Content about Pharmaceutical industry

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.

February 4, 2013
Perrigo launches generic scalp medicine

Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

ALLEGAN, Mich. — Drug maker Perrigo has launched a generic drug for treating problems of the scalp, the company said.

Perrigo announced the launch of clobetasol emulsion propionate foam in the 0.05% strength, a generic version of GlaxoSmithKline's Olux-E. The drug is used to treat moderate to severe dermatosis of the scalp.

February 1, 2013
Novartis recalls Triaminic Syrups and Theraflu Warming Relief Syrups

Novartis Consumer Health on Thursday voluntarily issued a recall of certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States prior to Dec. 31, 2011.

PARSIPPANY, N.J. — Novartis Consumer Health on Thursday voluntarily issued a recall of certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups that were manufactured in the United States prior to Dec. 31, 2011. 

The full recall resulted from a faulty child-resistant feature of the bottle cap may not function properly, enabling the cap to be removed with the tamper-evident seal still in place.

February 1, 2013
Pharmacists can improve health outcomes

A new study conducted by researchers at the University of Minnesota and nearby healthcare institutions shows that patients with diabetes experience better outcomes when they undergo face-to-face medication therapy management sessions with pharmacists.

Drug Store News has reported enough about the benefits of MTM to fill a book, but a scientific study showing a demonstrable benefit to it only makes the case stronger. It speaks to the growing role of the pharmacist as a key member of the patient's healthcare team, every bit as important as nurses and doctors, and also points to a role of growing importance to pharmacy retailers themselves as they seek to distinguish themselves in the marketplace.

A new study conducted by researchers at the University of Minnesota and nearby healthcare institutions shows that patients with diabetes experience better outcomes when they undergo face-to-face medication therapy management sessions with pharmacists.

January 30, 2013
FDA panel recommends approval for Boehringer Ingelheim COPD drug

A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

RIDGEFIELD, Conn. — A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

January 29, 2013
Eli Lilly reports 1% Q4 decline from Zyprexa patent expiration

Eli Lilly and Company reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.

INDIANAPOLIS — Eli Lilly and Company on Tuesday reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.

January 28, 2013
Amneal, South Korea-based Hanmi enter GERD drug deal

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

January 28, 2013
FDA accepts application for Genzyme MS drug

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

January 28, 2013
Pharmacy trends and outlook for 2013

Health care is evolving. As obvious of a statement as that is, it doesn’t change the fact that it is very real. Throughout last year, there was intense discussion on the Patient Protection and Affordable Care Act and what impact the outcome of the presidential election might have on its future. Now that the Supreme Court has ruled and elections are settled, healthcare companies and providers across the country are implementing strategies to meet ACA requirements.

Health care is evolving. As obvious of a statement as that is, it doesn’t change the fact that it is very real. Throughout last year, there was intense discussion on the Patient Protection and Affordable Care Act and what impact the outcome of the presidential election might have on its future. Now that the Supreme Court has ruled and elections are settled, healthcare companies and providers across the country are implementing strategies to meet ACA requirements.

January 25, 2013
Canadian provinces to reduce reimbursements for six generics

Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

NEW YORK — Canada's provincial and territorial governments have reached a deal that they said would save money on drugs, but that generic drug makers said had left them "disappointed."

January 25, 2013
FDA approves Gleevec for most common pediatric cancer

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

January 24, 2013
New asthma educational website launched

A division of drug maker Teva is partnering with an advocacy group focused on asthma in the launch of a new educational website about the condition.

WASHINGTON — A division of drug maker Teva Pharmaceutical Industries is partnering with an advocacy group focused on asthma in the launch of a new educational website about the condition.

The Asthma and Allergy Foundation of America and Teva Respiratory announced the launch of Get Smart About Asthma, which aims to increase understanding of how inflammation in the airways contributes to the disease's persistence and severity, as well as providing other educational materials.

January 23, 2013
FDA approves Novartis drug for rare blood disorder

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

January 23, 2013
Novartis, Cytos terminate licensing agreement for smoking-cessation drug

Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

SCHLIEREN, Switzerland — Cytos Biotechnology will regain rights to an experimental vaccine against nicotine addiction that it had licensed to Novartis, Cytos said Wednesday.

The company said that Novartis would discontinue the project, known as NIC002. Cytos granted Novartis a license for NIC002 in 2007, but phase-2 trial results in October 2009 indicated that the vaccine spurred the development of nicotine-specific antibodies in patients, but did not increase smoking cessation.

January 22, 2013
FDA addresses Tamiflu shortages

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 21, 2013
GSK submits approval application for albiglutide

Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

LONDON — Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

GSK announced the submission to the FDA of a regulatory approval application for albiglutide. The drug is not approved in any market yet, and the company plans to also seek approval in the European Union this year.

GSK assumed control of albiglutide with its $3.6 billion acquisition of Human Genome Sciences, announced last July.

January 18, 2013
Reports: Roche dips into Tamiflu reserve

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

January 17, 2013
Boehringer Ingelheim Pharmaceuticals starts phase-3 trial of HCV drug

Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals has enrolled the first patients in its late-stage trial of a treatment for hepatitis C, the drug maker said Thursday.

BI Pharmaceuticals is conducting the "HCVerso" trial of an HCV drug that combines faldaprevir, the experimental compound BI 207127 and ribavirin. The company has established trial sites in more than 25 states.

January 17, 2013
Report finds 'innovative and robust' global drug pipeline

More than 5,000 medicines are under development, of which 70% are potentially the first of their class, according to a new report.

WASHINGTON — More than 5,000 medicines are under development, of which 70% are potentially the first of their class, according to a new report.

January 17, 2013
SIDI Work Group releases voluntary supplier qualification guidelines

The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.

WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.