Showing posts with label Pharma/FDA News. Show all posts
Showing posts with label Pharma/FDA News. Show all posts

Monday, May 2, 2011

Teva Pharmaceuticals Wins Bid for Cephalon for $6.8 Billion

Last time Teva was in the news here it was related to the news of their collaboration with Proctor and Gamble with creating an over the counter drug and marketing business, to compete generally with a division of Johnson and Johnson.  Teva also last week began opening up manufacturing in Irvine, California, a plant that has been closed for quite a while now, so some relief for a few drugs that have been in short supply. 

Teva And Procter & Gamble Create Over the Counter Drug Marketing and Distribution Business-Do The Consumer A Favor and Start Bar Coding for Recalls-They Will Happen

From the Cephalon website:

Founded in 1987 as a biotech start-up, we have grown into one of the world’s top ten biopharmaceutical companies, with an impressive roster of first-in-class products, a deep and diverse pipeline, and total revenues of $2.81 billion in 2010. And even though we’ve grown to have thousands of employees in locations around the globe, we’ve never lost the agility and nimbleness of a start-up.image

Our portfolio of innovative treatments for central nervous system disorders, pain, and cancer include eight proprietary products in the United States, along with more than 100 products internationally. Our research pipeline is focused on developing new compounds and new indications for existing products, while our business collaborations capitalize on new products and smart drug delivery technologies.

In the amount of time I have been doing the blog here it has been interesting to watch and see TEVA grow.  They are based in Israel and for the most part have been one of the most aggressive generic drug companies.  In addition, they do have a few drugs of their own they have developed in house, so over all they are very diversified.  One drug they used to supply to the US was propofol and I don’t see any mention so far of that drug coming back on line for them with manufacturing.  

PHILADELPHIA Israel-based Teva Pharmaceuticals Industries Ltd. will acquire Cephalon Inc. of Frazer, Pa., in a $6.8 billion deal, the two companies announced Monday.

In recent weeks, Cephalon has warded off a hostile takeover attempt by Valeant Pharmaceuticals International Inc., which is headquartered in the Toronto suburb of Mississauga, Ontario.

Valeant's offer of $73 per share was trumped by Teva's offer of $81.50 per share for all outstanding shares.

Teva said the combined companies would have about $7 billion in sales. The deal would be made with cash on hand, lines of credit, and through the public debt market, Teva said.

http://www.google.com/news?hl=&q=teva&sourceid=navclient-ff&rlz=1B3GZAG_en___US424&ie=UTF-8






FDA Approves Diabetes Pill for Diabetes 2 For Both Stand Alone and Combined Treatments

The drug as approved can be used as a stand alone or in combination with other drugs to help patients control blood sugar and works by releasing  hormones  and by blocking the DPP-4 enzyme.  image

Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes joined forces in January 2011to work together on the drug.  I always talk about collaboration and here’s one good example that the Health IT folks can perhaps appreciate.  Any more so much of the research and development is done via the computer before a lab is created at the final stages before a trial begins.  BD

WASHINGTON — The Food and Drug Administration says it has approved a new diabetes pill from Boehringer Ingelheim and Eli Lilly for patients who can't control their blood sugar with older medicines.

FDA OKs new diabetes pill - Health - Diabetes - msnbc.com






Bristol-Myers Recalls Coumadin Blood Thinner For Being Over Potent

Here we go again with recalls and no system to easily identify and hope nothing gets missed as this is an important recall so say the least with a tablet was more imagepotent than stated.  With Coumadin being a blood thinner we can all figure out what means.  Shall we go back and revisit Dennis Quaid as a reminder?  He made a movie about it too.  The link below will bring more of this to light. 

Dennis Quaid Produces Documentary About Patient Safety - Chasing Zero: Winning the War on Healthcare Harm

Again, if a cell phone could be used as a scanner to find the affected bottles, it would certainly help the cause when locating recalled drugs.  BDimage

Microsoft Tags on CBS Early Show – Wake Up FDA, Pharma and Medical Device Companies –Scan Those Drugs, Medical Devices and Synchronize with an FDA Tag Data Base – Recalls, Theft Tracking and More….

So what does a consumer do, talk to your pharmacist….again sad we have technology to solve a lot of this today and nobody’s listening.  BD 

NEW YORK — Bristol-Myers Squibb Co. said Monday it is recalling one production lot of its blood thinner Coumadin after finding a tablet that was too potent.

The company said it tested a returned bottle of Coumadin and found that one tablet was more potent than expected.

An excessive dose of Coumadin, or warfarin, could create an increased risk of bleeding.

Bristol-Myers recalls Coumadin blood thinner - Health - msnbc.com






Sunday, May 1, 2011

Company Advertisements Get Caught Making False Claims And Are Called to Task And So Much of This Activity is in Healthcare

Back in October of 2010 I wrote about everyone marketing their “ass” off and in addition to the foods and other side of healthcare we have it with software and other claims too on the web.  It’s like a virus out there to grab the consumer buck and with all the ground breaking technologies we do have today in healthcare, it’s sometimes hard for all of us to distinguish which is which!image

Why Is Almost Everyone In Healthcare Marketing Their “Ass” Off

Having a mother that is a senior really helps out here with me gathering some of this information together as being a senior she’s a big target out there as she’s aging and what the economists and others sometimes refer to heartlessly as “expensive” and don’t forget we are all going to get there some day so not a bad idea to cut some of this crap out with relaying news and product information today. 

Here’s an example of what happened last year with some behavior patterns that got out of whack with the focus on pay for performance and wrangling that consumer, my Mom into what they were pushing that day. Shoot even her health care plan and the drug store were giving her conflicting standards on when she should check her glucose levels and she’s been doing this for 15 years and nowhere along the line did the “experts” on both sides mention the involvement of her doctor, so what’s wrong with this picture I ask?  Is this where “marketing your ass off” takes over for common sense and the current structure of healthcare?  I think we have some issues here and the end result is a huge lack of ethics and common sense at times. In some instances it is the pursuit of patient data that drives all of this so they can sell it and make money too. 

Compliance Police Out In Force for Seniors–Health Plans and Drug Stores Making Phone Calls-Business Models & Caller Behavior Sucks -A Result of Pay for Performance Efforts?

You can see where even myself, as hard as I try to be realistic can be taken in a bit imagewith Oreck vacuum cleaner’s claims.  Sure the UV light helps but to what extent were the claims made that consumers could rely upon?  They paid some money out as you can read below due to the FTC researching their claims.  Now this does not mean it’s a bad product at all, as they make one heck of a vacuum cleaner with a great reputation but could the UV light stand up to everything they claimed was the question.  There’s another company that boasts UC treatment for toe nail fungus too and I don’t know where their claims stand today either.  Obviously the product do function but again we are back the “marketing your ass off” paradigm. 

Germ-killing vacuum cleaner from Oreck uses UV light

“Oreck agreed to pay $750,000 to settle allegations about its boasts that the vacuums could "capture and destroy" the flu bug and other germs. The Federal Trade Commission accused the company of being unable to back its boasts.”

In some areas this is where 2 federal agencies need to work together as in the Cheerios advertising claim, so the FDA basically came out and said ok you are going to advertise like a drug with your claims, so now you are a drug and submit your data <grin>.   On some of thee areas lines over cross so collaboration is best.

Cheerios Classified as a “Drug” by the FDA

Drug companies get caught up in this too, like Bayer did with their claims about prostate cancer.  I had a conversation with the Prostate Cancer Foundation and asked their opinion to which they said they were all over it and would be following up for public awareness too as they are one of the first places consumers go to ask since they are the experts with research, development and so forth with this type of cancer.  You can read below the outcome of that one with the class action lawsuit filed for false advertising with the Men’s One A Day.

Bayer Claim That Vitamins Prevent Prostate Cancer Is Now A Class Action Lawsuit – False Advertising

In here too we have Pom Wonderful who has spoken about the benefits of pomegranate juice and they too were called on the carpet, so they just kind of exploited their efforts in a recent movie, sponsored by Pom Wonderful.  I do have to say though that prostate cancer gets more than their fair share of a lot of this when folks crunch some numbers without the scientific backing.  I like Pom, tastes good, and like it in a martini, so that’s why I buy it and of course I am not one who buys the product due to it’s prostate cancer claims being a female. <grin>.

FTC and FDA Tell Pom Wonderful To Change Their Advertising Claims or Submit for FDA Approval–Another Study Unrelated Claims Peaches and Plums Kill Breast Cancer Cells Too

It is kind of funny in a way that they are the big sponsor in the “Greatest Movie Ever Sold” and you can read my comments on how this rolls over to healthcare and I ask do we have the greatest healthcare system ever sold too? 

The Greatest Movie Ever Sold” Just Like “The Greatest Healthcare System Ever Sold”- Same Paradigms-Colbert Report (Video)

  If you don’t think you are being marketed beyond all belief today, just take one look at this house painted with social networking logos!  Social networks are great, I use them but common sense needs to enter here somehow too as some of them a driving more revenue for their pockets with some steroid and senseless advertising today too. 

Read the list below and take a look and just be aware as to what is documented by studies and research and don’t be afraid to ask questions or dig a little deeper and search some of this out on the web.  Marketing and superficial advertising today can lead us to believe that donkeys come with two heads as shown above if we are not careful.  BD

  • The Kellogg Co. agreed to dial back its advertising after being accused of going too far with claims that Rice Krispies could help your immune system. That followed a previous confrontation over claims the company's Frosted Mini-Wheats cereal was "clinically shown to improve kids' attentiveness by nearly 20%."
  • The Dannon Co. agreed to stop claiming that its Activia yogurt and DanActive drink, which contain probiotics, could relieve irregularity and help prevent catching colds or the flu.
  • NatureSmart LLC and Rexall Sundown Inc. -- makers of Disney and Marvel Heroes multivitamins -- agreed to pay $2.1 million after claiming their products had certain acids that promoted healthy brain and eye development in children. The FTC said the claims were false and could not be backed up.
  • Legacy Learning Systems Inc., which markets a popular series of guitar-lesson DVDs called the Learn and Master Guitar program, agreed to pay $250,000 after being accused of orchestrating a series of phony reviews and testimonials from supposedly regular folk or independent reviewers.
  • Wellness Support Network Inc. was accused of deceiving consumers "with baseless claims that its supplements would treat and prevent diabetes." The FTC said the Diabetic Pack and the Insulin Resistance Pack were essentially the same collection of vitamins and were sold with the claims they reduce insulin resistance and can prevent diabetes. They also said they were the product of "Nobel Prize-winning technology."
  • American Tax Relief, which heavily advertised on the Web, was accused of taking more than $60 million from consumers with tax debts after claiming they could shrink the amount they owed. Ironically, the company had its license suspended in California for failure to pay taxes.
  • The makers of POM Wonderful 100% Pomegranate Juice were accused of making boasts they couldn't back up that the drink and related supplements could prevent or help those with heart disease, prostate cancer, and erectile dysfunction.
  • Global U.S. Resources, which ran a massive marketing operation aimed at convincing out-of-work people that they could make thousands of dollars a month by stuffing envelopes, was accused of duping consumers to get up-front payments from them.
  • At least 18 different websites were issued formal warnings to stop confusing consumers about getting free credit reports. They were required to disclose in their advertising that every consumer is entitled to a free credit report each year from each of the three major credit-reporting agencies through the site AnnualCreditReport.c​om.
  • Gotcha! When companies make false claims- MSN Money






    Stem Cell Trial Participants Thank The Doctors Who Treated Them at the University of Miami–Stem Cells for Heart Failure

    We have a bit of this going on in Los Angeles too with amazing results being seen.  The video below shows one patient who received treatment at Cedar Sinai.  As you can read further this is double-blind” clinical trial to where some get real stem cells and others get a placebo treatment.  Patients are allowed of course to decide whether or not to participate and each case is different as there could be other options in some cases as well in the device world. 


    Watch CBS News Videos Online

    Stem Cell Trial Reports Success With Cardiovascular Repair With Reducing Size of Enlarged Heart and Increased Ability to Pump Blood

    The US is not alone with using stem cells for heart attack victims and you can read more about what’s occurring in the Netherlands.  Cytori is an interesting company that GE has investing that does the processing for the harvesting of the stem cells.

    Cytori To Begin Stem Cell Treatment in the Netherlands for Heart Attack Victims And Trial Results are Looking Very Good

    Research is working hard and heavy to move beyond the heart as well and see if perhaps the same regenerative methodologies would also work with other body parts such as the liver, kidney and pancreas.  What is also amazing too is the short amount of time that has lapsed here with having to inject stem cells directly into a beating heart and the ability to use a catheter through groin, which is what is done today to open artery blockages.  This is why stem cell research and development needs to continue and the ruling last week for this was a breath of fresh air and hopefully the NIH and the government can finally put this issue to bed so life saving technologies can continue.  BD 

    More than 50 patients reunited Friday to thank doctors who are treating them in a new series of clinical trials at University of Miami by injecting stem cells into their damaged hearts to heal them. Optimism reigned, although final results are years away.

    Irastorza, a Miami property manager, said he died briefly on Oct. 6, 2008. A genetic defect gave him such a serious heart attack that his heart stopped for a few minutes. Doctors who revived him said half his heart was dead and warned him to prepare for a short, disabled life. They wanted to insert a defibrillator into his chest.

    “I didn’t want that,” he said. “I didn’t want to give up sex and dancing.”

    On March 3, 2010, UM doctors used a catheter inserted through a slit in his groin to inject millions of tiny stem cells into his damaged heart.

    Under FDA rules for “double-blind” clinical trials, some participants got real stem cells, others got placebos for purposes of comparison. Most won’t find out which they got until the end of the trials in 2012.

    Stem Cell trial volunteers thank doctors at reunion lunch - Miami-Dade - MiamiHerald.com