Friday, December 13, 2024

Some Epilepsy Patients Worry Their Seizures Will Return Amid Medication Shortage

(12/12, Nicole Ireland, The Canadian Press) ...The shortage of Teva-clobazam, which began last May, is expected to last until April next year, according to Health Canada's drug shortages website...Another version of the drug, Apo-clobazam, is available but experts say some people can't take the medications interchangeably without risking breakthrough seizures...The reason for the Teva-clobazam shortage is listed as "disruption of the manufacture of the drug."... Full

UnitedHealth Group C.E.O.: Brian Thompson Was Never Content With the Status Quo

(12/13, Andrew Witty, The New York Times) ...We know the health system does not work as well as it should, and we understand people’s frustrations with it. No one would design a system like the one we have. And no one did. It’s a patchwork built over decades. Our mission is to help make it work better. We are willing to partner with anyone, as we always have — health care providers, employers, patients, pharmaceutical companies, governments and others — to find ways to deliver high-quality care and lower costs... Sub. Req’d

ICER Calls Out Gilead, J&J, Novartis and More in Latest Report On 'Unsupported' Price Increases

(12/12, Fraiser Kansteiner, Fierce Pharma) ...In its latest yearly report (PDF) on unsupported price increases for prescription drugs, the ICER has put a spotlight on 10 medicines that saw substantial price hikes last year. Of that lot, half of the drugs reviewed "lacked adequate evidence to support any price increase," the independent nonprofit said in a Thursday press release. These hikes led to $815 million in incremental added costs for U.S. payers last year, the ICER concluded... Full

Hikma And Richter Move Ahead With US Denosumab Filing

(12/12, Dave Wallace, Generics Bulletin) ...Hikma has made its first biosimilar filing in the US, with the US Food and Drug Administration accepting a submission for the firm's Gedeon Richter-partnered RGB-14 rival to Prolia/Xgeva (denosumab)...Companies known to have filed for denosumab in the US include Teva, Organon/Henlius, Fresenius Kabi, Celltrion and Samsung Bioepis. Meanwhile, other firms also have filings in the works, such as Biocon as well as Dr Reddy's and Alvotech which struck a partnership deal for US denosumab earlier this year. To compete in such a populated market, Mishlawi said, "I think we will have to depend on the costs and prices," rather than "like Sandoz, having a big basket of products and going to be the leader of the biosimilars. We just have very few."... Global Sub. Full

Vraylar Sales Growth Seen Slowing in 2025, Says Richter CEO

(12/12, Anita Komuves, Reuters) ...Hungarian pharmaceutical company Richter expects a slowdown in sales growth for its flagship product, Vraylar, next year while supply chain disruptions continue to pose challenges, CEO Gabor Orban told Reuters on Wednesday. Orban said 2025 would be a difficult year for Richter as supply chain disruptions that started with the coronavirus pandemic and were exacerbated by the war in Ukraine persist... Full

Roche Wins Vabysmo Prefilled Syringe EU Approval to Intensify Eylea Challenge

(12/13, Robert Barrie, Pharmaceutical Technology) ...The European Medicines Agency has approved Roche's Vabysmo (faricimab) in single-dose prefilled syringe form for three retinal conditions that cause blindness...GlobalData's Pharma Intelligence Centre predicts a continued decrease in sales over the next five years for Eylea amid increased competition from Vabysmo and biosimilars. By 2030, Roche's candidate is forecast to reach global sales of $8.78bn, whilst Eylea stutters to $2bn... Full

For a Leukemia that Keeps Returning, AbbVie Drug May Offer Chance for a Deep Remission

(12/13, Angus Chen, STAT Plus) ...CLL treatment has come a long way over the last decade, [Alexey Danilov, hematologist-oncologist at City of Hope] said. Targeted therapy approvals for the disease including the drugs Imbruvica from AbbVie and Venclexta from AbbVie and Genentech, as well as CAR-T cell approval, have become standard treatments that can offer CLL patients several years of remission. "But eventually everyone progresses," Danilov said. "Now, we are facing a new problem where patients who progress on targeted therapy have become an unmet medical need."... Sub. Req’d

Carlyle Backs Essential Refinancing and Other Funding News

(12/13, Phil Taylor, PharmaPhorum) ...Private equity group Carlyle has joined forces with other investors on a €900 million-plus recapitalisation of UK drugmaker Essential Pharma that will provide funds to expand its product portfolio and expand overseas. The financing from Carlyle's AlpInvest unit and Sixth Street will go towards building Essential's "diversified portfolio and late-stage pipeline across established and rare disease medicines," according to a company statement, which points to a continuation of a strategy of growth by acquisition under chief executive Emma Johnson, who took the helm last year... Full

Novo Nordisk's Ozempic Gets EU Regulator Endorsement to Reduce Kidney Risks

(12/12, Dominic Chopping, The Wall Street Journal) ...Novo Nordisk said the European Union's drug regulator supports a label expansion of its Ozempic diabetes drug to reflect its potential to lower the risk of conditions related to kidney disease in adults with Type 2 diabetes...Novo Nordisk has also filed for a label expansion in the U.S., and a decision is expected in the first half of 2025... Sub. Req’d

Ohio Justices' Opioid Ruling Shows Deals Were Based On ‘Nothing'

(12/11, Eric Heisig, Bloomberg Law) ...Drug companies have paid billions to settle allegations they contributed to the opioid epidemic based on a legal theory that they contributed to a public nuisance, harming cities, counties, and states—a legal theory that, at least in Ohio, is now considered faulty. That's because the Ohio Supreme Court on Tuesday likely obliterated a $650 million judgment obtained by two counties against CVS Pharmacy Inc., Walgreens Boots Alliance Inc., and Walmart Inc. when it found the public-nuisance claims against the pharmacy megachains weren't viable... Full

GLP-1 Barriers Begin to Break Down

(12/12, Jakob Emerson, Becker's Hospital Review) ...Competitors like Lilly have introduced discounts for their GLP-1 products to expand their market share — over 16 new weight loss drugs are expected by 2029, and financial analysts project that prices could decline by more than 10% annually by 2027 as competition intensifies. Other developments include Teva Pharmaceuticals' launch of the first generic version of Victoza, a GLP-1 drug originally approved in 2010 for Type 2 diabetes and later for reducing cardiovascular risks in diabetes patients. The introduction of generics is expected to increase competition and bring costs down... Full

FDA Recalls More Than 233,000 Bottles of Antidepressant Over Possible Cancerous Chemical

(12/12, Anthony Robledo and Taylor Ardrey, USA Today) ...The U.S. Food and Drug Administration classified capsules of duloxetine, sold by New Jersey-based company Rising Pharmaceuticals, as a Class II risk on Dec. 5. The risk level is the FDA's second most severe level as it could cause "temporary or medically reversible adverse health consequences." The bottles contain the "presence" of nitrosamine drug substance impurity, N-nitroso-duloxetine, that exceeds the recommended interim limit, according to the FDA... Full

Gap in Biosimilar Knowledge Causes Barriers to Implementation | ASHP Midyear

(12/12, Brian Nowosielski, Amanuel Y. Kehasse, PharmD, PhD and Ashley Gallagher, Drug Topics) ..."Educating patients and making sure that we address their concerns is key. A lot of providers have concerns to use biosimilars, especially for the non-medical switch. So, educating providers why this will be important clinically and financially for the health care system would be key," Amanuel Kehasse, PharmD, PhD, Ambulatory Clinical Manager - Specialty Pharmacy, Boston Medical Center Health System, told Drug Topics... Full

Lawmakers Scramble To Finalize Year-End Health Deal Amid Spending Standoff

(12/12, Jalen Brown, InsideHealthPolicy) ...Despite the growing likelihood of a three-month extension for health programs alongside a continuing resolution (CR) to fund the government through mid-March, lawmakers are making a last-ditch effort to strike a deal on a longer-term health package as their deadline draws nearer. But this may be an uphill battle, as lawmakers remain divided over the topline spending number and offsets, a key source knowledgeable about the negotiations told Inside Health Policy Thursday (Dec. 12) evening... Sub. Req’d

Experts Weigh Benefits of Drug Price Negotiation and Other Price-Curbing Strategies

(12/12, Shannon Firth, MedPage Today) ...Policy experts punched holes in drug companies' claims that the Medicare Drug Price Negotiation Program will stunt innovation and weighed in on other drug price-curbing strategies during a webinaropens in a new tab or window hosted by the National Institute for Health Care Management Foundation on Wednesday... Full

NCPA Joins NACDS to Argue for Pharmacy Protections in New Medicare Part D $2 Drug List Model

(12/13, NCPA) ...To ensure protection for pharmacies under this model, NCPA and NACDS called on CMS to provide fair and transparent reimbursement for the generic drugs on the list... Full

The Push for Medicare Site-Neutral Pay Reform

(12/12, Ben Leonard and Chelsea Cirruzzo, Politico) ...Advocates and opponents of policies having Medicare pay the same price for the same services at different locations, including Sens. Bill Cassidy (R-La.) and Maggie Hassan (D-N.H.), spoke at POLITICO's "Defining Site-Neutrality" event Wednesday in Washington. Cassidy — the incoming chair of the Senate Health, Education, Labor and Pensions Committee — will soon have significant latitude over health policy with unified Republican control of Washington. He said Wednesday he'll prioritize site-neutral payment policy next Congress... Full

Private Medicare Plans Must Cover Biogen's ALS Drug, US Agency Says

(12/12, Sriparna Roy, Reuters) ...The Centers for Medicare & Medicaid Services has directed private insurers providing Medicare Advantage plans to cover Biogen's amyotrophic lateral sclerosis drug Qalsody after finding instances of coverage denial...The ALS Association, a patient advocacy group, late on Wednesday said it began working with CMS to investigate "unjust denials" of coverage for the drug by insurance companies, who labeled the drug as "experimental"... Full

Real-World Evidence Helps Open Accelerated Approval Pathway For Neurodegeneration Therapies

(12/12, Bridget Silverman, Pink Sheet) ...US FDA's agreements with plans to seek accelerated approval of Clene's amyotrophic lateral sclerosis drug and uniQure's Huntington's disease gene therapy reflect growing pressure to expand the expedited pathways for neurodegenerative diseases. Clene will use expanded access protocol data to support CNM-Au8's effect on a surrogate endpoint measuring neurofilament light protein as part of a planned second quarter 2025 NDA submission... Global Sub. Full

Congress, Don't Waste the Work Done for PBM Reform

(12/12, Steven C. Anderson and Jay Timmons, DC Journal) ...Passing PBM reform now would deliver immediate relief to patients' wallets, strengthen shop floors and lower prices at the primary counters nationwide. PBM reform is one thing that Congress can agree on before the end of the year. Patients, pharmacies and manufacturers shouldn't have to wait any longer... Full

House Republicans Launch Investigation into CVS Caremark for Potential Antitrust Violations

(12/12, Nathaniel Weixel, The Hill) ...House Republicans want to know whether pharmacy benefit manager CVS Caremark violated federal antitrust laws by threatening independent pharmacies to keep them from using money-saving tools outside the PBM's network. In a letter to CVS obtained by The Hill, House Judiciary Committee Chair Jim Jordan (R-Ohio) asked the company for documents and communications about pharmaceutical hubs, a type of digital pharmacy service that can streamline the process of accessing and managing complex, high-cost specialty medications for patients... Full

Biosimilars Forum Welcomes Henlius as Newest Member

(12/12, Biosimilars Forum) ...The Biosimilars Forum has announced Henlius (2696.HK), a global biopharmaceutical company, as its newest member. Henlius joins the Biosimilars Forum during a critical time for the U.S. biosimilars industry — as the Forum leads initiatives on behalf of the industry to make lower-cost, FDA-approved biosimilars accessible to patients that need them... Full

The IRA And Post-Approval Clinical Research For Cancer Medicines

(12/12, Kirsten Axelsen, Henry Grabowski and Genia Long, Health Affairs) ...As the IRA is implemented, it is expected that the development of medicines for cancer will be affected by the DPNP. The impact on the level and mix of oncology drug investment should be studied carefully, together with how the program affects health outcomes, including cancer survival. The effect of the DPNP on oncology could be addressed by policymakers by lengthening the small molecule DPNP implementation period (given the significant "pill penalty" observed in our analyses)... Full

Stakeholders Urge Greater Collaboration to Promote Innovative Manufacturing

(12/13, Joanne S. Eglovitch, Regulatory Focus) ...A proposed US Food and Drug Administration (FDA) draft strategy document on innovative manufacturing should stress greater collaboration with other regulators to promote the use of advanced technologies, according to comments posted by biopharmaceutical stakeholders who added that the plan lacks detail on leveraging artificial intelligence and machine learning (AI/ML) in innovative manufacturing... Full

Hochul Signs Bill Capping Consumer Cost for Epinephrine Auto-Injectors at $100

(12/12, Nicholas Grassonicholas, Newsday) ...Gov. Kathy Hochul announced Thursday she had signed legislation aimed at making epinephrine — currently the only drug capable of preventing a fatal allergic reaction — more affordable. The state legislation will require health insurers to cover epinephrine auto-injectors and cap the out-of-pocket costs consumers may have to pay at $100, Hochul's office said in a release Thursday... Sub. Req’d

Judge Allows Pharma Suit Over Illinois Pricing Law to Continue

(12/12, Celine Castronuovo, Bloomberg Law) ...The national group representing the generic drug and biosimilar industry may press on with its lawsuit against an Illinois anti-price gouging law after a federal judge on Thursday denied the state's motion to dismiss the case. The Association for Accessible Medicines has until Jan. 3 to file a motion for a preliminary injunction on the Illinois law, Judge Virginia M. Kendall of the US District Court for the Northern District of Illinois said in a status hearing on Illinois Attorney General Kwame Raoul's (D) request to toss the industry group's complaint... Sub. Req’d

UK Clinical Trial Reforms Pass ‘Major Milestone'

(12/12, Francesca Bruce, Pink Sheet) ...New regulations on clinical trials should help the UK remain a popular destination for multinational trials, according to the MHRA, the country's medicines regulator. The much-awaited revisions to the UK clinical trials framework were laid down before the parliament on December 12,, bringing wide-ranging changes to the clinical research landscape a step closer... Global Sub. Full

MEPs Urge Progress On Pharma Reform Negotiations

(12/12, Martin Greenacre, Science | Business) ...MEPs from across the political spectrum have called for a swift conclusion to the ongoing reform of the EU's pharmaceutical legislation, to stimulate innovation and improve access to medicines. "We have to close the pharma package in the next year," MEP Nicolás González Casares, from the S&D group, told a conference organised by pharma industry lobby EFPIA on Tuesday. After bitter negotiations, the European Parliament finally adopted its position on the reform in April, shortly before breaking up for the European elections... Full

NHS Medicine Regulator Costs More Lives Than It Saves

(12/12, Laura Donnelly, The Telegraph) ...The NHS medicines watchdog is costing more lives than it saves, a study has suggested. The research, published in The Lancet, examined the health effects of decisions by the National Institute of Health and Care Excellence (Nice) over 20 years...The researchers said this was because many new drugs approved by Nice were more expensive than medicines already being used by the NHS... Full

Denmark Takes A Deep Dive Into Improving Alternative Drug Pricing Agreements

(12/12, Francesca Bruce, Pink Sheet) ...A realistic price and the offer of risk-sharing could help alternative pricing agreements be more attractive to AMGROS, Denmark's procurement agency for hospital medicines, according to the body's CEO, Flemming Sonne. AMGROS wants to capitalize on industry's growing interest in these agreements and ensure they are better able to help deliver high cost innovation to patients... Global Sub. Full

Rising Healthcare Costs Remain the Greatest Concern of Swiss Residents

(12/13, Swissinfo.ch) ...Healthcare policy is a major concern for 48% of Swiss people in 2024, compared with 40% last year, the UBS Worry Barometer 2024 found. Rising health insurance premiums account for part of this increase in the poll results, according to the conclusions of the study authors. Around 32% of the 2,250 people surveyed are also concerned about the climate, but this is lower than in recent years. Old-age pensions remain a worry for 29% of respondents... Full

China's Basic Health Insurance For Innovative Drugs Needs Reform

(12/13, Xu Hu, Pink Sheet) ...An imbalance between the increasing number of approved innovative drugs and decreasing funding for basic health insurance in China is driving insurance reform. Commercial insurance in the country is lagging elsewhere but also means there is more space to explore novel models...A hybrid payment system using a mix of commercial and basic government insurance would appear to be most suitable for China... Global Sub. Full

China's Health Program to Support Financial Burden On Patients

(12/13, Wang Xiaoyu, China Daily) ...A new round of China's bulk buy program for drugs will include 385 products from 234 companies in an effort to further reduce the financial burden of patients, according to the National Healthcare Security Administration. The bulk buy program sees drug manufacturers cutting prices of generic drugs for large-volume contracts with public hospitals. The latest bidding was held in Shanghai on Thursday... Full

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