Thursday, October 10, 2024

European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, A Proposed Biosimilar to Prolia® and Xgeva®

(10/10, Alvotech) ..."EMA acceptance marks an important step towards making AVT03 available to patients and caregivers in Europe," said Joseph McClellan, Chief Scientific Officer of Alvotech. "Successful progression in the development of multiple biosimilar candidates demonstrates how Alvotech is able to leverage its end-to-end biosimilars platform in support of broader access to affordable biologic medicines."... Full

Biocon Biologics Report Explores Pathways to Increase Biosimilar Adoption in Low- and Middle-Income Countries

(10/9, Express Pharma) ...The study outlines six policy recommendations aimed at increasing access to and usage of quality-assured biosimilars in LMICs. These recommendations include strengthening regulatory systems, enhancing national policies to support biosimilar adoption, encouraging local manufacturing, providing guidance on biosimilar prescribing, promoting education on biosimilars, and reinforcing pharmacovigilance measures... Full

Fresenius Kabi Slapped With Infringement Suit Over US Denosumab Biosimilars

(10/10, Dean Rudge, Generics Bulletin) ...The California-based originator has hit Kabi with a complaint in the US District Court for the Northern District of Illinois alleging infringement of 33 patents related to its denosumab brands. These include the denosumab active ingredient, as well as methods of manufacturing denosumab and denosumab products, and technologies necessary to produce, deliver, and use denosumab-containing medicines in patients... Global Sub. Full

Baxter Bringing Back Hurricane-Hit IV Supply Facility in Stages

(10/9, Christy Santhosh, Kashish Tandon, Reuters) ...Hospitals are beginning to curtail elective procedures and are reporting that they are managing closely the solution they give intravenously to each patient, Jefferies analyst Matthew Taylor wrote in a note. Managing solution includes controls on dosage, duration and flow rate... Full

U.S. Races to Replenish Storm-Battered Supplies of IV Fluids at Hospitals

(10/9, Christina Jewett, The New York Times) ...The situation could become even more dire now that Hurricane Milton is bearing down on Florida. On Tuesday, workers at B. Braun, makers of a fourth of the nation's IV fluids, loaded trucks at the company's plant in Daytona Beach with the medical bags and drove them north through the night to what they hoped would be a safer location... Full

Boehringer Open to Deals While ‘Laser-Focused' on Obesity Drug

(10/9, Laura Alviž and Sonja Wind, Bloomberg) ...Boehringer on Tuesday said it has started two late-stage clinical trials testing the medicine on patients with MASH and liver fibrosis after promising mid-stage data qualified it for an expedited review in the US. Late-stage trials are currently underway for survodutide as a treatment for obesity. The company isn't confining itself to GLP-1 based treatments in this field, [Ioannis] Sapountzis said. "We're certainly also seeing opportunities to go beyond GLP-1 based therapies, both for chronic weight management, but also in other interconnected areas."... Sub. Req’d

Stada Owners Ask for IPO Pitches Even as Sale Talks Continue

(10/9, Swetha Gopinath, Dinesh Nair, Eyk Henning, and Ryan Gould, Bloomberg) ...Bain Capital and Cinven invited banks to pitch for additional roles, including as bookrunners, for a listing of Stada, according to the people, who asked not to be identified as the information is private. While Stada's owners are still in talks about a deal with GTCR, there remains a discrepancy over valuation, the people said. No decisions have been taken and it's unclear whether Bain and Cinven will decide to pursue a sale or IPO of Stada, they said... Sub. Req’d

Roche CEO: Breast Cancer Pill Could Enter $12 Bln Market if Trials Succeed

(10/9, Ludwig Burger, Reuters) ...The pill belongs to a class known as oral selective oestrogen receptor degraders (SERD) to fight tumours that grow in response to oestrogen, which are estimated to account for up to 80% of all breast cancer cases. "Giredestrant, if it works, would be a product in a market with a potential of 10 billion-plus," CEO Thomas Schinecker said on Wednesday at a media event in Mannheim, Germany, adding he was confident in the company's oncology efforts even as it diversifies into other therapy areas... Full

GSK to Pay Up to $2.2B to Settle Almost All Zantac-Related Court Cases

(10/9, Katherine Lewin, Endpoints News) ...GSK said Wednesday that it is paying up to $2.2 billion to resolve 93% of its US state-based liability cases related to its heartburn medicine Zantac. The UK company also agreed to a separate agreement with Valisure, a company that claims to have discovered the link between Zantac and its generics to a carcinogen known as NDMA, for up to $70 million... Full

Eli Lilly, Insitro Ink a New Kind of AI Drug Development Deal

(10/9, Brittany Trang, STAT Plus) ...Machine-learning drug development company Insitro has inked three agreements with Eli Lilly for new medicines for metabolic diseases. But the deal is a little different compared to many recent deals between burgeoning artificial intelligence upstarts and established pharma giants: After identifying drug candidates, Insitro will be responsible for commercializing the drugs, and Lilly will be eligible for milestones and royalties... Sub. Req’d

Sanofi Invites Patients to ‘Rediscover MS' with New Educational Site On Disease Progression

(10/9, Andrea Park, Fierce Pharma) ...Hoping to raise awareness of this relatively new discovery among MS patients is Sanofi, which has sold Aubagio for relapsing-remitting MS for over a decade and has multiple other treatments for the disease currently in development. Sanofi recently launched a new website dedicated to educating "people living with MS, their care partners and the broader MS community" about the chronic smoldering process, Ellen Turpie, the drugmaker's global senior director of neurology marketing, told Fierce Pharma Marketing in an interview... Full

Peak Asthma Season Means More Inhaler Puffs, and More Emissions

(10/8, Monique Mulima, Bloomberg) ...Inhalers account for around 0.03% of global greenhouse gas emissions. But in the US, where metered-dose inhalers dominate, their emissions alone in 2020 were equivalent to those from driving almost 600,000 gas cars for a year or burning over 2.7 billion pounds of coal. "We're trying to treat conditions like asthma and COPD with these inhalers, and we're actually making it harder to breathe," said Jyothi Tirumalasetty, a clinical assistant professor at the Stanford University School of Medicine... Full

Amazon to Expand Prescription Delivery to 20 Additional Cities

(10/9, Caroline O'Donovan, The Washington Post) ...Next year, Amazon customers in 20 cities — including Dallas, Minneapolis and Philadelphia — will be able to get Amazon Pharmacy medications delivered by the company, Amazon Pharmacy VP Hannah McClellan Richards said Wednesday. And a growing number of those deliveries will be completed within less than 24 hours, the company said... Full

Five Crucial Trends Facing U.S. Drug Wholesalers in 2024 and Beyond

(10/9, Adam J. Fein, Drug Channels) ...During this period of volatility, the core business model of the Big Three public pharmaceutical distribution companies—Cardinal Health, Cencora, and McKesson—remains intact. Put simply: Buy low, sell high, collect early, and pay late. But as I explain below, wholesalers continue to position themselves as essential intermediaries by expanding their industry position and strengthening their economic fundamentals... Full

CMS Seeks Input To Further Develop Medicare $2 Generic Drug List

(10/9, Gabrielle Wanneh, InsideHealthPolicy) ...CMS is seeking stakeholder input ahead of launching an innovation center model that would establish a standard list of Medicare Part D drugs plan sponsors will be allowed to offer with a low, fixed monthly copayment of no more than $2 across all cost-sharing phases of the Part D drug benefit. The agency sent out a request for information Wednesday (Oct. 9) along with a sample list of 270 potentially eligible generic drugs... Sub. Req’d

CMS Looks to $2 Out-of-Pocket Cap for Some Commonly Used Generic Drugs

(10/9, Nicole DeFeudis, Endpoints News) ...The Association for Accessible Medicines, a trade group representing generics manufacturers and distributors, criticized the model in a statement to Endpoints News on Wednesday. "We appreciate CMS's interest in lowering seniors' costs through encouraging generic adoption, but this proposal does nothing to prevent PBM rebate games, ensure adoption of new generics, or otherwise secure the long-term sustainability of generic drug competitions," AAM said... Sub. Req’d

Covering Obesity Drugs Could Cost Medicare $35B by 2034, CBO Says

(10/9, Max Bayer, Endpoints News) ...The CBO analysis publicized Tuesday found that per patient, anti-obesity medications would cost the federal government $5,600 in 2026 and save it $50. By 2024, the costs could fall to $4,300, but the savings would only rise to $650. The discrepancy between the costs and the potential health savings runs contrary to a core argument made on behalf of the pharmaceutical manufacturers, patients and some lawmakers: that obesity being associated with myriad other more debilitating health conditions should be cause for widening access to effective treatments... Sub. Req’d

Corporate Interests and an Industry of Middlemen May Be Helping to Drive America's Prescription Drug Shortage

(10/9, NBC Washington) ...In hindsight, Darcy Filus said she realizes she was naive. She knew there were prescription drug shortages, but not that they were drugs used to treat cancer...For generic injectable drugs like Filus', shortages are all too common. And recent industry consolidation has made an already untenable situation worse...At the root of many shortages lies a harsh economic reality: these life-saving drugs just aren't profitable to make... Full

Mark Cuban Takes His PBM Fight to Employers

(10/10, Tina Reed, Axios ) ...He said he sees a tipping point coming, because companies increasingly face a legal threat if they mismanage workers' health benefits or just don't deliver on promises to hold down medical bills..."I'm going out there and talking to a lot of CEOs ... explaining to them they're getting ripped off."... Full

Video: Besides, Pharma and PBMs, Who Drives Up Drug Costs?

(10/9, Arundhati Parmar, MedCity News) ...Now, the FTC has sued the Big 3 PBMs for their practices tied to insulin. Some CEOs of pharma companies have been hauled to Congress to provide testimony about why drugs cost so much. However, it will be inaccurate to think that only these two entities drive up drug costs domestically. Others do too. As Paul Markovich, CEO of Blue Shield of California, explained in an event in spring, both drug distributors and hospitals are also to blame... Full

IRA Impact On Biopharma R&D Bears Watching, US FDA's Cavazzoni Says

(10/9, Michael McCaughan, Pink Sheet) ...Policy approaches intended to reshape biopharma research and development priorities need to focus on economic factors, not just regulatory pathways, FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni told a National Academy of Sciences, Engineering and Medicine panel developing a report on "Strategies to Better Align Investments in Innovations for Therapeutic Development with Disease Burden and Unmet Needs."... Global Sub. Full

CVS, UnitedHealth, Cigna Ask FTC's Khan to Disqualify Herself from Insulin Case

(10/9, Amina Niasse, Reuters) ...They filed their motions with the FTC's in-house court and shared it with Reuters. The companies said Khan, along with Slaughter and Bedoya, displayed bias against pharmacy benefit managers and prejudged their pricing models. CVS pointed to the commissioners' claims that volume-based discounts, or rebates, lead to higher prices for patients, and to Khan's appearance at a National Community Pharmacist Association event in 2022. The group, made up of independent pharmacists, has criticized pharmacy benefit managers... Full

Senate Pushes Pfizer for Details in Profit-Shifting Tax Probe

(10/10, Chris Cioffi, Bloomberg Law) ...Pfizer Inc.'s unwillingness to share information about its tax agreements with jurisdictions like Puerto Rico and Singapore is prompting new concerns that it's shifting profits out of the US to skirt its tax bill, the top Senate tax writer wrote in a letter to the pharmaceutical giant... Sub. Req’d

New FDA Exemptions Extend DSCSA Implementation Timeline To 2025

(10/9, Jessica Karins, InsideHealthPolicy) ...FDA is issuing exemptions to requirements of the Drug Supply Chain Security Act (DSCSA) for some trading partners, the agency announced Wednesday (Oct. 9), further extending the deadline beyond next month into 2025 for full implementation of the 2013 law that requires secure electronic drug tracking in the supply chain as hospitals and other providers struggle with drug shortages brought on by extreme weather... Sub. Req’d

Exclusive Q&A: FDA's Principal Deputy Commissioner on Taking Over for Califf, Adcomms, Accelerated Approvals and More

(10/9, Zachary Brennan, Endpoints News) ...With a new presidential administration next year, FDA Principal Deputy Commissioner Namandjé Bumpus would be in line to lead the agency if current Commissioner Robert Califf steps down after the election next month...Bumpus spoke with Endpoints about accelerated approvals, foreign inspections, diversity in clinical trials, advisory committee votes and more... Full

Illinois Advocates Seek Support for Drug Price Control Board

(10/9, Austin Williams, WJBD) ...Citizen Action/Illinois, along with other groups, convened a town hall meeting in Rockford Tuesday – the fifth in a series of such meetings the group has held since last spring – to push for passage of House Bill 4472, which would establish a Health Care Availability and Access Board... Full

The ‘Unintended Consequences' Of UK's New Pricing Scheme

(10/9, Ian Schofield, Pink Sheet) ...The implementation of the UK's 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG) has gone well on some fronts, but it has also brought a number of challenges, such as the "huge and complex" exercise of identifying reference prices for older medicines, according to the pharmaceutical industry association, the ABPI... Global Sub. Full

'India's Emergence as a Hub for Affordable, High-Quality Meds Is Commendable'

(10/9, Rupali Mukherjee, The Times of India) ...Every third tablet consumed globally is made in India, Union Minister of State for science and technology, Dr Jitendra Singh said here Wednesday at the CII Pharma & Life Sciences Summit. ``India's emergence as a hub for affordable, high-quality medicines is truly commendable. We now rank third in pharmaceutical production by volume and 14th by value'', he added... Full

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