PhRMA brings scientists to Capitol Hill
WASHINGTON — The Pharmaceutical Research and Manufacturers of America (PhRMA) on Wednesday brought 60 of its member companies’ researchers to Capitol Hill for meetings with members of Congress. The researchers will discuss with lawmakers how they can support developing new, innovative medicines.
“America's biopharmaceutical researchers and scientists are on the frontlines of cutting-edge science bringing new treatments and cures to patients,” PhRMA president and CEO Stephen J. Ubl said. “I'm excited that our companies will be visiting with members of Congress to share why it's critical to support pro-innovation policies that continue to allow America to be the leader in biopharmaceutical innovation around the globe.”
PhRMA said researchers will also discuss the strides made in recent years by the biopharmaceutical industry, among them innovative hepatitis C medicines and more than 500 medicines developed to treat rare diseases that affect 25 million Americans.
FDA approves Janssen’s Invokamet XR
SILVER SPRING, Md. — The Food and Drug Administration has approved Janssen Pharmaceuticals’ Invokamet XR, a once-daily, extended-release combination therapy of Invokana (canagliflozin) and metformin, the company announced Wednesday. The drug is indicated as a first-line treatment to improve blood glucose control in adults with Type 2 diabetes alongside diet and exercise.
“The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes,” Janssen VP medical affairs Dr. Paul Burton said. “Our Invokana portfolio now offers physicians even more choices for helping patients improve control of A1C levels and other important health measures, with numerous dosing options for monotherapy and for combination therapy with both metformin and metformin XR.”
Invokamet XR is available in 50-, 150-, 500- and 1000-mg dosage strengths. It contains a boxed warning for lactic acidosis, which is a rare but serious complication that can be caused by metformin accumulation.
Allergan acquires Akarna Therapeutics
DUBLIN — On the same day that it announced the acquisition of Tobira Therapeutics, Allergan acquired Akarna Therapeutics, a biotech company that, like Tobira, focuses on developing treatments for nonalcoholic steatohepatitis (NASH), a severe type of fatty liver disease.
Allergan will be acquiring Akarna Therapeutics and its portfolio of developing treatments for an upfront payment of $50 million plus potential clinical, regulatory and commercial milestone payments around its lead compound AKN-083. AKN-083, the company said is highly complementary to the two compounds being developed by Tobira Therapeutics.
“The acquisition of Akarna adds to our strategic approach to investing in innovation to advance the treatment of NASH for millions of patients who currently do not have therapeutic options to treat the disease,” Allergan president and CEO Brent Saunders said. “We look forward to advancing this unique compound into later stages of development, and to advancing our overall portfolio of NASH programs, as we focus on bringing forward effective treatments for this critical disease area.”
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