Content about Hepatology

January 20, 2014

The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.

NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week. 

Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.

December 13, 2013

According to published reports, Express Scripts may be looking to start a "price war" among the makers of the latest generation of drugs for hepatitis C — which promise much shorter treatment times than standard therapies, but also cost significantly more — in an effort to bring down prices.

The stakes are certainly high. According to Centers for Disease Control and Prevention, there are 3.2 million people in the United States chronically infected with hepatitis C and hence at risk for liver cancer, and the CDC recommends that anyone born between 1945 and 1965 get tested for the virus.

According to published reports, Express Scripts may be looking to start a "price war" among the makers of the latest generation of drugs for hepatitis C — which promise much shorter treatment times than standard therapies, but also cost significantly more — in an effort to bring down prices.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

June 21, 2013

A bill passed by the New York state legislature will require baby boomers visiting healthcare providers to be offered a hepatitis C screening.

ALBANY, N.Y. — A bill passed by the New York state legislature will require baby boomers visiting healthcare providers to be offered a hepatitis C screening.

The bill, S2750A/A1286, sponsored by Republican state Senate Health Committee chairman Kemp Hannon, was backed by AARP and requires those born between 1945 and 1965 to be offered a screening test. Many baby boomers across the state have hepatitis C without knowing it, and an estimated 200,000 New Yorkers are living with the disease, according to the organization.

May 31, 2013

A new, higher-dose formulation of a drug used to treat pancreatic disorders is now available, the drug's manufacturer said.

NORTH CHICAGO, Ill. — A new, higher-dose formulation of a drug used to treat pancreatic disorders is now available, the drug's manufacturer said.

AbbVie announced the launch of the new formulation of Creon (pancrelipase) delayed-release capsules. The drug is used to treat exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis, removal of the pancreas and other conditions. The new strength is the highest-dose pancreatic enzyme replacement therapy available in the United States, AbbVie said.

May 2, 2012

The Food and Drug Administration has approved a new treatment for a rare genetic disorder that affects 10,000 people worldwide.

NEW YORK — The Food and Drug Administration has approved a new treatment for a rare genetic disorder that affects 10,000 people worldwide.

Pfizer and Protalix BioTherapeutics announced Wednesday the approval of Elelyso (taliglucerase alfa), an enzyme-replacement therapy for the long-term treatment of Type 1 Gaucher disease.

July 12, 2011

The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

PLANEGG-MARTINSRIED, Germany — The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

4SC announced that it received the designation for resminostat, currently in phase-2 clinical trials as a treatment for hepatocellular cancer, or HCC. The FDA grants orphan drug designation to drugs for diseases that affect fewer than 200,000 people in the United States.

April 21, 2011

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

February 25, 2011

Over the years, a fatty liver has become an indicator of obesity and insulin resistance among humans, but researchers have found that people with fatty livers are five times more likely to develop Type 2 diabetes than their healthier counterparts.

NEW YORK — Over the years, a fatty liver has become an indicator of obesity and insulin resistance among humans, but researchers have found that people with fatty livers are five times more likely to develop Type 2 diabetes than their healthier counterparts.

February 16, 2011

French drug maker Sanofi-Aventis will acquire U.S. biotech giant Genzyme for $20.1 billion, under an agreement the two companies announced Wednesday.

CAMBRIDGE, Mass. — French drug maker Sanofi-Aventis will acquire U.S. biotech giant Genzyme for $20.1 billion, under an agreement the two companies announced Wednesday.

January 26, 2011

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

MORRISTOWN, N.J. — Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

Watson, through subsidiary Watson Labs, said it applied for approval of a generic version of Daiichi Sankyo’s and Genzyme’s Welchol (colesevelam hydrochloride). The drug, a powdered oral suspension, is used to reduce “bad” LDL cholesterol in patients with primary hyperlipidemia, either alone or in combination with a statin.

November 22, 2010

Impax confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the FDA for approval ...

HAYWARD, Calif. A generic drug maker confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the Food and Drug Administration for approval.

Impax said Daiichi Sankyo and Genzyme are seeking to block Impax's generic version of Welchol (colesevelam HCl) for oral suspension, in 3.75 g/packet and 1.875 g/packet strengths. The two drug makers filed suit for patent infringement against Impax in the U.S. District Court for the District of Delaware after being notified that the FDA accepted Impax's ANDA for the drug.

September 26, 2010

Nutramax Labs recently launched its Samsyl dietary supplement for liver health. Samsyl contains a blend...

EDGEWOOD, Md. —Nutramax Labs recently launched its Samsyl dietary supplement for liver health. Samsyl contains a blend of S-adenosylmethionine, or SAMe, along with a highly bioavailable silybin-soy phosphatidylcholine complex.

August 29, 2010

BioMarin Pharmaceutical on Monday announced its investigational treatment for a lysosomal storage disorder has received...

August 19, 2010

BioMarin Pharmaceutical has acquired privately owned biotechnology company ZyStor Therapeutics for $22 million, BioMarin said....

July 13, 2010

Treatments for liver cancer could emerge from a new research partnership between the world’s largest...

July 7, 2010

Generic drug maker Hospira will fill and package several drugs for Genzyme, according to published...

May 24, 2010

The Food and Drug Administration has approved a new treatment for a rare genetic disorder...

May 23, 2010

Biotech company Genzyme will pay $175 million to the federal government as part of an...

March 24, 2010

The Food and Drug Administration has approved a new use for a drug made by...

March 23, 2010

Genzyme Corp. will have to submit to inspections of one of its plants by the...

February 23, 2010

A Food and Drug Administration committee has recommended approval for a drug to treat a...