Thursday, August 14, 2025

Resilient Supply, Reliable Care: Safeguarding Europe's Generics in An Uncertain World

(8/14, Michal Nitka, European Pharmaceutical Review) ...In this article, Michal Nitka, Senior Vice President, Head of Generics Europe & Global Head OTC, Teva Pharmaceuticals, outlines how policy reform, digital innovation, and manufacturing resilience can secure sustainable access to essential treatments – ensuring generic medicines remain a cornerstone of equitable, reliable care...A 'one-stop shop' for strategic projects could accelerate investment by streamlining coordination between EU and national authorities... Full

Exclusive: US Pharma Tariffs Likely Weeks Away as Trump Plans for Alaska, Sources Say

(8/13, Maggie Fick, Andrea Shalal, Dave Graham, Reuters) ...One government official in Europe and a source with knowledge of the White House process, as well as two sources at European drug firms familiar with the process, told Reuters that the report and tariffs announcement was not imminent and likely weeks away. These sources spoke on condition of anonymity. A White House spokesperson, asked about media reporting indicating that the results of the probe could be several weeks away, cautioned that such reports were pure speculation unless confirmed by the White House. The spokesperson declined to give further details about the timing of the pharma probe or one involving semiconductors... Full

Trump Executive Order Targets US Pharma Supply Chain Resilience

(8/14, Dominic Tyer, European Pharmaceutical Review) ...The first iteration of SAPIR identified 86 medicines as being either critical or important for acute care, with no comparable alternative available. That initial ASPR list included Pfizer/Bristol Myers Squibb's anticoagulant Eliquis (apixaban), Gilead's HIV treatment Biktarvy (bictegravir) and Amgen's Neupogen (filgrastim). Under President Trump's latest executive order ASPR is required to develop a new, reduced critical drugs list within the next 30 days, looking at how existing funding can be used to maintain a six-month supply of their APIs, prioritising domestic manufacturing sources... Full

Killing the Cure: Why Tariffs On Medicine Backfire

(8/14, Justin Leventhal, RealClearMarkets) ...Ensuring the security of the U.S. pharmaceutical supply chain is essential. But trying to onshore the whole industry through punitive tariffs will only weaken it. Instead, the administration should focus on securing supply lines while keeping drug prices reasonable by encouraging manufacturers to foster a robust, diversified network of pharmaceutical manufacturers to supply the medicines Americans need... Full

HHS Touts MD-Based Manufacturer's Efforts To Boost Domestic Production

(8/13, Gabrielle Wanneh, Inside Health Policy) ...The Trump administration continues to work with the Maryland-based On Demand Pharmaceuticals (OPD) years after the first Trump administration initiated a collaboration between the company, HHS and the Defense Department as part of efforts to bolster domestic drug manufacturing and reduce the country's dependency on foreign countries for critical drug ingredients. Senior officials of the current HHS' Administration for Strategic Preparedness and Response (ASPR) visited the drug maker's manufacturing facility Wednesday (Aug. 13) as the company wants to increase its domestic capability to manufacture active pharmaceutical ingredients and final dosage forms... Sub. Req’d

Drugmakers Form New Group to Lobby On Impact of Medicare Drug Price Negotiations

(8/13, John Wilkerson, STAT+) ...The group is called the IRA Watchdog after the Inflation Reduction Act, which directed Medicare to negotiate the prices for some drugs. Its members are Merck, AstraZeneca, Bristol Myers Squibb Company, and Eli Lilly, according to lobbying disclosure records. The group describes itself as a "coalition analyzing the impact of Medicare Drug Price Negotiation on patients."... Sub. Req’d

Big Pharma Has a New Vision for Selling Drugs. It's Going to the Mattresses.

(8/14, Josh Nathan-Kazis, Barron's) ..."We acknowledge that the path forward to most-favored-nation [pricing] is not going to look the same for every drug class in every market," the White House official tells Barron's. "What we wanted to indicate in the executive order was that we were open to working with them to create pathways, depending on the specific challenges of those drugs." The spokesperson said direct-to-consumer is "potentially one of those pathways for the highly rebated, high volume drugs."... Full

PBMs Provide More than $145 Billion in Value Annually for Americans

(8/13, PCMA) ...University of Chicago Professor of Economics and current Chief Counsel for Advocacy at the Small Business Administration Casey Mulligan developed an economic model to estimate the overall value that PBMs provide to the American health care system. Dr. Mulligan's research, published in the National Bureau of Economic Research, found that overall, PBMs provide more than $145 billion in value to Americans annually and $148 billion in savings... Full

Combating Pharmaceutical Patent Thickets In The Trump Administration

(8/13, S. Sean Tu Aaron S. Kesselheim William B. Feldman, Health Affairs) ...Passing the Affordable Prescriptions for Patients Act would serve more as window dressing than true reform; it would have limited effect on reducing patent thickets. A better choice would be a combination of ETHIC and a legislative formulation of the USPTO rule. ETHIC would narrow the number of drug patents eligible for litigation, and a legislative formulation of the USPTO rule would deter the issuance of obvious variation patents in the first place by increasing the potential stakes for invalidation. Together, these measures would reduce existing pharmaceutical patent thickets and prevent future thickets from forming, thereby facilitating more timely entry of generic and biosimilar competition for the benefit of patients... Full

Industry Wants More Transparency, Dedicated Program for Complex Generics in GDUFA IV

(8/13, Joanne S. Eglovitch, Regulatory Focus) ...Teva also suggested a dedicated complex generic development program. Teva said that "potential learnings from the Biosimilar Biological Product Development (BPD) program could be leveraged and adapted to support development and approval of complex generic products in a dedicated program. Similar to the BPD fees, such a program could be funded by a dedicated fee for participation in the program to ensure the Agency has adequate resources to support such program for all complex generic products without need to limit participation to select few programs."... Full

Editorial: Drug Approvals Hit an FDA Wall

(8/13, The Wall Street Journal) ...The FDA's approval of new drugs has notably slowed this year. Annual novel drug approvals averaged 52 in the first Trump Presidency and 48 under Joe Biden, but there have been only 22 in the first seven months of this year. On current trend that would make 38 for the year. One concern is that regulators are nixing drugs under the false flag of raising scientific standards. A case in point is Replimune's melanoma treatment, which the FDA rejected last month. About a third of patients who hadn't responded to prior immunotherapy showed a strong response to Replimune's in a clinical trial... Sub. Req’d

Richter Sets Launch Timetable for Denosumab and Tocilizumab Biosimilars

(8/14, Dean Rudge, Generics Bulletin) ...Gedeon Richter has announced a staggered launch timetable for its denosumab and tocilizumab biosimilars, with sales of the denosumab biosimilar expected to begin in late 2025 in select European markets, specifically targeting a first-mover advantage. Meanwhile, the timeline for the firm's tocilizumab launch is contingent upon European Commission approval, anticipated in the first half of 2026. Richter's first-half financial results revealed growth in its Biotechnology division sales, although its General Medicines division faced slower growth due to supply chain issues and unexpected inventory write-offs... Global Sub. Full

Navigating Biosimilar Mandates and Prior Authorization in a Value-Based Cancer Care Model: Jason Bergsbaken, PharmD, MBA, BCOP

(8/13, Jason Bergsbaken, PharmD, MBA, BCOP and Alana Hippensteele, MA, AJMC) ...At a recent Institute for Value-Based Medicine® event, Jason Bergsbaken, PharmD, MBA, BCOP, discussed the operational and billing complexities of implementing value-based initiatives in oncology pharmacy, particularly with biosimilars. Bergsbaken, interim manager, oncology pharmacy at UW Health and clinical assistant professor at the University of Wisconsin-Madison School of Pharmacy in Madison, noted that how value is defined can differ for patients, providers, health systems, and payers, making alignment challenging... Full

Viatris Signals Ongoing Strategic Overhaul, Promises Update In Q3

(8/14, Dean Rudge, Generics Bulletin) ...Viatris is undergoing a companywide strategic review aimed at enhancing long-term competitiveness and transitioning toward more complex, higher-margin products. Additionally, the company is focused on addressing issues related to its Indore facility in India, which has suffered significant revenue impacts due to regulatory challenges. Viatris' management also spoke about adapting to proposed US tariffs, asserting that the company is positioned to manage potential impacts effectively, while emphasizing the importance of affordable medicine access... Global Sub. Full

CSL's Venofer Finally Faces Generic Competition as FDA Clears Copycats from Viatris, Sandoz and Amphastar

(8/13, Angus Liu, Fierce Pharma) ...Monday, Viatris and Amphastar Pharmaceuticals both said they have received the FDA's approval for their iron sucrose injection products to treat iron deficiency anemia in patients with chronic kidney disease. In both cases, the companies secured approval for their Venofer generics at three dose strengths—50 mg/2.5mL, 100mg/5mL and 200mg/10mL—in single-dose vials... Full

Lundbeck Raises Guidance Based On Solid 1st-Half Results

(8/14, The Pharma Letter) ...Danish CNS specialist Lundbeck has reported revenue grew 14% at constant exchange rates (CER), plus 14% DKK, to 12,258 million kroner ($1,915 million) in the first six months of 2025. Growth in the USA and Europe was the driver of this strong performance...Lundbeck noted that the significant pipeline progress in the first six months of 2025 reflects the continued evolution of Lundbeck's differentiated neuroscience portfolio, including an increased focus on assets targeting neuro-rare and neuro-specialty conditions... Sub. Req’d

Novo Nordisk Launches Weight-Loss Drug Wegovy in South Africa

(8/14, Nqobile Dludla and Siyanda Mthethwa, Reuters) ...Danish drugmaker Novo Nordisk introduced its weight-loss drug Wegovy in South Africa on Thursday, marking its debut in Africa and stepping up competition with Eli Lilly's Mounjaro launched in the country eight months earlier...Novo reaps the majority of its profits from Wegovy sales in the critical U.S. market, where it competes with Eli Lilly's obesity Zepbound drug and Mounjaro, its diabetes medication. But the company has said it plans to ramp up Wegovy sales outside of the U.S... Full

One in Four US Adults with Diabetes Used a GLP-1 Drug Last Year, Survey Finds

(8/14, Bhanvi Satija, Reuters) ...More than one in four U.S. adults with diabetes used one of the injectable medicines that target the GLP-1 protein last year, the U.S. Centers for Disease Control and Prevention said on Thursday...Use of the injectable drugs was highest among adults with diabetes aged 50–64 at 33.3%, reflecting the more significant disease burden in this group, the report said. A quarter or 25.3% of adults with diabetes aged 18 to 34 reported using a GLP-1 drug, while the adoption rate was 20.8% among those 65 and older... Full

Swiss Ministers Meet With Roche, Novartis Amid Tariff Crisis

(8/14, Fergal O'Brien, Bloomberg) ...Swiss Interior Minister Elisabeth Baume-Schneider and Economy Minister Guy Parmelin met Thursday morning with Roche chairman Severin Schwan and the president of Novartis's international unit, Patrick Horber, the government said in an e-mailed statement..."The participants in the meeting exchanged their views on the current situation in the pharmaceutical industry against the backdrop of discussions about the tariffs imposed by the US," the government said. Both ministers are preparing a wider roundtable with the pharmaceutical industry, which is planned for September... Full

Making British Life Sciences Regulation Competitive

(8/13, Mark Samuels, UK in a Changing Europe) ...Mark Samuels considers medicines regulation in the UK and argues there needs to be a clearer vision from regulators to ensure the UK remains competitive... Full

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

(8/13, Vibha Sharma, Pink Sheet) ...The European Medicines Agency has launched a one-year pilot allowing pharmaceutical companies to attend oral explanation meetings in person, but only when its scientific committees hold face-to-face plenary sessions. The pilot responds to industry feedback that highlighted the value of in-person interaction. It aims to test how in-person oral explanations can coexist with the EMA's current model, where the agency's scientific committees are alternating between in-person and remote plenary sessions. The EMA will assess the pilot's impact and share outcomes in Q3 2026... Global Sub. Full

China Pharma Firms Turn to Local Reagent Suppliers to Cut Costs and Delivery Times

(8/13, Andrew Silver, Reuters) ...Pharmaceutical research and development firms in China are increasingly interested in procuring critical supplies known as reagents from local manufacturers, industry executives and managers said, as they seek to cut costs and delivery times... Full

Don't Want Evergreening to Creep Into IPR to Make Medicines More Expensive: Piyush Goyal

(8/14, Abhimanyu Sharma, CNBC TV-18) ...Commerce and Industry Minister Piyush Goyal has said that data exclusivity in the Intellectual Property Rights (IPR) regime should be looked at without keeping any window for evergreening. Describing data exclusivity as the last missing link before India witnesses an inflow of billions of dollars of investment leading to millions of jobs, he made it clear that he doesn't want evergreening to creep into the Indian system to make medicines more expensive... Full

Korea Plans Fee Increase for Biosimilar Approval Reviews to Expedite Process

(8/14, Mun Su-bin, ChosunBiz) ...The government is pushing to raise the expense for the approval review fee for biosimilars (replica drugs of biopharmaceutical products). This expense is the cost that pharmaceutical companies pay when subjected to reviews by the Ministry of Food and Drug Safety. The government plans to shorten the review period by increasing the number of specialized reviewers through the fee increase. This is an extension of President Lee Jae-myung's pledge to 'focus on nurturing the pharmaceutical and biotech industries.'... 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.