Wednesday, August 21, 2024
Top News
Overcoming Challenges in Bioanalysis With Artificial Intelligence
(8/20, Blake Forman, Technology Networks) ...Technology Networks spoke to Mary Belfast, associate director of Automation, Specialty Bioanalytics at Teva Branded Pharmaceuticals, to learn more about some of the roadblocks to the widespread adoption of AI in bioanalysis. In this interview, Belfast also discusses some of the latest guidelines on AI implementation and validation... Full
Teva Faces Fresh Copaxone Kickbacks Case from Medicare Providers As it Defends Against DOJ Claims
(8/20, Zoey Becker, Fierce Pharma) ...The firms accuse Teva of "funneling hundreds of millions of dollars" through two third-party foundations to illegally subsidize the Medicare co-pay obligations of Copaxone patients...The stakes are high in the causation aspect of the case. A Teva-favoring ruling could mean the company could ultimately emerge victorious in the larger case, but if the court sided with the U.S., damages could exceed $10 billion and represent an "enterprise-threatening amount that may render a post-judgment appeal impossible," the company's lawyers previously argued... Full
Medicare Plans Accuse Teva of Covering Copays for Patients
(8/21, Phil Taylor, Pharma Phorum) ...A class action suit has been filed in the US against Teva, claiming that the company illegally subsidised the copays for patients prescribed its multiple sclerosis therapy Copaxone to boost its sales. The suit filed on behalf of Medicare Advantage coverage providers accuses the company of "funnelling hundreds of millions of dollars" to Copaxone (glatiramer acetate) patients through third-party foundations and companies... Full
110,000 Boxes of Antibiotic Recalled in France
(8/21, Zane Lilley, The Connexion) ...France's medical safety authority Agence nationale de sécurité du médicament (ANSM) announced the recall in a press release yesterday. Four lots of Amoxicillin are affected, three of which are marketed by Teva Santé and one by Sandoz. Batches with the lot numbers MT2985, MS8574, MS8584 (Teva Santé) and MR8824 (Sandoz) are those affected... Full
Industry News
Alvotech Aiming To Lead Competition On High-Dose Eylea Biosimilar
(8/21, Dean Rudge, Generics Bulletin) ...Having only revealed the existence of the biosimilar several months ago, Alvotech is aiming to be the first company to bring a biosimilar to Regeneron's recently launched high-dose Eylea (aflibercept) 8mg formulation to global markets – a "tremendous opportunity," the company believes, for both itself and its commercial partners Teva and Advanz Pharma... Global Sub. Full
Lucentis And Stelara Biosimilars Drive Formycon's 2024 Financials
(8/21, Urte Fultinaviciute, Generics Bulletin) ...The star of the first half of the year is Cimerli, a biosimilar rival to Genentech's Lucentis (ranibizumab), as its operating results "significantly exceeded expectations" in terms of volume and pricing. The ranibizumab biosimilar, also known as FYB201, has been launched in 19 countries so far, capturing 45% of US market share by volume and 79% in the UK, where it is marketed under the name Ongavia... Global Sub. Full
Zydus Q1: Novel Molecule Enters Phase I, Global Biosimilar Strategy To Shift?
(8/20, Vibha Ravi, Generics Bulletin) ...Zydus has begun Phase I trials for an anti-properdin drug in India while its sitagliptin franchise in US, distinct from Merck's Januvia and Janumet, looks promising. Meanwhile MD Sharvil Patel says a biosimilars entry in developed markets is possible if certain conditions are met... Global Sub. Full
Towa's First Quarter Performance Draws Analyst Optimism
(8/20, Adam Zamecnik, Generics Bulletin) ...Towa Pharmaceutical's performance in the first quarter of the 2024 financial year has industry analysts optimistic on basis of increased profit. The Japanese firm reported a 16.7% growth in gross profit from ¥20bn ($136.7m) in the first quarter of the 2024 fiscal year to ¥23.3bn in the 2025 fiscal year. At the same time, the company's operating profit rose by 38.5% to ¥5.7bn. Towa's ordinary profit grew by 23.5% to ¥8.6bn... Global Sub. Full
Propofol Injectable Emulsion Single-Dose Vials Receive FDA Approval
(8/20, Alexandra Gerlach, Pharmacy Times) ...Due to supply chain constraints, propofol is in chronic shortage and is currently on the American Society of Health System Pharmacists (ASHP) drug shortage list. As of June 3, 2024, ASHP indicates that shortages of propofol emulsion injections are due to increased demand and manufacturing delays, as well as the discontinuation of Teva's propofol in January 2023. The approval of Amneal's complex emulsion injectable aims to overcome this obstacle to improve patient care and increase supply of crucial anesthetic treatments... Full
Eli Lilly's Weight Loss Drug Slashes the Risk of Developing Diabetes in Long-Term Trial
(8/20, Annika Sim Constantino, CNBC) ...Eli Lilly's highly popular weight loss drug reduced the risk of developing Type 2 diabetes by 94% in obese or overweight adults with prediabetes compared with a placebo, according to initial results from a long-term study released Tuesday... Full
GLP-1R Market: A Two-Horse Race, Says GlobalData
(8/21, Express Pharma) ...According to GlobalData, the 11 approved drugs in the GLP-1R category generated $37.2 billion in 2023, cementing their place as one of the most lucrative therapies. Jasper Morley, Pharma Analyst at GlobalData, comments, "Novo Nordisk and Eli Lilly accounted for nine of the approved GLP-1R products in 2023 and encompassed 99 per cent of the sales. Successful GLP-1R products in 2023 included Novo Nordisk's Ozempic and Wegovy, which generated $13.9 billion and $4.6 billion, respectively, as well as Eli Lilly's Trulicity and Mounjaro, which generated $7.1 billion and $5.1 billion."... Full
Biosimilar CT-P42 Demonstrates Equivalence to Aflibercept for DME
(8/20, Cameron Santoro, The Center For Biosimilars) ...Patients with diabetic macular edema displayed similar outcomes when treated with biosimilar candidate CT-P42 or reference aflibercept (Eylea) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles, according to a study published in Ophthalmology Retina... Full
CNBC-TV18 Accesses USFDA's Warning Letter to Aurobindo Pharma's Eugia Unit-3
(8/21, Ekta Batra and Meghna Sen, CNBC TV 18) ...Brokerage firm Elara Capital said the warning letter points to significant data integrity issues, among other concerns. The report suggests that the timeline for remediation could exceed 18 months, based on past cases...While Aurobindo can continue selling existing products in the US market, the company will not receive approval for new products from Eugia Unit III until the issues are fully resolved...To mitigate the impact, Aurobindo Pharma is reportedly dual-filing products from Eugia Unit III and a new plant in Visakhapatnam... Full
Employers Are Bracing for Healthcare Costs to Spike in 2025. Here's Why
(8/20, Paige Minemyer, Fierce Healthcare) ...The Business Group on Health released its annual Employer Health Care Strategy Survey on Tuesday morning, which examines the trends that large employers are watching and their plans to address the healthcare challenges they may face. The survey projects that healthcare cost trend will jump to 8% in 2025, growing from 6% in 2022. Actual healthcare costs have increased by 50% since 2017, according to the report... Full
Big Employers Are Spending Even More Money On Pharmacy Costs, Driven by GLP-1s and Other High-Cost Therapies, Survey Says
(8/20, Ngai Yeung, Endpoints News) ...Those drug costs are driving total healthcare spending higher. Companies estimate that healthcare costs will reach $18,639 per employee in 2024, an increase from $17,201 last year. About a fourth of those costs are shouldered by employees in the form of premiums and out-of-pocket costs, while employers pick up the rest of the tab. GLP-1 drugs, which are used to treat diabetes and weight loss and have seen huge demand, are a main driver of employers' healthcare costs this year... Full
U.S. Policy & Regulatory News
FTC Backs FDA Plan to Remove Switching Study Requirement for Interchangeable Biosimilars
(8/20, Zachary Brennan, Endpoints News) ...The Federal Trade Commission is backing a recent FDA proposal to officially remove the requirement that biosimilar developers must run switching studies to obtain interchangeability designations..."The proposed guidance will increase the number of biosimilars available for pharmacy-level substitutions, which should lead to increased patient access and reduced cost," AMA CEO James Madara wrote... Full
Vizient Shares Feedback On FDA's Biosimilar Interchangeability Guidance
(8/20, Vizient, Inc.) ...In our comments, Vizient expressed strong support for FDA's decision to eliminate the requirement for switching studies to demonstrate interchangeability with a reference product, reiterating the undue burden and unnecessary nature of such studies. Additionally, Vizient applauded the agency for its efforts to rely on more recent data and experience in evaluating products to streamline approvals of interchangeable biosimilars... Full
Democrats Express Vague Commitment To March-In, Patent Abuse Crackdown
(8/20, Gabrielle Wanneh, InsideHealthPolicy) ...A final version of the Democratic party platform hints that Vice President Kamala Harris, should she win the 2024 presidential election, will press forward with the Biden's administration's controversial consideration of the use of march-in rights under the Bayh-Dole Act to ensure prescription drugs made with taxpayer dollars are made available to the American public at reasonable prices, or other efforts to ensure such drugs are affordable to patients... Sub. Req'd
COMMENTARY: Drug Price Controls Lead to Higher Costs, Fewer Choices
(8/20, Peter J. Pitts, InsideSources.com) ...The new price caps slash drug developers' income. That leaves less money for them to reinvest in finding cures — and drives away the investors crucial to getting new life-science companies off the ground. A University of Chicago study of a price control bill very similar to the one in the IRA found that it would reduce the number of drugs that come to market in the next 15 years by 135. The culprits behind high drug prices are PBMs... Full
New Survey: Insurers Confirm IRA Will Reduce Patient Treatment Options
(8/20, Nicole Longo, PhRMA) ...The IRA is just beginning to go into effect, but it is already resulting in significant unintended consequences for Medicare beneficiaries. Seniors could experience higher costs, fewer options and disruptions in their health care coverage because the IRA failed to rein in abusive insurer and PBM practices that limit patients' access to care... Full
Inflation, Ozempic Predicted to Jack Up Health Care Costs
(8/20, Sean Salai, The Washington Post) ...PricewaterhouseCoopers International Ltd. estimates that the cost of health insurance provided by private employers will jump 8% next year. That's the sharpest increase since 2012, when PwC found costs for the employer-sponsored health care market rose 8.5% two years after the Affordable Care Act became law and began lowering prices...PwC's Health Research Institute blames the latest spike on runaway inflation in hospital expenses, an explosion of mental illness and sharp demand for pricey diabetes and weight loss medications... Full
Carter, Walgreens Announce Donation of 900 Naloxone Units to Local Organizations
(8/20, Georgia Representative Buddy Carter) ...Rep. Earl L. "Buddy" Carter (R-GA) today announced that Walgreens will facilitate the donation of 900 units of naloxone, an overdose reversal drug, to organizations in Georgia's First Congressional District..."Walgreens is committed to removing barriers to naloxone access," said Dr. Priya Mammen, senior medical director in the Walgreens Office of Clinical Integrity... Full
CMS Negotiated Prices Set To Be Used In Some PDAB UPL Processes
(8/20, Luke Zarzecki, InsideHealthPolicy) ...The first round of negotiated prices for Medicare drugs could have larger pricing implications as state prescriptions boards (PDABs) may use the new maximum fair prices to set limits for how much manufacturers can charge for the drugs in their states. Colorado's PDAB is one board that can consider the negotiated prices in setting payment limits and is set to consider payment limits for two of the first-round drugs... Sub. Req'd
Pharmacy Benefit Managers Such As CVS Caremark Face Scrutiny
(8/20, Thomas Lee, The Boston Globe) ...Tom Siepka, chief pharmacy officer for the Community Care Collective in Boston, agrees that PBMs have done a lot of good for the industry. The organization helps nonprofit community health centers open their own pharmacies. But Siepka also thinks that the companies have focused too much on making money and generated more profits than they should be making... Sub. Req'd
Congress Probes Pharma Work with Chinese Military
(8/21, Maya Goldman, Axios) ...A bipartisan group of House lawmakers is scrutinizing hundreds of clinical trials they say U.S. drug companies conducted with medical centers connected to China's military over the last decade...The group pointed to trials done with People's Liberation Army-affiliated institutions on Eli Lilly's Alzheimer's drug donanemab, which is sold under the brand name Kisunla, and Pfizer's axitinib, sold as Inlyta for kidney cancer... Full
US Manufacturing Unprepared for BIOSECURE Act's Repercussions
(8/21, Keerthi Vedantam, BioSpace) ...While the bipartisan bill has yet to pass, the anticipated effects are already rippling through biopharma, with the legislation threatening to put a strain on an already tenuous biopharmaceutical supply chain. The solution, [Fernando Muzzio] and others argue, is to finally bring U.S. manufacturing into the 21st century so the country may begin producing its own drugs at scale... Full
Cavazzoni Urges Proactive Measures to Avoid CRLs for Biologics Manufacturing Issues
(8/20, Ferdous Al-Faruque, Regulatory Focus) ...Speaking at a meeting on biologics and biosimilars chemistry, manufacturing, and controls (CMC) hosted by the Duke Margolis Institute for Health Policy at the National Press Club on Tuesday, CDER Director Patrizia Cavazzoni, said it's in everyone's best interest to be proactive and address manufacturing deficiencies early on. She noted that 20 years ago, there were much fewer biologics in drugmakers' portfolios, but today, they represent a significant portion of the market... Full
State Bill Would Put Brakes On Pharmacy Drug Gatekeepers
(8/20, Ron Leuty, San Francisco Business Times) ...A California bill would require the licensing of pharmacy benefit managers - key gatekeepers for drug pricing and reimbursement - and outlaw so-called "spread pricing" that has helped drive those firms' profits...Senate Bill 966 was passed by the Assembly's appropriations committee last week... Full
Michigan Drug Affordability Legislation Remains Stalled As Election Nears
(8/20, Colin Jackson, Michigan Public NPR) ...A bill package to create a prescription drug affordability board has been stalled in a House committee since last fall after passing the state Senate. Senator Darrin Camilleri (D-Trenton) sponsors the package. He said he believes making medications more accessible is a priority for his party regardless of election outcomes... Full
International News
ICH Explores New Platform To Facilitate Global Evaluation Of CMC Changes
(8/20, Vibha Sharma, Pink Sheet) ...The International Council for Harmonisation will soon be launching a formal process to gather information from potential IT vendors on whether it is possible to develop a secure, standardized regulatory platform that drug sponsors can use to submit post-marketing chemistry, manufacturing and controls (CMC) changes for evaluation by multiple regulators... Sub. Req'd
UK Medicines Agency Wants ‘Up To Five Years' Notice Of New Applications
(8/20, Ian Schofield, Pink Sheet) ...The UK medicines regulator, the MHRA, in planning to take a more formal approach to gathering data on products coming through companies' pipelines so as to have a better idea of the number and type of drug applications it can be expected to deal with over the coming years... Sub. Req'd
Germany Fears Drug Shortages Due to New Chinese Spying Laws
(8/21, The Pharma Letter) ...The German Pharmaceutical Industry Association (BPI) reported that four German states have suspended routine inspections of Chinese pharmaceutical facilities, amid concerns that these activities could be treated as spying under broad new regulations. These concerns are already impacting the supply chain, with several active ingredient certificates, necessary for the continued production of various drugs, set to expire soon... Sub. Req'd
Local Clinical Trial Waiver Will Accelerate Access to Lifesaving Drugs: Kiran Mazumdar-Shaw
(8/21, Pharmabiz.com) ...The Central Drugs Standard Control Organisation has recently made a forward-looking decision to waive local clinical trials for several categories of new drugs approved in the US, UK, Japan, Australia, Canada and the EU. This policy shift promises faster access to advanced therapies, offering a ray of hope to millions of Indian patients, particularly those in urgent need of lifesaving treatment, said Kiran Mazumdar-Shaw, chairperson, Biocon and Biocon Biologics... Full
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