Massachusetts introduces new legislation governing compounding pharmacies
BOSTON – New legislation overseeing compounding pharmacies was introduced Sunday in Massachusetts, according to a report in The Boston Globe.
The bill will require specialized training for compounding pharmacists and would hospital pharmacies to undergo inspections by state regulators to ensure they are in compliance with Massachusetts rules. Hospital pharmacies are presently not subject to monitoring by the state's pharmacy board, according to the report.
The compromise legislation also expands the pharmacy board from 11 to 13 members, The Boston Globe reported, and would require that eight of its members be pharmacists, including one with expertise in sterile compounding.
Following FTC approval, Actavis closes deal on Forest Laboratories
DUBLIN — Actavis and Forest Labs. on Monday announced that the U.S. Federal Trade Commission has voted to approve Actavis' proposed acquisition of Forest. The transaction was officially closed Tuesday in a cash and equity transaction currently valued at approximately $28 billion. The combination creates one of the world's fastest-growing specialty pharmaceutical companies, with annual revenues of more than $15 billion anticipated for 2015.
"The combination of Actavis and Forest creates an innovative new model for success in the global specialty pharmaceutical industry, built to compete within today's evolving healthcare landscape," stated Brent Saunders, CEO and president of Actavis. "Our business model is driven by a broad portfolio of strong brand, generic and OTC products, a commitment to development-focused, results-oriented research and development and the size and scale needed to efficiently and cost-effectively meet the needs of our global customer base," he said. "The new Actavis is uniquely positioned to deliver exceptional long-term financial performance and expand access to pharmaceutical products for patients around the world.
In conjunction with the close of the acquisition, Paul Bisaro, formerly chairman and CEO of Actavis, has been named to the position of executive chairman of Actavis; Saunders, formerly CEO and president of Forest, has been named CEO and president of Actavis; Robert Stewart, formerly president of global operations for Actavis, has been named COO; Bill Meury, formerly EVP sales and marketing for Forest, has been named EVP commercial, North American Brands; and David Buchen, formerly Actavis' chief legal officer, has been named EVP commercial, North American Generics and International.
Actavis announced the appointment of three new members to the company's board of directors, including Actavis' newly appointed CEO and president Saunders. In addition to Saunders, the new members of the Actavis Board are Nesli Basgoz and Christopher Coughlin, both of whom are former members of the Forest board.
"Actavis' best-in-class commercial engine is powered by a specialty brand business that is now positioned to compete with the world's leading pharmaceutical companies, marketing more than 35 products across seven therapeutic market segments and maintaining blockbuster product franchises in five therapeutic categories, as well as a global generics business that remains an industry powerhouse, with operations in approximately 60 countries and a top 10 position in more than 25 markets across the world," Saunders said.
The FTC vote in support of the transaction follows Actavis and Forest's agreement to a proposed consent order, pursuant to which the companies have agreed to divest certain products as a condition to obtaining FTC approval. Actavis will divest two approved applications to Impax Laboratories — Lamotrigine orally disintegrating tablets and Ursodiol tablets.
Forest will divest its approved application and manufacturing rights for propranolol extended release capsules to an affiliate of Catalent Pharma Solutions. The product will continue to be marketed by Breckenridge Pharmaceutical. In addition, Forest will end its license and supply agreement with Valeant Pharmaceuticals for the generic version of Tiazac (diltiazem). Separate from the consent order, but still subject to the consummation of the Actavis and Forest transaction, Forest also has agreed to end its license and supply agreement on the brand version of Tiazac, returning full rights to the product to Valeant.
Study: Vitamin D deficiency associated with higher rates of heart disease, cancer
NEW YORK — A vitamin D boost may prevent early death from heart disease and cancer, according to a large scale study by Mount Sinai and a consortium of international collaborators, published online in the June issue of BMJ and released Monday. Analysis of pooled data by Paolo Boffetta, director of the Institute for Translational Epidemiology and associate director for Population Sciences of the Tisch Cancer Institute at Mount Sinai, and collaborators showed a strong association between low vitamin D levels and risk of death in general death from cardiovascular diseases and in death from cancer, at least in older people with a history of cancer.
“Going into our study, the effect of vitamin D supplementation on risk of death was not clear,” Boffetta said. “Our analysis confirms the protective nature of this substance especially in elderly patients.”
Deficiency is most common in the elderly, who get less sun. Limited understanding of just how much vitamin D is needed to achieve protection has meant a lack of consistent recommendations on supplementation, and the verdict is still out. The current study results argue that those deficient in vitamin D are more likely to die before those who are not, Boffetta reported.
Researchers analyzed data from eight European and American studies that included 26,018 men and women ages 50 years to 79 years. Followup analysis showed that 6,695 study participants died during the studies, including 2,624 from cardiovascular diseases and 2,227 from cancer. Comparison of the lowest and the highest levels of vitamin D in the deceased showed those with the lowest concentrations had a pooled risk ratio of 1.57, or nearly double the risk of overall death as those with high concentrations. Risk ratios for cardiovascular and cancer deaths in those with cancer history were similar. Despite varying levels of Vitamin D between country, sex and season of blood draw, the association between low levels of vitamin D and death was consistent.
“Vitamin D’s protective effect is clear,” Boffetta said. “If our results are confirmed in additional studies, it could lead to recommendations for greater vitamin D supplementation in foods, and to a better understanding of its role in cancer prognosis.”
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