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Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems...The challenges in producing cellular and gene therapies and other cutting-edge products that meet standards for safety, efficacy, and quality was high on the agenda for biopharmaceutical companies at PDA/FDA annual joint regulatory conference...

• Center for Biologics Evaluation and Research...is expediting the development and approval of human cellular and tissue products...vetting new regenerative medicine advanced therapies, including those utilizing gene-editing technology to treat malignancies and diseases...
• National Institutes of Health...cell biology and tissue engineering to advance regenerative medicine...these products require very different manufacturing and dosing processes and raise multiple challenges for scale-up and for keeping cells alive during processing...
• CBER’s Office of Tissues and Advanced Therapies...devising standards for characterization and potency assays for regenerative products, stem cell therapies, therapeutic vaccines, gene therapies, antivenins and certain combination products…importance of controlling the manufacturing process for these products and...challenges in achieving the right level of product characterization based on critical quality attributes.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Medical technology continues to lose ground when it comes to all U.S. venture capital investment as value-based care takes hold of the healthcare system and the industry fights to get rid of a device tax...The share of medical technology venture deals dropped to just 4% of total deals last year compared to the industry’s 13% share 25 years ago...There were 420 medical technology venture deals in 2016 out of more than 10,000 total venture deals...medical technology companies had been paying a 2.3% medical device tax on sales under the Affordable Care Act until a two-year moratorium began in January 2016. Before the device tax was put on hiatus, the IRS collected between $1 billion and $2 billion a year in 2013, 2014 and 2015...This move away from fee-for-service medicine to value-based models means insurance companies don't always pay for the medical device a doctor wants to use. Purchasing of devices at large multi-hospital systems has shifted from doctors to “hospital purchasing committees,”.. medtech products...have digital health elements embedded into them...Inherently, digital health solutions are more solution-based...and they have the ability to measure outcomes...Whether medical technology companies can develop products that improve outcomes and measure them will be key...

Allergan Plc’s decision to pay a Native American tribe $15 million a year rather than let one of its blockbuster drugs be scrutinized by the U.S. Patent & Trademark Office is part of a backlash against an agency review panel that has been dubbed a “death squad.”...The drugmaker earlier this month transferred ownership of patents protecting a medicine with $1.49 billion in sales last year to the Saint Regis Mohawk Tribe of upstate New York. The tribe, which will receive royalties every year, says that as a sovereign entity it is immune from such civil patent challenges....The creative -- and untested -- maneuver is designed to circumvent the Patent Trial and Appeal Board...critics say the board has made it too easy for rivals to attack patents and they’re pressing Congress, the courts and the patent office for changes...companies such as Google or Apple Inc., which are among the biggest users of the review board to fend off what they consider nuisance lawsuits from companies looking for a quick payday...the Supreme Court agreed to take a case to determine if the reviews are constitutional -- critics of the reviews say a patent is a property right that only federal courts can revoke. But even those who want to see the system dismantled say that case is a long shot...The patent office has been considering changes to its procedures...

The Advanced Lyophilization Technology Hub, a consortium of experts at Purdue University, has published a 10-year road map to identify improvements that are needed to freeze drying, or lyophilization, a mainstay of drug manufacturing that has seen little fundamental change since it was introduced to the pharmaceutical industry in the 1940s. The roadmap represents the collective knowledge of more than 100 individuals from industry, academia, and government laboratories who focus on lyophilization...“Ultimately, we’d like to help bring about high-quality, lower cost, more readily available pharmaceuticals and food products that are made with lyophilization or related new technologies,” said Elizabeth Top, a professor at Purdue’s Department of Industrial and Physical Pharmacy...the road map identifies the key factors driving change, gaps in technology that require research solutions, industry needs, educational roles and regulatory issues that will help shape the field over the next decade...Improvement is most urgently needed in products, process, and equipment...