Content about Regulatory and Washington

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.

May 2, 2012

The National Retail Federation is responding to a report from the Federal Reserve that revealed that debit card swipe fees collected by the nation's largest banks have dropped significantly since reform regulations took effect last fall.

WASHINGTON — The National Retail Federation is responding to a report from the Federal Reserve that revealed that debit card swipe fees collected by the nation's largest banks have dropped significantly since reform regulations took effect last fall.

May 2, 2012

With new Massachusetts state regulations allowing pharmacists to administer a broad range of immunizations, Walgreens has significantly expanded vaccine availability at all of its 165 locations across the state, and now is offering immunizations daily for 12 vaccines currently recommended by the Centers for Disease Control and Prevention, the retail pharmacy operator announced Wednesday.

DEERFIELD, Ill. — With new Massachusetts state regulations allowing pharmacists to administer a broad range of immunizations, Walgreens has significantly expanded vaccine availability at all of its 165 locations across the state, and now is offering immunizations daily for 12 vaccines currently recommended by the Centers for Disease Control and Prevention, the retail pharmacy operator announced Wednesday.
  

May 1, 2012

The philanthropic arm of the American Pharmacists Association has announced this year's recipients of an award that recognizes pharmacists who increase medication adherence, reduce drug misadventures and promote the use of national treatment guidelines.

WASHINGTON — The philanthropic arm of the American Pharmacists Association has announced this year's recipients of an award that recognizes pharmacists who increase medication adherence, reduce drug misadventures and promote the use of national treatment guidelines.

May 1, 2012

Generic drug maker Mylan has released a version of a drug used to treat bacterial infections, the company said.

PITTSBURGH — Generic drug maker Mylan has released a version of a drug used to treat bacterial infections, the company said.

Mylan announced the launch of doxycycline hyclate delayed-release tablets in the 150-mg strength. The launch follows a decision by the U.S. District Court for the District of New Jersey that Mylan's product did not infringe patents covering the drug's branded version, Doryx. Warner Chilcott, which markets Doryx, had brought the case.

April 30, 2012

Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

WHITEHOUSE STATION, N.J. — Mylan will be barred from marketing a generic version of a Merck cardiovascular drug until the drug's patent expires, under a court ruling announced Friday.

Merck said the U.S. District Court for the District of New Jersey ruled against Mylan in two patent infringement suits related to the drugs Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin). Specifically, the court ruled that a patent covering the drug, RE 42,461, is valid and enforceable and enjoined Mylan from launching until the patents expiration in April 2017.

April 30, 2012

Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former's generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.

April 30, 2012

An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

NEW YORK — An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

In an article posted on its website, CNN told the story of 46-year-old Darlene Gant, a woman with stage-four breast cancer, as she wrote letters to be given to her 11-year-old son on his upcoming birthday, and at future events, such as his high school and college graduations and marriage.

April 27, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

April 27, 2012

The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating erectile dysfunction, the agency said Friday.

The FDA announced the approval of Vivus' Stendra (avanafil).

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," FDA Office of Drug Evaluation III deputy director Victoria Kusiak said.

April 27, 2012

Two companies have settled with Teva over the latter's efforts to launch a generic version of an emergency treatment for allergic reactions.

NEW YORK — Two companies have settled with Teva over the latter's efforts to launch a generic version of an emergency treatment for allergic reactions.

Under the agreement, involving Mylan and Pfizer's Meridian Medical Technologies subsidiary, Teva will be allowed to launch a generic version of EpiPen (epinephrine) auto-injector in June 2015, assuming it wins approval from the Food and Drug Administration. Mylan Specialty markets the EpiPen, which Meridian manufactures.

April 27, 2012

The National Association of Chain Drug Stores has expressed its support for enactment of the Pharmacy Audit Integrity Program, a law that will establish standards in the pharmacy audit process conducted by pharmacy benefit management companies in the state of Minnesota.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores has expressed its support for enactment of the Pharmacy Audit Integrity Program (HF 1236/SF 973) by Minnesota governor Mark Dayton. The law will establish standards in the pharmacy audit process conducted by pharmacy benefit management companies in the state of Minnesota.

NACDS sent a letter of support to Dayton prior to enactment, emphasizing the importance of this legislation in ensuring transparency in the PBM audit process.
 

April 27, 2012

The National Retail Federation on Thursday urged the Federal Trade Commission to move cautiously in establishing regulations for mobile payments and said any rules that are adopted should parallel those for the underlying form of payment and not be specific to the technology.

WASHINGTON — The National Retail Federation on Thursday urged the Federal Trade Commission to move cautiously in establishing regulations for mobile payments and said any rules that are adopted should parallel those for the underlying form of payment and not be specific to the technology.

April 26, 2012

The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

April 26, 2012

The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores expressed its support for the legislative package that will serve as a starting point for the reauthorization of the Prescription Drug User Fee Act in a letter to the bipartisan leadership of the Senate Committee on Health, Education, Labor and Pensions.

April 26, 2012

Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

WASHINGTON — Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

April 25, 2012

The Consumer Healthcare Products Association on Wednesday testified before a House subcommittee to urge legislators to restore over-the-counter medicines' eligibility under flexible spending accounts.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday testified before a House subcommittee to urge legislators to restore over-the-counter medicines' eligibility under flexible spending accounts.

April 25, 2012

On the final evening of the National Association of Chain Drug Stores' annual meeting in Palm Beach, Fla., the organization honored two industry leaders with chain pharmacy's highest honors.

PALM BEACH, Fla. — On the final evening of the National Association of Chain Drug Stores' annual meeting in Palm Beach, Fla., the organization honored two industry leaders with chain pharmacy's highest honors.

NACDS recognized Andrew Giancamilli, former Rexall Pharma Plus CEO and past NACDS chairman, with the Sheldon W. Fantle Lifetime Achievement Award. M. Jerome Brown, former Unilever VP industry and customer development, received the Robert B. Begley Award.

April 25, 2012

The National Community Pharmacists Association has sent a letter to a Senate committee regarding legislation that would reauthorize the Prescription Drug User Fee Act.

ALEXANDRIA, Va. — The National Community Pharmacists Association has sent a letter to a Senate committee regarding legislation that would reauthorize the Prescription Drug User Fee Act.

April 25, 2012

The U.S. District Court for the Western District of Pennsylvania on Wednesday denied a preliminary injunction filed by pharmacy trade groups in an effort to block the looming merger between pharmacy benefit managers Express Scripts and Medco.

PITTSBURGH — The U.S. District Court for the Western District of Pennsylvania on Wednesday denied a preliminary injunction filed by pharmacy trade groups in an effort to block the merger between pharmacy benefit managers Express Scripts and Medco.

April 24, 2012

Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

SILVER SPRING, Md. — Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

The Food and Drug Administration released a report Monday detailing its strategies for what it called transforming from a domestic to a global public health agency.

April 24, 2012

The National Association of Chain Drug Stores Foundation announced that $350,000 in scholarships were awarded through its 2012 Pharmacy Partners Scholarship Program.

PALM BEACH, Fla. — The National Association of Chain Drug Stores Foundation announced that $350,000 in scholarships were awarded through its 2012 pharmacy partners scholarship program.

The announcement was made at the NACDS Annual meeting in Palm, Beach, Fla.

April 24, 2012

Disruptive innovation. That's the role pharmacy needs to play in the shaping of a new healthcare paradigm — one that achieves greater outcomes at lesser cost through increased involvement of retail health care. That was the theme of a presentation given Tuesday by the National Association of Chain Drug Stores' new chairman Greg Wasson, who also serves as Walgreens president and CEO.

PALM BEACH, Fla. — Disruptive innovation. That's the role pharmacy needs to play in the shaping of a new healthcare paradigm — one that achieves greater outcomes at lesser cost through increased involvement of retail health care. That was the theme of a presentation given Tuesday by the National Association of Chain Drug Stores' new chairman Greg Wasson, who also serves as Walgreens president and CEO.

April 24, 2012

The charitable arm of the National Association of Chain Drug Stores has elected three new members to its board of directors.

PALM BEACH, Fla. — The charitable arm of the National Association of Chain Drug Stores has elected three new members to its board of directors.

The board, which now will expand to 23 members for 2012-2013, include Rite Aid's SVP and chief communications officer Susan Henderson; GlaxoSmithKline VP channel development and sales Joseph Kucharski; and Pfizer Worldwide Pharmaceuticals VP corporate government customers David Moules.