Monday, August 5, 2024

Teva's Vision 2025: Building On Momentum for Future Market Leadership

(8/4, Sophie Shulman, CTech) ...As Richard Francis enters his second year as Teva's CEO, his strategy appears to be taking effect...Teva's strategic focus under Francis is on its pipeline of future generic drugs, which are in accelerated development. In the previous quarter, Teva announced progress in developing olanzapine for treating schizophrenia and recently updated on faster-than-expected progress with its key drug candidate, Anti-TL1A, for treating digestive system diseases, which it is developing with the pharmaceutical giant Sanofi... Full

The Generics Bulletin Top 50, Part One: Top Ten Ranking Conceals Changes For Industry Leaders

(8/5, David Wallace, Generics Bulletin) ...Sandoz, Teva And Viatris Maintain Hold On Top Three...Meanwhile, second-ranked Teva is no stranger to major changes this year, just over 12 months ago unveiling its new ‘Pivot To Growth' strategy that is seeing the company lean away from commodity generics to focus more on its innovative assets – including major 505(b)(2) opportunities like long-acting injectable risperidone and olanzapine, as well as biosimilars – while still retaining significant generics interests where they can be profitable... Global Sub. Full

Our Key Business Segments Well Positioned for Growth: CS Muralidharan, Sun Pharma

(8/2, The Economic Times) ...However, our outlook on speciality products remains very positive and I expect our existing products will continue to grow. Even in the current quarter, we saw good growth in Ilumya, Cequa, Winlevi and Odomzo. And as such, we do not see any concern for growth front. "The second factor for the sequential decline partly was also the sales of lenalidomide in the US for Q1 was not large. Somewhat broadly in line with Q4 FY24, as we said that the sales of generic lenalidomide tends to be episodic and fluctuates between quarters," says CS Muralidharan, CFO, Sun Pharma... Full

Sun Pharma's Hair Loss Drug in the Cross Hairs in US

(8/3, Viswanath Pilla, The Economic Times) ...Sun Pharma's much anticipated US commercial launch of its specialty product Leqselvi (deuruxolitinib) is facing uncertainty due to a patent dispute..."Currently, a patent infringement action and a motion seeking a preliminary injunction have been filed by lncyte," Sun Pharma said. The company said it intends to "rigorously oppose" the motion and patent infringement action. "The decision of the Leqselvi launch will be governed by the decision of the court on the motion," it said... Full

Towa Charts Path Forward In Medium Term Business Plan

(8/2, Adam Zamecnik, Generics Bulletin) ...Ahead of Towa Pharmaceutical's awaited financial first quarter results for the 2025 financial year appearing next week, Generics Bulletin has reviewed the firm's recently published "Proactive" medium-term business plan to see the company's path out of the Japanese generic drug crisis. Towa's sixth medium-term business plan charts the company's path to 2026. Similarly to the firm's fifth medium-term business plan, the recently published presentation underlines the company's ongoing ambition to reinforce its domestic position following the impact of Japan's generic drug crisis... Global Sub. Full

Xbrane And Biogen End Deal For Cimzia Biosimilar

(8/5, David Wallace, Generics Bulletin) ...Biogen has decided to terminate an alliance with Xbrane Biopharma linked to the firm's proposed biosimilar to Cimzia (certolizumab pegol). The move represents the latest setback for Xbrane, with the firm acknowledging that losing Biogen as a partner will impact its financial goals over the next year... Global Sub. Full

BioNTech Counts On Shift to Cancer Drugs After Second Quarter Losses Quadruple

(8/5, Rachel More, Reuters) ...The company also saw a 23% drop in quarterly revenue to 128.7 million euros, mainly due to lower sales of its COVID-19 vaccines, whose development in partnership with U.S. partner Pfizer and wide use during the pandemic made the small German biotech firm a household name. "Our second quarter revenues correspond to the current demand of a seasonal endemic COVID-19 vaccine market," finance chief Jens Holstein said in a statement... Full

US FDA Says All Doses of Lilly's Weight-Loss and Diabetes Drug Are Now Available

(8/2, Bhanvi Satija, Sneha K, Reuters) ...All doses of Eli Lilly's weight-loss drug Zepbound and diabetes drug Mounjaro are now available, the U.S. Food and Drug Administration's updated shortage list showed on Friday. However, the regulator has not yet removed the drugs off its shortage list...The FDA continues to actively monitor drug availability and work with the company to ensure a stable supply of safe and effective drugs, the agency stated in an email... Full

Lilly, Novo Nordisk Battle for Weight-Loss Market Lands at the Pharmacy Shelf

(8/5, Maggie Fick, Patrick Wingrove, Reuters) ... As Eli Lilly's weight-loss drug Zepbound gains ground in the U.S. against Novo Nordisk's Wegovy, some doctors say their guiding principle for writing prescriptions is simple: which drug can my patients actually get at the pharmacy...Five U.S. doctors specializing in obesity told Reuters they prescribe whichever of the two drugs is more likely to be available at the time, even if that means a patient has to switch between them, to ensure continued treatment... Full

Novo Nordisk Spends Record Amounts On Research to Fend Off Weight-Loss Rivals

(8/5, Ian Johnston, Financial Times) ...Novo Nordisk is ploughing record amounts into research and development as it seeks to stave off growing competition from other pharma groups breaking into the booming weight-loss sector. Chief executive Lars Fruergaard Jørgensen will face questions on Wednesday about how the company behind the popular Wegovy and Ozempic drugs plans to stay ahead of rivals, as it reports first-half results... Sub. Req'd

USFDA Gives Nod to Lupin's Generic Formulation to Treat Eye Diseases

(8/5, Financial Express) ...Global pharma major Lupin Limited on Monday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1%... Full

North Carolina Pharma Company Being Sold for $525 Million

(8/3, Chris Roush, Business North Carolina) ...A North Carolina company that developed an attention deficit hyperactivity disorder drug is being sold for $525 million in cash. Ironshore Therapeutics, which is based in Morrisville, agreed to be purchased by Stoughton, Mass.-based Collegium Pharmaceutical in a deal that would be boosted by an additional $25 million depending on the drug's sales in 2025... Full

US FDA Issues 3 Form 483 Observations to Gland Pharma's Pashamylaram Facility

(8/5, Business Standard) ...The said inspection was concluded with three Form 483 Observations. "These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity, the company said in a statement... Full

Celltrion Secures Contracts with All 3 Major US PBMs for Zymfentra

(8/5, Lee Han-soo, Korea Biomedical Review) ...Celltrion said Monday that it has successfully secured a contract with the top three pharmacy benefit managers (PBMs) in the U.S., effectively covering about 75 percent of the U.S. insurance market for its new drug Zymfentra (ingredient: infliximab), known as Remsima SC outside the U.S. The three largest PBMs in the U.S. -- CVS Health, Express Scripts, and Optum -- collectively manage about 80 percent of the market... Full

Samsung Bioepis Sets New Pricing Benchmark with Afilivu

(8/5, Sodam Park, HiT News) ...Samsung Bioepis has made history by being the first to release a biosimilar of a biologic drug with expired patents, significantly impacting the pricing of subsequent drugs. According to industry sources on July 29th, Samsung Bioepis listed 'Afliivu,' a biosimilar of the macular degeneration treatment Eylea (ingredient: aflibercept), on the reimbursement list as of May 1st this year. The maximum price was set at $257.70, approximately 49% of the original biologic Eylea's maximum price of $521.84. While biosimilars are typically priced at 70% of the original, Samsung Bioepis voluntarily lowered the price as a strategic decision... Full

Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline

(8/3, Skylar Jeremias, The Center For Biosimilars) ...In addition to the overall 3.81% drug price inflation predicted in 2025, several originator biologics set to face biosimilar competition in the next few years are projected to increase their list prices, according to Vizient's Pharmacy Market Outlook Report for Summer 2024. Of the top 10 drugs expected to have price increases, 4 (denosumab, pembrolizumab, secukinumab, and etanercept) have biosimilars in the pipeline, and 2 of these already have biosimilars approved by the FDA (denosumab, n = 2; etanercept, n = 2... Full

Report Finds Increase in Specialty Drug Trend, Spend

(8/2, Sandra Levy, Drug Store News) ...Commenting on the report, Aleata Postell, head of Walmart Specialty Pharmacy said, "Despite downward pressure by biosimilars and generic specialty medications, specialty drug spend and trend increased in 2023. Patients who use specialty medications continue to rise, coupled with a pipeline heavily weighted towards specialty drugs, the specialty segment is a vital and essential component to overall health care. The insights and data in this report help to sharpen our pharmacy strategy and reinforce our commitment to managing costs while delivering the highest possible health outcomes."... Full

Narcan to Combat Overdoses Now Stocked at Some MBTA Stops

(8/4, Spencer Buell, The Boston Globe) ...It's an approach that has been catching on in recent years. Boxes containing naloxone, sometimes dubbed NaloxBoxes, have been popping up on the walls of churches, colleges, libraries, and other public places. The initiative to add them to T stops had been pushed by a group of young activists called Harvard College Overdose Prevention and Education Students, who said they were inspired by the disturbing reality that people were overdosing and dying just steps from their campus... Full

US PBM Reform: ‘Bust Them Up' A Theme For 2025?

(8/2, Laura Helblin, Pink Sheet) ...Another House hearing again showcases the bipartisan desire to enact reforms to the US pharmacy benefit management sector. Legislators also sound ready to push for more significant actions than "transparency" measures would promise, but that means waiting until 2025... Sub. Req'd

‘Ending As It Began': Drug Price Talks

(8/2, David Lim and Lauren Gardner, Politico) ...The first Medicare drug price negotiations formally came to a close Thursday - but under a strict confidentiality agreement between drugmakers and CMS, the final prices are still under wraps..."The first round of government price setting is ending as it began: without clear standards for how prices are set and without adequate protections to make sure patients have access to their medicines," Scott Frotman, spokesperson for industry group Biotechnology Innovation Organization, said... Full

Pharmacy Benefit Managers Under Pressure To Reform For Years, But It Hasn't Yet Mattered

(8/4, Joshua P. Cohen, Forbes) ...Ultimately, it will be up to regulators and the judicial system to decide on the legality of PBM tactics. In turn, enforcing rules or punitive penalties may lead to change. Furthermore, potential implementation of a slew of pieces of legislation aimed at curbing PBM power could expedite reform. Until then, however, it's largely status quo in the American prescription drug supply chain... Full

Medicare Scrambles to Keep Prescription Drug Plan Premiums Stable Ahead of Elections

(8/5, John Wilkerson, STAT Plus) ..."I think basically that means that if [Medicare officials] don't do something to intervene, that people will see big jumps in how much they're being asked to pay for their Medicare Part D benefits, at least in the stand-alone plans," said Stacie Dusetzina, a professor of health policy at Vanderbilt University Medical Center... Sub. Req'd

Medicare Lags, Medicaid Leads for Biosimilar Uptake

(8/2, John Gever, MedPage Today) ...From 2016 to 2022, private insurance, Medicaid, and Medicare all substantially increased the proportion of infliximab prescriptions for which biosimilar versions were provided. But the increase was much slower under Medicare compared with the other two payer types, according to Eric T. Roberts, PhD, of the University of California San Francisco, and colleagues writing in Arthritis & Rheumatology... Full

Senate Appropriators To CMS: Allow Easier Part D Biosimilar Access

(8/2, Jessica Karins, InsideHealthPolicy) ...The Senate Appropriations Committee is encouraging CMS to eliminate obstacles to biosimilar drug access to save money for Medicare Part D patients in the spending bill report it advanced this week. While unlikely to become law, the bill provides a look at policies Democrats might pursue if they control Congress in 2025... Sub. Req'd

Access is Unequal to Weight-Loss Drugs Ozempic and Wegovy: Study

(8/5, Tina Reed, Axios) ...Prescriptions for blockbuster drugs that treat diabetes, obesity and heart disease are soaring, but the mix of payers shows access to the drugs is far from equitable, per a study published in JAMA Health Forum... "If only certain patient populations get access to these medications — those primarily with private insurance, more generous health plans — then there's a huge percentage of the U.S. population that isn't getting access to these medications," said lead author Christopher Scannell... Full

GDUFA And BsUFA Fees Set To Leap

(8/2, Derrick Gingery, Generics Bulletin) ...The agency used a 10-year average with updated figures to calculate the FY 2025 PDUFA application fee and limit the impact of submission volatility, but still allowed GDUFA and BsUFA fees to skyrocket...The GDUFA fee for an abbreviated new drug application will increase 27.5% to $321,920, while the BsUFA fee for an application requiring clinical data will skyrocket 44.4% to $1.47m... Global Sub. Full

Washington Joins Suit Accusing Regeneron Inflated Medicaid Prices for Eye Treatment

(8/2, Michaela Bourgeois, KOIN) ...Attorney General Ferguson's office announced the partnership on Friday, claiming the New York-based company increased the price it charged Medicaid for Eylea, which ended up costing state Medicaid programs millions of dollars for the medication... Full

States Are Setting Up Affordability Boards To Rein in Drug Costs

(8/2, Susan Ladika, Managed Healthcare Executive) ...So far, 11 states have approved establishing PDABs, and about a dozen more are considering doing so. Colorado has a setup like Maryland's, with a five-member board and a 15-member advisory council, which were put in place in 2021. This year, it became the first in the country to try to curb prices - and the first to face a lawsuit as a result... Full

Swiss New Drug Approval Times Lag Further Behind EU & US

(8/2, Ian Schofield, Pink Sheet) ...While Swiss new drug review procedures generally took longer last year than in 2022, there was a "substantial" reduction in review times for products submitted under Project Orbis, this year's benchmarking study has found...The US Food and Drug Administration "was again significantly faster than Swissmedic," the agency said, noting that throughput times at the FDA were 31% shorter for NAS applications and 48% shorter for new indications... Sub. Req'd

Importance of Funding for New Medicines in Irish Budget 2025

(8/5, The Pharma Letter) ...Ahead of Budget 2025, the Irish Pharmaceutical Healthcare Association (IPHA), which represents the international research-based biopharmaceutical industry, reiterates the importance of funding new medicines which are an integral and vital part of our healthcare system... Sub. Req'd

John Whelan: Pharma in Ireland Has Bounced Back, But How Long Will it Last?

(8/4, John Whelan, Irish Examiner) ...Ireland's long-term focus on the pharmaceutical industry has paid dividends for the export sector over many years, boosting revenue growth when other sectors have faltered, and ploughing billions into research and manufacturing facilities. Hence, when a dip in revenue hit the sector in 2023, the first in over a decade, there was concern in government circles, as well as the wide-ranging supply chain that relies on the pharma sector, that we were reaching the end of an era of growth, with implications for the wider economy... Full

In Japan, Sales of Eisai and Biogen's Alzheimer's Drug Begin to Accelerate

(8/2, Amber Tong, Endpoints News) ...Biogen and Eisai's Alzheimer's drug Leqembi is off to a slow start in the US. But it's big in Japan. On Friday, Eisai revealed in an investor presentation that Japanese revenue accounted for 1.5 billion out of 6.3 billion yen ($40 million) in total quarterly revenue for the drug. Those sales of Leqembi, which Eisai described as "ahead of the business plan," represent five-fold growth from the previous quarter and took up a larger portion of global revenue... Full

Big Pharma Resists India's Drug Price Controls

(8/2, The Pharma Letter) ...Pharma giants are vehemently opposing the Indian government's proposal to apply the trade margin rationalization formula to certain drugs with the aim of reducing drug prices. The Organization of Pharmaceutical Producers of India, an industry body representing multinational drugmakers, has argued that the move will adversely affect patient assistance programs that offer costly cancer care and rare disease treatments... Sub. Req'd

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