Monday, September 8, 2025

Colorado Must Face Teva's Lawsuit Over Free Allergy Pen Law

(9/5, Diana Novak Jones, Reuters) ...A unanimous three-judge panel of the Denver-based 10th U.S. Circuit Court of Appeals upheld a lower court's ruling rejecting Colorado's motion to dismiss the generic drugmaker's lawsuit. In an opinion authored by U.S. Circuit Judge Bobby Baldock, the panel agreed that Teva's claim that Colorado is violating federal law is enough to overcome the state's general protection from lawsuits provided by the U.S. Constitution. Representatives for Teva did not immediately respond to a request for comment on the ruling... Full

10th Circuit Confirms Colorado Can Be Sued Over EpiPen Pricing Law

(9/5, Michael Karlik, Colorado Politics) ...EpiPen manufacturer Teva Pharmaceuticals USA, Inc. alleged the law violated the "takings clause" of the Fifth Amendment, which forbids the government from taking private property "for public use, without just compensation." Days before the law was scheduled to take effect, U.S. District Court Judge Daniel D. Domenico turned down the request for a preliminary injunction. He acknowledged the law would require Teva's property to be taken, but believed it was not appropriate to block the law prior to the actual taking... Full

10th Circuit Keeps War Over Colorado's $60 EpiPen Program Alive

(9/5, Amanda Pampuro, Courthouse News Service) ...The Ronald Reagan appointee focused on the ongoing impact of the law on companies like Teva. "Plaintiff alleges an ongoing violation of federal law — that the affordability program's reimburse or resupply requirement violates the Fifth Amendment's Takings Clause," Baldock wrote for the panel. "Plaintiff seeks relief properly characterized as prospective — injunctive relief enjoining enforcement of the reimburse or resupply requirement against plaintiff."... Full

White House Opens Door to Lower Tariffs On Some Food, Pharma Products

(9/6, Ben Berkowitz, Axios) ...The White House says it will consider lowering tariffs on hundreds of products across sectors including food and pharmaceuticals, depending on what specific deals can be struck with trading partners...Late Friday night, the administration released a memo on a new tariff annex called the "Potential Tariff Adjustment for Aligned Partners" (PTAAP)...The pharmaceuticals list is even longer, offering potential exemptions on amino acids, vitamins and other essentials. The natural resources list includes a wide variety of wood products (which could help furniture companies facing the prospect of new tariffs), as well as some gems... Full

Japan-Made Generic Drugs Will Be Exempt from Trump's Reciprocal Tariff 

(9/5, Anna Brown, Endpoints News) ...Generic pharmaceuticals from Japan will be exempt from a 15% reciprocal tariff on the country's exports to the US, President Donald Trump said in a new executive order. The order marks the second trade deal Trump has announced that exempts generic pharma products from tariffs. But the industry still awaits the outcome of the administration's investigation into pharmaceuticals, which could lead to levies on both generic and branded drugs... Sub. Req’d

Akazawa Says U.S. Trade Deal Not Settled as Japan Awaits Pharma and Chip Orders

(9/7, The Japan Times) ...Japan's broad trade agreement with the United States is "not settled," as Washington has not issued the expected presidential orders on tariffs for pharmaceuticals and semiconductors, Tokyo's top tariff negotiator said Saturday. "While a presidential order has been issued concerning adjustments to general tariffs as well as automobile and auto parts tariffs, presidential orders for most-favored-nation status for pharmaceuticals and semiconductors have not been issued," Ryosei Akazawa told reporters after returning from talks in Washington... Full

Lutnick Targets Swiss Pharma Giants for Making Money Off America

(9/5, Josh Wingrove, Lisa Abramowicz and Jonathan Ferro, Bloomberg) ..."The Swiss like to say they're a small country of only 9 million people - a small country, a rich country," he said Friday in an interview on Bloomberg Television's Surveillance. "And how did they become so rich? They sell us pharmaceuticals like it's going out of style, right? They make so much money off America, that's why they're rich. So let's hear what they have to say."... Sub. Req’d

Steep Drug Tariffs Could Lead to Short-Term Shortages

(9/5, Tomas J. Philipson, RealClearHealth) ...It is possible that even triple-digit tariffs would not compel companies to shift production of these drugs to the United States in the near future, and even if they did, short-term shortages are still likely... Full

The Real Drivers of Drug Prices

(9/8, NOTUS PartnerLab) ...The American pharmaceutical industry not only brings new treatments and cures to market, but also serves as a major driver of US economic growth. Stephen J. Ubl, President and CEO of PhRMA, discusses how to balance innovation and affordability, while explaining some of the often overlooked factors that contribute to drug prices... Full

Sticker Shock? Cost Of Orphan Drug Medicare Negotiation Relief May Complicate Future Fixes

(9/5, Cathy Kelly, Pink Sheet) ...Two new research papers illustrate the extent of the orphan drug exemptions to Medicare price negotiation in the so-called "One Big Beautiful Bill." The findings highlight how the exemptions could significantly reduce the savings from the negotiation program, which may influence future legislative attempts to provide additional relief to drugmakers. The papers identify several drugs that will benefit from the expanded orphan drug exemptions in the near term, including Merck's Keytruda. But they give different expectations for J&J's Darzalex, BMS's Opdivo, and Incyte's Jakafi... Global Sub. Full

AAM Slams Novartis Patent Tactics As Barrier To Affordable Entresto

(9/8, Dean Rudge, Generics Bulletin) ..."[The AAM has] an interest in ensuring that, as the district court held here, patent holders cannot use old, overbroad patents to enjoin sales of pharmaceutical technologies that had not been invented at the time they were filed, and which the patents do not describe or enable," the association outlined... Global Sub. Full

2025 Generic and Biosimilar Medicines Savings Report Highlights Value and Vulnerability

(9/5, John Murphy III, AAM) ...While the overall price of generic medicines is consistently dropping, the overall price of brand drugs is consistently increasing. In fact, in 2018, the amount spent on eight different brand products equaled the total U.S. spending on ALL generic products...But flash forward to 2023 and we learn the sum of the amount spent on just two brand molecules - Ozempic and Humira - was greater than the total spent on 1,000 generic drugs combined... Full

FDA Aims To Curb Unauthorized GLP-1 Ingredients With ‘Green List'

(9/5, Maaisha Osman, Inside Health Policy) ...Under the new directive, only active pharmaceutical ingredients (APIs) manufactured at facilities that have been inspected or formally evaluated by the FDA -- and found to comply with federal standards -- will be allowed into the country. APIs from unapproved sources will be subject to automatic detention at U.S. ports of entry, without the need for physical examination... Sub. Req’d

US FDA Tightens Control Over Obesity Drug Ingredient Imports Amid Safety Concerns

(9/5, Puyaan Singh, Reuters) ...The health regulator said it had previously identified serious concerns with compounded weight-loss drugs, including dosing errors, use of unapproved salt forms and side effects, with some requiring hospitalization. As part of its heightened scrutiny, the FDA sent an import alert on Friday authorizing detention without physical examination (DWPE) at U.S. ports. This will allow the agency to seize shipments that appear to be non-compliant with federal requirements, without inspecting them on arrival. Importers must now provide proof of quality and compliance before their goods are released... Full

FDA is Readying More Surprise Inspections for Foreign Drug Sites, Makary Says

(9/5, Zachary Brennan, Endpoints News) ...The FDA is in the process of changing to more "surprise inspections and having a basic safety inspection list so we're not putting companies through the ringer in the United States and then letting companies overseas have a much lighter inspection load," Makary said Thursday at the Maryland Technology Council's Bio Innovation Conference... Sub. Req’d

'Several Concerning Observations': FDA Sheds More Light On Reasons it Rejected Drugs

(9/5, James Waldron, Fierce Biotech) ...The latest batch of 89 rejection letters was uploaded Sept. 4 along with a pledge by the agency to begin publicly releasing this type of communication at the same time the documents are issued to sponsoring companies. As with the initial mailbag of more than 200 CRLs that the FDA made available back in July, a dive into yesterday's letters sheds further light on the agency's often-opaque drug review process... Full

Ohio to Tighten Oversight of Weight-Loss Copies by Limiting Inventory

(9/8, Amina Niasse, Reuters) ...Ohio is taking steps to more tightly regulate how some large drug-compounding pharmacies in the state operate, including those making weight-loss drug copies, by limiting the amount of medicine they keep on hand. The move could have implications for online telehealth companies that rely on Ohio-based pharmacies producing copies in specialized doses, including one in the state owned by Hims and Hers... Full

Alkermes, Takeda Show Encouraging Data On Narcolepsy Drugs

(9/8, Elaine Chen, STAT+) ...Alkermes and Takeda Pharmaceuticals said Monday that their respective drug candidates for a form of narcolepsy substantially helped patients stay awake, fueling the race to develop a new class of therapies that could transform sleep medicine... Sub. Req’d

Lilly's Blood Cancer Drug Meets Main Goal in Late-Stage Study

(9/8, Mariam Sunny, Reuters) ...Eli Lilly's blood cancer treatment Jaypirca helped patients live longer without the disease getting worse, the U.S. drugmaker said on Monday, meeting the main goal in a late-stage study in previously untreated patients. The drug, chemically known as pirtobrutinib, was tested in patients with a type of chronic lymphocytic leukemia, or small lymphocytic lymphoma (CLL/SLL), compared to chemoimmunotherapy... Full

AstraZeneca's Rivalry with J&J in Certain Lung Cancer Patients Heats Up as it Reports Tagrisso Combo Survival Data

(9/8, Lei Lei Wu, Endpoints News) ...In a Thursday release, J&J oncology head Yusri Elsayed said the survival time with the Rybrevant and Lazcluze combination is "projected to exceed four years" compared to the three-year survival it reported with the Tagrisso arm. "Those other numbers" are "just purely projections," said EVP of AstraZeneca's oncology business unit Dave Fredrickson when Endpoints News asked about what J&J disclosed about its median OS result. "The FLAURA2 data are the only reported median overall survival data. And those data, again, they're definitive, they're statistically significant," Fredrickson said... Sub. Req’d

Now Sun Pharma, Lupin Work On Anti-Obesity Pill to Cut Costs, Address Jab Aversion

(9/8,Priyanka Sharma, Mint) ...Both companies have submitted their plans to the Drugs Controller General of India (DCGI), seeking regulatory approval to proceed. Currently, leading anti-obesity drugs like Eli Lilly's Mounjaro, which is available in injectable form, and Novo Nordisk's Wegovy, available as a pill and an injection, are limiting accessibility and patient comfort. While there is no data comparing the efficacy of the oral and the injectable semaglutide variants, experts believe that the injectable form is more effective for weight loss because it delivers higher doses and is absorbed more completely... Full

Regulatory Opportunities to Advance Generic Drug Repurposing

(9/5, Mia Williams, MPH, CHES, Beth Boyer, MPH and Tanisha Carino, PhD, Duke Margolis Institute for Health Policy) ...Addressing the barriers to generic drug repurposing is not a one-dimensional challenge and will require efforts across the biomedical system of researchers, developers, funders, regulators, and payers. In this paper, we explore the role that drug regulators, specifically at the U.S. Food and Drug Administration (FDA), could play in unlocking the full potential of generic drugs to improve patient access to affordable treatments... Full

Permira Seeks $4Bn for Sale of Contract Drugmaker Cambrex

(9/6, Oliver Barnes and Antoine Gara, Financial Times) ...Permira has put its contract drugmaker Cambrex up for sale targeting a valuation of as much as $4bn, as US-based outsourcers benefit from an onshoring push by pharmaceutical companies under pressure from Donald Trump's administration...Contract drugmakers such as Cambrex, which outsource the production of everything from active pharmaceutical ingredients to vials and syringes for pharma companies, have been a huge beneficiary of this push, as the sector looks to reverse decades of moving manufacturing abroad to cut costs... Sub. Req’d

US FDA Wraps Aurobindo Pharma's Bachupally Plant Inspection with 8 Observations

(9/5, Sheersh Kapoor, CNBC TV-18) ...The inspection, covering both oral solids and injectable units, was conducted between August 25 and September 5, 2025. At the end of the inspection, the regulator issued a Form 483 with eight procedural observations... Full

5 Drugs in Shortage

(9/5, Alexandra Murphy, Becker's Hospital Review) ...Here are five new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists... Full

I'm the CEO of GoodRx. A New Era of Access Demands Smarter Design for Direct-to-Consumer Drug Pricing

(9/5, Wendy Barnes, Fortune) ...For too long, the cost of prescriptions has been shrouded in mystery. Patients show up at the pharmacy counter only to be blindsided by costs they never saw coming, confused by copays, high deductibles, and opaque coverage rules. It's no wonder almost a billion prescriptions are left at the pharmacy counter each year. A well-structured DTC pricing model offers a way forward. By allowing patients to pay a simple, predictable cash price without having to navigate insurance hurdles, it can expand access to critical treatments... Full

Ministers Seek to Gag Drug Giants Ahead of Trump Visit

(9/8, Hannah Boland, The Telegraph) ...Ministers are scrambling to silence drugmakers' criticism of NHS pricing ahead of Donald Trump's state visit amid fears it could trigger a standoff with Sir Keir Starmer. The Government has been attempting to quell anger from pharmaceutical bosses over concerns they have been urging the US president to intervene on a row over rebates when he visits the UK next week...Sources said Downing Street was "desperate to keep pharmaceuticals off the agenda" for Mr Trump's state visit on September 17. One insider said officials were concerned that the Prime Minister would "look silly if Trump hits him with it mid-press conference"... Full

EU Urged to Ramp Up Ambition On Growth and Innovation

(9/8, The Pharma Letter) ...In a post, Sara Lowemark, head of international relations at Lif, said there was a clear urgency in ensuring the strategy becomes more than a paper exercise. A well-functioning internal market, she argued, is vital for the pharmaceutical industry's ability to drive European competitiveness and growth. She also called for a sector-specific "omnibus" to prevent overlapping legislation, pointing out that unnecessary regulatory layers hinder investment and slow down digital and green transitions... Sub. Req’d

Netherlands Pushes for More Generic Drug Imports from India

(9/5, Rishika Sadam and Sriparna Roy, Reuters) ...The Netherlands is aiming to increase imports of Indian generic drugs into the country, as it looks to diversify its portfolio and avoid supply constraints, Dutch government officials and industry experts said at an event on Friday. India, popularly referred to as the 'pharmacy of the world, exported $616 million worth of drugs in fiscal year 2025 to the Netherlands, making it India's seventh largest export market. The biggest market for India is the U.S., where tariff concerns linger... Full

India and Israel Ink Bilateral Investment Agreement to Boost Trade Ties

(9/8, Manoj Sharma, Fortune India) ...While most of the details about the BIT are yet to come out, the agreement is seemingly aimed at enhancing the ties in high-tech manufacturing, research & development and providing the outlook for future Israel-India partnership. The current investment agreement could enhance the overall investment across complementary areas between the two countries...In terms of Israel's major investments in India, during April 2000–March 2024, Israel's direct FDI into India was $334.2 million. There are over 300 investments from Israel in India, mainly in the high-tech domain, agriculture and water. Teva Pharmaceuticals, Ecoppia, Naa'n Dan Jain, Aqwise, Polemix, Eli Hajaj, among others, are among the leading Israeli companies with an Indian presence... Full

India and China Vie for Leadership in Biotech and Pharma R&D

(9/8, The Pharma Letter) ...As China signals a stronger policy push for biotech innovation, India's Prime Minister Narendra Modi has called on scientists and entrepreneurs to intensify research and development and secure patents for new drugs and medical technologies, framing innovation as critical to India's pharmaceutical self-reliance and global leadership, reports The Pharma Letter's India correspondent... Sub. Req’d

China Pharma Deals Threaten U.S. Biotech

(9/8, Tina Reed, Axios) ...China-sourced antibodies, heart treatments and other drug candidates will make up almost 40% of all licensing deals this year, up from less than 3% five years ago, according to Evaluate Pharma...China's biotech boom comes as the U.S. is paring federal funding for biomedical research and freezing grants to universities and medical research institutes... Full

China's Biotech Industry is Gaining On The US. Can Tariffs Hold Them Back?

(9/6, Alice LiTo, South China Morning Post) ..."For decades, the US has been the global leader in biotechnology innovation. Now, the Commission finds that the US is dangerously close to falling behind China," the bipartisan National Security Commission on Emerging Biotechnology said in a report to the US Congress in April. Dependence on China for numerous critical elements in the supply chain represents a "national security vulnerability", the commission said, adding the impact of biotechnology innovation already extends beyond health to industries as varied as agriculture, infrastructure, manufacturing and defence. The ever-present threat of tariffs also continues to cast a pall over the sector, with US President Donald Trump expressing an interest in levying new duties on pharmaceuticals... Full

WHO Adds GLP-1s to Essential Medicines List

(9/5, Nicole DeFeudis, Endpoints News) ...The decision could make products like Novo Nordisk's Ozempic and Eli Lilly's Mounjaro more widely available around the world, as the WHO's list is used as a tool for countries identifying their own medicine priorities. Insurers may also use the list when making reimbursement decisions. The updated registry names Novo Nordisk's semaglutide, and specifies Novo's liraglutide and Eli Lilly's dulaglutide and tirzepatide as therapeutic alternatives. The WHO said its decision "applies specifically to people with multiple comorbidities — Type 2 diabetes, heart or kidney disease and obesity."... Sub. Req’d

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