Drug companies face scrutiny from lawmakers looking to lower cost

wbjournal | April 16, 2019

Members of the Health Care Financing Committee on Thursday pressed pharmaceutical industry representatives to identify ways drug manufacturers can help bring more transparency to their pricing and lower costs for consumers. "You all have had a long time to be transparent," Sen. Cindy Friedman, the committee's Senate chair, said. "Pharmaceutical companies have had a long time to come to the table and say let us be as transparent as our insurance companies are and as all the other parts of health care that we patrol. You have had that opportunity, and you haven't done it. With all due respect, we want you at the table but we need you to be equal partners and be willing to understand that you have skin in the game, we have skin in the game, everybody in this room does." Friedman directed her comments to Leslie Wood of the Pharmaceutical Research and Manufacturers of America, Patrick Plues of the Biotechnology Industry Organization, and Robert Coughlin of the Massachusetts Biotechnology Council, who testified together during a hearing on drug pricing, access and transparency bills. The hearing, at its outset, was so crowded that advocates and interested parties spilled out of the open doorways into the hall. Much of the testimony focused on legislation filed by Sen. Jason Lewis and Rep. Christine Barber that takes various steps in hopes of managing the rising costs of prescription drugs, which Lewis said was the most urgent health policy issue facing lawmakers. He said prescription spending in MassHealth has doubled over the past five years, growing at twice the rate of other MassHealth spending.

Spotlight

The rise of performance-based managed care contracts is requiring pharma companies to demonstrate drug value in producing health outcomes and/or health economic benefits.1 While performance-based contracts are currently still relatively rare, even without these contracts, managed care plans are making decisions on formulates based on evidence of value. They are also looking to guidelines and the treatment pathways being adopted by providers which are also driven by evidence of outcomes and value.

Spotlight

The rise of performance-based managed care contracts is requiring pharma companies to demonstrate drug value in producing health outcomes and/or health economic benefits.1 While performance-based contracts are currently still relatively rare, even without these contracts, managed care plans are making decisions on formulates based on evidence of value. They are also looking to guidelines and the treatment pathways being adopted by providers which are also driven by evidence of outcomes and value.

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BUSINESS INSIGHTS

Element Further Expands Its Life Sciences Testing Business With Additional Pharmaceutical and Biotech Testing Capabilities in North America and Europe

Element Materials Technology | January 15, 2022

Element Materials Technology (Element) completed its sixth life sciences-focused acquisition of 2021, with the formal completion of the acquisition of JMI Laboratories. Element has now built out its expertise and capability for pharmaceutical and biopharmaceutical customers, expanding to a team of more than 1,000 experts in 23 facilities across North America and Europe. This significant step change in pharmaceutical and medical testing capabilities from Element forms part of its broader strategic shift to increase its global presence in Life Sciences and Connected Technologies. “Our expansion into life sciences and connected technologies over the last two years has seen us gain a leadership position in these strategically important end-markets. As we celebrate 10 years of being a standalone Element business, we see more and more opportunities to work closely with our customers throughout their product and testing lifecycles.” Jo Wetz, Element CEO Cherie Gudz, Vice President, Life Sciences Americas, said: “In a world still dealing with a pandemic, the life sciences sector has never been more vital. The six acquisitions this past year alone cements Element’s commitment to continue to build a scale business in this vital sector, which now forms our largest global end-market. We are thrilled to have JMI’s team and expertise join the Element family”. Based in North Liberty, Iowa, JMI is a market leader in antimicrobial resistance monitoring studies utilized for US-FDA regulatory and new drug application submissions, through their proprietary SENTRY Antimicrobial Surveillance Program. It offers microbiology and molecular testing services to assist in the development of new antimicrobials and clinical trial support. The Company is CLIA accredited and able to test under GLP conditions. The business is notable for its team of highly scientific and well-published industry recognized experts in the field, including 10 MD/PhDs with extensive knowledge of microbiology and antimicrobials, and can consult on a broad range of scientific topics covering epidemiology, mechanisms of resistance in bacterial and fungal organisms, microbiology diagnostics and susceptibility testing methods.

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RESEARCH

Regeneron, following in Lilly's footsteps, wins FDA emergency nod for COVID-19 antibody cocktail

Regeneron | November 24, 2020

Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business. Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago. In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19. “The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others. Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday. Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution. The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab. Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.

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PHARMA TECH

CPhI partners with Informa Pharma Intelligence to present the 2021 Hybrid Edition of CPhI - P-MEC Expo in the National Capital Region ( NCR)

Informa Pharma Intelligence | November 26, 2021

Informa Pharma Intelligence, one of the leading business intelligence providers and knowledge partners, is pleased to announce the 2021 hybrid edition of CPhI – P-MEC conducted by CPhI Conference. The Online Conference & Networking is being held between 15th to 30th Nov 2021, while the In-Person event is being held between 24th to 26th Nov 2021 at India Expo Centre– Greater Noida, Delhi. In a bid to stay afloat towards increasing contemporary demand towards high quality, low cost pharma solutions, CPhI & P_MEC India has curated a platform through this event for a gateway to latest trends and innovative solutions that the market has to offer. The event aims to build better pharma community engagements, network amongst the fraternity and source innovative solutions on-site from exhibitors who have footprints both domestically and globally, and covering the entire pharma supply chain - from APIs, machinery, technology, packaging, outsourcing, finished products and biopharmaceuticals. The industry is anticipated to have a steady growth trajectory and the event organised by CHhI India has focused on the key driving factors for the same. The expansion of medicine manufacturing pertaining to the evolving epidemiological profile of the country will be instrumental for India being the preferred drug manufacturing destination on a global scale. Additionally the event aims to encourage the development of the research-based pharma fraternity. "The Indian pharmaceutical industry has been growing at double digits year-on-year, and remains committed to not only providing solutions to the healthcare needs of the country, but also to the world. As the world is battling the pandemic at different levels, here in India, we remain committed to ramping up production capabilities of some key medicines across infectious and non-infectious diseases to ensure their availability and accessibility to the country and the world. The CPhI – P-MEC India show is the single location for all pharmaceutical and allied companies to get together and share insights, techniques and technology that will help meet these demands." Speaking at the sidelines of the CPhI – P-MEC India show, Mr Yogesh Mudras, Managing Director, Informa Markets in India As a part of the management team of the CPhI – P-MEC 2021 event, Mr Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence said, "As a representative of the world's leading pharmaceutical business intelligence provider, its heart-warming to be a part of the CPhI – P-MEC event where we get to share meaningful insights drawn from real-time news, trends, market analysis, special reports, to key pharmaceutical companies in the country and the world. Globally we provide intelligence to over 10,000 customers and 3,000 of the top pharma, biotech and biosimilar companies with the collective support of more than 300 respected Business Intelligence subject matter analysts, editors, and thought leaders located across countries. The 2021 CPhI – P-MEC event will be a great opportunity to reconnect with the stakeholders of the pharmaceutical world and provide them with any form of data intelligence and analysis as needed." The Indian pharmaceutical market is growing at 15% annually, twice the world market growth rate. While its generics market is growing strong, it is also evolving into a cradle for new drugs. Therefore, with India being one of the strongest emerging markets in the global pharma industry, it presents great opportunities for all international pharmaceutical companies to explore, the platform by CPhI & P-MEC provides full access to the exhibitors to source new pharma solutions and find the right partners for your business with the ongoing hybrid expo showcasing the full drug development supply-chain from exporting, outsourcing, manufacturing, machinery, regulations, pricing, and market access to, packaging, labelling, and digitalization. The P-MEC event is the single destination in the country today for all things associated with the latest innovative pharma solutions that the world has to offer. The venue will also host the latest types of equipment associated with research and development and analytical solutions followed by cleanroom engineering design, certifications and the latest types of air purification solutions. The packaging technology on display will include a comprehensive range of glass, pouches, bottles, caps, tubes and plastic packages as well as printing and trademark solutions. CPhI India is a sister brand of CPhI Worldwide – A key event that all professionals from the international pharmaceutical and allied industries look forward to year on year. CPhI India and its co-located event, P-mec India, are the largest and most comprehensive pharmaceutical industry events in South Asia. This event is specifically important to the country as India is already labelled as the pharmacy of the world in addition to the vaccine manufacturing prowess showcased in 2019-2020. About Informa Pharma Intelligence Trusted by over 3,000 of the world's leading pharmaceutical, biotech, medical device companies, and CROs, the Pharma Intelligence suite of intelligence solutions, which include Datamonitor Healthcare™, Sitetrove™, Trialtrove™, Pharmaprojects™, Biomedtracker™, Scrip™, Pink Sheet™ and In Vivo™, deliver vital, accurate, and timely intelligence and analysis about the drug development pipeline to pharmaceutical and biomedical decision makers around the world. A global team of subject area experts track and analyse key diseases, clinical trials, drug approvals and R&D activities, to deliver data needed to make decisions and create real-world opportunities for growth. About CPhI Conferences The world's largest pharmaceutical exhibition, CPhI Worldwide represents every stage of the pharmaceutical supply chain - from ingredients and FDF, to machinery, packaging, outsourcing and biopharmaceuticals. Each year the CPhI brand unites more than 100,000 pharmaceutical professionals from all over the world through exhibitions, conferences and online communities. CPhI offers healthcare experts a chance to network, identify business opportunities and expand the global market through online and in-person interactions, with events in Europe, China, Korea, India, Japan, Southeast Asia and North America.

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