Archive for July, 2007
The rise (and possible fall) of the glitazones - so far
January 1997: The FDA approves Rezulin to treat type 2 diabetes the first glitazone drug, a class of drugs that help the body use insulin more effectively.
May 1999: The FDA OKs Avandia, the second glitazone.
July 1999: The FDA approves Actos, the third glitazone.
March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.
April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.
February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.
March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.
May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."
Source: USA Today
May 1999: The FDA OKs Avandia, the second glitazone.
July 1999: The FDA approves Actos, the third glitazone.
March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.
April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.
February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.
March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.
May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."
Source: USA Today
Now Sanofi Aventis start buying back shares
Sanofi-Aventis SA, whose shares have fallen 10 percent since a U.S. panel rejected its most promising medicine last month, may follow rivals GlaxoSmithKline Plc and Pfizer Inc. and seek to win back investors with cash.
The world's third-largest drugmaker is expected to say second-quarter profit barely grew this week. The Paris-based company may also disclose plans to spend as much as 30 billion euros ($40.9 billion) on its own shares by 2011, buying it time to convince investors that other drugs in development are worth waiting for, says HSBC Securities analyst Kevin Scotcher.
Like Pfizer and Glaxo, Sanofi is struggling to boost profit as key medicines lose revenue to generics. Last month's setback will make it harder to replace sales lost to cheaper versions of some of the company's biggest drugs, including Ambien, the sleep pill that lost patent protection in April. A buyback would signal Sanofi is confident about drugs in its pipeline and quash speculation it may buy Bristol-Myers Squibb Co., analysts said.
``Saying they're going to put money into a buyback rather than make a big acquisition would be saying `we're sticking to what we're doing,''' New York-based Scotcher said in a July 25 telephone interview. ``What they need to do on Aug. 1 is make a statement about a specific amount for a specific period.''
More at Bloomberg
The world's third-largest drugmaker is expected to say second-quarter profit barely grew this week. The Paris-based company may also disclose plans to spend as much as 30 billion euros ($40.9 billion) on its own shares by 2011, buying it time to convince investors that other drugs in development are worth waiting for, says HSBC Securities analyst Kevin Scotcher.
Like Pfizer and Glaxo, Sanofi is struggling to boost profit as key medicines lose revenue to generics. Last month's setback will make it harder to replace sales lost to cheaper versions of some of the company's biggest drugs, including Ambien, the sleep pill that lost patent protection in April. A buyback would signal Sanofi is confident about drugs in its pipeline and quash speculation it may buy Bristol-Myers Squibb Co., analysts said.
``Saying they're going to put money into a buyback rather than make a big acquisition would be saying `we're sticking to what we're doing,''' New York-based Scotcher said in a July 25 telephone interview. ``What they need to do on Aug. 1 is make a statement about a specific amount for a specific period.''
More at Bloomberg
Now Sanofi Aventis climb on the wholesale bandwaggon
Sanofi-Aventis is set to become the third drug major to switch to an exclusive distribution system for its medicines in the UK, with the announcement that, from November 1, its products will be distributed by AAH, Phoenix and UniChem only.
The change is being made to improve supply-chain efficiency and integrity in the delivery of its medicines to patients, said the French-based drugmaker. The three firms will offer 100% national coverage across the UK, including Northern Ireland, there will be no change to their wholesaler status and they will continue to control both discounts and delivery frequency, it added.
Announcement of this latest limited distribution deal was embargoed until this morning (July 30), so representatives of the wholesaling industry have yet to comment. However, the British Association of Pharmaceutical Wholesalers (BAPW) has been fiercely critical of the first two such arrangements, announced by Pfizer last October and AstraZeneca in April this year, warning that these new and varied distribution arrangements could damage the robustness of the pharmaceutical supply chain and the ability of patients to receive medicines quickly and easily, with the potential for hidden costs to the National Health Service (NHS).
Pfizer announced its ground-breaking sole-supplier deal with Alliance Boots unit UniChem last September, stating that selling its prescription medicines direct to UK pharmacists and dispensing doctors would enable it secure the supply chain for its medicines and reduce the risk of counterfeit medicines.
In March this year, the deal was unsuccessfully challenged in the High Court by a group of eight wholesalers, including AAH, which then in April was named by AstraZeneca as one of just two wholesalers alongside UniChem, which would distribute its products in the UK from later this year.
Commented AAH group managing director Steve Dunn: Pharmacists will be relieved that this is not another single-channel scheme like that implemented by Pfizer which relies upon one agent to meet the complex demands of every pharmacy, hospital and dispensing doctor everywhere in the UK.
However, AstraZeneca has now said that implementation of the new distribution arrangements will be delayed until early next year.
Many observers are highly sceptical about the companies claims that they are taking these steps to minimise the risk of counterfeit medicines entering the supply chain, and believe that their real motive is to destroy the parallel imports market.
And some experts believe that such distribution deals will actually worsen the risk of patients receiving counterfeit medicines; an across-the-board take-up of such programmes could lead to pharmacists looking to buy their products elsewhere, including from less reputable sources, warned Dispensing Doctors Federation chief executive David Baker, speaking at the BAPW annual conference earlier this year.
However, according to Sanofi-Aventis UK supply chain director, Mike Isles, the new arrangements will enable the company to maintain the service levels that our customers experience today, whilst improving supply chain efficiency in the delivery of our medicines to patients.AAH, Phoenix and UniChem already distribute nearly 90% of all medicines in the UK, and pharmacists should already have existing arrangements with one or more of these wholesalers, ensuring continuity of supply, the company adds.
Meantime, as other drugmakers, including Eli Lilly and Novartis, are reported to be readying their own limited distribution deals, a market study into the new arrangements by government watchdog the Office of Fair Trading (OFT) is due to report its findings by the end of the year.
By Lynne Taylor, PharmaTimes
The change is being made to improve supply-chain efficiency and integrity in the delivery of its medicines to patients, said the French-based drugmaker. The three firms will offer 100% national coverage across the UK, including Northern Ireland, there will be no change to their wholesaler status and they will continue to control both discounts and delivery frequency, it added.
Announcement of this latest limited distribution deal was embargoed until this morning (July 30), so representatives of the wholesaling industry have yet to comment. However, the British Association of Pharmaceutical Wholesalers (BAPW) has been fiercely critical of the first two such arrangements, announced by Pfizer last October and AstraZeneca in April this year, warning that these new and varied distribution arrangements could damage the robustness of the pharmaceutical supply chain and the ability of patients to receive medicines quickly and easily, with the potential for hidden costs to the National Health Service (NHS).
Pfizer announced its ground-breaking sole-supplier deal with Alliance Boots unit UniChem last September, stating that selling its prescription medicines direct to UK pharmacists and dispensing doctors would enable it secure the supply chain for its medicines and reduce the risk of counterfeit medicines.
In March this year, the deal was unsuccessfully challenged in the High Court by a group of eight wholesalers, including AAH, which then in April was named by AstraZeneca as one of just two wholesalers alongside UniChem, which would distribute its products in the UK from later this year.
Commented AAH group managing director Steve Dunn: Pharmacists will be relieved that this is not another single-channel scheme like that implemented by Pfizer which relies upon one agent to meet the complex demands of every pharmacy, hospital and dispensing doctor everywhere in the UK.
However, AstraZeneca has now said that implementation of the new distribution arrangements will be delayed until early next year.
Many observers are highly sceptical about the companies claims that they are taking these steps to minimise the risk of counterfeit medicines entering the supply chain, and believe that their real motive is to destroy the parallel imports market.
And some experts believe that such distribution deals will actually worsen the risk of patients receiving counterfeit medicines; an across-the-board take-up of such programmes could lead to pharmacists looking to buy their products elsewhere, including from less reputable sources, warned Dispensing Doctors Federation chief executive David Baker, speaking at the BAPW annual conference earlier this year.
However, according to Sanofi-Aventis UK supply chain director, Mike Isles, the new arrangements will enable the company to maintain the service levels that our customers experience today, whilst improving supply chain efficiency in the delivery of our medicines to patients.AAH, Phoenix and UniChem already distribute nearly 90% of all medicines in the UK, and pharmacists should already have existing arrangements with one or more of these wholesalers, ensuring continuity of supply, the company adds.
Meantime, as other drugmakers, including Eli Lilly and Novartis, are reported to be readying their own limited distribution deals, a market study into the new arrangements by government watchdog the Office of Fair Trading (OFT) is due to report its findings by the end of the year.
By Lynne Taylor, PharmaTimes
SiCKO “hitman” interviewed
Julia Schopick has posted an audio interview on Honst Medicine, which she conducted with Lee Einer, the man Michael Moore dubbed (facetiously) the insurance industry "hitman" in SiCKO!
I hope you will give it a listen, because Lee was very forthcoming with lots of "secrets" that weren't addressed in SiCKO.
He also expands on other "secrets" that were exposed in the film.
Go here.
I hope you will give it a listen, because Lee was very forthcoming with lots of "secrets" that weren't addressed in SiCKO.
He also expands on other "secrets" that were exposed in the film.
Go here.