Monday, June 25, 2018

FDA: New suppliers to ease 2 cancer drug shortages

Federal regulators have approved new suppliers for two crucial cancer drugs, easing shortages that had been ratcheting up fears that patients, particularly children with leukemia, would miss lifesaving treatments.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement for Doxil, a drug for recurrent ovarian or bone marrow cancer. The Johnson & Johnson drug hasn't been available for new patients for months because Johnson & Johnson's contract manufacturer had to shut down production over serious quality lapses.

Sun Pharma Global FZE of India will supply the replacement.

The FDA also has approved a new supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL, for lymphomas and for the bone cancer osteosarcoma.

The version with preservatives, the one that has been scarce, can be toxic or cause paralysis in children and other patients getting the drug either by injections into spinal cord fluid or at very high doses.

APP Pharmaceuticals LLC will make the preservative-free version of methotrexate.

The FDA had approved the release of a batch manufactured by Ben Venue Laboratories Inc. shortly before it closed several factories at its complex in Bedford, Ohio, due to quality problems.

"We have made real progress. … We believe that (suppliers) will be able to meet the demands of patients in the U.S. market" for the two drugs indefinitely, FDA Commissioner Margaret Hamburg told the Associated Press. "It's a huge relief for us."

Many medical and drugmaker groups, along with the White House, applauded the news but cautioned that much still must be done to resolve all the problems causing drug shortages.

There are currently 283 separate prescription drugs in short supply or unavailable nationwide, and regulators and manufacturers say shortages are a long-term problem that will continue to give patients and doctors nightmares.

Comments
Nelson intensifies criticism of Trump administration over immigrant children

Nelson intensifies criticism of Trump administration over immigrant children

WASHINGTON – Sen. Bill Nelson said Monday he has many unanswered questions following a visit to the Homestead facility housing young immigrants and asserted it's "obvious" there is no plan for reuniting those children with their parents.Speakin...
Updated: 1 minute ago
FHP: Pedestrian dies Monday in Spring Hill crash

FHP: Pedestrian dies Monday in Spring Hill crash

SPRING HILL — A Kentucky woman was killed around 2 a.m. Monday after a vehicle hit her as she was walking along Hayes Street.Kathellyn Pereira, 22, was driving eastbound in the inside lane on Northcliffe Boulevard approaching Hayes Street, authoritie...
Updated: 6 minutes ago
Top things to do in Tampa Bay for June 26

Top things to do in Tampa Bay for June 26

Summer Circus Spectacular: The annual summer shows from Sarasota’s Circus Arts Conservatory brings Ringling veterans to the stage to feature acrobatics, juggling, comedy and aerial work. 11 a.m. and 2 p.m., Historic Asolo Theater, 5401 Bay Shore Road...
Updated: 11 minutes ago
Driver deliberately struck family riding on New Tampa bike path, killing father, police say

Driver deliberately struck family riding on New Tampa bike path, killing father, police say

TAMPA — Pedro Aguerreberry pedaled along New Tampa Boulevard on Sunday pulling his son Bennett in a trailer as his other son Lucas rode alongside them.As father and sons headed east on a paved bike path, a former star track and field athlete named Mi...
Updated: 14 minutes ago
Ashley Moody’s acceptance of public campaign financing sparks clash with rival

Ashley Moody’s acceptance of public campaign financing sparks clash with rival

Republican Ashley Moody will seek public campaign financing matching money in her campaign for attorney general, according to a request filed with the Florida Secretary of State's office.Moody, a former circuit judge from Plant City, is the top fundr...
Updated: 24 minutes ago
Local tax referendum unlikely for Pasco County schools

Local tax referendum unlikely for Pasco County schools

Pasco County school district finance officials say added retirement and security expenses drive a projected budget shortfall of more than $1 million for the coming year. They're looking for ways to make ends meet.Unlike other districts, though, ...
Updated: 27 minutes ago
Tampa reports small sewage spill

Tampa reports small sewage spill

A faulty plug on a pressurized sewage pipe led to about 7,150 gallons spilling and ending up in a nearby retention pond in north Tampa Sunday, officials said.The leak was in a force main which conveys sewage to the city's Howard F. Curren sewage plan...
Updated: 30 minutes ago
Ron DeSantis releases first TV ad touting Trump, military record

Ron DeSantis releases first TV ad touting Trump, military record

After much speculation about when U.S. Rep. Ron DeSantis would hit the airwaves, his campaign has released his first ad in the governor's race.The flashy ad begins with a deep-voiced narrator describing the Congressman, alternating with giant text re...
Updated: 1 hour ago
The Old Man from ‘Pawn Stars,’ Richard Harrison, dies at 77

The Old Man from ‘Pawn Stars,’ Richard Harrison, dies at 77

LAS VEGAS — Pawn Stars patriarch, Richard Benjamin Harrison, who was known as "The Old Man," has died at age 77. Gold & Silver Pawn’s Facebook page posted Monday that Harrison was surrounded by "loving family" this past weekend and died peacefully. T...
Updated: 1 hour ago
Rapidly expanding fact-checking movement faces growing pains

Rapidly expanding fact-checking movement faces growing pains

ROME - Political fact-checkers from more than 50 countries gathered here to take stock of a fast-growing journalistic movement that has gained clout and influence while attracting criticism and heightened skepticism in an increasingly partisan age.Fa...
Updated: 1 hour ago