QDIS Blog

Adeza has a new drug to help prevent premature births and is seen is a promising drug as reported by Forbes.

Adeza Shares Seen As Attractive Following FDA News - Forbes.com:

The article covers that the Reproductive Health Drugs Advisory Committee has recommended for approval Gestiva indicated to prevent premature births. Premature births occur much more frequently now than in past years mainly due to advancements made in fertility treatments; currently about 12% of all births are premature (less than 37 weeks gestation). Also, premature births tend to be very costly to the health care system. According to this site March of Dimes put the cost in 2003 of $11 billion for preterm birth.

Further Resources

• Press Release from Adeza on FDA recommendation for approval
• Adezas Gestiva recommended for FDA approval - Pharmaceutical Business Review

• FDA questions effectiveness of Gestiva at preventing preterm labor

Technorati Tags: Gestiva, premature birth, Adeza

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

The take home lesson from this article is that bird flu in humans concentrates more in the throat whereas the normal flu concentrates in the nose.

Study Adds Details on Bird Flu, Humans - New York Times:

This finding may allow doctors to more quickly to diagnose bird flu in humans. There doesn’t appear to be any other new information here.
Technorati Tags: avian flu, bird flu, H5N1

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I posted some time ago about medical errors and the recent report about them from the Institute of Medicine. In getting caught up on old podcasts, I came across an episode of the NPR show Science Friday from July 28 that had a show regarding medical errors. Give it a listen as it covers the topic quite well.

Technorati Tags: podcast, prescribing errors, medical errors

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Seems there is more to the story I reported recently concerning Advanced Cell Technology techniques to produce stem cells without destroying the embryos.

Stem cell experiment killed embryos, researchers say - baltimoresun.com

Although it may be possible to extract stem cells without destroying embryos, in this case, they actually extracted cells several times and did indeed destroy the embryos in this case. The report was accurate but there seems to be a misunderstanding. Here is an excerpt from this article:

M. William Lensch, a stem cell researcher at Harvard, said using the method to create stem cell lines might be more difficult than the study implies because it’s not clear why only a small percentage of the extracted cells formed new lines.

“I think the study was written in a clever way so that it’s technically correct, but what they claimed beyond the paper, and on the Nature Web site and in the popular press, isn’t right,” he said.

In an interview yesterday, Dr. Robert Lanza, the senior author, noted that he and his team never claimed the embryos survived the experiments. When the study was published, Lanza and other experts had noted in interviews that embryos routinely survive when single cells are extracted in genetic tests at fertility clinics.

It seems more work needs to be done but I feel it is a step in the right direction and the work should continue with the hope in the near future of actually accomplishing what was reported in the popular press.

Technorati Tags: Advanced Cell Technolgy, stem cell, stem cells

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

In what I consider very good news, the Drug Enforcement agency (DEA) has announced they are easing rules on prescribing of powerful narcotic drugs such as Oxycontin.

Feds may ease limit on painkillers - Yahoo! News:

There has long been concern about abuse particularly with Oxycontin among younger people. Oxycontin is a schedule II controlled substance meaning it has a high potential for abuse and has stringent controls in place to limit access to the drugs.

Currently people suffering from pain must visit their doctors every 30 days in order to get a new prescription. The new rules would allow for a 90 day supply which is reason in my opinion. This will help those who get their drugs via mail order since many operate by giving a 90 day supply of the drug.

If you know of anyone suffering from chronic pain who has had to go through all this in order to continue functioning this will come as great news.

Technorati Tags: Drug Enforcement Agency, narcotics, pain killers

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

I was remiss in not posting about this earlier. The FDA has listed several “Canadian” websites and a list of drugs that are likely counterfeit.

FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various Canadian Websites that Apparently Sell Counterfeit Products

Among those listed are some of the most common prescription drugs.

• LIPITOR Cholesterol disorders
• CRESTOR Cholesterol disorders
• ZETIA (US name) / EZETROL (Canadian name) Cholesterol disorders
• DIOVAN High blood pressure
• HYZAAR High blood pressure
• ACTONEL Osteoporosis in postmenopausal women
• NEXIUM Gastroesophageal reflux disease (GERD)
• CELEBREX Arthritis-related pain
• ARIMIDEX Breast cancer
• PROPECIA Male-pattern baldness

Here is the list of websites run by Mediplan:

• www.RxNorth.com;
• www.Canadiandrugstore.com;
• www.Rxbyfax.com;
• www.Northcountryrx.com;
• www.Canada-pharmacy.com;
• www.My-canada-pharmacy.com;
• www.NLRX.com;
• www.Canampharmacy.com;
• www.Canada-Meds-For-Less.net; and
• www.Canadian-safe.com

I do want to say that drugs in Canada are safe but that some of these websites online are not truly Canadian based and their backgrounds are difficult to establish. Also, even if they are, some seem to be purchasing cheap drugs from countries who may not meet the good manufacturing guidelines the FDA uses.

This is a major problem not only in Canada but world-wide. Drug counterfeiting is a high priority with the FDA and progress is being made with the use of RFID tags, but much more work remains to be done.

You always have to ask if the risk (counterfeit drug, sub-optimal doses, potential contamination, etc.) are worth the savings that may occur. I would not get drugs from Canada via an online website for any of my family members. A better use of your time would be to find help from either the pharmaceuticals company that makes your drug (many offer assistance programs but don’t advertise that fact) or go the Partnership for Prescription Assistance website. Here they explain the various programs and what it takes to qualify for them.

Other Resources from the FDA website

Importing Prescription Drugs from Foreign Sources
Consumer Education: Buying Medicines From Outside of the United States
Buying Medicines and Medical Products Online
Combating Counterfeit Drugs
Generic Drug Prices in the U.S. Are Lower Than Drug Prices in Canada

Technorati Tags: drug cost, drug imports, FDA

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

A company in India know as Granules India has come up with the concept of making a pharmaceutical formulated intermediate (PFI) for use in generic drugs.

FDA’s thumbs up to PFI reverberates through outsourcing industry:

Currently generic manufacturers may outsource the production of the active pharmaceutical ingredient (API) and use this to make a formulation such as a pill or capsule. Basically, PFI would be a mixture of the API and excipients and be ready for directly feeding into hoppers for compression into pills or filling of capsules. This concept has created a stir in the outsourcing pharmaceutical industry. This is an area I’m definitely keeping an eye on in the future.

Technorati Tags: FDA, pharmaceutical formulated intermediate

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Looks like Neurocrine will continue with its development of Indiplon based on recent news.

Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA

Seems the FDA wasn’t happy with the pharmacokintetic/food effect profile provided in the application. The FDA it seems would like to see additional meal profiles to see what effect various meals may have on the distribution of Indiplon in the body. The press release states that Neuocrine will have a meeting with the FDA in October of this year for further clarification. If indeed this is the only sticking point, then it should be relatively easy for Neurocrine to perform additional studies to resolve this issue.

It would be interesting to know what the nature of the problem was. My guess (and it is only a guess) is that Neurocrine may have looked at food consumed hours before taking the drug and not at taking the drug in conjunction with food just before going to bed. Also, some people with insomnia tend to eat fairly large meals right before attempting to go to sleep and this may contribute to problems with the drug’s half-life. Remember, one of the claims for Indiplon is that it lasts longer than others on the market and this may also be why the larger dose was not approvable whereas the lower dose levels were approval (if further work was done).

Technorati Tags: Indiplon, Neurocrine, sleeping pill

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

M&A activity seems to be picking up recently. Seems AnorMED does not want to be acquired by Genzyme.

AnorMED Board recommends shareholders reject hostile Genzyme offer and not tender shares: Financial News - Yahoo! Finance:

I think this sets the stage for a hostile takeover. It rally depends on how much Genzyme wants to spend to acquire AnorMED. Agai, I think Genzyme will up its offer and that AnorMED will accept it.

Here is AnorMED’s pdf on rejecting the offer.

Technorati Tags: Anormed, Genzyme, pharma M&A, pharmaceutical deals

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |

Seems Barr Labs isn’t the only one interested in the Croatian company Pliva.

Actavis sets Barr higher in bidding war for Pliva:

I posted earlier about Barr Labs wanting to buy Pliva and now it seems there may be a bidding war betwen Barr and Actavis. Barr originally said they would pay $2.3 billion cash and then Actavis offered $2.5 billion. Barr has stated they will respond by Sept 8 (Friday of this week).

It should be noted that Actavis already owns about 20% of Pliva and both companies seem to really want Pliva but for different reasons. Although not know in the US, Pliva is one of the largest drug makers in eastern Europe (both generic and ethical pharmaceuticals) and sells in about 30 countries.

Actavis has already been on a buying binge with eight acquisitions in the last year. Im not looking for anything to settle on this until years end at the earliest and will likely drag on into 2007.

Technorati Tags: Barr Labs, pharma M&A, pharmaceutical deals, Pliva, Actavis

Email Ed Vawter

Bookmark it with: | del.icio.us | Digg it | Furl | Simpy | Spurl | My Yahoo! |