Content about Pharmaceutical industry

August 27, 2013

AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

LONDON — AstraZeneca has bought Maryland-based biotech company Amplimmune, the drug maker said.

AstraZeneca announced the acquisition of privately owned Amplimmune through its MedImmune biologics research and development subsidiary, saying it would boost its cancer drug pipeline. Amplimmune's pipeline includes several experimental treatments, such as AMP-514, a monoclonal antibody currently in preclinical development for which the company hopes to apply to start clinical trials before the end of the year.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

NEW YORK — Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 26, 2013

Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

THOUSAND OAKS, Calif. — Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

Onyx, based in South San Francisco, Calif., has a portfolio of cancer drugs, including the injected multiple myeloma drug Kyprolis (carfilzomib), as well as Nexavar (sorafenib) tablets, developed with Bayer HealthCare Pharmaceuticals; Stivarga (regorafenib) tablets, developed by Bayer; and palbociclib, developed by Pfizer.

August 20, 2013

The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a generic drug for depression made by Par Pharmaceutical Cos., the drug maker said Tuesday.

Par announced the approval of bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline's Wellbutrin XL and is used to treat major depressive disorder. The company already markets the generic drug in the 150-mg strength.

August 20, 2013

Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

NEW YORK — Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

August 20, 2013

A variety of macroeconomic factors are driving growth in the generic drug market in Southeast Asia.

KUALA LUMPUR, Malaysia — A variety of macroeconomic factors are driving growth in the generic drug market in Southeast Asia.

According to CPhI, which is sponsoring the CPhI Southeast Asia Summit 2013 in Bangkok next month, the drug industry in the region is projected to grow to $3.9 billion by 2016, and macroeconomic factors, such as government policies, stable economies and growing population are driving generics.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.

August 8, 2013

Can one of the nation's premier specialty pharmacies maintain its focus on each patient it serves while simultaneously smashing its own growth records and reaching national power-player status in the rarified world of specialized medication services?

Can one of the nation's premier specialty pharmacies maintain its focus on each patient it serves while simultaneously smashing its own growth records and reaching national power-player status in the rarified world of specialized medication services?

August 8, 2013

For traditional retail pharmacies, one of the biggest roadblocks to entry into the specialty arena is the limited availability of many complex medicines.

For traditional retail pharmacies, one of the biggest roadblocks to entry into the specialty arena is the limited availability of many complex medicines. More and more of these high-ticket, high-touch drugs are entering the market via very restricted and exclusive networks as pharmaceutical manufacturers increasingly demand that the pharmacies dispensing those medicines demonstrate advanced clinical, documentation and patient-support capabilities, including the ability to improve adherence rates, conduct risk evaluation and mitigation strategies, and manage and monitor patient outcomes.

August 8, 2013

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health.

The world is turning generic. That's the takeaway from the latest trends in the drug industry, according to IMS Health. In 2012, according to the healthcare industry analytics firm, dollar sales of drugs fell by 1% to $325.7 billion, but prescriptions grew by 1.2% as generic drugs' share of total drugs dispensed grew to nearly 83%.

August 8, 2013

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

Lupin said the FDA approved its ranolazine extended-release tablets in the 500-mg and 1,000-mg strengths. The drug is used to treat chronic angina.

Ranolazine extended-release tablets are a generic version of Gilead Sciences' Ranexa, which had sales of about $443.4 million during the 12-month period that ended in March, according to IMS Health.

 

July 31, 2013

The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

Perrigo announced the FDA approval of fluticasone propionate lotion in the 0.05% strength. The drug is a generic version of Fougera Pharmaceuticals division PharmaDerm's Cutivate and is used to treat inflammatory and pruritic manifestations of atopic dermatitis in patients ages 1 year and older.

The drug has annual sales of about $19 million, according to Symphony Health Solutions.

 

July 31, 2013

Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

WASHINGTON — Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

The Pharmaceutical Research and Manufacturers of America said in a report released Wednesday that drug makers had 444 drugs in clinical development or awaiting Food and Drug Administration approval for a range of diseases, ranging from mild to serious.

July 29, 2013

Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said.

PARSIPPANY, N.J. — Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said Monday.

Actavis said it had filed with the Food and Drug Administration for approval of tapentadol extended-release tablets in the 50-mg, 100-mg, 150-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson subsidiary Janssen Pharmaceuticals' Nucynta ER. The drug is used as a continuous, around-the-clock analgesic over a long period of time.

July 29, 2013

Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

NEW YORK — Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

July 26, 2013

A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

PRINCETON, N.J. — A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

Sandoz, the generics division of Switerland-based Novartis, said the U.S. Federal Circuit Court of Appeals invalidated nine patents owned by Israel-based Teva Pharmaceutical Industries covering the drug Copaxone (glatiramer acetate).

July 24, 2013

Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer.

MISSISSAUGA, Ontario — Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer, GSK said Wednesday.

The drug maker announced Health Canada's approval of Tafinlar (dabrafenib mesylate) and Mekinist (trametinib) in patients with melanoma that can't be removed by surgery or has spread to other parts of the body.

July 23, 2013

A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial.

PITTSBURGH — A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial, Mylan said Tuesday.

Mylan alleges that GlaxoSmithKline breached a contract the two companies had made when it agreed to supply competing drug maker Apotex with paroxetine hydrochloride extended-release tablets, a generic version of Paxil CR. The Third Circuit Court of Appeals' ruling reversed a summary judgment dismissing Mylan's claim.

July 22, 2013

A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

WASHINGTON — Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

July 22, 2013

An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

HOLZKIRCHEN, Germany — An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

July 19, 2013

The Council for Responsible Nutrition announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.

WASHINGTON — The Council for Responsible Nutrition on Thursday announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.