Category: Food and Drug Administration

After Hair-Loss Drug Came Years of Erectile Dysfunction

Erectile dysfunction is difficulty achieving and maintaining a sufficient erection to have sex. “In fact, in 2012, the Food and Drug Administration announced a label change for Propecia and Proscar , requiring the manufacturer to warn that the medication may be associated with ‘libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug'”.

FDA Files New Appeal Over E-Cigarettes

… yrockets for top performers! Other channels seek to redefine convenience! The economy enters a new stage. The growing health-and-wellness trend. Fuel demand; oil’s slide; multicultural momentum; and data, data, data!

Your chicken’s been bleached, and feds approve

… bug parts are indeed safe for consumption. According to their “Defect Levels Handbook,” these standards “present no health hazard.” As to our bleached chicken consumption, the feds insist , “The antimicrobial chemicals sprayed on chicken carcasses, …

Here’s Why Trevena Dropped 11.8% Today

The pre-revenue company didn’t announce any surprises one way or the other. However, investors appear to be considering the near-term consequences of swelling expenses that won’t be offset by product sales anytime soon.

TiGenix Receives Positive Feedback from the FDA on Cx601 Global Phase III Trial Protocol

TiGenix NV , an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platform of allogeneic stem cells, announced today that it has received positive feedback from the U.S. Food and Drug Administration on an improved protocol for its global Phase III trial for the treatment of complex perianal fistulas in Crohn’s disease patients.

Advaxis Announces FDA Acceptance of IND for Groundbreaking…

Advaxis, Inc. , a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration has indicated the Investigational New Drug application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in collaboration with Amgen , can proceed. This ground-breaking IND paves the way for bringing a new precision immunotherapy for the treatment of cancers into the clinic this year.

This common food likely just caused a big E. coli outbreak

Authorities are scrambling after a popular health food caused a big E. coli outbreak in multiple states across the nation. A dozen people, including children, have come down with E. coli in five states, and authorities think they have narrowed it down to a likely suspect: I.M. Healthy SoyNut Butter, a substitute for peanut butter.

FDA approves first drug to limit frequent waking to urinate

The treatment is a nasal spray intended for adults who wake up at least twice a night to urinate. The Food and Drug Administration said the spray, called Noctiva, is not approved to treat all causes of frequent nighttime urination, so doctors must determine the cause and best treatment for each person.

Is My Dog or Cat a Healthy Weight? Important Questions to Ask the Vet

Your 8-year-old chocolate lab is putting on weight, and you know she should probably lose a pound or two. But when she looks at you pleadingly with those big brown eyes, how can you resist handing out just one more treat? “Just as obesity has become a serious problem in people, it’s also a growing problem in pets, one that can seriously harm your pet’s health,” says Carmela Stamper, a veterinarian in the Center for Veterinary Medicine at the U.S. Food and Drug Administration .

UPDATE 1-Roche says drug combo cuts breast cancer deaths in key trial

Combining Roche’s Perjeta and Herceptin drugs with chemotherapy reduced recurrence of aggressive breast cancer or death compared to Herceptin and chemo, the Swiss drugmaker said on Thursday. “These results from the positive Aphinity study represent an important addition to the body of data for Perjeta in the treatment of people with HER2-positive early breast cancer,” Sandra Horning, Roche’s chief medical officer, said.

BIDMC scientists discover vulnerability that offers new strategy to…

Physicians currently have no targeted treatment options available for women diagnosed with an aggressive form of breast cancer known as triple-negative breast cancer , leaving standard-of-care chemotherapies as a first line of defense against the disease. However, most women with TNBC do not respond to these broadly-targeted chemotherapies, and those who do often develop resistance to the drugs.

When cancer treatments do more harm than good

When my 80-year-old father was diagnosed with Hodgkin’s disease, he was so weak that he could no longer walk, and his oncologist worried that chemotherapy might do more harm than good. But there was a new drug available, a “targeted therapy” that uses antibodies to destroy cancer cells while apparently leaving the rest of the patient’s cells alone.

U.S. Food and Drug Administration

This is the first test to use procalcitonin , a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions. , Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis

The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory tract infections, such as community-acquired pneumonia, and stopped in patients with sepsis. This is the first test to use procalcitonin , a protein associated with the body’s response to a bacterial infection, as a biomarker to help make antibiotic management decisions in patients with these conditions.

Celltrion’s Rituxan biosimilar wins Eur…

South Korea’s Celltrion announced Wednesday that the European Medicines Agency has granted sales approval to Truxima, its biosimilar drug referencing Roche’s blockbuster lymphatic cancer drug Rituxan. Truxima is the first ever Rituxan biosimilar to be approved by the European drug regulator, as well as the first ever Europe-approved biosimilar monoclonal antibody used to target cancer.

Cell Medica: Lead Cancer Immunotherapy Candidate Receives FDA Fast Track Designation

Cell Medica, a leader in developing cellular immunotherapy for the treatment of cancer, today announced the U.S. Food and Drug Administration has granted Fast Track designation to its lead oncology product CMD-003 for patients with relapsed/refractory lymphoma and post-transplant lymphoproliferative disease associated with the oncogenic Epstein Barr virus . CMD-003, also known as baltaleucel-T, is an investigational therapy in which the patient’s T cells are activated to kill malignant cells expressing EBV antigens.

Options and Expectations for Cannabis-based products

Associate Health Minister Peter Dunne has written to medical and pharmaceutical organisations clarifying the range of appropriately manufactured cannabis-based products that could be prescribed in New Zealand. Following on from the decision to delegate decision-making responsibility to the Ministry of Health on medical decisions to prescribe cannabis-based products, MrDunne last week wrote to New Zealand’s Medical Association, Medical Council and Pharmaceutical Society outlining the list of internationally available products and his “ongoing expectation is that medical professionals consider the prescribing of cannabis-based products with an open mind.”

Smartphones are revolutionizing medicine

… are turning to smartphones for use in their daily work, seeing them as a useful tool for managing electronic health data and figuring out the most effective clinical trials, said Gregory Hager, professor of computer science at Johns Hopkins …

Smartphones are revolutionizing medicine

… are turning to smartphones for use in their daily work, seeing them as a useful tool for managing electronic health data and figuring out the most effective clinical trials, said Gregory Hager, professor of computer science at Johns Hopkins …

Appili gets $2.8M in ACOA funding

… Kevin Sullivan. The company is now manufacturing the clinical batch of the antibiotic to the standards required by Health Canada and the U.S. Food and Drug Administration for human clinical trials this year. Earlier this year ATI-1501 was granted …

Scientists create scorecard index for heart-damaging chemo drugs

Joseph Wu and his colleagues used lab-grown heart cells to assess the effect of chemotherapy drugs on heart muscle. Steve Fisch Researchers at the Stanford University School of Medicine used heart muscle cells made from stem cells to rank commonly used chemotherapy drugs based on their likelihood of causing lasting heart damage in patients.