Content about Branded

January 20, 2012

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot.

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot. Because it’s the top-selling drug, well, ever — with 2010 sales well in excess of $7 billion in the United States alone — Lipitor’s loss of patent protection on Nov. 30, 2011, didn’t start or end the patent cliff but in many ways symbolized it.


January 19, 2012

The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

PRINCETON, N.J. — The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

January 19, 2012

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

Gilead announced the FDA approval of Viread (tenofovir disoproxil fumarate) in the 150-mg, 200-mg and 250-mg strengths combined with other antiretroviral drugs in patients ages 6 to 12 years while also approving an oral powder formulation for children ages 2 to 5 years. The agency approved the drug in the 300-mg strength for adults in 2001 and for patients ages 12 to 17 years in 2010.

January 18, 2012

Galderma Labs has launched a newly designed pump dispenser for a drug used to treat rosacea, the drug maker said Tuesday.

FORT WORTH, Texas — Galderma Labs has launched a newly designed pump dispenser for a drug used to treat rosacea, the drug maker said Tuesday.

Galderma announced the availability of the dispenser for MetroGel (metronidazole) gel in the 1% strength. The drug is used to treat bumps and blemishes in patients with rosacea. The Food and Drug Administration approved the pump in October.

January 18, 2012

Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

DUBLIN — Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

The two said the it now will be a specialty biopharmaceutical company called Jazz Pharmaceuticals plc and will be based in Dublin.

January 17, 2012

Danish drug maker Novo Nordisk is partnering with cooking show host Paula Deen to launch a campaign to help adults find ways to manage challenges associated with Type 2 diabetes, the company said Tuesday.

PRINCETON, N.J. — Danish drug maker Novo Nordisk is partnering with cooking show host Paula Deen to launch a campaign to help adults find ways to manage challenges associated with Type 2 diabetes, the company said Tuesday.

Deen and her sons, Bobby and Jamie, star in a series of videos as part of the Diabetes in a New Light initiative, in which Deen is sharing her personal diabetes story for the first time.

January 17, 2012

The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

WASHINGTON — The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

The Pharmaceutical Care Management Association announced Tuesday the launch of its new "That's What PBMs Do" ad campaign, which includes print and video ads that focus on what the PCMA called PBMs' role in reducing pharmacy costs, Medicare Part D and mail-order pharmacy.

January 17, 2012

A late-stage clinical trial to evaluate a drug in Alzheimer's disease patients came up short, the drug's developers said Tuesday.

NEW YORK — A late-stage clinical trial to evaluate a drug in Alzheimer's disease patients came up short, the drug's developers said Tuesday, prompting them to cease its development.

Pfizer and Medivation announced results of the phase-3 "CONCERT" trial of Dimebon (latrepirdine), a trial that had lasted 12 months and enrolled 1,003 patients worldwide. The drug, which the companies have studied since 2009, was originally developed by Soviet Union scientists in the 1980s as an antihistamine.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 13, 2012

Bristol-Myers Squibb has officially launched its tender offer for Inhibitex, the drug maker said Friday.

NEW YORK — Bristol-Myers Squibb has officially launched its tender offer for Inhibitex, the drug maker said Friday.

Bristol said it had commenced a $2.5 billion offer to buy all outstanding shares of Inhibitex, an Alpharetta, Ga.-based company developing treatments for hepatitis C. The company's leading product is INX-189, an orally administered drug currently in phase-2 clinical trials.

Bristol announced its intention to buy Inhibitex Monday. The New York-based drug maker said it would make Inhibitex a wholly owned subsidiary following the acquisition.

January 12, 2012

Drug maker Octapharma USA has appointed David Holliday as VP commercial development, the company said.

HOBOKEN, N.J. — Drug maker Octapharma USA has appointed David Holliday as VP commercial development, the company said.

January 11, 2012

A special focus on its diabetes franchise will define Amylin Pharmaceuticals' corporate strategy, the company's chief executive said at a recent conference sponsored by J.P. Morgan.

SAN DIEGO — A special focus on its diabetes franchise will define Amylin Pharmaceuticals' corporate strategy, the company's chief executive said at a recent conference sponsored by J.P. Morgan.

January 11, 2012

Fleming Pharmaceuticals has sold rights of several of its products to Valeant International, Fleming said Wednesday.

ST. LOUIS — Fleming Pharmaceuticals has sold rights of several of its products to Valeant International, Fleming said Wednesday.

Fleming announced the sale of the OTC nasal spray Ocean, the prescription kidney dialysis vitamin supplement Nephrocaps, the magnesium supplement Magonate and ProBarimin QT, a medical food product for patients who have received weight loss surgery. Financial terms were not disclosed.

January 10, 2012

Shire has acquired U.S. rights to a drug used to treat chronic constipation in women from Johnson & Johnson, the company said Tuesday.

PHILADELPHIA — Shire has acquired U.S. rights to a drug used to treat chronic constipation in women from Johnson & Johnson, the company said Tuesday.

Shire announced the acquisition of rights to Resolor (prucalopride) from J&J subsidiary Janssen Pharmaceuticals. Financial terms were not disclosed.

Shire acquired European rights to the drug in 2010 when it bought Belgian drug maker Movetis, which itself had acquired rights to the drug from Janssen.

 

January 9, 2012

Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

ALLEGAN, Mich. — Drug maker Perrigo is buying a privately owned distributor of diabetes products, the company said Monday.

Perrigo announced the $36 million acquisition of Alpharetta, Ga.-based CanAm Care, whose assets include Dex4 hypoglycemia products, insulin delivery syringes and pen needles, lancing, wound care and compression stockings.

January 4, 2012

Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

ALLEGAN, Mich. — Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.

Under the terms of a patent-infringement suit settlement, Perrigo can commercially launch its generic desloratadine product July 1. The new product launch may be a prescription or over-the-counter product, depending on its status at the time of launch, Perrigo stated.

January 3, 2012

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

Gilead said the FDA planned to review the application for the Quad by Aug. 27.

The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.

January 3, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

January 3, 2012

The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.

January 3, 2012

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

January 3, 2012

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

SEATTLE — The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

The company said that the panel will review the NDA for pixantrone, which is designed to treat relapsed or refractory aggressive non-Hodgkin's lymphoma in patients who failed two or more lines of prior therapy.

January 3, 2012

While physicians and pharmacists alike generally view electronic prescribing with favor, several barriers stand in the way of their realizing its full benefit, according to a November government study.


While physicians and pharmacists alike generally view electronic prescribing with favor, several barriers stand in the way of their realizing its full benefit, according to a November government study.


January 3, 2012

Pharmacy technology provider PDX is partnering with Mscripts to allow existing PDX Classic and Enterprise Pharmacy System customers to add mobile to their customer-facing offerings, the companies said.

SUPPLIER NEWS — Pharmacy technology provider PDX is partnering with Mscripts to allow existing PDX Classic and Enterprise Pharmacy System customers to add mobile to their customer-facing offerings, the companies said. The features will give pharmacies an outreach channel to improve their bin management and will-call services, as well as allow them to easily identify aging prescriptions and use the Mscripts mobile application to remind customers to pick up their prescriptions.


January 3, 2012

The role of the pharmacist has evolved considerably over the past decade, and few things exemplify that evolution more than pharmacists taking an active role in patients’ medication therapies and consulting with them one-on-one.


The role of the pharmacist has evolved considerably over the past decade, and few things exemplify that evolution more than pharmacists taking an active role in patients’ medication therapies and consulting with them one-on-one.


January 3, 2012

Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

JERUSALEM — Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.

Yanai, who has served in this capacity for five years, has helped Teva expand from a mainly generics business to a more diversified pharmaceutical company, with expected 2012 revenue of approximately $22 billion, and an expanded footprint in the European, Asian and Latin America markets.