Monday, August 11, 2025

US Pricing Reform: New Products Offer ‘On Ramp' To Implementation, Lilly's Ricks Says

(8/8, Cathy Kelly, Pink Sheet) ...Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be "hard to sustain or justify," while other companies suggested a growing interest in direct-to-consumer sales programs...Ricks argued that by phasing reforms in with new products first, "it gives it sort of a ramp." "Having an on-ramp makes sense to me because a sudden change in either environment would be hard to sustain or justify so the idea of new products is a reasonable proposition provided that the reimbursement rates in Europe can rise really based on cost per QALY analysis and other things, and the US gross-to-net situation can change," he said... Global Sub. Full

Trump Is Promising to Slash Drug Prices by 1,500%. Here's What's Really Happening

(8/11, Tami Luhby, CNN Business) ..."The administration, by itself, has relatively limited power to affect drug prices across the US market," Benedic Ippolito, a senior fellow in economic policy studies at the right-leaning American Enterprise Institute, told CNN. "Congress has tons of power, but the administration, if they're acting by themselves, there's just only so much they can do." Still, Trump's comments are signaling "strong political will," and it would be unwise for drugmakers to dismiss them, said Milena Sullivan, policy practice director at Avalere Health, a consulting firm with pharmaceutical companies as clients... Full

The Dysfunctional Drug Discount System's Serious Implications On Patient Health

( 8/10, Kenny Cole, MedCity News) ...The current drug discount system is failing vulnerable patients – those it was designed to help. While well-intentioned, the savings these programs promise rarely trickle down to patients. With limited options, uninsured or underinsured patients are unable to effectively manage their conditions, leading to increased complications that add to financial pressures on them and on the medical system. The system is in dire need of reform to improve the health and well-being of the country... Full

What Trump's Pharmaceuticals Tariff Threats Mean for Patients

(8/8, Samantha Fields, Marketplace) ...Mariana Socal, an associate professor at the Johns Hopkins School of Public Health, said that it would also be easier for makers of brand-name drugs to absorb tariffs. "But for generic drugs, you know, they are not patented — very cheap drugs. The markup for the drug manufacturer is not that high, and manufacturers are already squeezed in their profits for these drugs," she said. So, with tariffs, they could start losing money, noted Marta Wosinska at Brookings... Full

FDA Issues Guidance On Remote Inspections Amid Staffing Struggles

(8/8, Luke Zarzecki, Inside Health Policy) ...As experts have warned a smaller federal workforce could force FDA to rely on remote inspections rather than in-person inspections, the agency recently released final guidance on conducting remote regulatory assessments in an effort to promote greater consistency in how format is used, touting the benefits of the evaluations to help approve drugs more quickly... Sub. Req’d

FDA Reinstates Ousted Top Vaccine Regulator Vinay Prasad

(8/9, Steff Danielle Thomas, The Hill) ...Vinay Prasad, a top vaccine regulator ousted from the Food and Drug Administration (FDA) late last month, is set to return to his post, according to the Department of Health and Human Services (HHS). "At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research," HHS spokesperson Andrew Nixon told The Hill in a statement. "Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration."... Full

In Internal FDA Town Hall, Employees Raise Concerns About Staffing, Impromptu Expert Meetings

(8/8, Lizzy Lawrence, STAT) ...STAT obtained recordings of Friday's CDER staff meeting, and of another meeting last week with CDER's Office of New Drugs. In those meetings, FDA employees pushed for answers on whether the agency would restore funding for research fellows, when they will be allowed to easily attend conferences again, and why FDA's leaders are holding ad-hoc panels instead of advisory committee meetings with experts whose conflicts of interest are clearly delineated... Full

America's Drug Regulator is in Turmoil

(8/10, The Economist) ...To appreciate the dilemmas the Food and Drug Administration (FDA) faces when it reviews new drugs targeting rare diseases, consider the recent rollercoaster ride of Sarepta Therapeutics, a biotech firm...Peter Marks, director of the FDA's biologics centre at the time, approved the treatment despite reviewers' concerns about limited clinical data. Some hailed that as proof the FDA could be nimble in cases where sufferers had few options. The treatment costs an eye-watering $3.2m per patient, so the drug's approval delivered Sarepta a major payday. But in the past four months three patients on Sarepta's treatments have died from acute liver failure... Sub. Req’d

Novartis Gets Boost as Autoimmune Drug Suceeds in Key Trials

(8/11, Katerina Petroff, Bloomberg) ...Novartis AG said an experimental medicine helped patients with an autoimmune disease in late-stage studies, offering a boost for the Swiss drugmaker's efforts in the field. Patients with Sjögren's disease, a condition that affects moisture in the body, improved when treated with ianalumab, according to a statement Monday. The drug was well tolerated, lifting the treatment's prospects to become the first targeted treatment for the condition, Novartis said... Full

FDA Approves Boehringer's Pill for HER2-Mutated Lung Cancer

(8/8, Lei Lei Wu, Endpoints News) ...The regulator greenlit zongertinib on Friday for previously treated patients with HER2-mutant non-squamous non-small cell lung cancer. The pill, a HER2 tyrosine kinase inhibitor, will be marketed as Hernexeos. The list price for a 60-tablet bottle of Hernexeos is $21,667.01 and a 90-tablet bottle is $32,501, a spokesperson for Boehringer told Endpoints. Patients either take 2 or 3 pills of the therapy once a day, depending on their weight... Sub. Req’d

Kashiv Joins Forces With MS Pharma In MENA For Omalizumab

(8/8, Dave Wallace, Generics Bulletin) ...Kashiv BioSciences and MS Pharma have agreed a licensing and supply deal for MS Pharma to commercialize Kashiv's ADL-018 proposed Xolair (omalizumab) biosimilar in the Middle East and North Africa region...Other omalizumab biosimilar sponsors with products currently in development include Celltrion, whose Omlyclo (omalizumab-igec) was approved with an interchangeability designation by the US Food and Drug Administration in March, as well as Teva with its TEV-45779 candidate... Global Sub. Full

Generic Entresto Floods US Market Following MSN Patent Victory

(8/8, Dean Rudge, Generics Bulletin) ...The US market is now seeing a surge of generic versions of Novartis' heart failure medication, Entresto, following key legal victories by MSN Laboratories. As many as 10 generic formulations are being rolled out, including an AB-rated version launched by Novadoz Pharmaceuticals, a subsidiary of MSN. Torrent Pharmaceuticals also confirmed the launch of its generic version in July. The FDA has approved additional generics from various Indian companies, which are preparing to launch... Global Sub. Full

Lupin Launches Glucagon Injection, Targets $122 Million Annual Market in US for Low Blood Sugar

(8/11, Moneycontrol) ...Leading player in the branded and generic formulations and API space, Lupin launched an emergency kit for the treatment of severe low blood sugar in the US, a company statement said on August 11. The drug category has an estimated annual sale of $122 million in the US, according to IQVIA data. Shares of Lupin were marginally higher in the session, sharply rising after the announcement was made public. Lupin's 'Glucagon for Injection USP' (1mg/vial), packaged in an emergency kit, is a bioequivalent to Eli Lilly's... Full

As Novo Nordisk Ramps Up Lawsuits Over Wegovy Copies, Investors Ask Where is Hims?

(8/11, Maggie Fick and Diana Novak Jones, Reuters) ...In Novo Nordisk's legal fight against dozens of U.S. pharmacies and companies selling cheaper copies of its weight-loss drug Wegovy, one name remains conspicuously absent: Hims & Hers. The high-profile telehealth company continues to sell compounded versions of Wegovy at lower prices, testing the limits of federal restrictions on such copies and contributing to weaker sales growth for Novo... Full

The World Needs More Than Drugs to Fight Obesity, Writes Novo Nordisk's Ex-Boss

(8/11, The Economist) ...A shift in focus is needed on many fronts. Obesity must be universally recognised and addressed as a multi-faceted societal responsibility rather than an individual one. This means restrictions on junk-food marketing to children and continued work to reduce the stigma associated with the disease. It also calls for urban planning that supports people's health, for instance by emphasising physical exercise over travelling by car. In short, the world must prioritise prevention... Sub. Req’d

EpiPen Patent Expiry Opens New Era for Innovation

(8/8, Ross Law, Pharmaceutical Technology) ...The upcoming EpiPen patent expiration on September 11, 2025 sets the stage for a pivotal shift in the epinephrine delivery market. Mylan acquired the rights to the injector pen for treating anaphylactic reactions following the $6.7bn acquisition of Merck KGaA's generics business, Merck Generics, in 2007. Mylan has since faced criticism for inflating the price of EpiPen and constraining patient access. The company has faced numerous lawsuits over the years in relation to overcharging drug wholesalers for access...In January 2025, Mylan reached a $73.5m settlement with KPH Healthcare Services following accusations that it conspired with Pfizer and Teva Pharmaceuticals to delay the release of generic EpiPens, thereby maintaining a monopoly and inflating prices for epinephrine autoinjectors... Full

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

(8/8, Francesca Bruce, Pink Sheet) ...Coupled with the serious threat posed by a most-favored nation (MFN) drug pricing policy, the lack of clarity surrounding tariffs to be applied to medicines coming into the US from the EU is creating a very difficult operating environment for European pharmaceutical companies. Nevertheless, the European Commission is listening to the concerns of smaller companies and discussions on how to make the EU more competitive for these firms have been increasing, said Alexander Natz, secretary general of EUCOPE... Global Sub. Full

Swiss Leaders Seek Roche, Novartis Talks Amid US Tariffs

(8/10, Bastian Benrath-Wright, Bloomberg Law) ...Switzerland's government has reached out to local drugmakers Roche Holding AG and Novartis AG to discuss the tariff situation, a spokesperson said, after the country was hit with the highest US levies in the developed world..."The departments concerned maintain regular contact with all sectors, including the pharmaceutical industry," a spokesperson for the interior ministry told Bloomberg in an emailed statement. "Talks are also planned in the current situation."... Sub. Req’d

U.S. Trade Policy Is Jeopardising the U.S. – India Pharma Supply Chain

(8/8, Ankit Shrivastava, Express Pharma) ...At first glance, these may seem like geopolitical tit-for-tats. But in reality, they risk upending a critical supply chain corridor between two of the world's largest democracies—particularly in pharmaceuticals. This escalation, while framed as a geopolitical response, threatens to create serious downstream consequences for millions of American consumers, especially those who rely on affordable, high-quality medicines manufactured in India. For an administration that claims to prioritise domestic health and economic resilience, this tariff push is dangerously shortsighted... Full

Is Generic Pharma Insulated From Trump's Tantrums?

(8/9, Joe Mathew, Fortune India) ...The feasibility of increasing domestic capacity for pharmaceuticals and pharmaceutical ingredients to reduce import reliance is being looked at. The impact of current trade policies on domestic production of pharmaceuticals and pharmaceutical ingredients, and whether additional measures, including tariffs or quotas, are necessary, is also being studied. Trump's plan is clear. He is beginning with Big Pharma but is not ending with them. Any measure by Trump to reduce import dependence on such critical products will impact the generic pharmaceutical industry in the medium to long term... Full

India's Pharma Surge Through Generic Drug Boom

(8/8, The Pharma Letter) ...The Jan Aushadhi Kendras, the flagship initiative of the Indian government aimed at making quality generic medicines accessible and affordable to all, is rewriting the narrative of affordable medications. With over 16,900 outlets operational, the scheme has introduced over 2,110 generic medicines and 315 surgical products. Many of these are priced 50% to 80% lower than their branded counterparts. The latest wave of launches includes essential drugs across cardiovascular, anti-diabetic, and cancer therapies, offering not just savings in cost but therapeutic parity... Sub. Req’d

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