“After discussions with the FDA, we have a greater appreciation for its concern about the proliferation of caffeine in the nation’s food supply,” Wrigley President Casey Keller said. “There is a need for changes in the regulatory framework to better guide the consumers and the industry about the appropriate level and use of caffeinated products.”

In a world where everyone is constantly moving, food and beverage companies have hit it big with products featuring extra caffeine. Many soda makers have introduced “energy” drinks, and super-caffeinated shots like 5 Hour Energy claim to give the consumer a boost when they’ve hit the 3:00 slump. But it’s also a time when parents are concerned about the effects of extra caffeine and sugar on their children, and the Food and Drug Administration says they want to look further into it before they can give their stamp of approval.

Though the gum has always been marketed with similar energy products rather than with candy, the company says they will comply with any regulations set forth. Each stick of gum contains around 40 milligrams of caffeine, which is the equivalent of half a cup of coffee.

The devices, made of cobalt-chromium-molybdenum alloys, slide against each other when patients walk or run using them. With enough of that sliding, small bits of metal particles can wear off the cup or other parts of the implant where components connect. The particles can then cause damage to soft tissue and bone around the implant and joint.

In addition to the pain caused by what doctors call an “adverse reaction to metal debris” (ARMD), the process can loosen the implant. In extreme cases this can cause the hip implant to fail, meaning more surgery would be required to replace it.

The FDA also stated that metal ions can be released into the bloodstream, traveling to other parts of the body where they can cause symptoms or illnesses. However, reactions to the metal wear particles seem to be specific to patients, and the FDA does not have enough data to say just how high the concentration of metal ions is in a patient’s body.

As a result of the warning, the FDA is recommending that surgeons consider alternative hip implants, such as metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or ceramic-on-metal, depending on a patient’s age, sex, weight, diagnosis, and activity level. It is also recommended that patients with metal-on-metal hip implants receive yearly or biyearly physical exams and radiographs.

Canagliflozin, which Johnson & Johnson has given the proposed trade name of Invokana, will, if further approved by the FDA later this year, be the first of a new type of diabetes drugs to be available in the U.S. It is a selective glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidneys, which increases glucose excretion and lowers blood glucose levels. People with type 2 diabetes have kidneys that reabsorb greater-than-normal amounts of glucose back into the body.

“We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the U.S. to help them manage their type 2 diabetes,” said Dr. Peter Stein, head of the Metabolism Development and Diabetes Disease Area departments at Janssen Research & Development, the Johnson & Johnson R&D company that developed the drug. “Today’s outcome represents an important step toward achieving that goal.”

The approval came after the results of a phase 3 clinical trial were presented at diabetes conferences last year. According to Janssen, the trial, which looked at 10,285 patients, was the “largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes” ever submitted to health authorities. The results showed that canagliflozin improved glycemic control and was associated with weight loss and lower blood pressure. The side effects of the drug included yeast infections and urinary tract infections.

The committee voted 9 to 6 to recommend Kynamro, and Isis will include the recommendation in its application for FDA approval. Though the vote will be considered when the drug is reviewed, the FDA is not bound by the recommendation.

“We are very encouraged by the support for Kynamro at today’s Advisory Committee meeting, which marks a significant and positive step in our efforts to bring this important new therapy to patients and families affected by this often unrecognized genetic disorder,” said David Meeker, President and CEO of Genzyme, Isis’ marketing partner for the new drug. “There is still a great need for the HoFH patients, who have exhausted conventional medications and still have LDL cholesterol levels 2 to 4 times above normal. Genzyme looks forward to working with the FDA as it completes its review of the Kynamro application.”

In making its decision, the committee reviewed data from a phase 3 study of Kynamro in HoFH patients, three other “supportive ” phase 3 studies of high-risk hypercholesterolemia patients, and and ongoing long term extension study

The drug will be marketed under the name Stivarga by Bayer HealthCare Pharmaceuticals. It is approved to treat patients that have already been treated for colorectal cancer, but seen the disease metastasize and spread to other parts of the body. The treatment is a multi-kinase inhibitor that blocks specific enzymes that promote cancer growth.

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research.

Last month, a drug named Zaltrap was approved to treat adults with metastatic colorectal cancer.

Stivarga was approved one month ahead of when the FDA was expected to complete its review of the drug. The treatment was fast-tracked by the FDA under its priority review program, which expedites a six-month review for drugs that are “major advances” in treatment.

A study of 760 patients with metastatic colorectal cancer showed the effect of Stivarga. Studies showed that patients who received Stivarga saw a delay in tumor growth with a median of two months compared to those receiving a 1.7-month-median placebo. Overall, the patients treated with the drug lived a median of 6.4 months compared to placebo patients, who lived a median of five months.

The active ingredient in BG-12 is the compound dimethyl fumarate. The trials, which were published yesterday in the New England Journal of Medicine, were financed by Biogne Idec, a biotechnology company that creates drugs for neurological and autoimmune disorders. The company is seeking U.S. Food and Drug Administration (FDA) approval for the treatment.

“The publication of both dimethyl fumarate pivotal studies in NEJM is another achievement for this important investigational therapy,” said Dr. Katherine Dawson, senior medical director at Biogen Idec Neurology Research and Development and co-author of the published studies. “The data from its clinical development program consistently indicate that dimethyl fumarate may provide tangible benefits and address existing treatment needs of people living with MS. We are working closely with regulatory authorities across the globe with the aim of making the review of dimethyl fumarate as quick as possible.”

The two studies found that both twice-a-day and thrice-a-day 240mg treatments with BG-12 reduced the proportion of patients with relapsing-remitting MS who relapsed by anywhere from 44% to 51%. Both studies were two-year global clinical trials that investigated BG-12 compared to a placebo.

Just last week, a once-a-day pill for the treatment of relapsing forms of MS called Aubagio was approved by the FDA.

“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Dr. Russell Katz, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”

According to the National Institutes of Health, MS is a chronic autoimmune disease that affects the central nervous system. It disrupts the communication between the brain and the body, causing motor skill disruption for nearly every part of the body, depending on which nerves in the brain are damaged.

As for the drug itself, side effects seen during drug trials included diarrhea, abnormal liver tests, nausea, and hair loss. Also, the box warnings for the drug warn of possible liver problems and fetal harm, including the risk of birth defects. Doctors will have to check patient’s liver function and give a pregnancy test before starting treatment with Aubagio.

“Many people living with MS struggle with the additional burden of injectable therapies administered daily to weekly,” said Dr. Aaron Miller, medical director at the center for multiple sclerosis at Mount Sinai Medical Center. “The FDA’s approval of Aubagio, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease.”

The medication is approved for the treatment of adults with chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) that has resisted prior therapy. The American Cancer Society estimates that almost 5,500 new CML cases will be diagnosed in 2012, and that just over 600 people will die of the disease. Just over 10% of new leukemia cases are CML, and over half of the people who get it are over the age of 65. According to Pfizer, Bosulif blocks CML cell growth by inhibiting the Abl and Src signaling pathways.

“Bosulif is an important new addition to the CML treatment landscape,” said Dr. Jorge Cortes, professor of medicine in the Department of Leukemia at the University of Texas, and a lead investigator of the Pfizer’s registrational study for Bosulif. “Despite recent advances, an unmet need remains for many CML patients who are refractory to one or more tyrosine kinase inhibitors.”

Bosulif was quickly approved because of its status as an orphan drug. Orphan drugs are drugs that have been developed to treat rare diseases and conditions. In the U.S. and E.U., orphan drugs are fast-tracked for approval, and companies can often charge a premium for them. The wildly expensive scorpion antivenom Anascorp is another example of a recently approved orphan drug.

Despite the troublesome laboratory tests just two years ago, the FDA has approved the drug for the American population, 35 percent of which is currently overweight or obese. However, those who are hoping for a “get thin quick” miracle pill will no doubt be extremely disappointed, as Belviq is to be taken alongside a proper diet and adequate exercise. The approval comes in the wake of doctors demanding new weight-loss treatment options.

Of course, like just about every drug on the market, users can expect to experience some side-effects, which include depression, migraine, and memory lapse. The FDA also stated that patients should stop using the drug after three months if they have not lost at least five percent of their body weight. Extended usage of the drug after that period of time will not increase the likelihood of weight loss.

“This is good news because it tells us that the FDA is indeed treating obesity seriously,” Obesity Society President Patrick O’Neil explained to the AP. “On the other hand, it’s not the answer to the problem — or even a big part of the answer.”

Weight loss pills have a storied history of safety concerns. Fen-phen, for example, was linked to heart-valve damage back in 1997. However, doctors readily prescribed this medication to their overweight patients despite the fact that it wasn’t approved by the FDA.

Qnexa, another drug that’s been pushing for approval, is considered to be one of the more promising weight-loss drugs currently vying for attention. The FDA is expected to rule on it this July. Belviq, meanwhile, will likely launch sometime next year.

The FDA states that the fake version of Adderall contain the wrong active ingredient. Spotting the differences between the two is relatively easy for those who have used the product in the past. The counterfeit pills are white with no visibile markings, while the real tablets are orange/peach in color and have “dp” printed on one side and 30 on the other. The number 30, of course, is a reference to the dosage.

“Consumers should be extra cautious when buying their medicines from online sources,” the FDA explained in a media statement. “Rogue websites and distributors may especially target medicines in short supply for counterfeiting.”

According to Daily Dose, Adderall is currently in very short supply, and has been for a while now. This may explain why so many knock-offs have started popping up online.

Other ways to identify the bogus pills include:

• Blister packaging
• Numerous misspellings on the packaging
• The pills, in addition to being white, are round and smooth

If you think you’ve gotten your hands on some counterfeit Adderall, pay a visit to the FDA’s MedWatch website and fill out a report.