Archives for September 2015

FDA approves two new diabetes drugs

FDA  has cleared two new drugs, insulin degludec injection (Tresiba—Novo Nordisk) and insulin degludec/insulin aspart injection (Ryzodeg 70/30—Novo Nordisk), for adults with diabetes. Insulin degludec injection, a long-acting insulin analog, was approved to improve glycemic control in adults with type 1 and type 2 diabetes. The drug is administered subcutaneously once a day. Insulin degludec/insulin aspart injection, a combination of a long-acting insulin analog and a rapid-acting insulin analog, was approved to improve glycemic control in adults with type 2 diabetes. The most frequently adverse events reported with the two drugs in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site, itching, rash, edema, and weight gain. FDA notes that neither drug should be used in adults who have diabetic ketoacidosis.

FDA warns about pain pill in kids

The Food and Drug Administration says it’s investigating the use of a pain pill called tramadol in children and teens under the age of 17 because some of them can develop dangerously slow breathing.

FDA approves new oral medication to treat patients with advanced colorectal cancer

The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

AbbVie Seeks FDA Approval for Imbruvica’s Label Expansion

Imbruvica is already approved in the U.S. for the treatment of patients with mantle cell lymphoma or CLL who have received at least one previous therapy and for CLL patients (treatment naïve) with del 17p. It is also approved for the treatment of patients with Waldenstrom’s macroglobulinemia.
We remind investors that Imbruvica was added to AbbVie’s portfolio following the Pharmacyclics acquisition in May 2015. AbbVie has a development and commercialization agreement with Johnson & Johnson’s (JNJ – Analyst Report) Janssen Biotech, Inc. for Imbruvica.
We are encouraged by AbbVie’s efforts to expand Imbruvica’s label further. AbbVie expects Imbruvica peak sales of more than $7 billion and U.S. sales of about $1 billion in 2015. Imbruvica is currently being studied alone and in combination with other treatments for several types of blood cancer. Label expansion would boost the drug’s sales further.
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Dr. Reddy’s Laboratories Ltd. (RDY – Analyst Report), Gilead Sciences Inc. (GILD – Analyst Report) and Johnson & Johnson. While Dr. Reddy’s and Gilead are Zacks Rank #1 (Strong Buy) stocks, Johnson & Johnson holds a Zacks Rank #2 (Buy).

Update on pregnancy, lactation drug labeling after FDA ruling

A significant change to the labeling of many drug products officially occurred June 30, when a final rule issued by the FDA, the Pregnancy and Lactation Labeling Rule, became effective. This rule applies only to drug products available in the United States by prescription and does not affect the labeling of drug products available over-the-counter.e insert, and it contains useful and invaluable information, including indications, dosing, adverse effects, contraindications and use in specific populations such as pregnant women and pediatrics, among other information. This information is vital

FDA Panel Votes Against Painkiller From OxyContin Maker

Federal health advisers have overwhelmingly voted against a proposed painkiller from the maker of OxyContin due to risks of overdose.

Purdue Pharma is seeking FDA approval to market a harder-to-abuse version of the immediate-release drug oxycodone. The company already sells an extended-release formulation of the drug OxyContin, which is designed to thwart crushing or snorting.

Ergonomic Stool

Puncture proof ergonomic chair. Contoured seat and back provide comfortable support. Puncture and tear resistant black polyurethane foam with tough outer self-skin performs maintenance free in tough environments. Independent seat and back tilt angle adjustment allow personalized positioning. Backrest features 35″ to 42″H and 2″D adjustments. 16″ to 21″ pneumatic seat height adjust. Seat: 18-1/2″W x 17″D x 2″ Back: 16-1/2″W x 12″H. Strong 5 blade base includes both casters for mobile use and glides for stationary use. Available with or without arms. Easy assembly.

PARTICLE COUNTER

Kit includes everything you need: 3 channel laser diode particle counter w/internal pump. 0.3um- 5.0um Good to ISO 4. NIST traceable. Computer download software and USB cable Isokinetic Probe. Calibration Filters Rechargeable batteries (4.5 hour constant use life), charger and AC adapter. Lockable Hardened Carrying case for all components. Huge 8 Line COLOR display. Internal HEPA. Retains 8,000 sample records.

PREFILTERS

Prefilters – ASHRE high efficiency Merv 11 Filter 20″ x 20″ x 2″

CHEMOTHERAPY SHARPS COLLECTOR

Chemotherapy Sharps collectors, yellow, 5 gal. For incineration. Biohazardous. Dimensions: 18 in. x 10.5 in. x 7.5 in.8 collectors/unit. Sold by the unit only.