Thursday, July 24, 2025

Roche in Talks With Washington On Selling Drugs Direct to Patients

(7/24, Hannah Kuchler, Financial Times) ...Roche is in talks with the US government to cut out the pharmaceutical industry's intermediaries and sell medicines directly to patients, as drugmakers try to see off the threat of dramatic price cuts under President Donald Trump's proposed reforms. Thomas Schinecker, Roche's chief executive, said half of all the earnings in the supply chain went to intermediaries, known as pharmacy benefit managers, who take "zero risk" on innovation. "So if the United States would like to cut prices by 50 per cent, it's very easy. We go direct. And this is one of the discussions that we're having with the United States, and that would bring down costs quite quickly," he said... Sub. Req’d

Roche Considering Selling Drugs Directly To US Patients CEO Says

(7/24, Bhanvi Satija and Maggie Fick, Reuters) ...An industry source told Reuters on Wednesday that the most viable DTC candidates were small-molecule drugs dispensed at retail pharmacies - such as treatments for diabetes, cardiovascular conditions, or respiratory diseases like asthma - because they are simpler to distribute and price directly for patients compared to complex medicines, such as some cancer drugs, which often require special handling and injection... Full

Pharma Companies Pour Billions Into US Manufacturing To Tariffs

(7/23, Steve Banker, Forbes) ...Jena Santoro, Global Head of Research & Analytics at Everstream Analytics, states that the previously reported grace period of approximately one to one and a half years for pharmaceutical companies to relocate their manufacturing operations to the U.S. - before the tariffs take effect - appears to remain in place. This grace period would allow drug manufacturers time to adjust production strategies and investments. Everstream is a provider of AI-based supply chain risk management solutions... Full

The Myth of All-American Drugs and What Trump's Tariffs Miss About Pharma Supply Chains

(7/23, Frank Vinluan, MedCity News) ...Firms may try to push some tariff cost on to consumers, said James Gellert, executive chair and former CEO of RapidRatings International, a financial technology company that assesses supply chain risk of public and private companies, including pharma companies. But Gellert also expects costs will be shared across the supply chain, which will test business relationships. The companies best suited to weather tariffs are those that collaborate with their suppliers, sharing financial information to figure out what a tariff means for a supplier's ability to maintain inventory and deliver a good... Full

Restoring America's Generic Drug Independence

(7/23, Andrew Reberg, Coalition For A Prosperous America) ..America faces chronic drug shortages due to a collapse in domestic generic manufacturing and overdependence on risky foreign suppliers. A Section 232 Tariff Rate Quota (TRQ) system would protect U.S. producers by limiting predatory imports, enforcing safety standards, and securing reliable supply from trusted sources. The PILLS Act would jumpstart U.S. pharmaceutical production through targeted tax credits and investment incentives. Together, these policies would restore U.S. manufacturing, rebuild secure supply chains, and ensure Americans have access to safe, reliable medicine made at home... Full

Klobuchar, Lee, Durbin, Grassley Introduce Bipartisan Legislation to Increase Competition and Lower Prescription Drug Prices for Consumers

(7/23, U.S. Senator Amy Klobuchar) ...The bipartisan Short on Competition Act would allow the Secretary of Health and Human Services (HHS) to grant expedited reviews and inspections, and temporary importation when there is, or is likely to be, a prescription drug shortage or when there are fewer than five competitors in a market for prescription drugs that have been approved for at least 10 years... Full

PBMs, Not Patents, Are Blocking Access to Lower-Cost Medicines

(7/23, Lindsey Seidlitz, PhRMA) ...Since 2014, the three largest pharmacy benefit managers (PBMs) have excluded 1,584% more medicines from commercial formularies, according to a new report from Cencora. Formularies are the lists of medicines covered in commercial health plans, often organized into tiers. The report highlights a concerning trend: the average annual increase in medications being excluded from formularies was 27%. What is most alarming is that PBMs are excluding more generic and biosimilar medicines than ever before... Full

340B Transparency: CMS Proposes Claims Repository For Medicare Part D Drugs

(7/23, Cathy Kelly, Pink Sheet) ...CMS is taking the first steps toward developing a 340B claims repository to help avoid duplicating price concessions between the 340B program and Medicare Part D. Plans for the claims repository were announced as OMB holds stakeholder meetings on a pending guidance about switching to a rebate model in 340B, a policy manufacturers support as a way to enhance transparency and right-size the level of price concessions they must provide. CMS also is proposing a provider survey on 340B discounts to provide a basis for lowering Medicare reimbursement to better align with 340B prices... Global Sub. Full

MFN: Short-Term Savings, Long-Term Losses

(7/23, Justin Leventhal, RealClearHealth) ...In the U.S., we wouldn't face those delays directly, since other nations don't reference our prices. But if we adopt MFN pricing, referencing Europe's lower prices, we incentivize delayed launches of lifesaving medicines for 500 million people in Europe, creating unnecessary suffering and death, without bringing down our prices. By design policies like MFN necessarily slash pharmaceutical revenues, which in inevitably reduces R&D investments. Europe has experienced this reality, falling behind in pharmaceutical research. But there is no need to copy Europe's mistakes to lower drug prices. Instead of price controls, we should reform the way we regulate the pharmaceutical industry. These changes can reduce prices without compromising the health of a continent or reducing innovation. Reforms should start with price transparency... Full

FDA Begins Accepting Applications For New Review Voucher Program

(7/23, Jessica Karins, Inside Health Policy) ...FDA is now accepting statements of interest for its new Commissioner's National Priority Review Voucher, inviting companies to declare their eligibility for the program based on criteria like increasing drug affordability or onshoring drug production... Sub. Req’d

Political or Professional? Makary's Overhaul of CDER, CBER May Reshape Leadership Norms

(7/23, Zachary Brennan, Endpoints News) ...FDA Commissioner Marty Makary's gutting of the agency's top leadership, and his appointment of two outsiders — Vinay Prasad and George Tidmarsh — to lead the important centers, could significantly change those norms by shifting the roles from their traditional status as government professional staff into political appointees..."I am concerned with center directors overruling evidence-based recommendations of the FDA reviewers who actually provided detailed analysis of the data submitted, particularly when those overrulings occur based on untested hypotheses, personal opinions, or other peripheral reasons," Harvard's Aaron Kesselheim told Endpoints... Sub. Req’d

US FDA Extends Review of GSK's Blood Drug

(7/23, Sneha S K and Sriparna Roy, Reuters) ...The health regulator has set an action date of October 23, which provides the FDA with time to review additional information provided in support of the application...The "odds of approval have clearly gone up (from a near zero after the advisory committee)," Barclays analyst Emily Field said, adding that investors were bracing for a negative decision from the FDA...GSK said it is confident in the data supporting Blenrep combinations and looked forward to ongoing conversations with the FDA as they continue their review... Full

India's Dr Reddy's Plans to Launch Genericesity Drugs in 87 Countries Next Year, CEO Says

(7/23, Rishika Sadam, Reuters) ...Drugmakers are racing to get a share of the global obesity drug market, expected to generate around $150 billion in sales by the early 2030s, after Denmark-based Novo and its U.S. rival Eli Lilly saw extraordinary demand for their medicines. Dr Reddy's initially plans to launch the generic version of semaglutide - the active ingredient of Novo's Wegovy and diabetes medicine Ozempic - in Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry, Israeli said... Full

Biocon Biologics ‘Strategically' Expands Enbrel Biosimilar With A Launch In Australia

(7/24, Urte Fultinaviciute, Generics Bulletin) ...Biocon Biologics' newly launched Nepexto (etanercept) biosimilar will be marketed by local partner Generic Health in Australia. Nepexto was one of seven biosimilars that the Indian firm acquired outright from former partner Viatris in 2023, with access to 120 countries across advanced and emerging markets. In the US, the two FDA-approved etanercept biosimilars – Sandoz's Erelzi (etanercept-szzs) and Samsung Bioepis' Eticovo (etanercept-ykro) – face marketing restrictions until 2029... Global Sub. Full

Novo Nordisk Loses Wegovy Patent Fight Against Generics Maker Viatris

(7/23, Alexis Kramer, Endpoints News) ...A federal district court in Delaware ruled Tuesday that a submission by Mylan Pharmaceuticals (now part of Viatris) for a generic version of the popular weight-loss drug doesn't encourage physicians or patients to infringe a Novo Nordisk patent. That patent covers the use of long-acting GLP-1 peptides. Viatris's proposed label does not instruct users to perform the patented method, namely, administering a semaglutide product without another therapeutic agent for weight loss or to treat diabetes or hypertension, the court said... Sub. Req’d

Dr Reddy's Q1 Earnings Quite In Line; Focus Now Shifts To Key Launches Ahead

(7/24, Khushi Keswani, Moneycontrol) ...The focus has now shifted to Semaglutide, the GLP-1 agonist being pursued as a generic version of Ozempic/Wegovy. Dr Reddy's reaffirmed plans to launch the product in Canada in January 2026, once exclusivity expires. Rollouts in 87 markets are expected through FY26–27. While the company has secured pen capacity of 10–12 million units via partners, its own Vizag facility will only come online in FY28 — a delay that could limit early upside. Still, management was optimistic... Full

Roche Profit Beats Forecast On Strong Sales of Cancer Allergy Drugs

(7/24, Miranda Murray and Bhanvi Satija, Reuters) ...Swiss drugmaker Roche reported better than expected first-half operating profit on Thursday, driven by strong sales of breast cancer and asthma treatments..."We are confident in our continued strong momentum and resilience of our business due to our innovative on-market portfolio and pipeline," said CEO Thomas Schinecker. He said Roche was still targeting a high single-digit percentage increase in full-year adjusted earnings per share... Full

USP Expert Discusses Balancing Drug Cost, Quality and Access in a Changing Trade Landscape

(7/23, Carrie Harney, JD, Pharmacy Times) ...In this interview with Pharmacy Times®, Carrie Harney, JD, vice president of US Government & Regulatory Affairs at US Pharmacopeia (USP), explores how tariff policies could reshape generic drug economics, worsen shortages of sterile injectables, and place pressure on already strained pharmacy operations. Harney highlights the complex interplay between cost, quality, and geographic sourcing in today's drug supply chain—and underscores how pharmacists can play a pivotal role in advocating for resilient, equitable policy solutions... Full

Orient Pharma, AvKARE Recall Nearly 80K Bottles of Cholesterol Drug Over Impurity Concerns

(7/23, Joseph Keenan, Fierce Pharma) ...Taiwanese drugmaker Orient Pharma and AvKARE of Tennessee have each initiated separate recalls of the high cholesterol drug pitavastatin. Both product pulls have been chalked up to failed impurity and degradation tests. Orient, which launched its recall of 57,504 pitavastatin bottles on June 11, was manufacturing the drug for Teva Pharmaceuticals, according to the FDA's weekly enforcement report... Full

Drug Shortages Decline, But Strains Persist Health Systems: ASHP

(7/23, Alexandra Murphy, Becker's Hospital Review) ...ASHP estimated the country is on pace to meet a record fewer than 100 drug shortages in 2025, the lowest total since 2006. In the second quarter of 2024 alone, ASHP recorded 300 ongoing drug shortages while the first quarter saw 323 active drug shortages, the highest number since the organization began tracking supply data.  While the number of new shortages declines, many of the older shortages have persisted into mid-2025, affecting hospitals and health systems. Sterile injectables, ADHD medications and controlled substances such as oxycodone and morphine remain difficult to source, Dr. Ganio emphasized... Full

US Tariffs And The EU's Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

(7/23, Francesca Bruce, Pink Sheet) ...Companies are increasingly turning to more diverse CMO networks and nearshoring strategies to meet the challenges posed by global measures aimed at promoting domestic manufacturing, including tariffs in the US. Nearshoring and better managed CMO networks can keep final drug prices down. Companies need to consider a range of regulatory issues, including quality management and GMP compliance... Global Sub. Full

MHRA's Framework Point-of-Care Personalized Medicine Goes into Effect

(7/23, Ferdous Al-Faruque, Regulatory Focus) ...The UK Medicines and Healthcare products Regulatory Agency's (MHRA) new framework, which allows certain personalized breakthrough medicines to be administered at the point of care to patients, went into effect on Wednesday. The agency said the regulation is the first of its kind and will significantly speed up the availability of treatments such as cell and gene therapy (CGT) products... Full

UK Signs Biggest Post-Brexit Trade Deal With: What's in It for Both Sides?

(7/24, Anurag Kumar, Times Now) ...India and the UK have signed a historic free trade agreement, slashing tariffs and boosting bilateral trade by $34 billion annually. The deal offers major gains for Indian exports and UK businesses, expands market access, ensures fair treatment in services, and paves the way for deeper economic cooperation and job creation...The agreement includes a chapter on intellectual property, but Indian officials confirmed that it does not compromise India's ability to produce and export generic drugs, addressing key concerns around healthcare access... Full

China Takes Strong Measures To Ensure Affordable Medicines During the Five-Year Plan Period

(7/24, Xinhua) ...The official noted that some pharmaceutical companies abused their pricing autonomy and disrupted market order through practices such as offering kickbacks, monopolizing the market, and controlling sales. He said that while the NHSA resolutely supports high-quality medical innovation and respects the autonomy of companies in setting drug prices, it has also taken a stronger role in managing medicine pricing and maintaining market order... Full

Report Highlights Areas of Intensifying Competition in Chinese Market

(7/23, The Pharma Letter) ...Small molecule drugs now account for the largest share of new drug approvals in Eastern markets, as detailed by a report from PharmCube. Thanks to their long presence in the global market, small molecule drugs accounted for the lion's share of new drug approvals in China with 51% of the total approved in 2024, the report states..."With China at the center stage of the global biopharmaceutical industry, competition in the country will only escalate with the continued emergence of novel products every year in a race that will not only galvanize the industry but also bring benefit to patients worldwide," the report concludes... Sub. Req’d

Leqembi Facing 15% Price Cut In Japan

(7/24, Lisa Takagi, Pink Sheet) ...Japan's cost-effectiveness assessment for Eisai's Alzheimer's drug Leqembi proposes a maximum 15% reimbursement price cut, although the final figure and timing have yet to be confirmed. Result came despite Eisai presenting several dissenting views on the analysis, including on the therapy's long-term efficacy. Japan's CEA scheme is itself also under a review which will look at other country's similar programs... Global Sub. Full

Number of New Domestic Drugmakers Steadily Declining in Russia

(7/24, The Pharma Letter) ...According to data of the Russian research agency Kontur.Fokus, in the first half of 2025, only 47 new pharmaceutical companies were registered in Russia, which is 22.95% less than in the same period last year. This is the lowest figure in the last four years: in 2023 there were 61 registrations, and in 2022 - 69. In the meantime, in addition to the current crisis in Russia, analysts attribute the decline to a high level of market saturation. According to them, a surge of interest in opening of new pharmaceutical companies in Russia was observed in 2022–2023, when new domestic drugmakers appeared as a result of the reduction of presence by global pharmaceutical companies... Sub. Req’d

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