FDA Approves Faster Acting ED Drug–More Need For Speed?

Well I guess 15 minutes extra can be a long wait so here’s a new approval that cuts the wait time down to 15 minutes instead of 30 minutes.  BD

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An erectile dysfunction drug that reduces by half the time patients need to take the pill before sexual activity has won approval for marketing in the United States.

The drug, Stendra, is the first erectile dysfunction drug approved by the U.S. Food and Drug Administration that can be taken about 15 minutes prior to sexual activity.

Stendra was first approved in 2012 when it was indicated for use 30 minutes before sexual activity.

http://www.foxnews.com/health/2014/09/18/faster-acting-erectile-dysfunction-drug-gets-fda-approval/

FDA Approves New Drug For Treating Diabetes 2 As A Stand Alone Or Combined With Other Therapies

Trulicity is manufactured by Indianapolis-based Eli Lilly and Company and is not for treatment of diabetes one. The drug is a weekly injection and part of a new class of drugs that induce the pancreas to create extra insulin after meals.

There will be  a boxed warning that rats tested with the drug had cases of thyroid cancer and post studies will be required as listed below.  BD 

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The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

Type 2 diabetes affects about 26 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.

"Type 2 diabetes is a serious chronic condition that causes blood glucose levels to rise higher than normal,” said Mary Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Trulicity is a new treatment option, which can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of type 2 diabetes.”

Trulicity has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylurea, thiazolidinedione, and prandial insulin. Trulicity should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); those with severe stomach or intestinal problems; or as first-line therapy for patients who cannot be managed with diet and exercise.

The FDA is requiring the following post-marketing studies for Trulicity:

• a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients; 
• a study to assess potential effects on sexual maturation, reproduction, and CNS development and function in immature rats;
• a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity; 
• a clinical trial comparing Trulicity with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment; and
• a cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease.

The FDA approved Trulicity with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Trulicity.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm415180.htm

FDA Approves Oral Drug To Combat Constipation For Patients On Long Term Opioid Painkillers–Personalized Medicine..

Ok with the title a little sarcasm but I really didn’t know that this was a specific type of constipation and that a special drug was needed for relief?  As you read the article the design of the drug is to ensure you don’t lose any painkilling ability of the Opioid drug.  I didn’t even know that was a side effect of taking a drug to relieve constipation if one were taking an Opioid.  Guess the ones off the shelf are not as good anymore? 

The drug is due to release the first quarter of 2015 and was first approved to treat severely ill patients receiving palliative care where the off the shelf remedies did not provide relief.  The drug is not for patients being  treated for cancer.  BD 

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(Reuters) - The U.S. Food and Drug Administration approved an oral therapy to treat opioid-induced constipation developed by Nectar Therapeutics and AstraZeneca Plc .

The decision opens the door for peripherally acting mu opioid receptor antagonists, which have been linked with cardiovascular risk in the past.

This class of opioid-induced constipation (OIC) drugs are designed to fight the effects of opioid painkillers on the gut without compromising centrally mediated pain relief.

The agency on Tuesday asked the developers to conduct a postmarketing study to further evaluate the potential risk of heart-related side-effects.

"If you look at the way they structured the deal with Nektar, clearly they think this is a multi-billion dollar drug," he said.

http://www.reuters.com/article/2014/09/16/astrazeneca-fda-idUSL3N0RG4TT20140916

New Diet Pill, Contrave Gets FDA Approval–One Active Ingredient is an Antidepressant

It will carry warnings about increased risk of suicidal thoughts and we don’t know the cost yet.  Not all HMOs cover obesity either as they are not convinced of the long term use and effectiveness.  I don’t know after some of what I hear about antidepressants today, if I were in need of losing weight, don’t know if I would trust some of these pills myself.  We sure like to map obesity in the US and it’s not getting any better.  BD

Obesity Just As Big As Ever In the US–More Failed Ineffective Models As Technology Is Not The Cure With, Many Proof of Concepts Not Working, Obesity Algorithms Are Not the Answer

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(Reuters) - A new diet pill Contrave got approval to be sold in the United States on Wednesday, only the third obesity treatment in more than a decade to win approval from the Food and Drug Administration.

Made by Orexigen Therapeutics Inc, Contrave is a combination of the antidepressant bupropion and Orexigen's formulation of naltrexone, designed to prevent drug dependence.

The company did not say when the pill would become available or how much it would cost.

Contrave joins Vivus Inc's Qsymia and Arena Pharmaceuticals Inc's Belviq, both approved in 2012, in the battle to be the treatment of choice and at least one analyst expects the new entrant's sales to top that of its rivals by 2016.

http://in.reuters.com/article/2014/09/11/us-usa-obesity-orexigen-idINKBN0H602U20140911?feedType=RSS&feedName=health&utm_source=dlvr.it&utm_medium=twitter&dlvrit=309303

FDA Approves Keytruda for Advanced Melanoma–Break Through Immunotherapy Drug With Potential To Treat Other Types of Cancer

Below is a video from UCLA from a patient who enrolled in the trial and how it changed her life and got her out of a wheelchair.  Keytruda is designated as a “breakthrough drug”. 

Kathy Thomas, 59, of Torrance, California, was diagnosed in September 2011 with melanoma that had spread to her liver and was invading her left breast. She underwent several therapies that did not work, and she was weakening fast.

"I lost weight. I threw up nearly every day," Thomas said. "My hair was thinning. I just had no strength at all. I was so sick I had to use a wheelchair."

Thomas met with Ribas in 2012 but was skeptical about enrolling in a trial to test an experimental therapy. She soon overcame her hesitation.

"I decided I wanted to survive," she said. "I wasn't going to let this disease beat me."

Since enrolling in the study, Thomas' tumors have shrunk. She regained her strength and her appetite. She's out of her wheelchair and walking normally again. She said she has experienced no side effects from the therapy, and she travels monthly to San Francisco to visit her grandson.

"I just enjoy life now, really enjoy it," she said.  For more information about Keytruda clinical trials at UCLA, members of the public are invited to call 888-798-0719.

Her story above is about melanoma that had grown and was moving in her body.  Keytruda is marketed by Merck.  The drug also has the potential to treat other cancers that the immune system can find.  25% of the folks in the trial saw their tumors shrink. 

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The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.

Melanoma, which accounts for approximately 5 percent of all new cancers in the United States, occurs when cancer cells form in skin cells that make the pigment responsible for color in the skin. According to the National Cancer Institute, an estimated 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.

Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.

“Keytruda is the sixth new melanoma treatment approved since 2011, a result of promising advances in melanoma research,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Many of these treatments have different mechanisms of action and bring new options to patients with melanoma.”

The five prior FDA approvals for melanoma include: ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), and trametinib (2013).

Keytruda’s efficacy was established in 173 clinical trial participants with advanced melanoma whose disease progressed after prior treatment. All participants were treated with Keytruda, either at the recommended dose of 2 milligrams per kilogram (mg/kg) or at a higher dose of 10 mg/kg. In the half of the participants who received Keytruda at the recommended dose of 2 mg/kg, approximately 24 percent had their tumors shrink. This effect lasted at least 1.4 to 8.5 months and continued beyond this period in most patients. A similar percentage of patients had their tumor shrink at the 10 mg/kg dose.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm

Customed Issues Recall of Sterile Convenience Surgical Packs–Largest Recall Ever Recorded by the FDA

Ok so these are all over the place and it’s a Class One Recall and the manufacturing is done in Puerto Rico.  BD

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Fajardo, PR, August 22, 2014 –(PR.com)– On June 3rd, 2014 Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. No serious injuries or deaths have been reported as of August 21, 2014. Customed’s convenience sterile surgical packs are used primarily in hospitals or medical offices for surgical interventions such as: Anesthesiology; Arthroscopy; Cardiovascular; Dental, Ear, Nose, and Throat (ENT); Gastroenterology and Urology; General and Plastic Surgery; General Hospital; Neurology; Obstetrical and Gynecological; Ophthalmic; and Orthopedic procedures.Consumers who have products should stop using the product lots included in the tables below.

Customed, Inc. is:
· Notifying its distributors by mail
· Arranging for the products return (after the included response form is completed)
· Requiring distributors to notify any customers who received the product through redistribution.Affected Products Information:
· The recall includes the product catalogs and lot numbers in the table below.
· Manufacturing Dates: January 9, 2009 to May 19, 2014
· Distribution Dates: January 2009 to May 2014

The firm voluntarily recalled the products after becoming aware of the adhesion defect through Customed Quality System and has notified the FDA of this action.

http://www.customedhealing.com/en/customed-press-release/

CardioMEMS HF System-FDA Approved Implanted Monitoring Device Helps Reduce Hospital Admissions For Patients With Congestive Heart Failure

This is a very worthwhile medical device and the video below shows a quick summary of how it works. 

The patient lays on a pad to transmit the information and it measures the pressure in the pulmonary artery. 

Any pressure changes can be seen and caught before the patient has to go to the ER with any fluid build up.  Medications can be adjusted if needed. 

You can see the pad in the video whereby the device is checked at the end of the procedure.

There’s no shortage of screens in the operating room.  It’s energized from the outside so there’s no having to go in and retrieve the device either.  This is the first tool cardiologists have to truly monitor the patient’s condition.  BD 

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The CardioMEMS HF System is the first and only FDA-approved heart failure monitoring device that has been proven to significantly reduce hospital admissions when used by physicians to manage the condition. The technology features a sensor that is implanted through a catheter into the pulmonary artery (PA) to directly measure PA pressure. Increased PA pressures appear before weight and blood pressure changes, which are often used as indirect measures of worsening heart failure.

“All the patient has to do is lie back on a special pad,” explained Bradford E. Warden, M.D., director of the WVU Heart Institute and chief of the WVU School of Medicine Section of Cardiology. “Radio waves are then transmitted to an external electronic system, and the device measures pressure in the pulmonary artery. It lets us notice any pressure changes three or four weeks before the patient develops pulmonary edema (fluid in the lungs) from exacerbated congestive heart failure. It gives us a chance to get pulmonary edema under control by adjusting medications while keeping the patient out of the hospital and in the comfort of his or her own home.”

“The last time, I was having shortness of breath,” explained Uchic. “I have to go over to Oakland (Md.) if I need to see someone in a hurry. This monitor will help the doctor decide if I should take more of my diuretic or other medications, and it should save me a trip to the hospital.”

http://www.newswise.com/articles/view/622471/?sc=rsla&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+NewswiseLatestNews+%28Newswise%3A+Latest+News%29

Roche To Buy InterMune Of Brisbane, California for $8.3 Billion

Pirfenidone is the drug sold under the name of Esbriet in Europe and Canada and does not yet have US FDA approval but according to the article below, it sounds promising it could happen before the end of the year.  The drug treats scarring of the lungs and there’s been no cause determined yet as it affects 70-200k Americans.  As scarring builds up people lose the ability to breathe and eventually die.  There are no other treatments for this condition other than some off label use and the other option is a lung transplant. 

Boehringer Ingelheim of Germany is also working on a drug to treat Idiopathic pulmonary fibrosis, which is the official diagnosis.  BD 

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The Swiss drug maker Roche agreed on Sunday to buy InterMune — which sells a drug to treat a deadly lung disease — for $8.3 billion, as pharmaceutical companies continue to seek new products to bolster their offerings.

The price, $74 a share, represents a 38 percent premium to InterMune’s closing price on Friday and a 63 percent premium to the price on Aug.12, before news reports that InterMune might be acquired.

The acquisition was announced amid a flurry of pharmaceutical deals and attempted deals.About $87 billion in pharmaceutical acquisitions were made in the first half of this year, eclipsing the total for all of 2013, according to Evaluate, a research company. The total for the first half does not include the $54 billion acquisition of Shire by AbbVie, which was announced in July.

InterMune, based in Brisbane, Calif., has one product on the market: a drug called pirfenidone to treat idiopathic pulmonary fibrosis, a fatal scarring of the lungs.

http://dealbook.nytimes.com/2014/08/24/roche-to-buy-drug-maker-intermune-for-8-3-billion/?partner=socialflow&smid=tw-nytimesbusiness

Hydrocodone-Combination Products Have Now Been Reclassified as Schedule II Drugs

The new classification goes into effect in 45 days.  In 2008 HHS received a petition to make this change and at that time the drugs were left as a Schedule III.   A year later the DEA made the request once again to be re-evaluated. 

The change was made due to the extreme abuse of the pain killers and the fact that they are addictive.  The Federal Register has all the details on the change.  Schedule 3 drug prescriptions expire 6 months after the day they are written.  There’s more drugs on the Schedule III list than you think and you can take a look here for most of them, some are actually surprising.  BD

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The U.S. Drug Enforcement Administration (DEA) has reclassified hydrocodone-combination products as the more restrictive Schedule II drugs in an attempt to curb drug abuse. The DEA published the Final Rule in the Federal Register on Aug. 22. The Final Rule will take effect in 45 days and will apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States.”

“Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said Michele Leonhart, DEA administrator, in a press release. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

Schedule II drugs are substances with accepted medical uses that have a high potential for harm and abuse, according the Controlled Substances Act. Hydrocodone-combination products contain both hydrocodone (a Schedule II drug) and other ingredients like acetaminophen, and were originally classified as Schedule III drugs.

http://www.painmedicinenews.com/ViewArticle.aspx?d=Web%2BExclusives&d_id=244&i=August+2014&i_id=1092&a_id=28024

AliveCor Receives FDA Approval For Patients To Use the Heart Monitor Smart Phone App and Device To Detect Atrial Fibrillation (AFib) And Alert Their Doctors

This is pretty good stuff and I have written about AliveCor before, when it was first only allowed to be used by veterinarians, and then later the FDA approved the use of the Heart Monitor for Doctor and Patient use.  The patient as I understand it still needs a prescription from a doctor to use the device and I would guess under most circumstances it would be a cardiologist.  In addition, AliveCor has the option of having the ECG read by a US board certified cardiologist.  Below are a couple back links. 

FDA Finally Approves AliveCor Iphone Enabled Heart Monitor, Now and the Cat and Dogs Have to Share the Technology With Us

While Waiting for FDA Approval for an IPhone ECG Company Launches Popular Veterinary Version–Cats and Dogs Get Heart Attacks Diagnosed

Now that the algorithm has been approved by the FDA, it should be available within a month or two and the company hopes to develop even more algorithms in time.  The AliveCor Heart Monitor records, stores and transfers ECG rhythms and detects presence of atrial fibrillation.  I think the device is great for a doctor to carry around with them if they desire. 

A physician can integrate the reports with an EMR as well.  So far the only one I see listed is Practice Fusion and it does cost $15 a month for the service but you do get the device free which is normally $199 alone.  This is the type of mHealth apps and devices I like to see and again this is way more than just a simple consumer app.  BD

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AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor's automated analysis process (algorithm) instantly detects if patients are experiencing AFib through real-time electrocardiogram (ECG) recordings taken on the mobile phone based AliveCor® Heart Monitor, so physicians can intervene before potentially life-threatening conditions, like strokes, occur. Through AliveCor's ECG analysis service, patients can confirm their results with a U.S. board-certified cardiologist or a personal physician.

"The ability to automatically detect serious heart arrhythmia using mobile technology has the potential to save lives, reduce healthcare costs and allow patients and their caregivers to make informed decisions about cardiac care," said Euan Thomson, president and chief executive officer of AliveCor. "Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September."

The AliveCor Heart Monitor is intended to record, store and transfer electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The AliveCor Heart Monitor is compatible with all iPhone models and most Android mobile devices. Users will continue to have the ability to access their data confidentially anytime, anywhere.

http://www.news-medical.net/news/20140821/FDA-approves-AliveCor-algorithm-for-detecting-AFib-through-ECG-recordings-on-mobile-phone.aspx

Express Scripts Cutting Off Access to Prescriptions for Compounded Drugs In September

One by one with pharmacy benefit managers the compensation for compounded drugs is going away.  This time it’s Express Scripts that is sending letters to patients and doctors with a mid September cut off.  Millions of patients benefit from compounded drugs.  Most patients using compounded drugs don’t have an alternative, why they are using compounded drugs to begin with.  So this is just great.  Already in July Optum/United Healthcare stated that compounded drugs will need a prior authorization in some parts of the country so they are not gone there yet but could be denied. 

In July United Healthcare HMO Patients Using Compounded Drugs Will Need To Have Doctor Submit Prior Authorization For Review In Western 3 States

Over billing seems to be some of the reasons but in California, a compounded prescription can’t go over $600.  Probably one of the most publicized cases with compounded drugs goes back to NECC in Massachusetts with contamination where several people died.  That case was an extreme one and many compounded drugs are not used in IVs such as their products.

Meningitis Fungus Investigation and Research Continues With FDA Inspection While Massachusetts Hospitals Contact Cardiac Patients About a Heart Medication Also Created at NECC

This controversy focuses on drugs that are not IV and are more or less blended creams to treat pain, etc.  The cost of the drugs supplied to compounders has risen also.  There are some legitimate complaints here with expensive diaper rash products, etc. that can be bought in another fashion but what about the rest of the drugs?  What are pharmacy benefit managers doing about expensive drugs that are not compounded too, and there’s a lot of those. 

Many hormone replacement drugs are compounded to an specific mix for patients as well. 

They should work on all of them as we are to the point to where drug companies and insurers need to work together as we are broke and there’s little the patient can pay any longer when it comes to expensive co-pays for high tiered drugs or those not covered at all.   Express Scripts also laid off 400 people as many moved over to United Healthcare who has their own pharmacy benefit management company and moved patients over to their own subsidiary.  BD 

Express Scripts To Lay Off 400 People Tampa As United Healthcare Moves Patients To Their Own Pharmacy Benefit Management Company-Subsidiary Watch

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FAIRHOPE, Ala., Aug. 14, 2014 /PRNewswire/ -- Express Scripts, the nation's largest pharmacy benefit manager, is offering ambiguous and misleading reasons for ending coverage of customized prescription medications for 540,000 individuals in order to conceal financial motives, a Patients and Physicians for Rx Access said Thursday, Aug. 14. The organization is fighting to stop the unprecedented benefit cuts being made by Express Scripts and other pharmacy benefit managers.

"In July Express Scripts began sending form letters to more than a half-million patients nationwide, saying it will stop paying for their compounded medications on September 15," said Jay McEniry, executive director of Patients and Physicians for Rx Access. "Patients are sharing those letters with us.  The letters are filled with misleading statements designed to confuse these patients while denying them access to important medications prescribed by their doctor."  

Some Express Scripts patients have received letters that fail to tell them their compounded prescription coverage is ending, instead describing the cutoff as a "clarification" of coverage. Those letters mention nothing of the mid-September cutoff date. Both versions of the letter instruct patients to replace their customized prescriptions with mass-produced, FDA-approved medicines, but warn that Express Scripts may not cover the new medications either.

In presentations regarding these benefit cuts, Express Scripts executives have told other audiences that the company's goal is to save hundreds of millions of dollars annually by ending coverage of essentially all compounded medicines before the end of 2014. When talking to patients, however, Express Scripts attempts to conceal its financial motives with misleading statements, McEniry said.

http://www.marketwatch.com/story/540000-patients-lose-compounded-prescription-coverage-says-patients-and-physicians-for-rx-access-2014-08-14

FDA Approves New Merck Drug for Insomnia

The drug is the first in it’s class to help you fall asleep and stay asleep.  As you can read there are 4 different strengths listed below.  BD 

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The U.S. Food and Drug Administration today approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

Belsomra is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra alters the signaling (action) of orexin in the brain.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble with attentiveness, learning, and memory.

“To assist health care professionals and patients in finding the best dose to treat each individual patient’s sleeplessness, the FDA has approved Belsomra in four different strengths – 5, 10, 15, and 20 milligrams,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409950.htm

Canadian Drug Stores Still Doing a Booming Business as Some Drugs Are Vanishing from Pharmacy Benefit Managers and Are Too Expensive for Medicare Participants..

This is a good story right here about Advair.  As mentioned the drug company recovered their R and D cost a long time ago, so what do they do next, patent the inhaler for a longer coverage time, since the drug itself is off patent.  For a 3 month supply the cost was $1036.00 and then the price went up to $1240.00.  Medicare pays most of that price.  The cost of the same in ordering from Canada is $250 for the same amount, even less than the co-pay. 

In Canada and in the UK drug companies are somewhat regulated on what they can charge but no in the good old USA and sales of Advair were over 8 billion.  The couple referenced here had to take out a reverse mortgage too because of the cost of their medications, mainly his wife.  Advair is made by GlaxoSmithKline, who by the way is putting some of their older drugs out to bid for private equity firms to bid on and buy.  What’s going to happen then, God only knows with PE firms running and managing pharmaceuticals. 

Private Equity Firms Exploring Options to Buy Old Drug Brands From GlaxoSmithKline and Sanofi, Glaxo Has Already Opened the Door Asking For Bids From PE Firms

One thing also worth a mention by not going through Express Scripts they don’t have to deal with the predictive analytics data that is created at all the PBMs today either.   Everyone thinks they can predict who’s not going to take their meds and plus a little of this is charged into the cost in the US as well.    

Express Scripts- New Program to Contact and Predict Patients Who May Not Be Taking Their Medicine Based On Ingenix Algorithms–We Want the Revenue Please Don’t Stop

Consumers are broke and it’s up to the insurers and drug companies to sit down and negotiate, not us.  BD 

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Brent and Henni Christensen consider themselves patriotic Americans and strong supporters of Medicare.

Nevertheless, the Huntington Beach couple buy most of their prescription drugs from an online Canadian pharmacy at prices much lower than in the United States.

In January, the biggest manager of prescription drug benefits for insurers and drugstores, a company called Express Scripts, said it would no longer reimburse Advair purchases because the drug had become too expensive.

This week, Express Scripts said it had cut a new deal with Glaxo and would start reimbursing Advair purchases again next year. It's unclear how the accord will affect prices. Express Scripts said it will classify Advair as a "non-preferred" drug, meaning that patient co-pays will be higher than for preferred meds.

What cost $1,240 in the United States ran about $250 in Canada — even less than their U.S. copay.

Advair's patent protection expired in 2010, but Glaxo's patent on the inhaler used to administer the drug lasts until 2016. There are currently no generic alternatives for the drug.

http://www.latimes.com/business/la-fi-lazarus-20140808-column.html?track=rss&cid=dlvr.it&dlvrit=52116

FDA Authorizes Use of Non Approved Ebola Virus Test - Special Emergency Use Provision

A vaccine doesn’t look to be on track until the end of 2015 but at least the test is available.  The outbreak in the US would be extremely rare but at hospitals where patients are being treated, like Emory they will need the test to be available just in case someone was accidentally exposed, etc.  Around 55% of those infected end up dying.  BD

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The FDA has authorized use of an unapproved Ebola virus test under a special emergency-use provision, although efforts to develop a vaccine for the deadly illness are unlikely to bear fruit until 2015, officials say.

The test-tube diagnostic test was developed by the U.S. military and is used to detect the Zaire strain of Ebola, which has infected at least 1,711 and killed 932 in West Africa.

"The test is designed for use in individuals, including Department of Defense personnel and responders, who may be at risk of infection as a result of the outbreak," FDA spokeswoman Stephanie Yao said in a statement. 

"Two other companies, Tekmira and BioCryst Pharmaceuticals, receive funding from the Department of Defense's Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development," read a statement from the U.S. Department of Health and Human Services.

http://www.latimes.com/science/sciencenow/la-sci-sn-ebola-vaccine-20140806-story.html

FDA Approves Another New Diabetes 2 Drug

There’s no shortage on the attack of diabetes 2 and drugs that are used to combat it.  Just recently we had another drug approved and both are to be used with changed lifestyles and this drug, Jardiance does not depend on insulin levels to work. 

FDA Approves New Drug For Diabetes 2 - Farxiga

The drug was also approved in Europe as well.  The drug is not for people with diabetes one.  BD 

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Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes .

The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.

The drug is designed to be taken once a day to reduce a patient's blood sugar levels by blocking glucose reabsorption in the kidneys and removing excess glucose through urine. Unlike other diabetes treatments, it does not depend on a patient's insulin levels to be effective.

http://www.businessweek.com/ap/2014-08-01/fda-approves-lilly-boehringer-diabetes-drug

Amgen to Lay Off 2900 Employees, Close Two Plants As Profits Are Up 23% 2nd Quarter

This is a restructuring move the article states and it’s not due to lost revenue that’s for sure. The Bothell, Washington operation will be closed impacting 600 jobs in Seattle and 50 at the manufacturing plant and it currently is the largest biotech employer in the area. 

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Biotech giant Amgen Inc. said it would lay off up to 2,900 employees and close facilities in Washington state and Colorado, as the Thousand Oaks company moved to reign in expenses and focus on new drugs.

Those cuts could amount to nearly 15% of its 20,000 worldwide employees. Amgen said it would use the savings -- as much as $700 million a year -- to support global launches of new products.

Word of the cuts came as the company announced strong second-quarter results that beat Wall Street estimates.

Bradway did not say how many of the job cuts would be at its sprawling Thousand Oaks campus. He said the company intends to focus on "reducing layers of management" as part of the cuts.

Amgen announced the cuts on the same day that it said it posted a 23% increase in second-quarter profit. Revenue was up 11%, the company said.

http://www.latimes.com/business/la-fi-amgen-will-lay-off-up-to-2900-workers-close-plants-in-two-states-20140729-story.html?track=rss&cid=dlvr.it&dlvrit=52116

FDA Approves New Tamper Proof Oxycodone Painkiller From Purdue Pharma - Targiniq

This is a new tamper proof drug which means if it is crushed it looses it affect, but of course people can still swallow the pills.  Purdue will have to conducted follow up studies on rates of abuse, addiction and death as that’s a standard anymore for any Opioid drugs.  BD

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Washington • The Food and Drug Administration has approved a new combination pain pill from the maker of OxyContin that is designed to discourage abuse by painkiller addicts.

Purdue Pharma’s new drug Targiniq ER is an extended release tablet that combines oxycodone — the active ingredient in OxyContin — with the drug naloxone. FDA regulators approved the drug for daily, round-the-clock pain that does not respond to other medications.

Stamford, Connecticut-based Purdue has often been cited by public health advocates as a key contributor to the overprescribing of opioids. In 2007, Purdue Pharma and three of its executives paid $634 million and pleaded guilty to charges of misleading the public about the safety and addictiveness of OxyContin.

http://www.sltrib.com/sltrib/money/58216959-79/abuse-fda-drug-oxycontin.html.csp

UPS Accelerates US Medical Device Deliveries With 36 New Healthcare Compliant Field Stocking Locations

I wrote about this once before and actually talked to an executive at UPS about this.  We we talking about insulin pumps and the ability to have a replacement out to a patient in a hurry as they are stocked at the UPS facility and not at the manufacturer’s location or warehouse.   The article states that 80% of the US hospitals are reachable with a shipment within 4 hours.  Of course this mean you have to pay for it and I’m sure it’s not standard UPS ground rates:)

I said too at one point in time you could see the pharmacy benefit management start moving into such warehouses and while we are not there yet, well who knows. 

UPS Healthcare Fulfillment Centers Continue to Grow And What Effect Could This Have on the Future Further Changing the Pharmacy Benefit Business?

Here’s a coupe more additional back links, so you can see their plant noted below have taken place according to this article.  In Louisville, pharmacists fill 4000 orders a day or insulin pumps and they are employed by UPS.  They are connected directly to the Medtronic fulfillment system so the order is filled as it if was pulled from a Medtronic warehouse.  There are a total of 46 dedicated healthcare distribution centers in the UPS system.  BD 

UPS Expanding Healthcare Focus With Giant Warehouses for Temperature Sensitive Drugs and Vaccines

UPS to spend $100 million on 4 New Global Distribution Centers To Serve Biotech, Pharma and Medical Device Companies

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The company said the 36 new healthcare-compliant Field Stocking Locations mean that for medical device manufacturers, products can reach more than 80% of US hospital beds in just four hours.

The world’s biggest package delivery firm said the Field Stocking Laboratories feature temperature-controlled or monitored environments to meet the storage needs for medical items.

UPS claimed that the new supply chain approach would help manufacturers manage their inventory more efficiently while meeting increasingly stringent industry standards and regulations — while also cutting inventory costs.

John Menna, UPS vice president of global healthcare strategy said: “Due to an increasingly complex regulatory environment and significant cost pressures, medical device manufacturers are looking to the supply chain to lower costs through inventory reduction and enhanced visibility.

Along with its network of US Field Stocking Laboratories, the company now has 46 dedicated healthcare distribution facilities worldwide.

http://postandparcel.info/61891/news/companies/ups-accelerates-us-medical-device-deliveries-with-new-network/

Genentech (Roche) To Buy Seragon Pharmaceuticals - Breast Cancer Therapies $750 Million Cash & Up To An Additional Billion Based on Performance

Seragon has only been in business for around a year or so.  As you can see $750 cash and an addition billion depending on how the drugs perform at certain milestones.  From the website below: 

“At the core of Seragon Pharmaceuticals, are the scientists, clinicians, management and investors of Aragon Pharmaceuticals, Inc. that discovered and developed the breakthrough 2nd generation anti-androgen ARN-509. Aragon was acquired by Johnson & Johnson in August, 2013 for $650 million in cash up front along with $350 million in contingent development milestone payments. Seragon will apply this expertise and proven track record in developing next-generation ER targeting agents to treat endocrine-resistant breast cancer. In addition, with their unique mechanism of action, these novel agents are predicted to have robust activity in early stage disease, thereby supplant existing therapies across the spectrum of breast cancer disease states. This class of agents also has potential to treat other ER-driven cancers as well, such endometrial and ovarian cancers. “

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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced it has entered into a definitive agreement to acquire Seragon Pharmaceuticals, Inc. (Seragon), a privately held biotechnology company based in San Diego, California. With this acquisition, Genentech obtains rights to Seragon’s entire portfolio of investigational next-generation oral selective estrogen receptor degraders (SERDs) for the potential treatment of hormone receptor-positive breast cancer.

“This year, breast cancer will claim the lives of nearly 40,000 women in the United States, and up to half of these women will have a disease that is driven by the estrogen receptor,” said Richard Scheller, Ph.D., executive vice president and head of Genentech Research and Early Development. “We believe these investigational oral SERDs could one day redefine the standard of care for hormone receptor-positive breast cancer.”

Under the terms of the agreement, Genentech will make an upfront cash payment of $725 million, plus additional contingent payments of up to $1 billion based on achievement of certain predetermined milestones.

http://www.gene.com/media/press-releases/14567/2014-07-01/genentech-announces-definitive-agreement

FDA Files Injunction Against California Drug Company Distributing Vaginal Wipes & Lubricants, Remove Your False Advertising or File Your Drug Application

We have seen this before and the one that comes to mind was back a ways when Cheerios was told to file an application for their false advertising but look how long this has gone on here, since 2010 and the company ignored the the warnings on several occasions.  BD

“Laclede Incorporated is a leading contract manufacturer of private label and custom formulations, based in Southern California. For over 25 years Laclede has been producing products for Fortune 500 CPG corporations, up-and-coming- entrepreneurs and leading retailers all over the globe.”

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On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval.

According to the complaint, Laclede is in violation of the Federal Food, Drug, and Cosmetic Act for introducing unapproved and improperly labeled (misbranded) drugs for sale across the country. The prebiotic vaginal products named in the complaint are:

    Luvena Prebiotic Vaginal Moisturizer and Lubricant
    Luvena Prebiotic Enhanced Personal Lubricant
    Luvena Prebiotic Feminine Wipes
    Luvena Prebiotic Daily Therapeutic Wash

The complaint requests, among other things, that the court issue a permanent injunction order requiring Laclede to cease distribution of these drug products until the company obtains an approved new drug application from the FDA or until all drug claims have been removed from the products’ labels, marketing materials, and any websites controlled by or related to Laclede.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm403561.htm