Content about Pharmaceuticals policy

February 1, 2011
Biosimilars regulations 
unlikely to unfold soon

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011
Generics discounts ignite Medicare Rx competition

Just when you thought the low end of the generic drug price spectrum couldn’t get any more commoditized, the $2 price point debuted with a big splash in September 2010.


February 1, 2011
ReportersNotebook — Chain Pharmacy, 2/7/11

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.





February 1, 2011
Three issues that will define 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011
AZ&Me sees participation increase in 2010

Nearly half a million people participated in AstraZeneca's prescription savings programs.

January 31, 2011
MAP, Allergan to co-promote Levadex

Anticipating regulatory approval, MAP Pharmaceuticals and Allergan will collaborate to promote a drug for treating acute migraine to physicians.

January 31, 2011
Mylan looks to market generic Lidoderm

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

January 31, 2011
Transcept announces PDUFA action date for Intermezzo

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

January 27, 2011
Amylin trims losses in Q4, full-year results

Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

January 27, 2011
GSK receives complete response letter for Avodart

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

January 26, 2011
Teva, APP develop generic Gemzar

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

January 25, 2011
Teva receives FDA action letter for generic Lovenox

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011
Matrix Labs' generic Protonix DR receives FDA approval

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

January 24, 2011
Survey: Patients oppose PSE prescription mandate

As many as 71% of cough-cold sufferers in search of decongestant relief oppose a prescription requirement for pseudoephedrine, according to a survey commissioned by the Asthma and Allergy Foundation of America released Monday.

January 21, 2011
Watson forecasts successful year

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

January 20, 2011
Report: Genzyme CEO calls acquisition by Sanofi-Aventis a long process

Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

January 19, 2011
Government obtains permanent injunction against Deltex

A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

January 19, 2011
Impax responds to reports about generic Lipitor

In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

January 18, 2011
Karl Matuszewski joins First DataBank

Drug database provider First DataBank has appointed former Gold Standard/Elsevier editor-in-chief Karl Matuszewski as VP clinical and editorial knowledge-base services, the company said Tuesday.

January 17, 2011
Court: Teva, Barr Labs must hold off on generic versions of Sensipar

Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

January 17, 2011
FDA extends review time of AstraZeneca's vandetanib

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

January 13, 2011
K-V: FDA will approve Gestiva by PDUFA date

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

January 13, 2011
Study: Healthcare companies think REMS in need of major overhaul

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

January 12, 2011
NCPA sends letter to House committee chairman on ways to help pharmacy, patients

The independent pharmacy lobby has issued a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., with insight on how certain current or proposed federal regulations can burden pharmacies and their patients.

January 12, 2011
Walgreens encourages mail-order pharmacy patients to make the switch

It seems that many mail-order pharmacy patients are unaware that they can receive their 90-day supply of prescription medications at community pharmacies.

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