Tuesday, November 19, 2024

Teva and Immunai Partner to Improve Clinical Decision Making

(11/18, Emily Kimber, PharmaTimes) ...The multi-year collaboration will utilise Immunai's proprietary immune cell atlas, AMICA, as well as its AI model, the Immunodynamics Engine (IDE), to improve clinical decision making in Teva's immunology trials... Full

Teva Announced a New Collaboration: The AI Platform Will Be Used By The Company in Clinical Trials

(11/14, N12) ..."At Teva we are constantly looking for the 'next thing' in science," said Dr. Eran Harari, Senior Vice President of Teva's Global R&D. "Working with Immunai and harnessing the power of their innovative tools and artificial intelligence-based solutions will help increase innovation to drive our R&D strategy. This collaboration will provide important insights into patient responses and therapeutic mechanisms in immunology and immuno-oncology, and will allow us to optimize our clinical trials and improve patient outcomes."... Full

Blue Cross to Drop Coverage of Costly Specialty Drug Humira

(11/18, Mark Sanchez, Crain's Grand Rapids Business) ...Blue Cross Blue Shield has already started examining another specialty auto-immune drug, Stelara, for possible change in coverage when it gets a biosimilar competitor in 2025, said Chief Pharmacy Officer Atheer Kaddis. He expects Blue Cross Blue Shield to launch a biosimilar strategy for Stelara in early 2025. While the insurer may make exceptions for certain high-cost specialty drugs, its future goal is to move coverage whenever a biosimilar drug becomes available, Kaddis said... Sub. Req’d

Towa Ramps Up Profit Expectations As It Enjoys Sustained Domestic Demand

(11/18, Dave Wallace, Generics Bulletin) ...Improved volumes thanks to strong domestic demand for its generics and a lower-than-expected full-year R&D spend have pushed Japan's Towa to raise its financial expectations for 2024, with the firm's operating margin now set for 8.9% this year compared to a previous forecast of 7.5%... Global Sub. Full

Samsung Bioepis Snags Second EU Denosumab Biosimilar – But More Are On The Way

(11/18, Dave Wallace, Generics Bulletin) ...Samsung Bioepis has become only the second firm to gain a European Medicines Agency endorsement for its denosumab biosimilars to Prolia and Xgeva, with the agency's Committee for Medicinal Products for Human Use issuing positive opinions for the company's rival versions under the names Obodence and Xbryk...In early October, Teva said it had filed in Europe for a Prolia biosimilar. And shortly afterwards, Alvotech also disclosed that it had filed its AVT03 version with the EMA, with the company partnered on denosumab with both Stada and Dr Reddy's in Europe... Global Sub. Full

Formycon Is Latest To Win EMA Endorsement For Aflibercept

(11/18, Dave Wallace, Generics Bulletin) ...Formycon's FYB203 biosimilar rival to Eylea (aflibercept) has become the latest version of the ophthalmic brand to be endorsed in the EU, receiving a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use under two different names. Although a positive opinion from the CHMP does not constitute formal approval, the European Commission typically acts within 67 days to convert these into pan-European marketing authorizations... Global Sub. Full

AstraZeneca Pharma to Launch COPD Drug in January 2025; Stock Up 3%

(11/19, Business Standard) ...The pharmaceutical company had received the import and market permission from the Drugs Controller General of India for Breztri Aerosphere on December 2, 2023. "We wish to further update that AstraZeneca Pharma India Limited will launch Breztri Aerosphere in January 2025 in India. Breztri Aerosphere is indicated for the maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with chronic obstructive pulmonary disease," the company said in an exchange filing on Monday... Full

Samsung Bioepis Gets EC's Approval for Opuviz

(11/19, Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's Samsung Bioepis Co., Samsung Biologics Co.'s fully owned biosimilar subsidiary, and the US-based Biogen said on Tuesday the European Commission (EC) approved Opuviz (Aflibercept), its biosimilar to Beyer's Eylea for the treatment of various eye diseases... Full

Celltrion Announces Phase 3 Results of Actemra and Prolia Biosimilars at U.S. Conference

(11/19, Jasmine Choi, Business Korea) ...CT-P47 and CT-P41 are currently undergoing approval procedures in major countries worldwide, including the U.S. and Europe. A Celltrion representative stated, "By additionally disclosing the global Phase 3 clinical data of CT-P47 and CT-P41 at this conference, we have once again confirmed their efficacy and safety," and added, "As these two biosimilars are part of Celltrion's next-generation pipeline, we will do our best to bring them to market as soon as possible."... Full

Lilly Pill Cuts Genetic Form of Cholesterol Nearly 86% in Study

(11/18, Julie Steenhuysen, Reuters) ...The drug, muvalaplin, reduced levels of lipoprotein(a), or Lp(a), by 70% using a traditional blood test and by nearly 86% based on a more specific test developed by the company, researchers reported at the American Heart Association meeting in Chicago. Lilly's drug is the only oral treatment in a field of several injectable therapies being tested to treat high Lp(a), a risk factor for heart disease that affects one in five individuals globally... Full

US Supreme Court Declines to Hear Patent Dispute Over Bausch Blockbuster Diarrhea Drug

(11/18, Blake Brittain, Reuters) ...The justices declined to hear an appeal by Norwich Pharmaceuticals of a lower court's ruling that its proposed generic would infringe patents owned by Bausch unit Salix Pharmaceuticals for using Xifaxan to treat the liver-related brain disorder hepatic encephalopathy. In doing so, the justices let the lower court's ruling stand...Bausch has separately agreed to allow Xifaxan generics from Teva Pharmaceuticals, Sun Pharmaceuticals and Sandoz starting in 2028 after settling related patent disputes... Full

SC Directive On Case Involving Zydus' Breast Cancer Biosimilar Drug Takes a Fresh Turn

(11/18, PT Jyothi Datta, The Hindu BusinessLine) ...The legal battle involving Sigrima, Zydus Lifesciences' biosimilar version of Roche's breast cancer drug Pertuzumab, has taken a fresh turn, and this could affect further generic competition on the drug, said a section of Intellectual property and industry voices. According to legal reports, the Supreme Court, on Monday, had refused to grant interim relief to Zydus in its battle against a Delhi High Court injunction that had restrained it from making and selling Sigrima. The issue has been directed back to the Delhi HC, the report added... Full

Novo Nordisk Launches Wegovy in China With Prices Below US

(11/18, Amber Tong, Bloomberg Law) ...Novo Nordisk A/S is launching its top-selling Wegovy obesity drug in China at a fraction of the US price, a key step in unlocking a big, fast-growing market for its blockbuster franchise...Novo Nordisk didn't confirm the China price in an email to Bloomberg, saying it was listed by online pharmacies not authorized to sell Wegovy. The price at public hospitals will become available on each province's procurement system once the company goes through the bidding and listing process, a spokesperson said... Sub. Req’d

BioRationality: A Proposal to Create a New Association With Rational Scientific Agenda

(11/18, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...A decade and a half after biosimilars were recognized in the US, we have only 16 products as multiple biosimilars, while more than 100 molecules await entry. This disappointment is highly touted by the associations as a great success, quoting that adopting biosimilars saves money—this was expected, but how little this saving is rarely mentioned. The high cost of development is keeping biosimilars in the hands of big pharma, who will only pursue high-market products to allow them to make sales projections to keep their stocks high... Full

Experts: FDA, Not FTC, May Take Orange Book Lead Under Trump

(11/18, Maaisha Osman, InsideHealthPolicy) ...Legal experts predict the Federal Trade Commission's expected switch to a GOP chair under President-elect Donald Trump's incoming administration, coupled with Sen. Bill Cassidy's takeover of the Senate health committee, could result in FTC dialing back its Orange Book oversight and FDA taking on a bigger role... Sub. Req’d

RFK Jr. vs. Vivek: Trump World's Two Paths for Pharma Regulation

(11/19, Maya Goldman, Axios) ...Both influential MAGA allies say there are deep problems with America's drug development system. But RFK Jr., the Health and Human Services secretary designee, is calling for more oversight of drugs and vaccines and diminished federal funding for R&D. Ramaswamy, a biotech entrepreneur who will lead a new "Department of Government Efficiency" with Elon Musk, is a small government aficionado who's called for fewer barriers to bringing drugs to market... Full

Despite Fears Over RFK Jr. Pick, Industry Should Focus More On FDA Job: Analyst

(11/19, Zoey Becker, Fierce Pharma) ...If confirmed by the Senate, the BMO analyst expects RFK Jr., an environmental lawyer with no medical credentials, to focus on U.S. food and nutrition policy, rather than "targeting the pharmaceutical industry or parroting long-debunked rhetoric on vaccines (which have become culturally and politically unpopular)," Seigerman wrote in a Friday note to clients... Full

How Medicare Is Causing Patients To Overpay For Prescription Drugs

(11/18, John C. Goodman Lawrence J. Wedekind, Health Affairs) ...Surprisingly, with policy makers focusing on the role of drug manufacturers, almost no attention has been paid to the way in which traditional Medicare (as opposed to Medicare Advantage plans) causes the elderly and people with disabilities to overpay for the drugs they use. This occurs for three reasons: traditional Medicare requires three separate insurance plans for comprehensive coverage, traditional Medicare drug plans are required to community rate, without adequate risk adjustment, and pharmacy benefit managers (PBMs) are able to calculate patients' coinsurance based on list prices, rather than on the actual discounted prices the PBM pays the manufacturers... Full

The Human Cost of Inaction On PBM Reform

(11/18, Earl L. "Buddy" Carter, Bil and Shanon Schmidtknecht, DC Journal) ...The case against pharmacy benefit managers (PBMs) and for much-needed reforms of our broken prescription drug pricing system has been convincingly made. What is needed now is a sense of urgency to enact legislation that will rein in these greedy, monopolistic corporations before more people are hurt... Full

Fierce Health Payer Summit Looks to The Future for Insurers: Value-Based Care, PBMs and Prior Auth

(11/18, Emma Beavins, Fierce Healthcare) ...Payer industry executives gathered with Fierce Healthcare journalists to discuss the most pressing issues for U.S. payers like prior authorization, value-based care and pharmacy benefits. The first day panels included discussions of individual exchange plans and broker fraud, the changing landscape of Medicare Advantage (MA) given this year's high-profile exits and the staggering changes to Medicare Part D in 2025. Payer experts also discussed the shared burden of prior authorization and how to make healthcare insurance more equitable... Full

Journal of Managed Care + Specialty Pharmacy (JMCP): It Is Time For A More Nuanced Discussion About PBMs

(11/18, PCMA) ...Commentary published in the Journal of Managed Care + Specialty Pharmacy (JMCP) by Susan A. Cantrell, MHL, RPh, CAE, CEO of Academy of Managed Care Pharmacy (AMCP) defends the critical role of pharmacy benefit managers, and cautions that legislation narrowly targeting PBMs could increase prescription drug costs... Full

Makers of Weight-Loss Drugs Want Your Employer to Pay for Them

(11/19, Peter Loftus, The Wall Street Journal) ...Lilly and Novo Nordisk are hoping to win over employers on the idea that obesity and its complications are already a huge cost in terms of healthcare, workers' compensation and disability. By offering employees coverage for the weight-loss drugs Zepbound and Wegovy, companies can save money in the long run, the messaging goes. Whether these efforts succeed will help shape the size of the anti-obesity drug market, which some analysts predict could top $100 billion in annual sales... Sub. Req’d

The FDA's Risky Action On Compounding Weight Loss Drugs

(11/19, Scott Gottlieb, STAT) ...If the FDA shows that its regulations can be selectively enforced to align with objectives on drug pricing, it is likely to face even more pressure to loosen its oversight of other compounded drugs. The precedent it set on Makena, and potentially now tirzepatide, could leave the agency hard-pressed to maintain control over these critical policies in the future... Full

Campaign Urges Canada To ‘Save Big With Biosimilars'

(11/19, Dave Wallace, Generics Bulletin) ...Industry group Biosimilars Canada has launched its latest campaign, this time aimed at convincing businesses of the benefits of using biosimilars as part of employee health benefit plans. The #SaveBigWithBiosimilars campaign, running on professional networking site LinkedIn since 14 November, includes an "employer handbook on biosimilars" that has been designed to "provide companies with information to unlock the full value of biosimilars to transform their employee health benefits."... Global Sub. Full

England: NICE Finds Its Advice Can Cut Drug Appraisal Times By Three Months

(11/18, Neena Brizmohun, Pink Sheet) ...The health technology assessment institute said its "unique insights" could help companies effectively prepare for their appraisals, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster... Global Sub. Full

EMA Seeks Feedback On New Platform To Bridge Gaps In Regulatory Science Research

(11/18, Eliza Slawther, Pink Sheet) ...The EMA is seeking feedback on its proposal to introduce a platform for addressing gaps and research needs in regulatory science. Industry will be able to observe some meetings, and possibly play a more active role in the platform after the initial one-year pilot phase. The aim is to bring together academic researchers working in regulatory science with regulators to improve how medicines are evaluated... Global Sub. Full

EMA Proposes Research On Challenging Regulatory Topics, New Research Platform

(11/18, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) has published an updated list of regulatory science research needs (RSRN) that it hopes will lead to better regulatory tools and practices. It also published a concept paper to create a European Platform for Regulatory Science Research to improve stakeholder discussions on regulatory science issues... Full

European R&D Spend Outpaced by USA – With Increasing China Competition

(11/18, The Pharma Letter) ...New research published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) provides in-depth analysis of the economic footprint of the pharmaceutical industry in Europe, across member states and compares Europe to other regions of the world. It shows a ‘strong and growing' industry which contributed a total of 311 billion euros ($328 billion) to the European Union-27 economy in 2022... Sub. Req’d

Swiss Price Watchdog Slams Excessive Prices for Generic Medicines

(11/19, Swissinfo.ch) ...The cheapest generic medicines available in Switzerland are more than twice as expensive as in other countries, according to a study by the Swiss price watchdog...Original medicines with expired patents cost on average only 62% of the Swiss price in other countries, price watchdog Stefan Meierhans reported in his newsletter on Tuesday. The cheapest generic drug was available abroad for 39% of the Swiss price, i.e. 61% cheaper. Even in the most expensive comparison country, Spain, the cheapest generic drug cost 27% less. In the United Kingdom, the average price was only 16% of the Swiss price... Full

China Opens Up Non-End-To-End Manufacturing Of Biologics Within, Across Border

(11/19, Xu Hu, Pink Sheet) ...China implements a new pilot scheme allowing non-end-to-end manufacturing of certain biologics before possible nationwide implementation for all such products, with resource optimization and aligned quality management systems among the main goals...This new policy may allow foreign pharma firms' Chinese partners to take over some crucial manufacturing steps, which will provide opportunities for the Chinese companies to learn and adopt advanced production techniques and quality management systems. This in turn may encourage further collaborations and innovations in technologies... Global Sub. Full

Decoding Big Pharmas' Next Move in a More Complex China

(11/18, Wang Fangqing, The Pharma Letter) ...Big pharmas are not deterred by China's increasingly complex business environment. Instead, they are changing strategies to minimize risks while continuing to benefit from China, said speakers at ChinaTrials held last week in Shanghai. "Big pharmas used to focus on commercial strategies in China, but now they are looking into holistic strategies that would cover R&D and manufacturing for China and global," said Fangqing Zhang, a Shanghai-based partner at McKinsey... Sub. Req’d

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