Warner Chilcott settles with Zydus over generic Asacol HD
DUBLIN — A subsidiary of Actavis has reached a settlement with a generic drug maker that will allow the launch of a generic version of a treatment for ulcerative colitis in 2015.
Actavis said its Warner Chilcott subsidiary had settled with Zydus Pharmaceuticals USA and Cadila Healthcare over Zydus’ generic version of Asacol HD (mesalamine) delayed-release tablets.
Financial terms of the deal were not disclosed, but Warner Chilcott will give Zydus a royalty-bearing license to market its generic product starting in November 2015, pending its approval by the Food and Drug Administration. If Zydus does not receive FDA approval, it will be allowed to market an authorized generic version of the drug starting in July 2016.
Asacol HD had sales of $122 million during the quarter that ended on June 30, according to Warner Chilcott.
FDA seeks to limit use of antibiotics in animal feed to curb rise of resistant bacteria
SILVER SPRING, Md. – The Food and Drug Administration is planning to limit the use of antimicrobials in food animals in an effort to stem the rise of antibiotic-resistant bacteria, the agency said Wednesday.
Some antimicrobials have historically been added to the feed and drinking water of livestock in order to allow them to gain more weight with less food, but some of them are also used to treat infections in humans. This has fed worries among health experts that the practice may play a role in the growing trend of bacteria that are immune to antibiotics, which also is a reason why experts advise people to take antibiotics only when medically necessary.
The FDA’s plan focuses on antibiotics that are used both for human infections and as feed and water additives for food animals. In a guidance, the agency is laying out a plan for animal drug companies to voluntarily revise their product labeling so that it doesn’t encourage their use in meat production and is asking the companies to notify the agency of their intent to sign onto the strategy within three months.
"Implementing this strategy is an important step forward in addressing antimicrobial resistance," FDA deputy commissioner for foods and veterinary medicine Michael Taylor said. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
The agency also has issued a proposed rule to update existing regulations relating to veterinary feed directive, or VFD drugs, and expand the oversight of veterinarians when they’re used.
"This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need," FDA Center for Veterinary Medicine director Bernadette Dunham said. "We realize that these steps represent changes for veterinarians and animal producers, and we have been working — and will continue to work — to make this transition as seamless as possible."
Counterfeit drugs, digital technology emerge as major issues influencing health care in 2014
NEW YORK — While the Patient Protection and Affordable Care Act will undoubtedly reshape the U.S. healthcare industry for years to come, it is only one of many factors that will emerge next year, according to a new report released Wednesday.
The report, Top Health Industry Issues for 2014, by PwC’s Health Research Institute, was based on a survey of 1,000 consumers and interviews with health industry leaders.
According to the report, the 10 issues that stand out as the top focus for the industry are:
- Price transparency is growing as purchasers – consumers and employers – are demanding and receiving more information on cost and quality
- Employers are exploring new health insurance options through private exchanges
- New regulation aims to eliminate counterfeit medications in the drug supply chain
- States are turning to managed care to help contain Medicaid long-term care costs
- All healthcare companies need to rethink their roles and business models in the new health economy
- Healthcare companies will need to change their rules on innovation — embrace “fail fast” approaches
- Social, mobile, analytics, and cloud technologies are driving new health industry business models
- Corporate venture capital is picking up the slack as traditional venture funding slows for pharmaceutical start-ups
- Technology is redefining the healthcare job market
- Drugmakers must rethink their clinical trial research methods, embracing alternative approaches
“While health insurance exchange implementation is driving headlines today – in reality the next 12 months will be marked by how well the industry addresses a range of core business challenges," PwC U.S. health industries leader Kelly Barnes said. "Our annual Top Issues report identifies the main concerns facing the health industry in 2014. Businesses must address rapid innovation and competition from non-traditional players, but above all they must respond to empowered consumers as customer-centric transformation sweeps healthcare.”