Thursday, October 30, 2008

Phillies win!! Economy doomed?

It's worth it...every 25 years or so...and this post has all the charts and graphs to prove it...

link to Drug Channels post regarding economic impacts of the Phils winning the Fall Classic

Wednesday, October 29, 2008

Only 59% of Pharma Companies...

Own Dedicated Compliance Departments, According to Research by Cutting Edge Information

Can this possibily be correct???...

A stand-alone Quality function is a direct requirement of federal law governing GMP activities...21CFR etc etc etc

I'll have to download the report and read it...that's's so questionable, I'll take the time to read it...

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance. The study, "Monitoring and Ensuring Pharmaceutical Compliance," highlights the growing need for creating a dedicated compliance department.

With only 59% of pharma maintaining a dedicated department for compliance, there are still a healthy percentage of companies who remain vulnerable to unforeseen regulatory changes. Building a strong compliance management team will give the staff the necessary power to effectively manage their internal clients' changing needs.

Maintaining a dedicated compliance department also signals to outside agencies that the company takes regulation seriously. Giving an outward appearance of a company willing to police itself goes a long way in the court of public opinion. The damage done by a compliance misstep can take a long time to recover from -- both legally and in the eyes of company stakeholders.

link to full article

link to report download

Tuesday, October 28, 2008

Diabetes drug costs soaring, top $12B last year

I think they've found the new blockbuster...

Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion.

Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.

The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.

And a second study, also out Monday, adds to evidence that metformin — an inexpensive generic used reliably for decades — may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.

"We need to pay attention to this," said Dr. David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."

The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.

link to full article

Thursday, October 23, 2008

China arrests 6 for role in contaminating milk

How many points in this story make no sense?...the over-under is 4...

BEIJING – China arrested three people Thursday for allegedly adding a toxic chemical to fresh milk to mask the fact that it was watered down and three others for selling the chemical.

The practice of adding melamine, a nitrogen-rich substance used in making plastics and fertilizers, to milk supplies is blamed for killing four babies in China and sickening tens of thousands.

The babies were sickened by powdered infant formula that authorities believe was made from tainted fresh milk. Melamine has also been found in other Chinese dairy products, including yogurt, candy and cream cookies.

More than 3,654 Chinese children remain hospitalized for kidney stones or other symptoms caused by ingesting melamine, the Health Ministry said Thursday. Three were in serious condition.

The official Xinhua News Agency said all six suspects arrested Thursday worked in Inner Mongolia, a region of sprawling grasslands that has become China's dairy heartland. Countless small dairy farms dot the grasslands, with milk collected at stations and then sold to large dairy companies.

One suspect, identified by Xinhua only by his surname Cui, ran a collection station and allegedly confessed to mixing about 25 gallons of water to 544 gallons of fresh milk. He then added 21 ounces — about three or four cups — of fake protein, which contained melamine, to hide the fact that it was diluted.

link to full article

Wednesday, October 22, 2008

Many biological medicines draw safety warnings

Why does follow-on monitoring for safety seem like such a strange idea?...

WASHINGTON, Oct 21 (Reuters) - About a quarter of biological medicines approved in the United States and Europe since 1995 have triggered safety warnings in the years after entering the market, Dutch researchers said on Tuesday.

Immune system disorders, infusion reactions, infections and cancer concerns were among the reasons for safety warnings for biological medicines, which are made with proteins derived from living cells rather than the chemicals used in typical drugs.

These medicines, called biologics or biologicals, are typically injected and treat a range of conditions including anemia, rheumatoid arthritis, hepatitis and cancer.

Thijs Giezen of Utrecht University in the Netherlands and colleagues tracked safety-related regulatory actions involving 174 biological medicines approved in the United States or the European Union between January 1995 and June 2007.

link to full article

Monday, October 20, 2008

Counterfeiters can get life in jail under new US Act

US President George W Bush has signed a bill under which counterfeiters can be sentenced to life imprisonment if their crime causes the death of an individual.

The passing of the Prioritizing Resources and Organization for Intellectual Property Act of 2007 (PRO IP) strengthens the US court’s power to punish those convicted of counterfeiting; a measure big pharma has been calling for.

By increasing its maximum penalty the US has brought its punishment more closely into line with China, which sentenced a man to life in prison for causing 14 deaths by using a fake ingredient in human immunoglobulin.

The sentence for inflicting serious bodily harm as a result of counterfeit products has also been increased and can now result in up to 20 years in jail. Both sentences can also carry a fine.

In addition to increasing the punishments for trafficking counterfeit goods the new legislation also ramps up US preventative powers.

link to full article

Friday, October 17, 2008

Chinese government summons major dairy companies

to buy up the plants of the company that produced contaminated milk...somehow these facilties have "great value"???...

BEIJING – China summoned five of its major dairy companies to a meeting Friday over the fate of Sanlu Group Co., the company at the center of a tainted milk scandal that has sickened thousands and led to the deaths of four children, state media reported.

The five companies were brought to Beijing to discuss the purchase of the company, the 21st Century Business Herald, a major business daily, reported Friday.

The government is trying to revive its dairy industry and contain the fallout after baby formula contaminated with melamine was blamed for the deaths of four infants and the sickening of about 54,000 other children in China.

The Health Ministry said Wednesday that 5,800 children were still hospitalized — six of them in serious condition. In Hong Kong, the Department of Health said Friday two more children have developed kidney stones after drinking melamine-laced milk, bringing to 10 the total number of children with milk-related kidney stones.

Sanlu, a majority state-owned company whose products were the most heavily tainted, is now largely defunct, with companies looking to scoop up its assets.

link to full article

Wednesday, October 15, 2008

Results are In: Pharma Favors Obama

I don't normally discuss politics at work, but...

an interesting post over at Pharma Marketing blog...

Tuesday, October 14, 2008

US proposes country-of-origin labelling

A good start...we have to start protecting ourselves...

A bill has been introduced to the US Senate that would require the country-of-origin of APIs and excipients to be labeled on finished dosage forms.

This proposal covers both active pharmaceutical ingredients (APIs) and excipients present in prescription or over-the-counter (OTC) products.

Including excipients under the bill differentiates it from the proposal in the draft of the US Food and Drug Administration (FDA) Globalization Act, which was released in April.

Under the proposal the country-of-origin of each active and inactive ingredient would be listed in descending order based upon the quantity in the finished dose.

It appears that it will not be necessary to include the country of origin of all raw materials and intermediates, or the nation in which every step in the synthesis process occurs.

This would provide a more comprehensive view of the origins of an API or excipient but is not mentioned in the bill, probably due to the complexity of implementing such a measure.

link to full article

China orders more testing for liquid milk, powder

BEIJING - China is ordering all liquid and powdered milk manufactured before Sept. 14 to be taken off the shelves for melamine testing, a news report said Tuesday, the first time Beijing has issued a blanket recall of products since the tainted dairy scandal broke last month.

It is the latest in a series of measures China has taken to allay worries over the quality of Chinese products and restore consumer confidence since four babies died and tens of thousands of children were sickened after drinking tainted milk.

Authorities have blamed dairy suppliers for the crisis, saying they added the industrial chemical melamine to watered-down milk to fool quality control tests and make the product appear rich in protein.

Melamine can cause kidney stones as the body tries to eliminate it and, in extreme cases, lead to life-threatening kidney failure.

Citing a notice jointly approved by six government ministries and administrations, the official Xinhua News Agency said Tuesday that all milk powder and liquid milk produced before Sept. 14 must be subject to testing nationwide by manufacturers.

link to full article

Thursday, October 09, 2008

Opportunity Knocks for Big Pharma in Credit Crunch

A good article regarding the impacts of the economic situation on the Pharma market over at FierceBiotech...

The primary consequence of the credit crunch for non-financial companies is the loss of access to cheap debt

LONDON, Oct. 8, 2008- The key impact of the credit crunch on the corporate world is the abrupt loss of cheap debt. During the late 1990s and 2000s companies across all industries have exploited easy access to cheap debt to amplify or ‘leverage' their return to investors. However, triggered by the sub-prime crisis and the subsequent collapse of big name financial institutions, banks have no choice but to protect their own capital and stop lending - turning off this supply of cheap debt.

This leaves those companies that have taken on debt in the extremely uncomfortable position of having to either rapidly pay off their debts (‘deleveraging') or re-secure new debt at much higher interest rates - potentially threatening the viability of the firm. Datamonitor believes that large pharmaceutical companies have wisely stayed out of the cheap debt game and as a result, the credit crunch will actually play out as a net positive for an industry much in need of good news, according to Datamonitor head of company analysis Dr. Chris Phelps. "Pharma companies are not only expected to weather the financial storm successfully but to also use this period to exploit their unique cash strength by embarking on an acquisition spree."

link to full article

Monday, October 06, 2008

China detains 6 more suspects in milk scandal

You can't "check Quality into" a product...

Maybe you can "arrest Quality into" a product...

BEIJING - China pledged to improve food safety after authorities detained six more people in the country's contaminated milk scandal as the government increases efforts to restore public trust in Chinese-made food products.

The head of China's quality watchdog said the country is also stepping up checks on its exports to ensure they conformed to the food safety standards of recipient countries, the official Xinhua News Agency reported.

The Chinese government has been scrambling to show it is tackling the problem of melamine-contaminated milk powder and products blamed for killing four babies and sickening more than 54,000 children with kidney stones and other illnesses in China.

"Food safety concerns not only the health of the public, but also the life of business," said Wang Yong, the director of the General Administration of Quality Supervision, Inspection and Quarantine, the agency responsible for ensuring that China's food supply chain is safe.

Wang, who replaced Li Changjiang, the former director who resigned last month in the wake of the scandal, vowed to make "a substantial change in the production and distribution of dairy products."

link to full article

Thursday, October 02, 2008

Candy with chemical in Chinese milk found in Conn.

And now we have to deal with it...

But look closely at Paragrapgh 9...when does it change from a few rogue companies contaiminating a product to "Standard Operating Procedure"???...

HARTFORD, Conn. - An industrial chemical blamed for sickening thousands of infants in China was found in candy in four Connecticut stores this week, a state official said Wednesday.

Days after contaminated White Rabbit Creamy Candy was found in California, Connecticut Consumer Protection Commissioner Jerry Farrell Jr. said tests found melamine in bags of the candy sold at two New Haven stores, a West Hartford market and an East Haven store.

"We're concerned, obviously, there may have been bags sold of these before we got to them," Farrell said.

Anyone who has the candy should destroy it, Farrell said.

The contamination has been blamed for the deaths of four children and kidney ailments among 54,000 others. More than 13,000 children have been hospitalized and 27 people arrested in connection with the tainting.

Melamine, which is high in nitrogen, is used to make plastics and fertilizers and experts say some amount of the chemical may be transferred from the environment during food processing. But in China's case, suppliers trying to boost output are believed to have diluted their milk, adding melamine because its nitrogen content can fool tests aimed at verifying protein content.

Melamine can cause kidney stones, leading to kidney failure. Infants are particularly vulnerable.

Melamine has been associated with contaminated infant formula and other Chinese products containing milk protein.

On Wednesday, the Chinese government identified 15 more Chinese dairy companies as producing milk products contaminated with melamine, bringing the total to 20 companies. At least 100 batches of milk powder have been found to contain the chemical, according to data on the food safety administration's Web site.

link to full article