Zohydro: New pain med sounds like a many-headed monster – literally

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Zohydro: New pain med sounds like a many-headed monster – literally

February 27, 2014 12:16 pm by | 1 Comments

Maybe the FDA put a hidden meaning in the name of the new pain drug that everyone is worried about. When I hear “Zohydro,” I think of a boss that…


FDA approves GenPrime’s quick drug test for coke, speed, meth, barbiturates, THC

FDA approves GenPrime’s quick drug test for coke, speed, meth, barbiturates, THC

March 15, 2014 6:14 am by | 0 Comments

Federal officials have given the green light for Spokane biotech firm GenPrime to market a test kit that can help hospitals and employers conduct rapid tests for illegal drugs.
The test system, called D-Cipher, has taken two years for testing and appro…


Industry+FDA group tries to make device approval process less painful

Industry+FDA group tries to make device approval process less painful

November 25, 2013 7:10 am by | 1 Comments

Few things are more challenging to medical device companies than the regulatory barriers that they must overcome to bring products to market. Recognizing that scientific innovators and federal regulators were…



FDA expands Nexavar to late-stage differentiated thyroid cancer

FDA expands Nexavar to late-stage differentiated thyroid cancer

November 23, 2013 2:37 pm by | 0 Comments

(Reuters) – The U.S. Food and Drug Administration said on Friday it has expanded the approved use of the cancer drug Nexavar to include late-stage differentiated thyroid cancer.
Differentiated thyroid cancer is the most common type of thyroid cancer, t…


FDA approves GSK’s H5N1 bird flu vaccine

FDA approves GSK’s H5N1 bird flu vaccine

November 23, 2013 10:48 am by | 0 Comments

(Reuters) – The U.S. Food and Drug Administration said on Friday it has approved GlaxoSmithKline Plc’s pandemic flu vaccine for use in the event of an H5N1 bird flu epidemic.
The vaccine will be added to the national stockpile and will not be available…


J&J catches up to Merck and Vertex with FDA OK of hepatitis C pill

J&J catches up to Merck and Vertex with FDA OK of hepatitis C pill

November 22, 2013 6:54 pm by | 0 Comments

(Reuters) – U.S. regulators on Friday approved the use of Johnson & Johnson’s Olysio, also known as simeprevir, as a treatment for chronic infection with the liver-destroying hepatitis C virus.
Olysio, a protease inhibitor that blocks a specific pr…


Heart risks linked to Astellas stress test chemicals

Heart risks linked to Astellas stress test chemicals

November 20, 2013 11:53 am by | 0 Comments

(Reuters) – The U.S. Food and Drug Administration warned physicians on Wednesday that two chemicals used to conduct cardiovascular stress tests can cause heart attacks and death, and it suggested resuscitation equipment and trained staff be available w…


BioMarin’s Morquio A drug shows ‘modest’ benefit in treating rare genetic disorder

BioMarin’s Morquio A drug shows ‘modest’ benefit in treating rare genetic disorder

November 15, 2013 8:32 am by | 0 Comments

(Reuters) – An experimental drug to treat a rare genetic disorder that causes skeletal malformation and a host of related lung, eye ear and heart problems confers “modest” benefit, according to an initial review by the U.S. Food and Drug Administration…



Atossa Genetics working toward new FDA clearance, 2014 product launches

Atossa Genetics working toward new FDA clearance, 2014 product launches

November 12, 2013 6:04 pm by | 0 Comments

Atossa Genetics announced their Q3 earnings today, along with an update on their ForeCYTE Breast Health Test recall and plans for product launches and relaunches in 2014. Net loss for…


FDA has doubts about Sarepta’s experimental muscle disorder drug

FDA has doubts about Sarepta’s experimental muscle disorder drug

November 12, 2013 7:34 am by | 0 Comments

(Reuters) – Sarepta Therapeutics Inc said the U.S. Food and Drug Administration had raised concerns about the trial for the company’s experimental muscle disorder drug and considered the marketing application for the treatment to be premature.
Sarepta …


Med-tech startup moving forward with first lung infection fighting product

Med-tech startup moving forward with first lung infection fighting product

November 11, 2013 3:00 am by | 0 Comments

A Sacramento medical-device startup said today it’s teaming up with two other area companies, including one of the region’s leading heating-cooling contractors, to manufacture its first product, a home-purification system…


HIMSS: 4 reasons why the FDA should ease up on EMR regulations

HIMSS: 4 reasons why the FDA should ease up on EMR regulations

November 8, 2013 2:34 pm by | 1 Comments

HIMSS put forward its take on why health IT products, particularly electronic medical records, shouldn’t be considered a medical device. The group published a letter this week in response to…


Say goodbye to partially hydrogenated oils? FDA closer to banning trans fats

Say goodbye to partially hydrogenated oils? FDA closer to banning trans fats

November 7, 2013 9:55 am by | 0 Comments

WASHINGTON (Reuters) – The U.S. Food and Drug Administration on Thursday released a proposal to ban partially hydrogenated oils as no longer “generally recognized as safe,” a move it says…


FDA knows how to prevent drug shortages

FDA knows how to prevent drug shortages

October 31, 2013 11:48 am by | 0 Comments

(Reuters) – The U.S. Food and Drug Administration released a strategic plan for preventing drug shortages on Thursday and proposed a rule to require drug and biotechnology companies to promptly…


Zogenix’s long-acting drug to treat severe pain approved by FDA

Zogenix’s long-acting drug to treat severe pain approved by FDA

October 25, 2013 2:10 pm by | 0 Comments

(Reuters) – Zogenix Inc said the U.S. Food and Drug Administration approved its drug for treating pain severe enough to require around-the-clock, long-term treatment, sending the specialty pharmaceutical company’s shares…


Consumer group: FDA advisory panel chair is too pro-pharma

Consumer group: FDA advisory panel chair is too pro-pharma

October 24, 2013 2:26 pm by | 0 Comments

WASHINGTON (Reuters) – The consumer rights group Public Citizen has leveled conflict of interest charges at the chairwoman of an advisory panel to the U.S. Food and Drug Administration over her plans to counsel drug companies at a conference in Februa…