Content about Pharmaceutical industry

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

NEW YORK — The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

According to The New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.