BioRestorative Therapies, Inc. , a life sciences company focused on stem cell-based therapies, today announced that it has received clearance by the U.S. Food and Drug Administration to commence a Phase 2 clinical trial using its lead cell therapy candidate, BRTX-100, to treat chronic lower back pain due to degenerative disc disease related to protruding/bulging discs. The Phase 2 clinical trial is a 72 patient, randomized, double-blind, controlled, multi-center study designed to evaluate safety and efficacy of a single dose of BRTX-100 in treating chronic lower lumbar disc disease.
Category: Food and Drug Administration
Kiadis Pharma issues clinical and regulatory progress update on ATIR101a and ATIR201a
… cell transplantation (HSCT) in blood cancer. Following regulatory approval from the national authority in Canada (Health Canada), the Company is pleased to announce the initiation of its randomized, controlled, transatlantic Phase III trial with …
Is This Hot Marijuana Stock Too Expensive to Buy?
… lthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights
Farmers may see little effect as FDA implements ban on antibiotics in non-therapeutic animal feed
… restrictive regulations are coming,” Credille said. “We’ve got to look at different strategies to maximize animal health We’ve got to focus on biosecurity. “We’ve got to focus on vaccinations, deworming and preconditioning. It has to become a …
A shocking secret about Donald Trump has been leaked
President Donald Trump is apparently taking a certain kind of drug that is sure to land him plenty of scorn from his detractors. President Donald Trump has a secret that he doesn’t want anyone to know about.
This $7,800-a-month cancer drug caused rashes and rarely worked. Now…
… “Every medicine puts you at risk of side effects,” said Vinay Prasad, a hematologist-oncologist at Oregon Health and Science University who has studied the FDA’s accelerated approval of cancer drugs. “The question is: Are those side effects worth …
Important Investor Alert: Lundin Law PC Announces Securities Class…
Lundin Law PC , a shareholder rights firm, announces the filing of a class action lawsuit against Regulus Therapeutics Inc. . Investors who purchased or otherwise acquired Regulus shares between January 21, 2016 and June 27, 2016 inclusive , are encouraged to contact the firm in advance of the To participate in this class action lawsuit, click here .
Artificial Pancreas Device System Market Regulations for Forecast Period 2015-2025
Pancreas is one of the major endocrine gland which secretes hormones released directly into the blood. Pancreas is around 6 inches long located in the abdominal cavity.
Trump’s Hair Growth Medicine: What Is Finasteride?
Donald Trump’s personal doctor recently revealed that the president takes a handful of medications, including a daily aspirin to lower heart attack risk, an antibiotic to treat the skin condition rosacea, a statin to lower cholesterol – and a hair-loss drug called finasteride. The physician, Dr. Harold Bornstein, credited finasteride with helping maintain Trump’s head of hair, as well as his own long locks.
Health Highlights: Feb. 2, 2017
… of the greatest minds from around the world to maintain the high quality of our biomedical research enterprise and health care services,” they wrote. “Limiting the exchange of ideas, practices, and data across cultures has the potential to …
Chlorhexidine Gluconate: Drug Safety Communication – Rare But Serious Allergic Reactions
… contain a warning about the possibility of serious allergic reactions in their labels. In 1998, FDA issued a Public Health Notice to warn health care professionals about the risk of serious allergic reactions with medical devices such as dressings …
Merck 2017 forecast eases concerns over royalty payments, dollar
Merck & Co Inc reported better-than-expected U.S. quarterly sales for its key cancer drug, Keytruda, and forecast largely in-line 2017 results, which some analysts said allayed concerns over the impact of a strong dollar and royalty payments. The logo of Merck is pictured in this illustration photograph in Cardiff, California April 26, 2016.
Now we really know how Trump looks at America’s drug price…
Investors have less to fear with Trump’s drug pricing talk than they thought because it’s just that – talk. We know that because Republicans in Congress don’t seem interested in taking up the cause at all.
Toxins in your fast-food packaging?
… Six of the samples also contained a long-chain PFOA, even though the chemical is no longer widely used because of health hazards. PFOA could be present in these wrappers because recycled paper was used in their manufacture, Schaider said — an …
Benign prostatic hyperplasia and new treatment options – a critical appraisal of the UroLift system.
… approval in September 2013. UroLift has recently been approved by the UK National Institute for Clinical and Health Excellence (September 2015) as effective and safe and cost-effective for use in the UK health system. This review describes the …
NICO receives new clearance from FDA for brain surgery technology
The U.S. Food and Drug Administration in less than a 15-month period has granted a new and updated 510 clearance for two patented technologies made by NICO Corporation that are used in a new approach for brain surgery. Most recently, NICO received a new clearance for specific neurosurgical indications on its patented Myriad automated tissue removal technology.
A lawsuit against Coca-Cola sets a dangerous precedent for food and beverage companies
, the carbonated drink is just as dangerous to your health as a cigarette. Well, maybe not quite, but the soda giant and the American Beverage Association (ABA) are being sued by consumer activists who say their actions are just as bad as what the …
European agency will review BioCryst’s flu drug
BioCryst Pharmaceuticals Inc., maker of the flu drug Rapivab, announced Monday that the European Medicines Agency will review its drug for the treatment of flu symptoms in adults. The London-based overseer of drugs sold in the European Union will issue a decision within 210 days on whether to allow the sale of Rapivab in the EU’s 28 member states and Norway and Iceland, a market of more than 500 million consumers.
Novartis Signals Growing Ambitions for CAR-T Cancer Treatments
Novartis AG is pushing ahead with one of its most ambitious cancer therapies, a treatment that the Swiss drugmaker says has blockbuster potential as it extends that technology to a wider pool of tumor-ridden patients. Europe’s second-biggest drugmaker is planning to test its CAR-T treatments — which involve extracting immune cells and genetically engineering them to hunt and kill cancer cells before returning them into the patient’s body — on lethal cancers of the brain, pancreas, colon, ovary and lung.
3 Marijuana Stocks Ready to Soar in 2017
… lthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights
Consumer 14 mins ago 12:36 p.m.FDA confirms elevated levels of ‘toxic …
… that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.” Homeopathic teething products have not been evaluated or approved by the FDA for safety …
Something many people are giving to babies is dangerous, FDA syas
… that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.” Homeopathic teething products have not been evaluated or approved by the FDA for safety …
FDA confirms elevated levels of belladonna in certain homeopathic teething products
… process, according to Hyland’s. For generations, we at Hyland’s have been proud to offer safe, effective and natural health solutions to families like yours. In fact, for over 90 years, parents have trusted Hyland’s teething medicines to ease the …
FDA confirms elevated levels of belladonna in certain homeopathic teething products
… process, according to Hyland’s. For generations, we at Hyland’s have been proud to offer safe, effective and natural health solutions to families like yours. In fact, for over 90 years, parents have trusted Hyland’s teething medicines to ease the …
Homeopathic teething tablets containing belladonna pose unnecessary risk to children, FDA warns
… that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.” Homeopathic teething products have not been evaluated or approved by the FDA for safety …
Trump Should Keep The FDA From Regulating Cigars
… the United States District Court for the District of Columbia for an injunction against the FDA and the Department of Health and Human Services. That legal action is not finally resolved. The proposed additional regulations may include prohibiting …
FDA warns against use of homeopathic teething products
The U.S. Food and Drug Administration said on Friday it has found high amounts of a toxic substance in homeopathic teething tablets, warning of its potential risk to infants and children. According to laboratory analysis by the health regulator, the amounts of belladonna, a toxic substance, sometimes far exceeded the amount claimed on the label of these teething tablets.
Coca-Cola Hit With “Tobacco-Style” Lawsuit. Who Else Is at Risk?
, the carbonated drink is just as dangerous to your health as a cigarette. Well, maybe not quite, but the soda giant and the American Beverage Association (ABA) are being sued by consumer activists who say their actions are just as bad as what the …
Legislature: Cannabis extract could treat epilepsy
Marijuana starts more debates than just about any drug in America, and tetrahydrocannabinol is usually the component of the plant that gets the most attention. Cannabidiol, or CBD, is a component of cannabis that creates none of the psycho-activity associated with THC.
Latest Clinical Data from OncBioMune Supports Safety and Therapeutic…
In the ongoing Phase 1 clinical trial, ProscaVax is being evaluated for safety and efficacy in prostate specific antigen recurrent prostate cancer in hormone-naive and hormone-independent patients. Per protocol, 20 patients are expected to be enrolled in the 1a portion of the study, with therapy consisting of six ProscaVax induction vaccinations at a single dose.
Newer Hepatitis C Drugs May Pose Health Risks
Jan. 25, 2017 — Newer drugs to cure hepatitis C may put patients at risk for liver failure and other severe side effects, according to a new study from a U.S. nonprofit group that examines drug safety. The study by the Institute for Safe Medication Practices is based on an analysis of U.S. Food and Drug Administration data and reports from doctors worldwide on adverse events possibly caused by the nine widely used antiviral drugs, The New York Times reported.
Health Highlights: Jan. 25, 2017
Newer drugs to cure hepatitis C may put patients at risk for liver failure and other severe side effects, according to a new study from a U.S. nonprofit group that examines drug safety. The study by the Institute for Safe Medication Practices is based on an analysis of U.S. Food and Drug Administration data and reports from doctors worldwide on adverse events possibly caused by the nine widely used antiviral drugs, The New York Times reported.
Gilead Sciences Stock: What Could Go Wrong?
Intense competition and clinical trial failures could be among the headwinds that weigh down the company’s share price in 2017. shares have tumbled over the past year.
‘Red yeast rice’ statin alternative not harmless either, study says
A natural cholesterol-lowering supplement called red yeast rice could pose the same health risks to users as statin drugs, a new study contends. Red yeast rice could increase risk of muscle injury or liver damage, Italian researchers reported after reviewing 13 years of patient data.
‘Red yeast rice’ statin alternative not harmless either, study says
A natural cholesterol-lowering supplement called red yeast rice could pose the same health risks to users as statin drugs, a new study contends. Red yeast rice could increase risk of muscle injury or liver damage, Italian researchers reported after reviewing 13 years of patient data.
‘Red Yeast Rice’ Statin Alternative Not Harmless
A natural cholesterol -lowering supplement called red yeast rice could pose the same health risks to users as statin drugs, a new study contends. Red yeast rice could increase risk of muscle injury or liver damage, Italian researchers reported after reviewing 13 years of patient data.
Supplements unproven to fight colds, flu
… including dietary supplements, mostly to stay well, according to a survey conducted by the National Center for Health Statistics. Americans spend almost $30.2 billion a year on complementary approaches, the survey says. “I think many people are …
Trump Is Giving A Beleaguered Vaping Industry Renewed Hope
… faced a brutal year of new rules and regulations from the federal government and localities throughout many states. Health officials are pushing lawmakers to amend the laws governing traditional cigarettes to all vaping devices, despite evidence …
3 Biotechs Likely to Be Acquired in 2017
The year is still young, but we’ve already seen acquisitions of Ariad and CoLucid . Which biotechs could be scooped up next in 2017? Here’s why Clovis Oncology The number of big companies battling to acquire Medivationin 2016 shows that the oncology space is hot.
Skin cancer cream linked to 5 dog deaths:FDA
Five dogs have died from exposure to a skin cancer cream prescribed for people, according to the U.S. Food and Drug Administration. Ingesting very small amounts of the drug — fluorouracil topical cream USP 5% — can sicken or kill family pets, said the FDA.