FDA grants Breakthrough Therapy Designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC

FDA grants Breakthrough Therapy Designation for Roche's Alecensa (alectinib) for first-line treatment of people with ALK-positive NSCLC

Roche (SIX: RO, ROG; OTCQX: RHHBY) has received a second Breakthrough Therapy Designation (BTD) from the United States Food and Drug Administration (FDA) for its ALK inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.

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published in: 2016-10-06 15:54:30

FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes

FDA Approves 1st 'Artificial Pancreas' for Type 1 Diabetes

The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system - a so-called "artificial pancreas" - for people with type 1 diabetes.

"This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.

The device -- Medtronic's MiniMed 670G -- is what's known as a hybrid closed-loop system. That means it monitors blood sugar and then delivers necessary background (also known as basal) insulin doses. The device will also shut off when blood sugar levels drop too low.

However, this device isn't yet a fully automated artificial pancreas. People with type 1 diabetes will still need to figure out how many carbohydrates are in their food, and enter that information into the system, the agency noted.

Medtronic said the new device will be available by Spring 2017. The FDA approval is currently only for people aged 14 and older. The company is now conducting clinical trials with the device in younger patients.

The device has a continuous glucose monitor that...

published in: 2016-10-04 09:22:31

Could Prescribed NSAID Painkillers Raise Heart Failure Risk?

Could Prescribed NSAID Painkillers Raise Heart Failure Risk?

Use of prescription-strength ibuprofen,naproxen and other commonly used pain relievers may be tied to a higher risk ofheart failure, researchers report. These medications may raise a person's relative risk of heart failure by nearly 20 percent, according to the analysis of medical records for nearly 10 million patients. A person's risk of hospitalization for heart failure doubles for some NSAIDs used at very high doses, including diclofenac (Cataflam or Voltaren), etoricoxib (Arcoxia), indomethacin (Indocin), and piroxicam (Feldene), Arfe said. Also, "our findings -- which focused only on prescription NSAIDs -- might apply to over-the-counter NSAIDs as well," Arfe said. "Although over-the-counter NSAIDs are typically used at lower doses and for shorter durations, they are sometimes available at the same doses as prescription NSAIDs and they may be inappropriately overused."

Still, the nature of the study can only point to an association between NSAID use and heart failure risk -- it can't prove cause-and-effect. And one expert believes that most patients who need an NSAID for their pain can safely continue using the drugs. To look more closely at this link between NSAIDs and heart failure, Arfe and colleagues pored through millions of European health records from 1999 through 2010. The patients came from Germany, Italy, the Netherlands and the United Kingdom.

The analysis included a total of 27 individual NSAIDs,...

published in: 2016-09-29 07:45:58

FDA approves Companion’s Bluetooth-enabled insulin pen backed by Lilly

FDA approves Companion’s Bluetooth-enabled insulin pen backed by Lilly

The FDA has given its okay to Companion Medical’s InPen delivery system, which the company touts as the first U.S.-approved Bluetooth-enabled insulin pen.

The San Diego-based company’s device includes technology that can calculate and recommend the best dosing for patients, track the history and timing of doses, monitor insulin temperature, report information to health-care providers, and is compatible with  Eli Lilly's ($ELY) Humalog or Novo Nordisk's ($NVO) Novolog rapid acting insulins.

"The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally,” Sean Saint, Companion’s CEO, said in a statement.

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published in: 2016-09-21 14:54:27

Could EpiPen's plastic cap be Mylan's secret weapon?

Could EpiPen's plastic cap be Mylan's secret weapon?

To protect its monopoly, Mylan petitioned the FDA last year to reject a generic from Teva Pharmaceutical Industries. Teva's copycat was not equivalent, Mylan said, and shouldn't be eligible for approval.

In what way? Mylan cited EpiPen’s one-cap design, which releases at the push of a button, versus Teva’s device, which must be uncapped before use. A removable cap such as Teva’s could cause confusion, Mylan said, especially for patients dealing with an emergency.

The details of Teva's rejection aren't public, so there's no way of knowing whether the cap played a role. But it wouldn't be the first time that a delivery device kept copycat drugmakers at bay. GlaxoSmithKline, for instance, has enjoyed years of exclusivity on its respiratory blockbuster Advair, simply because its still-patented Diskus inhaler was too difficult to match.

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published in: 2016-09-21 14:00:48

Sanofi Files Suit Against Merck, Claiming Patent Infringements

Sanofi Files Suit Against Merck, Claiming Patent Infringements

PARIS—Sanofi SA said it filed a lawsuit against Merck & Co. for alleged patent infringements to prevent the U.S. drugmaker from launching a rival version of the French pharmaceutical giant’s best-selling diabetes treatment Lantus.

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published in: 2016-09-20 11:57:23

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.

DMD is a rare genetic disorder characterized by progressive muscle deterioration and weakness. It is the most common type of muscular dystrophy. DMD is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. The first symptoms are usually seen between three and five years of age, and worsen over time. The disease often occurs in people without a known family history of the condition and primarily affects boys, but in rare cases it can affect girls. DMD occurs in about one out of every 3,600 male infants worldwide.

Exondys 51 was approved under the accelerated approval pathway, which provides for the approval of drugs that treat serious or life-threatening diseases and generally provide a meaningful advantage over existing treatments. Approval under this pathway can be based on adequate and well-controlled studies showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit to patients (how a patient feels or functions or whether they survive). This pathway provides earlier patient access to promising new drugs while the company conducts clinical trials to verify the predicted clinical benefit.

Under the accelerated approval provisions, the FDA is requiring Sarepta Therapeutics to conduct a clinical trial to confirm the drug’s clinical benefit. The required study is designed to assess whether Exondys 51 improves motor function of DMD patients with a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. If the trial fails to verify clinical benefit, the...

published in: 2016-09-20 11:54:15

Severe Obesity and Heart Failure

Severe Obesity and Heart Failure

Researchers from Johns Hopkins University in Baltimore reviewed data from more than 13,000 American adults, average age 54. After accounting for other risk factors such as high blood pressurehigh cholesterol and diabetes, the researchers concluded that severe (morbid) obesity was a stand-alone risk factor for heart failure.

Severe obesity is defined as having a body mass index of 40 or higher, according to the U.S. Centers for Disease Control and Prevention. Body mass index is a rough estimate of a person's body fat. A BMI of 25 or below is generally considered normal weight.

"Obesity in our study has emerged as one of the least explained and likely most challenging risk factors for heart failure, because there is no magic pill to treat it, no drugs that can easily address the problem like there are for high cholesterol and high blood pressure," said Dr. Chiadi Ndumele. He is an assistant professor of medicine and member of Hopkins' Ciccarone Center for the Prevention of Heart Disease.

"Even if my patients have normal blood sugar, cholesterol and blood pressure levels, I believe I still have to worry that they may develop heart failure if they are severely obese," Ndumele said. "If our data are confirmed, we need to improve our strategies for heart failure prevention in this population."

The study was published recently in the Journal of the American Heart Association.

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published in: 2016-09-18 14:33:43

Ask the pharmacists: Why do my meds cost so much?

Ask the pharmacists: Why do my meds cost so much?

Until about 10 years ago, the common knowledge on the street was that brand-name drugs were a bit expensive but that generic versions, if available, were much, much cheaper. While most of that statement is true today, things have gotten complicated and all prices have gone way, way up.

Let's look at the various components of this issue and we'll start with brand-name drugs. These are usually the result of corporate research and enormous investment, frequently for more than a decade. The pharmaceutical company has to recoup its investment within the first 21/2 to 3 years, before similar products reach the market from competing companies. That price must cover the research and development for that product, but also the work that went into products that flamed out and never went to market. Many of these products, especially for chronic diseases, sell for around $600 for 90 tablets or capsules.

Next, let's look at the generic versions, which are permitted after the originator's patent expires. Patent life used to be 17 years but was raised to 20 years in the 1990s to be the same as in the European Union. The U.S. Food and Drug Administration allows the first generic product approved to have a 180-day exclusivity period. Typically, if the branded product sells (wholesale from the manufacturer) for $600, this first generic will sell at a 20 percent discount, or at about $480. The fun begins after 180 days, when perhaps a dozen or so other generic manufacturers join the fray. Now the price falls like the proverbial lead balloon, reaching $200 to $300 a bottle (and sometimes less) after several months. At those prices, most of the newcomers drop out of the market because they could not make a satisfactory profit.

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published in: 2016-09-05 10:26:13

Fried, Grilled or Baked Foods? They May Affect Type 2 Diabetes Risk

Fried, Grilled or Baked Foods? They May Affect Type 2 Diabetes Risk

Changing the way you cook could help reduce your risk of getting type 2 diabetes, a new study suggests.

Boiling, steaming and poaching look like the safest way to go, researchers say.

When you fry, grill or bake foods -- also called dry-heat cooking -- foods produce substances called advanced glycation end products (AGEs).

Higher levels of AGEs have been linked to insulin resistance, stress on the body's cells and inflammation, according to the study authors. These are troublemakers in terms of diabetes risk.

"When you look at people with chronic diseases like type 2 diabetes or dementia put on a high-AGE diet or a low one, those on the low-AGE diet show signs of decreasing inflammation," said the study's lead author, Dr. Jaime Uribarri. He's a professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City.

The researchers randomly assigned study participants to one of two diet groups. The regular-AGE diet group included 49 people; the low-AGE diet group had 51.

All were at least 50 years old. And they had at least two of the following five health concerns (or...

published in: 2016-09-04 11:06:30