Tuesday, August 5, 2025

Drug Makers Applaud OBBB's Expanded Orphan Drug Exclusion, But Start Date Unclear

(8/4, Gabrielle Wanneh, Inside Health Policy) ...Drug companies are enthusiastic about a more secure future for their rare disease portfolios now that CMS will have to permanently exclude all orphan drugs, including those that treat multiple conditions with no other approved treatment options, from Medicare drug price negotiations as a result of a provision in the One Big Beautiful Bill Act. However, a top market analyst notes there's no set date for when the new policy will take effect, meaning it's unclear whether it will be implemented for the next negotiation cycle... Sub. Req’d

Senate Dems Denounce OBBBA For ‘Bailing Out' Expensive Oncology Drug Makers

(8/4, Gabrielle Wanneh, Inside Health Policy) ...Senate Finance Committee ranking Democrat Ron Wyden (OR) and Sen. Catherine Cortez Masto (D-NV) are criticizing the president for, on the one hand, prioritizing lowering prescription drug costs by demanding "most favored nation" pricing from drug companies, while at the same time allowing GOP lawmakers to include in their budget reconciliation law a policy expanding the number of orphan drugs that can be excluded from Medicare drug price negotiations. While advocates of the expanded orphan drug exclusion say it will spur innovation, the senators argue in an Aug. 1 letter to the president that patients won't benefit if the prices of new drugs are high... Sub. Req’d

Listen: Pharma's Bitter Dose of Tariff Pressure

(8/5, Diederik Stadig, ING Think) ...President Trump has imposed a 15% tariff on EU pharmaceuticals and threatened even steeper levies elsewhere. At the same time, however, he is demanding that drug companies at home lower their prices. In this podcast, ING's Diederik Stadig explains why these competing aims cannot be reconciled, and what it could all mean for the industry and consumers... Full

Drugmakers Score Policy Win in a Prolonged Fight Against 340B

(8/4, Amy Baxter, PharmaVoice) ...The Trump administration unveiled a string of new healthcare policies last week, introducing a pilot program that introduces a major shift in favor of the pharma industry...In particular, drugmakers are worried about duplicate discounts, where a hospital allegedly purchases a drug at the discounted rate but also receives a Medicaid rebate. Rebates instead of discounts, they argue, would erase the problem... Full

Experts Highlight Critical Cost-Saving Role of PBMs to Lower Prescription Drug Costs

(8/4, PCMA) ...At a recent Federal Trade Commission (FTC) public listening session on "Lowering Americans' Drug Prices Through Competition," policymakers, academics, and industry leaders gathered to evaluate key drivers of high prescription drug costs. Several speakers emphasized the essential role that pharmacy benefit managers (PBMs) play in driving affordability, negotiating lower prescription drug costs, and improving access for patients... Full

The Solution to Foreign Freeloading On Prescription Drugs Starts Here at Home

(8/4, Wolfgang Klietmann, RealClearHealth) ...Negotiating trade agreements and cracking down on PBMs' and hospitals' abuse of patients would lead to real savings for patients -- without sacrificing innovation. If the United States instead imports other countries' price-control schemes, global medical R&D will collapse, with no country but China likely to pick up the slack. The White House is right to focus on making medicines more affordable. But not all solutions are equally effective. Patients, and researchers, are counting on the president and his advisers to choose wisely... Full

Arrington Leads Fight Against Foreign Countries Increasing Drug Costs

(8/4, House Budget Chairman Jodey Arrington) ...House Budget Chairman Jodey Arrington (TX-19) introduced the USTRx Act, legislation that creates a Chief Pharmaceutical Trade Negotiator at USTR, who would have the responsibility of identifying foreign price controls on drugs innovated in the United States that increase costs for American patients. This negotiator would issue an annual report on these practices and recommend remedies as appropriate... Full

Americans Should Have Access to Drugs Approved Overseas

(8/5, Jeffrey Singer and Bautista Vivanco, STAT) ...The point is that no regulatory agency will get things right all the time. However, when regulatory agencies compete with their counterparts in other countries, it motivates excellence and, more importantly, provides patients with options. Ultimately, patients have the right to make their own choices. It's their body and their health care. Too often, the U.S. government blocks access to safe, effective treatments that people and horses elsewhere use freely. If adults around the world can access safe, effective medicines without a doctor's permission, Americans should also be able to. No one should have to suffer needlessly or fight bureaucracy just to feel better... Full

August Brings Fresh Faces And Tough Calls To US FDA User Fee Calendar

(8/4, Bridget Silverman, Pink Sheet) ...The US FDA has 10 novel agents under review with August user fee goal dates, including five with a breakthrough therapy designation. After two early complete response letters for regenerative medicines, the August user fee calendar is dominated by CDER candidates, which could allow it to move towards Commissioner Martin Makary's ambitious approval goals. A history of failed trials may complicate the FDA's review of Tonix's sublingual cyclobenzaprine for PTSD and Outlook Therapeutics' Lytenava for wet age-related macular degeneration... Global Sub. Full

Pharmaceutical Companies Sue Oregon Over New Law On Discounted Drug Access

(8/4, Kristine de Leon, OregonLive) ...In two federal lawsuits filed over the past week, Novartis, AbbVie, Allergan, Durata Therapeutics, and Pharmacyclics argued that Oregon passed a law that violates federal law and the U.S. Constitution. Novartis and other drug companies are seeking to overturn a new Oregon law requiring drugmakers to offer discounts on drugs dispensed by outside pharmacies contracting with hospitals and clinics serving low-income populations... Full

Cipla Revs Up Biosimilars Engine Amid Winds Of Regulatory Change

(8/4, Anju Ghangurde, Generics Bulletin) ...Cipla's partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine "not too far" from that of a complex generic product amid an enabling regulatory environment...Cipla expects to launch a partnered filgrastim - its first biosimilar in the US - in the second quarter of fiscal year 2026, a key milestone for the company as it sets the stage for the "next generation" of growth in that market. FY26 is the 12 months ending March 31 next year... Global Sub. Full

Sandoz Targets 70% Price Cut for Weight-Loss Drugs in Canada

(8/5, Hannah Kuchler, Ilya Gridneff, Patrick Temple-West, Financial Times) ...Richard Saynor, chief executive of one of the world's largest generic drugmakers, said Sandoz had not finalised the price for its generic weight-loss and diabetes drug semaglutide but that a reduction of "60 or 70 per cent of the list price" was possible...Semaglutide goes off-patent in Canada in January next year. The generic Sandoz drugs have not yet been approved but the process has started. "As more [generic versions] come in, potentially the market would go down further," Sandoz told the Financial Times. "If you were selling this at $40 or $50 a month, the market could be three or two or three times bigger in terms of the number of patients." Much cheaper generic drugs in Canada could also create huge demand from the US... Sub. Req’d

Sandoz Rushes To Fill Gap After German Court Revokes Xarelto Patent

(8/4, Dean Rudge, Generics Bulletin) ...Germany's Federal Patent Court has invalidated Bayer's key patent covering once-daily use of Xarelto (rivaroxaban), paving the way for Sandoz to launch a generic version...In response to the decision, Bayer has indicated to Generics Bulletin that it is mulling an appeal. According to the court, generics manufacturers had argued that the patent should not have been granted due to a lack of inventive step, "and refer to findings from clinical trials with the active ingredient rivaroxaban that were already available on the priority date of the patent in dispute."... Global Sub. Full

Fresenius Announces Licensing Agreement with Polpharma Biologics to Commercialize a Proposed Vedolizumab Biosimilar

(8/5, Fresenius Kabi) ...Fresenius Kabi is expanding its growing biopharma portfolio through a new licensing agreement with Polpharma Biologics S.A. Under the agreement, Fresenius Kabi will exclusively commercialize Polpharma Biologics' vedolizumab biosimilar candidate PB016 globally (except in the Middle East and North Africa), pending approval by respective health authorities. Vedolizumab is a biologic therapy used to treat Crohn's disease and ulcerative colitis... Full

7 Drugs in Shortage

(8/4, Alexandra Murphy, Becker's Hospital Review) ...Clindamycin phosphate; benzoyl peroxide gel: Teva Pharmaceuticals has discontinued the combination topical gel containing clindamycin phosphate and benzoyl peroxide (25 mg/1 gram; 10 mg/1 gram) for dermatological use. The decision was based on business reasons...Irinotecan hydrochloride injection: Fresenius Kabi and Teva Pharmaceuticals are discontinuing various strengths of irinotecan hydrochloride injections used in oncology... Full

Samsung Bioepis' Second Quarter Comes Down From Milestone-Boosted Q2 2024

(8/4, Urte Fultinaviciute, Generics Bulletin) ...Samsung Bioepis reported a 24% YoY revenue decline in Q2 2025, due to receiving a milestone payment last year. Meanwhile, organic growth was reported at 28%, driven by "solid" uptake of its ustekinumab and eculizumab biosimilars that entered the US market earlier this year. The management also reaffirmed plans for the spin-off from the parent company Samsung Biologics, with completion expected by Oct. 1... Global Sub. Full

Amneal Pharmaceuticals, Inc. Q2 Profit Increases, Beats Estimates

(8/5, RTTNews) ...The company's revenue was supported by Specialty revenue, which increased 23% driven by key branded products, including CREXONT, RYTARY, and UNITHROID. Revenue from Affordable Medicines also increased 1% driven by strong performance of the company's complex product portfolio and new product launches... Full

Alembic Pharma's June Quarter Profit Grows 25 Percent On Strong US Generics Sales

(6/5, Viswanath Pilla, Moneycontrol) ...The international generics business, a key growth driver, grew by 20 percent to Rs 948.5 crore. Sales growth in the US generics market were strong, rising by 32 percent to Rs 628 crore, attributed to new launches and increased market share. The India branded business grew by 7 percent to Rs 541.7 crore, after the company launched two new products and remains focused on strengthening presence in key therapeutics segment... Full

India's Aurobindo Pharma Reports Profit Fall as Cost Rise Outweighs Sales Growth

(8/4, Kashish Tandon, Reuters) ...Most of India's generic drugmakers get a significant portion of their revenue from North America, where fierce competition has led to lower prices, weighing on the companies' margins. The U.S. contributed 44.3% to Aurobindo's topline. The drugmaker has benefitted from strong demand for its anti-retroviral drugs, which are used for the treatment of HIV patients. Among Aurobindo's rivals, Cipla beat quarterly profit estimates, while Dr Reddy's missed. However, both drugmakers saw weak sales in the U.S... Full

Pfizer Raises Annual Profit Forecast

(8/5, Bhanvi Satija and Michael Erman, Reuters) ...U.S. drugmaker Pfizer raised its full-year profit forecast on Tuesday after reporting better-than-expected results for the second quarter, boosted by strong demand for its heart disease drug, Vyndaqel, and blood thinner, Eliquis...The drugmaker has said it had enough manufacturing capacity across its 10 sites in the United States to mitigate any impact from tariffs and is open to shifting some production to these existing facilities... Full

Dongkook Pharmaceutical Expands Globally with Innovative Drugs

(8/5, Kim Eun-jin, BusinessKorea) ...Having maintained its status as an innovative pharmaceutical company until November 2026, Dongkook Pharmaceutical is currently expanding its influence in the international market by exporting finished and raw pharmaceutical products to over 50 countries worldwide... Full

Biogen is Building a 'Ventures' Team to 'Keep Early Portfolio Externalized'

(8/4, Kyle LaHucik, Endpoints News) ...Biogen, which has spent the past few years attempting to reshape itself, is putting together a so-called "New Ventures" team that will invest in external research that it could one day bring in-house, the company's head of corporate development told Endpoints News. The move is meant to give Biogen an advance look at emerging research while not having to build internal teams to do the early legwork on developing those new drugs. The biotech could eventually bring the external assets into its own pipeline once they mature and if Biogen sees a fit, said Adam Keeney, executive vice president of corporate development, in an interview with Endpoints... Sub. Req’d

Teva Shifts Popular Painkiller Production to Germany, Updates Packaging

(8/5, Navit Zomer, Ynetnews) ...Teva Pharmaceutical Industries said it will stop producing its widely used painkiller Acamol in Israel and move manufacturing to its facility in Ulm, Germany, in a cost-cutting move that will not result in layoffs. The company said the decision to relocate production from its plant in Kfar Saba—employing around 1,000 workers—is part of a broader global strategy to streamline operations and align Israeli products with European standards... Full

Health Canada Taking Longer to Approve Generic Drugs, Data Show

(8/5, Kelly Grant, Chris Hannay, The Globe and Mail) ...Health Canada is supposed to issue rulings on new generics – which are copies of branded drugs whose patents have expired – within 180 days of accepting submissions. In the fiscal year that ended March 31, the regulator hit that target 84 per cent of the time, down from 94 per cent the year before and 100 per cent in three other recent years. But the Canadian Generic Pharmaceutical Association (CGPA), which shared the internal Health Canada data with The Globe and Mail, says the delays are worse than they appear... Full

EU Awaits Trump Actions On Car Tariffs, Exemptions This Week

(8/4, Alberto Nardelli, Bloomberg) ...As a result of the US beginning to implement the deal, the EU has proposed suspending for six months a package of countermeasures it had prepared in the event they failed to reach an agreement, a European Commission spokesperson said on Monday. The US order, however, only covered so-called reciprocal rates and didn't spell out any exemptions, nor how Trump's sectoral measures would apply to trading partners. In addition to a universal levy, the US president has imposed 25% tariffs on cars and car parts and double that rate on steel and aluminum. He has also threatened to target pharmaceuticals and semiconductors in the near future... Sub. Req’d

EMA Tackles Guidance Void As Proposals For External Controls Grow

(8/4, Neena Brizmohun, Pink Sheet) ...The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used... Global Sub. Full

UK Decision Opens Up Competition On Forxiga

(8/5, Dave Wallace, Generics Bulletin) ...Generic rivals to AstraZeneca's Forxiga (dapagliflozin) can now launch in the UK after the Supreme Court lifted an injunction. Intellectual property protection for Forxiga was removed earlier this year when a key patent was found invalid. Legal proceedings have involved Viatris' Generics UK subsidiary, Glenmark, Sandoz and Teva... Global Sub. Full

Bulgaria's Populist Parties Push for Medicine Price Caps Ahead of Euro Adoption

(8/5, Krassen Nikolov, Euractiv) ...Bulgaria's competition watchdog has launched a sector-wide inquiry into the pharmaceutical market, just months before the country is expected to join the eurozone on January 1, 2026. The move follows rising political pressure to tackle inflation fears tied to the upcoming currency switch, with populist parties proposing price controls on basic goods and services, including medicines... Full

South Korea Pays Just a Quarter of US Drug Prices: Report

(8/5, Moon Joon-hyun, The Korea Herald) ...Prescription drug prices in South Korea are among the lowest in the developed world, with Koreans paying just 25.6 percent of what Americans pay on average for the same medicines, according to new data released by the Korea Biotechnology Industry Organization. The analysis, published Monday by KoreaBIO's Bio-Economic Research Center, compares 2022 prescription drug prices across 33 OECD member countries...The report also highlighted US price premiums over other major markets: 3.5 times higher than Japan, 3.3 times higher than France, 2.9 times higher than Germany, and 2.7 times higher than the United Kingdom... Full

Indian Drugmakers Face Uncertainty as Trump Threatens Steep Tariffs and Price Cuts

(8/4, Jomy Jos Pullokaran, CNBC TV-18) ...At present, India enjoys zero tariffs on the export of generic drugs to the United States. However, if the proposed 25% tariff is extended to the pharmaceutical sector, it could force Indian drugmakers to rethink their strategies. One possible response would be to pass on most or all of the added cost to consumers, which would drive up the prices of generic medicines in the US. Another option would be to reassess product portfolios and discontinue lines that become unviable under the new tariff regime. While setting up manufacturing facilities in the US could be considered, it is unlikely to offer any cost advantage in the case of low-margin generic drugs... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.