Content about Pharmaceutical industry

February 28, 2013

Survey: Many doctors ignore generic savings

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers.

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians' prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients' wishes.

February 26, 2013

Ranbaxy resumes production of cholesterol drug ingredients

Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

NEW YORK — Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

The Indian drug maker said it had initiated corrective and preventive actions, or CAPA, as it prepared to resume supplies of generic atorvastatin calcium tablets to the U.S. market. The drug is a generic version of Pfizer's Lipitor, and Ranbaxy became the first company to market a generic version in November 2011.

February 26, 2013

Reports: Elan not responding to acquisition offer from Royalty Pharma

A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan Corp., but hasn't heard back from it, according to published reports.

NEW YORK — A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan, but hasn't heard back from it, according to published reports.

The Associated Press reported that Royalty Pharma's $11-per-share offer for Elan represented a 4% premium over its closing price Friday. Royalty buys royalty interests in drug products that are in late-stage development or have already entered the market, but doesn't develop or market drugs of its own, the AP reported.

February 25, 2013

Generic tsunami eases, but leaves transformed Rx landscape in its wake

The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.

February 22, 2013

FDA commissioner praises generic industry's efforts on quality, shortages, follow-on biologics in GPhA speech

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

February 21, 2013

GPhA appoints board of directors for 2013

The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

ORLANDO, Fla. — The Generic Pharmaceutical Association re-elected its chairman from last year and appointed a new board of directors for 2013 whose members run from A to Z — as in Amneal to Zydus.

"We are grateful for the vision and support of the 2012 board of directors, and we are excited to move ahead with our chairman and our 2013 board," GPhA president and CEO Ralph Neas said. "In a time of enormous change and growth for our industry, leadership is critical."

February 19, 2013

FDA approves Aurobindo diabetes drug

The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

February 19, 2013

FDA grants priority review to ViiV drug for HIV

The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

LONDON — The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

The FDA gave the designation to dolutegravir, designed for use in combination with other antiretrovirual drugs in adults and adolescents. The agency gives priority review to drugs that offer significant improvement compared with products already on the market.

February 15, 2013

FDA approves Teva ADHD drug

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.

February 14, 2013

United Therapeutics resubmits application for pulmonary arterial hypertension drug

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 13, 2013

State of the Union address draws mixed responses from drug industry

Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

WASHINGTON — Some people liked President Barack Obama's State of the Union address Tuesday night, and some people didn't, and the response from the drug industry was no less mixed.

The Generic Pharmaceutical Association called for measures to lower healthcare costs, including ensuring that generic pharmaceuticals and biosimilars reach patients' hands quickly and also avoiding measures intended to provide savings that the GPhA said would raise prescription drug costs, though the grow didn't specify what those measures were.

February 12, 2013

Post-approval drug problems could be due to poor adherence in trials, study finds

Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

MCLEAN, Va. — Unexpected toxicities from prescription drugs that emerge years after regulatory approval may be due to poor medication adherence in clinical trials, according to a new study.

While much attention on medication adherence has focused on patients not taking the already approved drugs prescribed to them or not taking them properly, the new study, released Tuesday by Consumer Health Information, found problems with adherence in clinical trials as well.

February 12, 2013

Putney aims to compete in generic pet drug market with new launch

Putney has launched a generic version of a veterinary skin infection drug, the company said.

PORTLAND, Maine — Putney has launched a generic version of a veterinary skin infection drug, the company said.

Putney announced the launch of cefpodoxime proxetil, a generic version of Pfizer's Simplicef, used to treat certain skin infections in dogs. Putney said its product was the only generic version of Simplicef approved by the Food and Drug Administration.

February 12, 2013

Reports: GSK among companies looking to acquire Brazil's fourth-largest drug firm

GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

NEW YORK — GlaxoSmithKline may be looking to buy a Brazilian drug maker for up to $4 billion, according to published reports.

Reuters, citing unnamed sources, said GSK was one of several drug companies looking to buy Ache Laboratorios Farmaceuticos for $3 billion to $4 billion. Other companies looking to buy the drug maker included Novartis, Pfizer and Abbott Labs.

Reuters noted that the company was attractive to drug makers looking to expand their footprints in Latin America and that it was a major producer of prescription and OTC medications.

February 8, 2013

Elan sells Tysabri rights to Biogen Idec

Elan will sell the rights to its drug for multiple sclerosis to partnering company Biogen Idec for $3.25 billion plus royalties, the Irish drug maker said.

DUBLIN - Elan Corp. will sell the rights to its drug for multiple sclerosis to partnering company Biogen Idec for $3.25 billion plus royalties, the Irish drug maker said.

February 8, 2013

FDA gives tentative approval to Dr. Reddy's hypertension drug

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

February 8, 2013

GSK Consumer names new director of corporate development

GlaxoSmithKline has promoted Pam Prisk to director of corporate development for GSK Consumer Healthcare North America, effective immediately.

PITTSBURGH — GlaxoSmithKline has promoted Pam Prisk to director of corporate development for GSK Consumer Healthcare North America, effective immediately.

February 8, 2013

Rx-to-OTC switches could be boon as FDA looks at switch paradigm

A new report by Francesco International identified $35.7 billion worth of potential Rx-to-OTC switches in a wide range of indications, from hypertension and chronic obstructive pulmonary disorder to high cholesterol and erectile dysfunction, and the Food and Drug Administration has been looking at ways technology and pharmacists could be employed to ensure that patients taking drugs new to the consumer health space take them appropriately.

With growth in traditional pharmaceuticals expected to slow down significantly, a growing number of drug makers — branded and generic alike — see specialty drugs as their main sources of revenue for the foreseeable future. At the same time, those drug makers not invested in specialty may be looking for growth opportunities in consumer health.

February 8, 2013

Sanofi: Rolaids will be relieving heartburn with its return to the market by the end of the year

During a quarterly conference call Thursday, Sanofi president global operations Hanspeter Spek noted that Sanofi's consumer arm Chattem will be relaunching the heartburn remedy Rolaids.

PARIS — During a quarterly conference call Thursday, Sanofi president of global operations Hanspeter Spek noted that Sanofi's consumer arm Chattem will be relaunching the heartburn remedy Rolaids.

"We plan to relaunch the product, which has been absent of the American markets for production problems on the side of J&J," he told analysts. "We intend to launch the product by the end of 2013, which will further accelerate the performance of Chattem in the United States."

February 8, 2013

Taro, Sun slam brakes on acquisition deal

Israeli drug maker Taro Pharmaceutical Industries and Indian drug maker Sun Pharmaceutical Industries have terminated their merger agreement, the companies said in a joint statement Friday.

HAWTHORNE, N.Y. - Israeli drug maker Taro Pharmaceutical Industries and Indian drug maker Sun Pharmaceutical Industries have terminated their merger agreement, the companies said in a joint statement Friday.

Little explanation for the decision to halt the deal was given, except that terminating the agreement was "in the best interest of the respective companies and shareholders." Taro shareholders would have received $39.50 per share upon the closing of the deal.

February 6, 2013

FDA approves Elite Pharmaceuticals' opioid painkiller

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

NORTHVALE, N.J. — The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

Elite announced the FDA approval of its supplemental application for the manufacture and packaging of naltrexone hydrochloride tablets in the 50-mg strength. The company said the approval would allow it to start manufacturing and packaging the drug for its sales and marketing partner, Mikah Pharma, from which it bought rights to the drug in September 2010.

February 6, 2013

FDA approves Sandoz antibiotic

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the approval and launch of clindamycin in 5% dextrose in minibag form, the first generic version of Pfizer's Cleocin Phosphate in Dextrose 5%.

Sales of the branded version were $52.2 million in 2012, according to IMS Health.

February 6, 2013

Reports: Senators introduce bill to ban 'pay-for-delay' settlements

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

NEW YORK — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

February 5, 2013

Report documents opportunities, challenges for biosimilars

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

February 4, 2013

H. D. Smith names new EVP for specialty arm Smith Medical Partners

H. D. Smith announced the appointment of Tim Booth to EVP, Smith Medical Partners. Smith Medical Partners is a wholly owned subsidiary of H. D. Smith focused on specialty pharmaceutical distribution and services, and is part of the newly formed H. D. Smith Specialty Solutions group.

SPRINGFIELD, Ill. — H. D. Smith on Monday announced the appointment of Tim Booth to EVP, Smith Medical Partners. Smith Medical Partners is a wholly owned subsidiary of H. D. Smith focused on specialty pharmaceutical distribution and services, and is part of the newly formed H. D. Smith Specialty Solutions group.