FDA Targets Insulin Prices

FDA Commissioner Scott Gottlieb, MD.

FDA Commissioner, Scott Gottlieb, MD, announced another governmental mission to lower drug prices for Americans, this time targeting popular insulin drugs. Dr. Gottlieb proclaimed that for a product nearly 100 years old, very little market competition exists for the pharma giants charging “artificially high” prices that are forcing many Americans to ration medication and compromise their health. Dr. Gottlieb said, “We’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive.”

In order to increase competition and consequently lower insulin prices, the FDA will be reclassifying insulin as a biologic rather than a drug, a change that should finalize by March 2020. Without the difficulties of bringing a similar product to the market as a drug, more competitors will supply insulin products as biologics, therefore reducing prices across the board, according to the Commissioner. Sanofi, Eli Lilly and Co., and Novo Nordisk currently control 90% of the insulin market, which has seen list price increases of 15% to 17% per year from 2012 to 2016. Since 2013, the cost of insulin has nearly doubled, rising from an average list price of $405 per prescription that year to $666 in 2016, according to a 2017 analysis by the Health Care Cost Institute. Dr. Gottlieb closed the announcement of his most recent drug price regulation initiative by saying that the “new pathway we’re laying out today should help usher in a new era of competition for these products that’ll lead to lower prices and better access.”

Pfizer in the Hot Seat Once More

Having postponed its scheduled price hikes last year after Trump’s embarrassing call-out on Twitter, Pfizer is preparing for routine price hikes at the start of the new year. Democratic Senator Tammy Baldwin (Wis.) did not take the news lightly, accusing the pharma giant of “rather than playing games with costs of prescription drugs that millions of Americans depend on, you should make a firm and clear commitment to permanently roll back prices,” in a fiery letter to CEO Ian Read. The Senator, as well as the rest of the administration, are demanding specifics about the price increases, numbers on manufacturing and marketing costs, and Pfizer’s justification for the hikes as well as transparency and accountability from all pharmaceutical companies. It remains to be seen how Pfizer and the pharma industry will respond.

Accenture, Merck, and Amazon Web Services Revamp Life Sciences Platforms

The new cloud-based informatics research platform fosters intricate collaboration.

Accenture, a global business tech solutions provider, has teamed with Merck and Amazon Web Services to innovate early stage drug development with a single platform. This cloud-based informatics research platform provides an open partnership ecosystem that allows multiple tenants to collaborate securely and efficiently. The system, built on Amazon Web Services, is designed to help independent software vendors (ISVs) and life sciences companies team more effectively to accelerate drug discovery efforts and ultimately improve patients’ treatments, sooner.

From a modern user interface, life sciences researchers and informatics professionals can quickly aggregate, access, and analyze research data from multiple applications. ISVs can easily integrate technology components, applications, and content into the platform so that life sciences companies can give researchers access to innovative, best-of-breed capabilities, such as small-molecule and biological-entity registration, biological assay data capture, genomics data analysis, image storage and analysis, and artificial intelligence.

Hal Stern, Associate Vice President of IT Engineering at Merck Research Labs, said, “One of the key reasons we chose to collaborate with Accenture on the development of the research platform is because of their ability to enable and accelerate this technology partner ecosystem. Through the ecosystem, we are creating an environment that will make it easier for life sciences companies to on-board innovations from leading-edge technology vendors that really can advance science—whether experiment design and data management, visualization, or machine learning capabilities to improve decision making—and bring all this information together in a common platform and infrastructure for drug discovery.”

Currently, Accenture is working with more than 30 ISVs to incorporate their technology, applications, and content into the platform, including ChemAxon, SciBite, and Dotmatics. Merck and Accenture expect this community-based and tech-forward approach to drive research productivity and therapeutic innovation.

AXON Acquires U.K.’s Cherry

The healthcare communication agency continues to expand its global reach with the recent acquisition of Cherry, a London-based healthcare agency specializing in creativity, strategy, and digital to better connect brands with healthcare professionals and patients. Cherry’s clients will benefit from AXON’s wider network including their U.S. presence, as well as their strength in insights, data science, and exciting synergies in service offerings with the U.S.-based healthcare practice. The 80 employees at Cherry will continue to work out of their current headquarters while collaborating with AXON’s award-winning team locally and internationally.

Merck Tackling Dengue Vaccines in Brazil

Though development of dengue vaccines have proven costly, Merck has partnered with Brazil’s Butantan Institute to advance their respective dengue vaccine programs. Both parties will share their information and research, and the pharma giant will pay the Butantan Institute $26 million upfront and up to $75 million if its vaccine candidate meets specified development and commercialization milestones, plus potential royalties.

Both companies have dengue vaccines in the works, with Merck’s drug in Phase I studies and Butantan’s in Phase III. As part of the agreement, Merck will not enter the Brazilian market should their vaccine receive approval and they rollout sales globally.

Eli Lilly and Evidation Health Expand Tech Research Partnership

The pharma giant announced a multi-year collaboration that gives it access to Evidation Health’s Andromeda data platform. Evidation Health is a measurement company that helps innovative life sciences and healthcare companies understand how everyday behavior and health interact. Lilly hopes to find new ways to measure and understand a patient’s health by accessing consented data derived from smartphones, connected sensors, wearables, and even his or her own voice. The terms of the agreement are undisclosed.

Lilly scientists will use Andromeda to access private, collaborative, and secure analytics and then build algorithms to process raw data for use in clinical studies or to create their own predictive models. The goal is to turn complex, patient-generated behavior data into new, clinically meaningful insights that can transform how diseases are identified, treated, and monitored.

“Digital health advancements, including mobile devices and wearables, have the potential to improve and personalize health outcomes,” said Divakar Ramakrishnan, Lilly’s Chief Digital Officer. “By leveraging Evidation’s Andromeda platform, Lilly’s scientists are gaining a deeper understanding of the physiological, environmental, and contextual indicators that can help shape future advancements in medicine and medicine delivery.”

Currently, the diabetes market dominator is using Evidation’s data platform to analyze data from continuous glucose monitors and insulin pumps to improve the experience of people with diabetes and contribute to a connected ecosystem that includes an automated insulin delivery device and connected insulin pen.

Amgen Donates Cancer Drugs to Developing Nations

Amgen has announced a partnership with Direct Relief to distribute $93 million worth of Amgen cancer treatment and supportive therapies to 18 developing countries, including the Dominican Republic, Ethiopia, Ghana, Haiti, Honduras, India, Jamaica, and Malawi.

“Amgen’s mission is to serve patients around the world. We are pleased to work with Direct Relief, an organization with a strong network of high-quality cancer hospitals and clinics across the developing world, to make these innovative cancer medicines accessible to patients in need,” said Joshua Ofman, MD, Senior Vice President of Global Value, Access, and Policy at Amgen. The drugs, Amgen’s Neulasta (pegfilgrastim), Neupogen (filgrastim), and Vectibix (panitumumab), will be distributed via Direct Relief’s partner hospitals and clinics. The first shipment is already being distributed and is estimated to serve 7,400 low-income patients.

Astellas Acquires Potenza Therapeutics

Astellas has closed a deal with Potenza to acquire the drugmaker and the rights to its novel immuno-oncology portfolio. The two drug developers have been collaborating for the past three years, together discovering three investigational therapies for cancer that is non-responsive or resistant to the current generation of IO therapies.

“We are extremely proud of what the experienced Potenza team has accomplished to discover and create innovative therapeutics for the treatment of cancers,” said Dan Hicklin, PhD, President and CEO, Potenza, in a statement. “Over the past three and a half years, we have enjoyed a successful and productive partnership with Astellas. I am pleased that these therapies will now have access to the resources of a large international company, with world-class R&D and the strategic and financial backing to support the development of these innovative potential new medicines for cancer patients in need.”

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