax increases and spending cuts in the health care system that he announced earlier.
Together, Obama’s plans would provide $948 billion over a decade in savings and/or tax increases to help insure practically everyone and to slow the rate of soaring health care costs.
The president wants to cut $106 billion over 10 years from payments that help hospitals treat uninsured people. Spending on Medicare prescription drugs would fall by $75 billion over a decade.
And slowing projected increases in Medicare payments to hospitals and other providers — but not doctors — would save $110 billion over 10 years, the president said.
Obama called them “commonsense changes,” although he acknowledged that many details must be resolved. Some powerful industry groups called the proposals unwise and unfair.
“Payment cuts are not reform,” Rich Umbdenstock, president of the American Hospital Association, said even before Obama’s plan was announced. His group is urging hospitals with large proportions of low-income patients “to push back on proposed cuts.”
The pharmaceutical industry is wary of Obama’s plan to extract $75 billion over 10 years from Medicare prescription drug spending. The White House said “there are a variety of ways to achieve this goal.” For instance, it said, drug reimbursements might be reduced for people who receive both Medicare and Medicaid.
He proposed cutting $313 billion from the programs over 10 years. That’s in addition to the $635 billion “down payment” in tax increases and spending cuts in the health care system that he announced earlier.
Together, Obama’s plans would provide $948 billion over a decade in savings and/or tax increases to help insure practically everyone and to slow the rate of soaring health care costs.
The president wants to cut $106 billion over 10 years from payments that help hospitals treat uninsured people. Spending on Medicare prescription drugs would fall by $75 billion over a decade.
And slowing projected increases in Medicare payments to hospitals and other providers — but not doctors — would save $110 billion over 10 years, the president said.
Obama called them “commonsense changes,” although he acknowledged that many details must be resolved. Some powerful industry groups called the proposals unwise and unfair.
“Payment cuts are not reform,” Rich Umbdenstock, president of the American Hospital Association, said even before Obama’s plan was announced. His group is urging hospitals with large proportions of low-income patients “to push back on proposed cuts.”
The pharmaceutical industry is wary of Obama’s plan to extract $75 billion over 10 years from Medicare prescription drug spending. The White House said “there are a variety of ways to achieve this goal.” For instance, it said, drug reimbursements might be reduced for people who receive both Medicare and Medicaid.
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