Monday, September 30, 2024

  Top News

Copycat Drugmakers Will Be Low-Key Obesity Winners

(9/25, Aimee Donnellan, Reuters) ...Firms like Teva Pharmaceutical and Sandoz have started to launch the first copycats from the class of drugs which include Novo Nordisk's hugely successful Ozempic and Wegovy...The older versions of these drugs, which are less effective in treating obesity, have already lost exclusivity and are now being copied by the likes of Teva and Sandoz. The next crunch point will be in 2026, when semaglutide, the key ingredient in Novo's Wegovy and its prototype Ozempic, comes off patent in Canada... Full

Here Are the Medicare Part D Drugs Expected to Face 2025 Price Negotiations

(9/28, Dulan Lokuwithana, Seeking Alpha) ...GSK's, Astellas, Boehringer Ingelheim, and Teva Pharmaceuticals will enter the negation process for the first time with their blockbusters, Trelegy Ellipta, Breo Ellipta, Ofev, Tradjenta, and Austedo on the line for selections. Additionally, researchers argued that products such as Ibrance from Pfizer and Janumet from Merck will also be subject to the bargaining process... Full

  Industry News

FDA Approves Dupixent in COPD, Opening ‘Next Chapter' for Sanofi and Regeneron's Bestseller

(9/27, Andrew Dunn, Endpoints News) ...On Friday, the FDA approved Dupixent as an add-on to typical inhaled medicines for patients with inadequately controlled COPD, or chronic obstructive pulmonary disease, and high levels of a type of white blood cell called eosinophils. China regulators also granted a similar approval in COPD on Friday... Full

Sanofi, Regeneron Look to Seize Major Opportunity with Dupixent's COPD Approval

(9/27, Kevin Dunleavy, Fierce Pharma) ...Other companies are rushing to the space with prospective COPD medicines. Two weeks ago, GSK reported that its respiratory blockbuster Nucala plus inhaled maintenance therapy lowered the rate of moderate or severe exacerbations among COPD patients for up to two years. Amgen and AstraZeneca have hopes for their asthma drug Tezspire as a potential treatment for COPD, as it has shown effectiveness in treating patients with a high BEC. Additionally, Regeneron and Sanofi have a second COPD candidate in IL-33 inhibitor itepekimab, which is being tested in two phase 3 trials... Full

Roche Confirms Narrowed Pharma Focus, Fast Tracks Obesity-Drug Candidate -- Update

(9/30, Helena Smolak, Dow Jones) ...The Swiss pharmaceutical company on Monday outlined its new pharmaceutical strategy through 2030 and said it narrowed the set of disease areas it targets to 11, including obesity, confirming a report by The Wall Street Journal on Tuesday...Roche said it plans to focus on five key therapeutic areas as part of its new pharma strategy through 2030. The company will prioritize work in the areas of neurology, oncology and hematology, immunology, ophthalmology, and cardiovascular, renal and metabolism diseases, it said... Full

Celltrion Establishes Subsidiary in Vietnam, Targets Approval for Major Products by Year-End

(9/30, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it officially established a local subsidiary in Vietnam, with plans to secure approval for the sale of its major products by the end of this year. The newly launched subsidiary aims to enhance Celltrion's sales and marketing operations in the country... Full

Novo Nordisk to Decrease Some Insulin Pen Manufacturing, Transition Supply

(9/27, Zachary Brennan and Anna Brown, Endpoints News) ...The company's plans were disclosed in recent discussions with Doctors Without Borders, who described them to Endpoints News, as well as the WHO, the Australian government, and other governments and regulators. "We are not halting production of insulin in pens," Novo said in an email to Endpoints. "In some cases, we will no longer make human insulin available in pens. It will be made available in a vial and disposable syringe."... Full

Xbrane Hails FDA Win On ‘Streamlined' Nivolumab Trial Program

(9/27, David Wallace, Generics Bulletin) ...Xbrane says scientific advice from the US FDA on a "streamlined" clinical program for its proposed nivolumab biosimilar, comprising just a single trial, will cut the development costs and timeline for the Opdivo rival, making it more attractive as Xbrane seeks a commercialization partner... Global Sub. Full

Aurobindo Pharma Share Down 4% As Arm Gets 10 Observations from USFDA

(9/30, Business Standard) ..."The USFDA inspected Unit-II, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the company, situated at Gaddapotharam Village IDA, Jinnaram Mandal, Sanga Reddy District, Telangana. The inspection closed with 10 observations," Aurobindo Pharma said in its stock exchange filing... Full

Granules' Form 483: Trucks Full Of Documents, Deficient Maintenance, And Bird Droppings

(9/27, Urte Fultinaviciute, Generics Bulletin) ...The investigators found a "large number of torn pieces of GMP documents such as analytical balance printouts, worksheets with handwritten documentation" and a "large number of uncontrolled papers torn into pieces and crumpled having manufacturing and testing information."...Interestingly, some of the employees helped the FDA inspectors to put together some of the torn pieces, with the Quality Unit management then saying that the documents, which included original records, raw data, and metadata on QC and manufacturing unit, "should not have been destroyed."... Global Sub. Full

Lupin's Pithampur Facility Completes USFDA Inspection with 3 Observations

(9/28, Business Standard) ...The inspection concluded with 3 observations on both the API and Finished Product sides. The pharmaceutical major is addressing these observations comprehensively and will respond to the USFDA within the stipulated timeframe... Full

US FDA Concludes Inspection of Biocon Biologics' Insulins Facility in Malaysia

(9/28, Asmita Pant, CNBC TV 18) ...The FDA has issued a Form 483 with five observations related to the Drug Substance and Drug Product facilities, three observations for the Analytical & Microbiological Quality Control Laboratories, and none for the Medical Device Assembly and Warehouse operations... Full

Adderall Patients, Prescribers Hit with Shortage

(9/28, Chloe Morrissey, WKOW) ...It's not only the name brand Adderall that's facing a shortage. Many people, like Shultz, take the generic brand, but Forward Pharmacy Pharmacist Matthew Mabie says those brands are running low too...Three major wholesalers, McKesson, Cardinal and Cencora, supply nearly every pharmacy in the country. If one is out of a prescription, they're likely all out. Mabie said finding a substantial supply during a shortage is unlikely. Along with Adderall, other brands like Vyvanse and Focalin are also running short, and Mabie said there isn't a real solution to this problem right now... Full

UPMC Pharmacy Leader: 'Cost Plus' Models Threaten PBMs

(9/27, Jakob Emerson, Becker's Hospital Review) ...The rise of more transparent, "Cost Plus" pharmacy models is stirring debate within the pharmaceutical space as smaller players put pressure on the large PBMs...Chronis Manolis, senior vice president, pharmacy and chief pharmacy officer at UPMC Health Plan, joined the Becker's Payer Issues podcast to discuss his perspective on the PBM landscape and 'Cost Plus transparent models.'... Full

Why Drug Distributors Are Buying Cancer Specialists

(9/27, David Wainer, The Wall Street Journal) ...Most Americans pick up their prescription drugs at the local pharmacy, but many pricey medications are bought directly by medical providers. Think, for example, of a chemotherapy infusion delivered at a doctor's office. The intermediaries selling drugs to those doctors run a pretty good business. Now, the big three U.S. drug wholesalers -- McKesson, Cencora and Cardinal Health -- are taking control of the doctors, too, to lock them in as customers...But it is also a matter of eat or be eaten. "For drug wholesalers, either they align with medical oncologists, or their competitors can," Langdale says... Sub. Req’d

Amazon to Stock Opioid Overdose Reversal Drug Narcan at Its Warehouses

(9/27, Sebastian Herrera, The Wall Street Journal) ...Amazon.com will start stockpiling opioid overdose medication across its warehouse network, making it one of the largest U.S. employers to respond to government pressure to make lifesaving drugs available in the workplace. The retail giant said it plans to equip its North American facilities with the overdose reversal medication naloxone, sometimes known by the brand name Narcan... Sub. Req’d

Could Amazon Pharmacy Become the Largest Drug Store in the USA?

(9/29, Greg Petro, Forbes) ..."Baby boomers, still a sizable cohort, are often the ones bearing the brunt of high-cost prescriptions," Greg Zakowicz, an e-commerce expert at Omnisend, told Business Insider. As it expands its drug offerings, combined with its current subscriber base, Zakowicz said that Amazon Pharmacy "could become the top one or two pharmacies in the U.S."... Full

Future Biosimilar Trends, Challenges, and Opportunities

(9/29, Cameron Santoro, The Center For Biosimilars) ...Ivo Abraham, PhD, RN, director of the Center for Health Outcomes and PharmacoEconomic Research at the University of Arizona Cancer Center, discusses the evolvement of the biosimilar landscape throughout the years in an interview with The Center for Biosimilars®. Abraham addresses both biosimilars and generics, highlighting their potential to provide more access to patients at lower costs while recognizing the challenges of marketing biosimilars and the need for volume contracts to stay competitive... Full

  U.S. Policy & Regulatory News

CMS: Part D Premiums Will Decrease Due To Demo, IRA

(9/27, Sigi Ris, Amy Lotven, InsideHealthPolicy) ...Part D premiums are stable and will decline from 2024 to 2025 due to a voluntary premium stabilization demonstration announced at the last minute by CMS as well as premium stabilization included in the Inflation Reduction Act (IRA), CMS officials said in a press call Friday (Sept. 27). The news indicates CMS' hastily crafted voluntary Part D premium stabilization demo is working as intended to avert what had been expected to be premium increases... Sub. Req’d

Medicare Managed Care, Part D Premiums Projected to Fall in 2025

(9/27, Tony Pugh, Bloomberg Law) ..."Plans make business decisions each year, and the majority of what we're seeing this year is plans streamlining their offerings, but not leaving regions," a senior official at the Centers for Medicare & Medicaid Services said during a phone briefing with reporters Friday afternoon. "Meaning they may have had a handful of products in one region, and they have reduced that to less products. But it's not accurate to say that access or affordability has decreased in 2025," the official said... Sub. Req’d

Pharmacy Benefit Managers Are Putting Medications Out of Reach

(9/29, Elizabeth MacMenamin, Las Vegas Sun) ...We need greater transparency in how drug prices are set and how rebates are distributed. To foster genuine innovation and ensure fair pricing, we need a transparent market where medication costs are clear to prescribers, insurers and patients. This transparency will help assess the value of treatments and create incentives for advancements in health care, rather than reward those who manipulate pricing... Full

US Government Renews Threats Over J&J's Proposed 340B Rebate Model

(9/27, Nicole DeFeudis, Endpoints News) ...On Friday, HRSA Administrator Carole Johnson said in a letter that J&J has until the end of the month to pull the plug. If it doesn't, HRSA reminded J&J that the consequences may include terminating the company's pharmaceutical pricing agreement under 340B or referring the company to the HHS' Office of Inspector General. J&J's plan was originally set to take effect Oct. 15... Full

HRSA To Kick J&J Out Of 340B If It Doesn't Scrap New Rebate Plan By Monday

(9/27, Gabrielle Wanneh, InsideHealthPolicy) ...HRSA also told J&J it would ask the HHS Office of Inspector General to take enforcement action if the drug maker doesn't back down by the Sept. 30 deadline. A J&J spokesperson told Inside Health Policy Friday the company continues to stand by the legality of its rebate approach but would not comment on J&J's next steps... Sub. Req’d

US FDA Acknowledges Patient Frustration With CAR-T Boxed Warning

(9/27, Sarah Karlin-Smith, Pink Sheet) ...An FDA staff member focused on a patient's concerns about the negative consequences of the CAR-T boxed warning on secondary malignancies at a recent CBER listening session, hinting the agency may be considering "optimizing" the label. The patient suggested the agency put the risks and benefits of CAR-T in context with the risks and benefits of other treatments, noting many older options also cause secondary cancers... Sub. Req’d

Utilizing Generic Drug Awareness to Improve Patient Outcomes with Dr. Sarah Ibrahim

(9/27, U.S. Food & Drug Administration) ...In this podcast series, we aim to answer some of the most frequently asked questions that we've received from the public. My name is Dr. Sara Roach, and today's topic is improving patient outcomes with generic drug awareness...Today we are once again joined by Dr. Sarah Ibrahim, Associate Director for Stakeholder and Global Engagement in the Office of Generic Drugs, OGD, in FDA's Center for Drug Evaluation and Research, or CDER... Full

Newsom Sides with Health Care Industry in Rejecting Rules for Prescription Drug Middlemen, Hedge Funds

(9/28, Kristen Hwang, Cal Matters) ...Gov. Newsom in vetoing regulations for pharmacy benefit managers and hedge funds in health said his administration is working to protect consumers in different ways...The bill, authored by Sen. Scott Wiener, a Democrat from San Francisco, would have required the state insurance department to license pharmacy benefit managers. It would also have required pharmacy benefit managers to disclose prices paid to drug manufacturers and mandated 100% of any discounts negotiated be passed down to consumers... Full

California Governor Vetoes Tougher Rules for Pharmacy Middlemen

(9/28, Andrew Oxford, Bloomberg Law) ...The governor's latest veto reflects the concerns he has raised in the past about unintended consequences from cracking down on insurers, rather than the profits derived from pharmaceutical companies. Newsom wrote in a veto message that his administration will seek more data in the future on the role that PBMs play in drug prices. "Without a doubt, the public and the Legislature need a clearer understanding of how much PBM practices are driving up prescription drug costs," he wrote... Sub. Req’d

  International News

EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

(9/27, Eliza Slawther, Pink Sheet) ...High unmet needs is among the terms and definitions in the EU's regulatory reform package that are "very subjective" and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE's secretary general, Alexander Natz, tells the Pink Sheet... Sub. Req’d

Commission Cautious On Onshoring Drug Production to the EU

(9/27, Gerardo Fortuna, Euronews) ...Onshoring or 'reshoring' pharmaceutical production gained prominence after the COVID-19 pandemic, which exposed the EU's heavy reliance on non-EU countries for active ingredients and essential medicines. This dependency was exacerbated when those countries adopted protective trade measures, further straining EU supply... Full

England's NICE Says Severity Modifier Working, But Industry Wants Cost Restrictions Lifted

(9/27, Eliza Slawther, Pink Sheet) ...England's NICE reported a positive impact on the reimbursement of medicines from its severity modifier, which was introduced in 2022 and replaced the end-of-life modifier. However, the ABPI argued that the severity modifier has hindered patient access in some cases, and blamed the UK government for restricting NICE's spending... Sub. Req’d

Medicines Regulators Weigh Hope and Hype with New Alzheimer's Drugs

(9/30, Jessica Davis Plüss, Swissinfo.ch) ...Swiss medicines regulator Swissmedic is expected to decide by the end of the year whether to approve the first new drug for Alzheimer's disease in two decades. The decision won't be easy. Alzheimer's disease has baffled researchers for decades. Drugmakers have poured billions into the disease, which slowly destroys memory and thinking skills, but haven't come out with a new drug for at least 20 years... Full

Regulatory, Policy Reforms Crucial for Future of India's Pharma R&D: Report

(9/29, Press Trust Of India) ...India's regulatory and policy reforms are crucial for shaping the future of pharmaceutical research and development by streamlining approval processes, strengthening IP protections and incentivising innovation, as several policy challenges continue to hinder the growth of R&D in the sector, according to a report... Full

Pharma Firms Address Drug Regulator's Concerns Over Quality Test Failures

(9/30, Ekta Batra, CNBC TV 18) ...The Indian Pharma Alliance (IPA), representing 23 major pharma companies, has defended its member companies after the Central Drug Standard Control Organisation (CDSCO) flagged 53 commonly used medicines for failing quality tests...The IPA warned that linking spurious drugs to legitimate companies could damage reputations and harm India's standing as a reliable drug exporter... Full

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