Category: Food and Drug Administration

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.

Anavex Life Sciences Receives Grant From Rettsyndrome.org to Commence U.S. Phase 2 Trial in 2017

Anavex Life Sciences Corp. and the International Rett Syndrome Foundation, doing business as Rettsyndrome.org today announced that Rettsyndrome.org has committed a financial grant of a minimum of $0.6 million to cover the majority of a planned U.S. multicenter Phase 2 clinical trial of ANAVEX 2-73 for the treatment of Rett syndrome. Scheduled to begin in 2017, the trial will be a randomized, double blind, placebo-controlled study of ANAVEX 2-73 in patients with Rett syndrome lasting up to 12 weeks.

FTSE 100 movers: Burberry shines on update but Pearson tanks

London’s FTSE 100 was up 0.2% to 7,235.79 in afternoon trade, with updates from Burberry and Pearson in focus. Luxury retailer Burberry was the standout gainer after it reported 4% growth in underlying retail sales for the third quarter, boosted by a return to growth for the Asia Pacific region but with the Americas still in decline.

Flood of News Presents Buying Opportunity

… 5 million and 6 million patients. Beyond the FDA, word just came in from the Paul Ehrlich Institute, Germany’s health regulator, that the same trial could begin enrollment there. Though the trial will be enrolling 250 patients globally, approval is …

Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies

More than 30 years ago, Congress overwhelmingly passed a landmark health bill aimed at motivating pharmaceutical companies to develop new drugs for people whose rare diseases had been ignored. But lucrative financial incentives created by the Orphan Drug Act signed into law by President Reagan in 1983 succeeded far beyond anyone’s expectations.

Why Regeneron Pharmaceuticals, Inc. Stock Slipped 32.4% in 2016

A handful of issues concerning Sanofi Regeneron’s stock fell along with its biotech peers at the beginning of 2016, but it wasn’t long before more specific issues that continue to hound the company and its big pharma partner reared their ugly head. In March, patent litigation concerning the partners’ next-generation cholesterol-lowering drug, Praluent, drove down the stocks.

Sunovion Announces Pivotal Study Results for Novel Drug Candidate…

Sunovion Pharmaceuticals Inc. today announced that results of a pivotal Phase 2/3 study evaluating novel drug candidate dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder showed statistically significant improvement in the 4mg/day dose arm compared to placebo. The 2mg/day dose arm did not demonstrate a statistically significant difference from placebo.

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Hostess has recalled some of its Twinkies due to potential contamination with salmonella, an organism that can cause serious and sometimes fatal infections. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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If blowing your nose and coughing your lungs out don`t seem like the best way to spend your winter, Doctor Mark Goedecker with Wellspan Medical Group says you better boost your immune system. In our busy lives, it`s hard to enough sleep and eat right, which is why some of us turn to over the counter meds that claim to prevent sickness.

3 Little-Known Pharmaceutical Companies to Put on Your Radar

Over the past year, the best-performing drugmaker stocks all have had one thing in common: They received very little attention before providing patient investors windfall gains. Being considered insignificant in itself isn’t a great reason to scoop up shares of Teligent Brian Feroldi : Being called a “specialty generic” drug manufacturer might sound oxymoronic, but Teligent has stumbled on a clever business strategy that could make it a great stock to put on your watch list.

For Merck, Keytruda Is ‘Extraordinarily Positive’ : More Squawk From Jim Cramer

Merck’s lung cancer treatment will get a speedy review by the FDA, but it ‘knows better than to go out and give false hope,’ TheStreet’s Jim Cramer said. Shares of Merck were higher in late morning trading Wednesday, after the company announced the U.S. Food and Drug Administration would make a decision by May 10 on its lung cancer treatment that combines the immune system-boosting drug Keytruda with chemotherapy.

Palmer Candy Company recalling candy for possible Salmonella contamination

Palmer Candy Company announced a limited recall of certain chocolate products after being informed by a supplier that a milk powder ingredient used in a compound chocolate coating that they supply to Palmer Candy Company has the potential to be contaminated with Salmonella. The voluntary recall, in cooperation with the U.S. Food and Drug Administration , includes selected products produced between October 20, 2016, and December 9, 2016, and shipped by Palmer Candy Company to grocery, convenience store and wholesale customers nationwide.

Palmer Candy Company recalling candy for possible Salmonella contamination

Palmer Candy Company announced a limited recall of certain chocolate products after being informed by a supplier that a milk powder ingredient used in a compound chocolate coating that they supply to Palmer Candy Company has the potential to be contaminated with Salmonella. The voluntary recall, in cooperation with the U.S. Food and Drug Administration , includes selected products produced between October 20, 2016, and December 9, 2016, and shipped by Palmer Candy Company to grocery, convenience store and wholesale customers nationwide.

Palmer Candy Company recalling candy for possible Salmonella contamination

Palmer Candy Company announced a limited recall of certain chocolate products after being informed by a supplier that a milk powder ingredient used in a compound chocolate coating that they supply to Palmer Candy Company has the potential to be contaminated with Salmonella. The voluntary recall, in cooperation with the U.S. Food and Drug Administration , includes selected products produced between October 20, 2016, and December 9, 2016, and shipped by Palmer Candy Company to grocery, convenience store and wholesale customers nationwide.

Johns Hopkins researchers identify new biological target for treating spinal muscular atrophy

Johns Hopkins researchers along with academic and drug industry investigators say they have identified a new biological target for treating spinal muscular atrophy. They report they have evidence that an experimental medicine aimed at this target works as a “booster” in conjunction with a drug called nusinersen that was recently FDA-approved to improve symptoms of the disorder in mice.

Researchers identify new potential treatment for cancer metastasis

Breast cancer metastasis, the process by which cancer spreads, may be prevented through the new use of a class of drugs already approved by the U.S. Food and Drug Administration. Mayo Clinic researchers have identified that a key drug target, CDK4/6, regulates a cancer metastasis protein, SNAIL, and drugs that inhibit CDK 4/6 could prevent the spread of triple-negative breast cancer .

BioCryst Receives Health Canada Approval for RAPIVAB for the Treatment of Influenza

RESEARCH TRIANGLE PARK, N.C., Jan. 08, 2017 — BioCryst Pharmaceuticals, Inc. , a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that Health Canada has approved RAPIVAB i 1 2 , an intravenous treatment for acute, uncomplicated influenza.i 1 2 RAPIVAB is approved by the U.S. Food & Drug Administration and is also licensed for use in Japan and Taiwan as RAPIACTAi 1 2 and in Korea as PeramiFlui 1 2.i 1 2 i 1 2This RAPIVAB approval represents an important milestone for BioCryst and for our partner, Seqirus,i 1 2 said Jon P. Stonehouse, President & Chief Executive Officer .i 1 2 i 1 2We are excited that patients in Canada will soon have an I.V. option for the treatment of influenza infections.i 1 2i 1 2 RAPIVAB is being commercialized by Seqirus globally, excluding Japan, Taiwan, Korea and Israel.i 1 2 Seqirus is a … (more)

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… building, structure, or facility to smoking, which would include the use of ENDS, when necessary to maintain public health and safety. “Protecting the health and safety of our visitors and employees is one of the most critical duties of the National …

Legal haze clouds cannabis for pets

… client’s written consent is needed for any unorthodox treatment,” the memo stated. The Washington State Department of Health staffs the state’s Veterinary Board of Governors. The Department’s home page for veterinarians simply states, “The law …

FDA to probe exploding e-cigarettes

The U.S. Food and Drug Administration is probing the dangers of exploding batteries in e-cigarettes, following dozens of reports of devices that have combusted, overheated or caught fire and sometimes injuring user including a Fresno man last month. Last month, a Fresno man was taken to the hospital after being burned when his e-cigarette exploded as he rode a city bus.

Intuity Medical Increases Series 3 Funding to $55M With an Additional Close of $15M

The additional financing will help fund the infrastructure build and commercial launch of Intuity Medical’s POGO AutomaticTM Blood Glucose Monitoring System, the first fully-integrated blood glucose monitor SUNNYVALE, Calif., January 5, 2017– Intuity Medical, Inc., a privately-held company developing innovative technologies for diabetes management, announced today that it has closed an additional $15 million, which brings the total Series 3 equity financing for the company to $55 million.

FDA Probes Dangers of Exploding E-Cigarette Batteries

The U.S. Food and Drug Administration is probing the dangers of exploding batteries in e-cigarettes, following dozens of reports of devices that have combusted, overheated or caught fire and sometimes injured users. E-cigarettes are hand-held devices that vaporize liquid nicotine.

Cempra shares tumble 28% premarket after FDA says it can’t approve pneumonia drug application

The letter says that the FDA cannot approve the NDAs in their current form and says the company must provide additional safety data and resolve unspecified issues with its manufacturing facility. “Based on their review of the NDAs, the CRL stated that the FDA determined the risk of hepatotoxicity had not been adequately characterized,” the company said in a statement.