Monday, September 9, 2024

Generics Usher in An Era of Affordable and Effective Weight-Loss Treatments

(9/6, Dan Leonard, Medical Economics) ...Teva Pharmaceuticals just launched the first generic GLP-1 available to Americans. It's a generic version of the diabetes treatment Victoza -- which recently went off-patent -- and is expected to be 13.6% cheaper than the brand-name drug before rebates. After factoring in discounts, brand-name anti-obesity drugs already sell for 48% to 79% below their nominal "list" prices, so Teva's drug will presumably come with even deeper discounts to gain market share... Full

Can More Vyvanse Production Ease the A.D.H.D. Drug Shortage?

(9/6, Christina Caron, The New York Times) ...Many health care providers who specialize in treating patients with A.D.H.D. said that the D.E.A.'s decision was a positive development but that it was unclear just how much of an effect it might have on the shortage... Full

China Suspends Dr Reddy's ADHD Drug Due To ‘Serious Defects'

(9/9, Urte Fultinaviciute, Generics Bulletin) ...Indian generics giant Dr Reddy's has taken a hit in China after the National Medical Product Administration removed the firm's atomoxetine hydrochloride capsules from the country's procurement activities. An investigation carried out by the Chinese health agency "showed serious defects in aspects including the management of active pharmaceutical ingredients, manufacturing process validation, and quality control."... Global Sub. Full

Celltrion Chairman Seo Targets 5 Trillion Won in Sales Next Year, Eyeing CDMO Expansion

(9/9, Choi Mun-hee, Business Korea) ...During the event, CEO Seo Jin-seok gave a presentation titled "From Pioneer to Innovator," where he discussed Celltrion's new drug pipeline, the development status of follow-up biosimilars, and future plans. Celltrion is expanding its drug pipeline into the fields of antibody-drug conjugates (ADC) and multiple antibodies. Starting this year and continuing into next year, the company plans to sequentially unveil multiple "Best in Class" drug candidates, which are considered the most effective among drugs with the same mechanism, further solidifying its position as a leader in antibody therapeutics... Full

Sandoz Feels It Has The Ingredients To Make A Splash In ADCs

(9/9, Dean Rudge, Generics Bulletin) ...Sandoz's Strategic Review 2024 event gave the firm the chance to speak at length about its aspirations in the development of highly complex antibody-drug-conjugates, as well as the opportunity to build on its strong analytical characterization and regulatory experience in biosimilars and peptide development to offer oligonucleotides... Global Sub. Full

Astellas CEO Talks Future Beyond Xtandi as Japanese Drugmaker Puts Roots in Boston

(9/6, Ryan Cross, Endpoints News) ...This week, the Japanese drugmaker Astellas became the latest company to open a research hub in the region, following Eli Lilly, Novo Nordisk and other companies that recently set up similar outposts. "Innovation is our lifeline, and we need to have a footprint here," Astellas CEO Naoki Okamura told Endpoints News in an interview after a sake barrel-breaking ceremony to celebrate the opening of the company's new 62,000 square-foot research center in Cambridge, MA... Full

Samsung Settlement Clears Path To Launch US Soliris Biosimilar

(9/6, David Wallace, Generics Bulletin) ...Samsung Bioepis and Alexion have brought patent proceedings over Soliris to an end in the US, clearing the way for the Korean firm to launch its Epysqli biosimilar version of eculizumab. However, Amgen is also waiting in the wings with its own rival...A Samsung Bioepis spokesperson confirmed to Generics Bulletin that "all of the patent proceedings, including inter partes reviews related to Epysqli, have been dismissed as the result of the settlement between Alexion and Samsung Bioepis."... Global Sub. Full

Sun Pharma and Moebius Gain FDA Fast Track for Osteoarthritis Drug

(9/9, Pharmaceutical Technology) ...Sun Pharmaceutical Industries and Moebius Medical have received fast track designation (FTD) from the US Food and Drug Administration (FDA) for MM-II (Large Liposomes of DPPC [dipalmitoylphosphatidylcholine] and DMPC... Full

AstraZeneca Execs 'Not Worried' After IL-33 Drug Fails to Improve COPD Breathing in Phase 2

(9/8, James Waldron, Fierce Biotech) ...AstraZeneca's Caterina Brindicci, M.D., Ph.D., global head of respiratory and immunology late-stage development, BioPharmaceuticals R&D, told Fierce that today's phase 2 fail would "not at all" impact the pharma's late-stage strategy for tozorakimab. "In the phase 3 program we are targeting exactly the population where we saw a stronger signal in phase 2," Brindicci said in an interview... Full

Perrigo's Tab Owed To Shareholders Nine Years After Spurning Mylan's Hostile Takeover? $97M

(9/6, Malcolm Spicer, Generics Bulletin) ...An end to litigation filed by institutional investors, insurance companies and pension funds comes four CEOs after Perrigo's chief exec during Mylan's tender in 2015, Joseph Papa, resigned to lead another firm in 2016. Plaintiff attorneys are asking for up to 20% of settlement in fees... Global Sub. Full

Granules India's Gagillapur Facility Completes US FDA Inspection with 6 Observations

(9/7, Jomy Jos Pullokaran, CNBC TV 18) ...Drug firm Granules India Ltd on Saturday (September 7) said its Gagillapur facility in Hyderabad, Telangana, has completed a US Food and Drug Administration (USFDA) inspection, concluding with six observations...Granules India has committed to addressing these observations and will submit its response to the USFDA within the required timeframe... Full

Beyond CGRP: New Monoclonal Antibody Class Shows Promise for Migraine

(9/6, Megan Brooks, Medscape) ...A potential first-in-class therapy for migraine prevention has shown promise in a phase 2a proof-of-concept study, with a single infusion reducing migraine frequency over 4 weeks. The drug Lu AG09222 from Lundbeck is an investigational monoclonal antibody that targets a pathway in migraine that is distinct from pathways targeted by the calcitonin gene-related peptide (CGRP) migraine treatment drug class. It binds and inhibits pituitary adenylate cyclase–activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology... Full

Survey of Clinicians: Lower Cost of Biosimilars is the Main Driver of Treatment Choice in IBD

(9/7, Deana Ferreri, PhD, The Center For Biosimilars) ...Researchers surveyed clinicians from 63 countries to better understand whether biosimilars have improved access to biologic treatment in inflammatory bowel disease (IBD). They found that adalimumab and infliximab biosimilars are available in most cases, and the lower cost of biosimilars was the main driver of treatment choice... Full

Group Purchasing Organizations of 'Big 3' PBMs Cloud Transparency, Says Critic | PBMI 2024

(9/6, Briana Contreras, Managed Healthcare Executive) ...Greg Baker, CEO of AffirmedRx, gave a presentation at the 2024 PBMI Annual National Conference in Orlando titled, "Unveiling the Shadows: Exploring Detrimental PBM Trends and Their Impact on Employers." In this interview recorded prior to the meeting, Baker discussed what he views as the lack of transparency in the group purchasing organizations (GPOs) that the large PBMs have set up to manage rebates and ongoing vertical integration in the healthcare industry... Full

PBMs vs. Patients: The Hidden Battle for Affordable Biosimilars

(9/6, Maria T. Abreu, MD and Deborah Dyett Desir, MD, Healio) ...Biosimilar medications — drugs developed to be very similar, but not identical, to an FDA-approved biologic — were intended to play a vital role in increasing affordable options for patients struggling with a range of chronic conditions...Pharmacy benefit managers are making it exceedingly difficult for physicians to provide treatments, including biosimilars. PBMs — and the insurers who often own them — are constantly changing the medications they will cover, causing unnecessary burdens for physicians while disrupting patients' continuity of care... Full

Schumer Lists Rail Safety, Lowering Insulin Costs As Top Priorities for Rest of 2024

(9/8, Alexander Bolton, The Hill) ...Senate Majority Leader Chuck Schumer (D-N.Y.) circulated a letter to Senate colleagues Sunday afternoon warning them of the looming government funding deadline of Sept. 30 and highlighting rail safety legislation and proposals to lower the cost of insulin and prescription drugs as top priorities remaining in 2024. Schumer also said he would make it a priority to continue confirming President Biden's judicial and executive branch nominees over the next four months, as Democrats are in danger of losing their Senate majority... Full

Savings from Biosimilars Expanding, But Industry Faces Strong Headwinds in U.S.

(9/5, Steve Usdin, The BioCentury Show) ...In an interview with The BioCentury Show, Craig Burton, executive director of AAM's Biosimilars Council, called out business practices and government policies that are holding the industry back and discussed the ways a robust biosimilars market could promote biomedical innovation. Burton argued that lower-cost versions of biologic drugs are critical because they create headroom that allows the U.S. healthcare system to continue to invest in new innovative medicines... Full

CSRXP Joins Fellow Advocates for Lower Drug Prices to Urge House Judiciary Committee to Crack Down On Big Pharma's Patent Abuse

(9/6, The Campaign for Sustainable Rx Pricing) ...The Campaign for Sustainable Rx Pricing (CSRxP) joined several other prominent advocates for lowering prescription drug prices, including AARP, the ERISA Industry Committee, the National MS Society, the Purchaser Business Group on Health and Patients for Affordable Drugs (P4AD), on a letter Friday encouraging lawmakers on the U.S. House Committee on the Judiciary to advance bipartisan, market-based solutions to hold Big Pharma accountable for abuse of the patent system... Full

Biden Administration Finalizes Rules to Ensure Insurers Pay for Mental Health Care

(9/9, Lev Facher, STAT) ...The administration said the new rules will compel insurers to act on analyses they were already required to conduct to ensure they were covering mental health conditions on par with others. The rule prohibits plans from using more restrictive prior authorization for mental health than for physical health conditions. It also closes loopholes that exempted insurance plans sponsored by state and local governments from its requirements... Full

Three Areas to Watch: The Inflation Reduction Act and Prescription Pricing

(9/6, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post comes from H. John Beardsley, Senior Vice President of Corporate Strategy at CoverMyMeds. John discusses how the new maximum fair prices (MFPs) published by the Centers for Medicaid & Medicare Services will affect medication affordability, formulary negotiations, evidence-based strategies, and other aspects of the market... Full

Exclusive: Influential Democrat Will Oppose Biosecure Act Ahead of House Vote

(9/6, Jared Whitlock, Endpoints News) ...An influential member in Congress is slated to publicly disavow the closely watched Biosecure Act ahead of a planned House vote next week, according to a letter reviewed by Endpoints News...James McGovern (D-MA), ranking member of the House Rules Committee, said in the letter that the bill would essentially ban companies without due process... Full

They're Back! US FDA Panels Return To Normal And The Schedule Fills Up Fast

(9/6, Michael McCaughan, Pink Sheet) ...The September 9, review of Iterum Therapeutics plc's sulopenem will be a milestone event. The agency will be allowing all interested members of the public to attend in person for the first time since a March 4, 2020 Vaccines and Related Biological Products Advisory Committee meeting. The FDA has held a few "hybrid" meetings in 2024 as it prepared for the return to pre-COVID-19 practices, but the sulopenem meeting is the first with no restrictions on who can attend. The timing is in keeping with the prediction of Office of New Drugs Director Peter Stein earlier in the year that the agency would be back to in-person meetings in the fall... Sub. Req’d

Federal Judge Rejects Pharma Industry's Request to Halt Maryland's 340B Law

(9/6, Max Bayer, Endpoints News) ...A federal judge in Maryland has rejected a request from drugmakers and industry group PhRMA to stop a Maryland law that would lift restrictions on the amount of discounts directed at hospitals serving low-income or uninsured patients... Full

Judge Won't Block Maryland Law Mandating Discounts for Hospitals' Outside Pharmacies

(9/6, Brendan Pierson, Reuters) ...U.S. District Judge Matthew Maddox in Baltimore on Thursday refused to issue a preliminary order blocking the law while he hears a challenge to it by Pharmaceutical Research and Manufacturers of America (PhRMA), Novartis, AbbVie, and AstraZeneca. The judge's written order did not explain his reasoning, but referred to statements he made from the bench at a hearing on Wednesday... Full

Report: Pennsylvania Medicaid Paid $7 Million Extra, Blames PBMs

(9/6, Luke Zarzecki, InsideHealthPolicy) ...An audit of Pennsylvania Medicaid found an extra $7 million was spent for prescription drug benefits in 2022 because of pharmacy benefit managers, a lack of oversight from the state's Department of Human Services (DHS) and a lack of transparency from the PBMs... Sub. Req’d

EU Regulators Should Use AI Only When ‘Safe And Responsible,' Says EMA

(9/6, Eliza Slawther, Pink Sheet) ...Medicines regulators in the EU have "much to gain" from using AI models in their processes, but this technology must be used in a "safe and responsible" way, says the European Medicines Agency..A spokesperson for the EMA told the Pink Sheet that LLMs are not currently used to review marketing authorization applications, and said the agency could not provide "exact figures" on how widespread the use of AI by national EU regulators was... Sub. Req’d

Pricy New Cancer Drugs Offer Patients Hope But Pile Pressure On Health Budgets

(9/8, Sarah Neville, Financial Times) ...Linda Medendorp was told she was going to die. After seeing a doctor about persistent problems swallowing her food, tests showed the then 51-year-old had incurable cancer that had already spread from her stomach and rectum...The drug she received, Bristol Myers Squibb's Opdivo, is an immunotherapy — one of several classes of treatment to emerge in recent years that have made the outlook for cancer patients more promising than ever before...But for health systems that were struggling to cope with rising and ageing populations even before Covid ravaged budgets, innovation cannot be divorced from its price tag — a year's supply of Opdivo at its list price costs almost $200,000, according to a calculation for the FT by health policy consultancy ATI Advisory... Sub. Req’d

British Company Deliberately Hiked Price of Life-Saving Drug, Court Rules

(9/7, Alexander Butler, The Independent) ...Auden Mckenzie and Actavis UK, now known as Accord-UK, engaged in "cartel behaviour" by paying off competitors and raising the price of hydrocortisone tablets by 10,000 per cent between 2008 and 2018. NHS spending on the treatment then rose from around £500,000 a year to over £80m due to the company's monopoly, the Court of Appeal heard. The drug is used by tens of thousands of people in the UK to treat, in some cases, life-threatening conditions such as Addison's disease... Full

Don't Let Foreign Big Pharma Block Biosimilars. Govt Should Boost Access in India

(9/9, Ashwani Mahajan, The Print) ...Cancer, one of the most dreaded diseases, has become a worldwide epidemic. In India too, the number of people suffering from cancer is rising steadily. On the plus side, there has been significant progress in treatment in recent years, with several highly effective medicines being developed for various types of cancer. Due to decades of research, many of these medicines, once very expensive due to royalties, have now become more affordable. Still, some new treatments, which may offer even better outcomes, remain out of reach for many Indian cancer patients... Full

API Price Plunge Brings Forth Spectre of Chinese Predatory Pricing

(9/9, The Pharma Letter) ...A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. However, the drastic reduction, especially in API prices from Chinese sources, has raised alarm bells within the Indian pharmaceutical industry, with experts fearing it signals a predatory pricing strategy, reports The Pharma Letter's India correspondent... Sub. Req’d

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