Friday, October 4, 2024

Keytruda? Opdivo? Teva And mAbxience Broaden Partnership With PD-1 Biosimilar

(10/4, Dean Rudge, Generics Bulletin) ...Teva has been clear in its ambitions in the biosimilars space. Increase its pipeline to 20 assets, and launch six biosimilars by 2027, making use of a partner-orientated model to bring to bear its extensive commercial capabilities and regulatory expertise, while optimizing costs. Now, the Israeli firm has furthered its mission after penning an additional global licensing agreement with Spanish developer mAbxience, just six months after the first was struck, this time for an anti PD-1 oncology biosimilar... Global Sub. Full

Teva and mAbxience Team Up On Second Oncology Biosimilar

(10/3, The Pharma Letter) ...The global agreement to develop an additional unnamed oncology biosimilar further strengthens the alliance between Teva and mAbxience, underscoring their shared goal to provide cost-effective, high-quality biosimilar treatments that address critical unmet needs in oncology care...Teva will manage regulatory approvals and oversee commercialization in the designated markets, ensuring that patients around the world gain access to this oncology treatment... Sub. Req’d

Teva and mAbxience Partner to Develop Biosimilar Candidate for Oncology

(10/4, Pharmaceutical Technology) ...Teva business development executive vice-president Angus Grant said: "This agreement not only strengthens our alliance but also highlights our shared dedication to expanding access to critical oncology treatments. This collaboration with mAbxience reflects Teva's ideal strategic partnership model to optimise development costs, apply our regulatory expertise and leverage our extensive commercial capabilities to bring new treatment options to people living with serious medical conditions."... Full

‘There Is No Silver Bullet' – Sandoz's Haruvi Talks US Shortages

(10/3, David Wallace, Generics Bulletin) ...As Sandoz publishes a report on US drug shortages – dissecting their root causes, the current policy landscape and recommendations for future improvements – the firm's North America head and AAM chair Keren Haruvi speaks to Generics Bulletin about what can be done to alleviate continuing supply-chain failures... Global Sub. Full

End of Obesity Drug Shortage Threatens Patient Access to Compounded Shots That Lilly Calls Risky

(10/3, Shelby Livingston, Endpoints News) ...During the time that brand-name versions of tirzepatide, including Lilly's Mounjaro and Zepbound, and the GLP-1 semaglutide, made by Novo Nordisk, have been in shortage, compounding pharmacies have been permitted to make copies of the drugs...Now, patients on compounded versions of the drug may face a choice: Switch to a pricier brand-name shot, opt for a cheaper, less effective obesity drug — or forego treatment. "I suspect plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this," Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said in an email... Full

Eli Lilly Calls For Stop To GLP-1 Copies As Compounders Seek FDA Flexibility

(10/3, Maaisha Osman, InsideHealthPolicy) ...Eli Lilly says compounders must immediately halt mass production and marketing of copies of its GLP-1 drugs Zepbound and Mounjaro since these drugs are coming off FDA's drug shortage list. But compounders report ongoing difficulties for pharmacies in obtaining FDA-approved drugs, prompting the Alliance for Pharmacy Compounding (APC) to request FDA enforcement discretion to allow patients access to compounded versions for up to 60 days during the transition... Sub. Req’d

Hospitals Scramble for IV Fluids as Hurricane Helene Triggers Latest Drug Shortage

(10/3, Kay Lazar, The Boston Globe) ...Flooding from the storm damaged the plant in the Blue Ridge Mountains town of Marion that produces 60 percent of the country's IV supply, forcing its parent company, Baxter International Inc., to shut it. For now, local hospitals say they have not had to curtail procedures, but are taking small steps to manage their current supply, such as giving some patients other fluids when possible. However, it's unclear when the North Carolina plant would reopen, or other suppliers would fill the void, making it uncertain whether hospitals will be able to stretch their stockpiles long enough... Full

AbbVie Cuts 2024 Profit Forecast Citing R&D Expenses

(10/3, Mariam Sunny, Reuters) ...AbbVie on Thursday lowered its forecast for 2024 adjusted profit, citing the impact of $82 million in milestones, and research and development expenses related to acquisitions. The drugmaker expects annual adjusted profit per share in the range of $10.67 to $10.87, compared with its previous forecast of $10.71 to $10.91 per share, a regulatory filing showed... Full

With Refinancing Done, Focus Will Now Be On Debt Reduction: Biocon Biologics CFO

(10/4, Swaraj Singh Dhanjal, MoneyControl) ...Having refinanced debt worth $1.1 billion through a mix of offshore bonds and term loans, Biocon Biologics Limited, the biosimilars subsidiary of Biocon Limited, will now shift its focus towards paring the debt on its balance sheet, a senior executive of the company told Moneycontrol.com... Full

Alembic Pharma Gets US FDA Nod for Antihistamine Alcaftadine Ophthalmic Solution

(10/4, Business Standard) ...Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration for its abbreviated new drug application (ANDA) Alcaftadine Ophthalmic Solution. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lastacaft Solution of AbbVie Inc... Full

Calquence Closer to First-Line MCL Approval

(10/3, The Pharma Letter) ...AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). The Anglo-Swedish drugmaker's filing is based on ECHO Phase III trial which demonstrated that a Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy... Sub. Req’d

Aeon Plans For Next Phase In Bid For Botox Biosimilar

(10/3, David Wallace, Generics Bulletin) ...After meeting with the US Food and Drug Administration, Aeon Biopharma appears confident about the next steps for its ABP-450 (prabotulinumtoxinA) proposed biosimilar to Botox...Marc Forth, Aeon's president and chief executive officer, summarized that the firm was "encouraged by the outcome from the recent FDA meeting and the opportunity to advance our development of prabotulinumtoxinA utilizing the 351(k) biosimilar regulatory pathway." "We now have a clear path forward and plan to initiate analytical studies in Q4 2024," Forth confirmed... Global Sub. Full

Baltimore to Receive $80 Million in Opioid Settlement with Walgreens

(10/3, Christian Olaniran, CBS News) ...Baltimore City has won $80 million in a settlement with Walgreens, after claims that the pharmacy chain helped fuel the opioid epidemic in Baltimore. In the agreement, Walgreens will pay $45 million by the end of this calendar year and the remainder by December 31, 2025...The settlement brings the city's total recoveries from opioid settlements to $402.5 million. Baltimore also settled with CVS and Allergan for $45 million, Cardinal Health for $152.5 million, and Teva for $80 million... Full

US Charges Ten Individuals in Connection with Sale of Opioid Pills Worth $1.3 Billion

(10/3, Ismail Shakil, Reuters) ...U.S. authorities have charged ten individuals in connection with the unlawful sale of nearly 70 million opioid pills in what the Justice Department called the largest-ever criminal enforcement action targeting distributors of opioids and commonly abused prescription drugs, with a black-market value of $1.3 billion... Full

Exclusive: Thermo Fisher's Plant Making Infant RSV Drug Breached FDA Rules, Documents Show

(10/4, Patrick Wingrove, Reuters) ...Thermo Fisher's Greenville, N.C. plant has been found in breach of US FDA regulations, including twice this year. FDA's most recent inspection of Thermo Fisher plant found shortfalls in manufacturing of Sanofi's and AstraZeneca's Beyfortus RSV treatment. Sanofi says the FDA findings were addressed and all Beyfortus doses were approved by FDA before they were shipped... Full

After a Rocky Debut for New RSV Tools, Hopes are High as a New Season Approaches

(10/4, Helen Branswell, STAT) ..."Anyone who works in the pediatric field understands that if we can immunize children against RSV, whether it's through maternal vaccination or through nirsevimab, that's really going to be life-changing as far as admissions to the hospital," Peacock, director of the immunization services division in the Centers for Disease Control and Prevention's National Center on Immunization and Respiratory Diseases, told STAT in a recent interview...AstraZeneca and Sanofi, which make and market Beyfortus, did not anticipate the extent of the demand in the U.S. That has changed this year; Sanofi said recently there is enough product "for every eligible baby" here... Full

US Medicare Cost For Part D Redesign Could Far Exceed Earlier Projections, CBO Says

(10/3, Cathy Kelly, Pink Sheet) ...The Medicare Part D redesign established by the Inflation Reduction Act could cost the US government $10bn to $20bn in 2025, according to the Congressional Budget Office. The bids may overestimate actual costs but plans anticipate a spike in spending on GLP-1 drugs as well as increased utilization of higher-priced treatments encouraged by the new cap on out-of-pocket spending... Global Sub. Full

Higher Insurance Costs Eat into Savings from Drug Pricing Law by More Than Expected

(10/3, John Wilkerson, STAT Plus) ...A key aspect of the Democrat-passed law to lower drug prices is significantly more expensive to the government than expected, according to nonpartisan budget experts in Congress...Republicans pounced on the news, saying the drug pricing measures in the Inflation Reduction Act caused a spike in the cost of prescription drug coverage. Overall, the budget office said, the drug pricing law still reduces drug costs to the government and to seniors with high drug costs... Sub. Req’d

Competition is Really Key to Lowering Prescription Prices

(10/4, Keith Dean, Tallahassee Democrat) ...The real opportunity to meaningfully cut prescription prices comes from increasing competition in the pharmaceutical industry. Today, there are only a handful of big players dominating the drug manufacturing space, allowing them to set astronomical prices for their products, stall the approval of lower-priced alternatives, and abuse the patent system to maximize profits. The free market is being restricted and as a result, patients and employers in Florida are facing higher prescription drug costs... Full

Don't Fall for PhRMA's Misinformation – Biosimilars Are Safe, Effective, and So is the Biosimilar Red Tape Elimination Act

(10/3, Biosimilars Council) ...Now, Congress is considering the bipartisan Biosimilar Red Tape Elimination Act (BRTEA), which would streamline the regulatory process by removing the unnecessary distinction between biosimilars and interchangeable biologics. This common-sense proposal follows the FDA's recommendation to treat all biosimilars as interchangeable, eliminating redundant regulatory barriers... Full

Generic Competition and Drug Prices

(10/3, U.S. Food & Drug Administration) ...Access to affordable medicines remains a significant public health priority for FDA. The agency regularly conducts economic analyses to measure the impact additional approved generic equivalents can have on consumer generic drug prices. These studies have continually demonstrated that greater competition from generic drugs can help affordability and improve access to drugs for American patients and consumers... Full

Texas Lawsuit Alleges Conspiracy to Inflate Price of Insulin

(10/3, Nolan D. McCaskill, The Dallas Morning News) ...Attorney General Ken Paxton sued major pharmaceutical makers and other companies Thursday, alleging they violated Texas' consumer protection law and unjustly enriched themselves by conspiring to spike insulin prices by up to 1,000% over the past decade..."This complaint is baseless and should be dismissed," Eli Lilly said in a statement...In a statement, Novo Nordisk dismissed the lawsuit as "meritless" and vowed a vigorous legal defense... Sub. Req’d

Starting January 1st, Idaho's New Law Will Save Pharmacies and Patients Money

(10/3, Regan Gallo, KREM) ...A new Idaho bill will put money back into the pockets of both patients and pharmacies by targeting pharmacy benefit managers also known as "PBM's"...Idaho Representative Jordan Redman has been behind the new law, bringing lawmakers and local pharmacists together for over a year to make this bill a reality. But, according to Rep. Redman, these PBM's have found ways to pull money from both patients and pharmacies. He said these costs have caused pharmacies across the state of Idaho to close their doors... Full

EMA & European Medicines Regulatory Network to Improve Efficiency of Approval Processes for New Medicines in EU

(10/4, Pharmabiz.com) ...EMA and the European medicines regulatory network are working to further improve efficiency in the assessment and approval processes for new medicines in the European Union... Full

Trust and Inequalities Challenge EU's Healthcare Digital Transformation, Says EMA Chief Medical Officer

(10/3, Vasiliki Angouridi, Euractiv) ...The EU's digital transformation efforts were at the epicentre of the European Health Forum Gastein. Euractiv spoke to Steffen Thirstrup, the European Medicines Agency's Chief Medical Officer, about the challenges of healthcare digitalisation...Speaking on the sidelines of the European Health Forum Gastein (EHFG), Steffen Thirstrup said implementing the European Health Data Space (EHDS) will require national political will and investment... Full

UK Government Proposes Phased Rollout of Eli Lilly's Weight Loss Drug

(10/3, Nicole DeFeudis, Endpoints News) ...The UK's publicly funded healthcare system has proposed phasing its rollout of Eli Lilly's weight loss treatment tirzepatide to ensure those who need it most get early access. An estimated quarter of a million patients would receive the drug in the first three years under the phased launch, according to the UK's National Health Service. Tirzepatide is sold under the name Mounjaro in the UK for both weight loss and diabetes... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.