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Strativa gets FDA approval for opharyngeal candidiasis drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a new drug from Strativa Pharmaceuticals for treating thrush, the drug maker said Friday.

Strativa announced the FDA’s approval of Oravig (miconazole), a tablet intended for patients 16 and older with thrush, also known as oropharyngeal candidiasis. The company said Oravig was the first oral, local prescription formulation of miconazole approved for thrush in the United States. The drug is a buccal tablet, meaning it adheres to the gum to deliver the miconazole directly at the local site of infection.

“The FDA approval of Oravig underscores Strativa’s commitment to improving patients’ overall treatment experience by bringing to market new products that fulfill patient needs,” Strativa president John MacPhee said. “Oravig offers patients suffering from thrush a proven, effective treatment in a discreet and convenient once-daily formulation.”

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Study: Remicade more efficient in treating Crohn’s disease than generic competitor

BY Alaric DeArment

HORSHAM, Pa. Patients who had not received previous treatment recovered and healed better when taking a Johnson & Johnson biotech drug for Crohn’s disease than when taking a common generic drug for the disease, according to post-marketing clinical trial results published Thursday in The New England Journal of Medicine.

Results of a phase 4 study comparing J&J’s Remicade (infliximab) with azathioprine showed that a larger number of patients had steroid-free remission and mucosal healing when taking Remicade than when they took azathioprine. Crohn’s disease is an inflammatory, autoimmune disorder of the gastrointestinal tract that affects around half a million Americans.

“The results provide new insights into the benefits of starting Remicade alone or in combination with azathioprine –– earlier in the treatment of moderate to severe Crohn’s disease,” principal study investigator and medicine professor of France’s Centre Hospitalier Universitaire de Lille Jean-Frederic Colombel said.

The investigators found that after 26 weeks, 57% of patients taking Remicade and azathioprine together and 44% of those taking Remicade alone had remission of their disease without steroids, compared with 30% of those taking azathioprine alone.

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Babson College to host Strategic Planning and Management in Retailing program

BY Allison Cerra

WELLESLEY, Mass. Babson College will be offering two sessions of Strategic Planning and Management in Retailing, its seven-day open enrollment program on retail management.

As a leader in entrepreneurial management education, Babson said Strategic Planning and Management in Retailing works with retail leaders to identify and evaluate their organizations’ key success factors in order to plan more strategically and manage their businesses more effectively.

The program, designed for retail CEOs, senior and general merchandise managers, operations managers, district managers, and upper-level marketing, finance, human resources, and MIS managers, participants will learn to:

  • Strategically plan for growth, including financial modeling and productivity analysis
  • Analyze and interpret consumer, competitive, and market research
  • Develop and implement enhanced merchandising management and assortment strategies
  • Effectively manage strategic resources

Program faculty include: Lawrence Ring (faculty director) and John Strong.

The program will be held at The College of William and Mary from May 1-7 and at the Babson Executive Conference Center from September 11 – 17.

Click here to sign up.

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