Thursday, September 4, 2025

Strengthening Ghana's Fight Against Breast Cancer

(9/3, Noah Smith, Direct Relief) ...In 2002, [Dr. Beatrice Wiafe Addai] founded Breast Care International, or BCI, to break the silence surrounding breast cancer in Ghana...Access to cancer medication was inconsistent, often dependent on unreliable donations. That changed when Addai was introduced to Teva Pharmaceuticals by Direct Relief. In January 2022, Teva launched its Breast Cancer Access Program in partnership with BCI and Direct Relief. The program provides essential cancer medications to up to 400 women annually in Ghana...Teva and BCI have also extended their impact with regional projects: training doctors and physician assistants in early detection, equipping journalists to cover cancer accurately, and investigating links between environmental pollution and rising cancer rates in mining regions. "Teva has done a lot for the country, for our women, children, and country at large," Addai said... Full

Global Drugmakers Rush to Boost US Presence as Tariff Threat Looms

(9/3, Siddhi Mahatole, Kamal Choudhury and Puyaan Singh, Reuters) ...Companies with more exposure to the UK, the EU, South Korea and Japan are likely on better footing as these countries have secured favorable agreements capping tariffs at around 15%. But with many countries still engaged in trade talks with the U.S., businesses around the world are hedging their decisions pending more clarity on final tariff rates. Here's what drugmakers are doing to mitigate supply-chain risks and reassure investors... Full

Reductions in Drug Prices Possible With Most Favored Nation Executive Order But Large Reductions Unrealistic: Q&A With Kathy Oubre, MS

(9/3, Julia Bonavitacola; Kathy Oubre, MS, AJMC) ...In the first part of this Q&A, Kathy Oubre, MS, chief executive officer of the Pontchartrain Cancer Center, explained what the executive order signed by the president in May that aimed to bring "most favored nation" pricing to the US entails and whether his stated goal of reducing prescription drug prices in the US is realistic. Oubre also discusses how the US may see some benefit from the executive order if parts of it are implemented correctly... Full

Most Favored Nations

(9/3, Jennifer Graff and Eleanor M. Perfetto, RealClearHealth) ...Foreign drug prices are not the result of simple negotiations. They reflect the result of complex price setting systems designed to keep prices low and as such, referencing those prices also means importing each country's healthcare delivery system, costs, values, and priorities. If the goal is obtaining better value for US consumers, we must understand the complexities that lie below the surface on pricing. Here, we discuss these issues and provide examples to demonstrate why a copy-and-paste of foreign drug prices is more complex than it seems... Full

America's Pharmaceutical Supply Chain is in Crisis

(9/3, Buddy Carter, The Ripon Forum) ...The United States should never be dependent on the Chinese Communist Party for antibiotics and essential medicines. But that's exactly the dangerous position we are in today. China is not our friend. Every product component that then turns into a vial of medicine or a piece of medical equipment that is made in China is a missed opportunity to strengthen our economy and protect our people. We need to view pharmaceutical and health care supply chain independence just as we are viewing energy independence... Full

How Donald Trump Can Safeguard Our Drug Supply

(9/4, Tomas J. Philipson, Chicago Tribune) ...By targeting China with cost-increasing Pigouvian tariffs and sparing allies, Trump can ensure that the national security gains from drug tariffs don't come at the expense of our patients gaining from America's scientific and economic leadership in this vital industry... Sub. Req’d

Pfizer's CEO Defends Covid Vaccines, Suggests Trump May Deserve a Nobel Peace Prize

(9/3, Matthew Herper, STAT+) ...Pfizer CEO Albert Bourla on Wednesday defended the development of Covid vaccinations, including Pfizer's own, suggesting that they should have won President Trump a Nobel Peace Prize, in response to a social media post earlier this week in which Trump accused drug firms of not sharing data that could end a controversy that is causing the Centers for Disease Control and Prevention to be "ripped apart."... Sub. Req’d

Generic and Biosimilar Medicines Save $467 Billion in 2024

(9/3, AAM) ...The Association for Accessible Medicines and the Biosimilars Council today released the 2025 U.S. Generic & Biosimilar Medicines Savings Report. AAM's annual savings report highlights that generic and biosimilar medicines created $467 billion in savings in 2024 for patients and the overall healthcare system. Generics and biosimilars have saved over $3.4 trillion in the last decade. "Simply put: Generic medicines save money," said John Murphy III, President and CEO of AAM... Full

Discussing Drug Pricing and Innovation: Gottlieb On Fierce Pharma's ‘Health Matters'

(9/1, Scott Gottlieb, AEI) ...In the latest episode of the Health Matters podcast, former Food and Drug Administration Commissioner Scott Gottlieb joins WPP's Wendy Lund, GCI Health's Ryan Kuresman and Burson's Judy Stecker to discuss the forces reshaping U.S. health policy. Gottlieb warns that while new laws such as the Inflation Reduction Act may lower government spending on drugs, consumers are unlikely to see significant relief at the pharmacy counter. Insurers' tighter formularies and higher cost-sharing requirements, he said, could continue to drive affordability challenges for patients... Full

Dose of Reality: Study Finds Big Pharma's Patent Thickets On Just Four Brand Name Drugs Cost More Than $3.5 Billion in Two Years

(9/3, CSRxP) ...In case you missed it, a study recently published in JAMA Health Forum found lost competition due to Big Pharma's patent thickets on just four widely prescribed brand name drugs cost patients, taxpayers and the U.S. health care system more than $3.5 billion in excess spending over two years. The analysis included a review of delayed generic competition to imatinib (Gleevec), glatiramer (Copaxone), celecoxib (Celebrex) and bimatoprost (Lumigan). These brand name products all first began facing competition from more affordable alternatives between 2014 and 2018... Full

Welcome Back, Congress: Here's What To Know About PBMs

(9/3, PCMA) ...As Congress explores policies to make prescription drugs more affordable for Americans, lawmakers should support bills that will make the market more competitive and address the root cause of high drug prices - Big Pharma's egregious patent abuse... Full

Drug Quality Assurance Inspections Closer To Pre-Pandemic Levels, But Still Behind

(9/3, Grace Moser, Pink Sheet) ...The FDA increased its foreign facility inspections in FY 2024, but still has not reached its pre-COVID-19 pandemic levels. The largest increase in inspections was in China, as well as India. FDA officials logged an increase in US sites in FY 2024, but the growth was smaller than seen in several other countries... Global Sub. Full

PhRMA Launches Ad Campaign Urging Congress to Address '340B Medicine Mark-Ups'

(9/3, Dave Muoio, Fierce Healthcare) ...The pharmaceutical lobby is ramping up its opposition to nonprofit health systems' expanding use of the 340B Drug Discount program with the launch of an advertising campaign describing the subsidies as "a hidden tax on patients, employers and taxpayers."...The American Hospital Association (AHA), which represents the hospital industry, has broadly contested the pharmaceutical industry's claims and advocates against restrictions on providers' use of the program. "Classic PhRMA. Shifting the blame for high drug prices misses the Mark," an AHA spokesperson told Fierce Healthcare in response to the new ad campaign... Full

AstraZeneca Attorney Says State 340B Laws Will ‘Topple' the Federal Drug Discount Program

(9/3, Nicole DeFeudis, Endpoints News) ...An attorney for AstraZeneca urged an appeals court this week to strike down a Louisiana 340B law, arguing that state legislation around the country will eventually overtake the federal drug discount program. "At some point the whole thing is going to topple over, and the federal program is going to be skewed by all of these different state incentives," Allon Kedem, an attorney with Arnold & Porter, said during a Tuesday oral argument before the US Court of Appeals for the Fifth Circuit... Sub. Req’d

Express Scripts Fights to Keep Hawaii PBM Suit in Federal Court

(9/3, Celine Castronuovo, Bloomberg Law) ...Judge Leslie E. Kobayashi of the US District Court for the District of Hawaii improperly disregarded in her April ruling that Hawaii's lawsuit alleging the PBMs profited from artificially inflating the costs of prescription drugs "necessarily implicates the work Express Scripts performs as a federal contractor," the company wrote in its opening brief filed in the US Court of Appeals for the Ninth Circuit... Sub. Req’d

Lupin Leads US Competition On Risperdal Consta With CGT Exclusivity

(9/4, Dave Wallace, Generics Bulletin) ...Noting that its generic "has a 180-day CGT exclusivity," Lupin did not specify whether this related to certain or all strengths. This could be relevant as Lupin is not the only firm to have received FDA approval for rivals to Risperdal Consta. Two firms – Amneal and Teva – also have generic versions listed on the agency's database, with Amneal's approval covering the 25mg vial alongside Nanomi; and Teva sitting alongside Nanomi with approvals for the 25mg, 37.5mg and 50mg vials. Moreover, both Amneal and Teva also hold approvals for 12.5mg vials, which Nanomi does not... Global Sub. Full

‘That's Our Secret Sauce': Amgen's Doble On Biosimilar Success And The Next Chapter

(9/4, Dean Rudge, Generics Bulletin) ...Rather than siloing biosimilars from its innovative pipeline, Amgen treats both as part of a single integrated enterprise – a model that has delivered a perfect, 100% biosimilar approval track record, the vice president and general manager of Amgen's Biosimilars business unit, Marc Doble, explains to Generics Bulletin in an exclusive interview... Global Sub. Full

Celltrion Launches Stelkima and Omliklo in Australia, Accelerating Market Share Expansion

(9/4, Choi Mun-hee, BusinessKorea) ...Celltrion announced on Sept. 4 that it has launched Stelkima (ustekinumab), a treatment for autoimmune diseases, and Omliklo (omalizumab), a treatment for allergic diseases, in the Australian market...Celltrion anticipates accelerated market expansion, benefiting from the Australian government's biosimilar support system. The government is implementing support measures, such as simplifying approval procedures, to alleviate financial burdens by prescribing lower-cost biosimilars... Full

Gilead Breaks Ground On Foster City Manufacturing Hub as $32B US Investment Plan Plays Out

(9/3, Fraiser Kansteiner, Fierce Pharma) ...Gilead has broken ground on a new pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, the company said Tuesday...The company said it will utilize flexible pilot lab space, digital infrastructure and accelerated technology transfers at the site to "support the advancement of next-generation biologics across Gilead's pipeline." When all is said and done, Gilead expects the facility to stand out as "one of the most AI-enabled centers in the biopharma industry."... Full

Sanofi Sheds $13 Billion in Value On Weak Trial Results for Eczema Drug

(9/4, Maggie Fick, Reuters) ...The company has billed amlitelimab as a potential successor to Dupixent, and Barclays analyst Emily Field told Reuters investors had viewed amlitelimab as Sanofi's lead pipeline asset to follow on from that drug ahead of the data release. "That's why we're seeing a big reaction in the stock, because of the concern that Sanofi is not going to have enough in its pipeline to replace Dupixent after patent expiry," Field said. "This is increasingly looked at as a cliff stock."... Full

South Africa's Aspen Aims for Profit Turnaround with Insulin, GLP-1 Drugs

(9/3, Nqobile Dludla, Reuters) ..Aspen Pharmacare's manufacturing division aims to grow profit by 2027 by commercializing an insulin deal and producing GLP-1 drugs, after the ending of a major contract led to a full-year loss of 1.1 billion rand ($63 million)... Full

Aspen Gets Approval for Mounjaro Pen in South Africa, Stepping Up Novo Rivalry

(9/3, Nqobile Dludla, Reuters) ..."It's a hit, absolutely shooting the lights out. That whole market (GLP-1) has grown by well over, I think, 130% ... and Mounjaro has grown that market," Stephen Saad told Reuters in an interview on Wednesday. "I think within two years, this product wouldn't surprise me if it gets to a billion rand (in sales)." Saad said with the pens approved, the launch is imminent, which should alleviate shortages reported by users of the treatment... Full

Novartis Returns to Argo for Multifaceted $5B Cardiovascular Collab

(9/3, James Waldron, Fierce Biotech) ...The latest deal will allow Novartis to explore ANGPTL3—an RNAi therapeutic in phase 2 trials—in a combination study for dyslipidemia. The Swiss pharma will also have first right of negotiation to secure the license to ANGPTL3 further down the line... Full

Amneal Pharma is Scolded by FDA for Using Contaminated Bags for a Sterile Injectable Drug

(9/3, Ed Silverman, STAT+) ...In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to an Aug. 27 warning letter issued by the U.S. Food and Drug Administration...Making matters worse, the FDA found that Amneal relaxed "major defects" rates in order to accommodate the excessive particulate contamination found in the bags. "The inappropriately high tolerance for defective" bags meant the company could continuing using the bags, which the agency found "unacceptable."... Sub. Req’d

UK Pharma Trade Group Pushes for Overhaul of Government Evaluation of Life Sciences Investments

(9/3, Kevin Dunleavy, Fierce Pharma) ...The U.K. is losing business opportunities in the life sciences sector because the government undervalues the economic and social benefits of investing in the manufacturing of innovative medicines, according to a report from the Cambridge Economic Policy Associates (CEPA)...The report emerges as AstraZeneca, the country's largest company as measured by market cap, is planning to invest $50 billion in the U.S. over the next five years, while pulling some of its investments in the U.K. The company is also reportedly considering a move of its stock listing from London to the U.S. after years of jousting with U.K. regulators over taxes and drug policies, with AZ claiming that the government doesn't reward innovation... Full

Same Difference

(9/3, Josh Gissing, PharmaTimes Magazine) ...Beyond cost savings, biosimilars can fuel long-term innovation. By easing budget constraints, they enable reinvestment in research, diagnostics and next-generation treatments. Competition also drives improvements in drug delivery and patient-centric design. Policymakers must create a commercially viable environment for biosimilars. Patients and professionals need assurance of their safety and effectiveness, and must understand that biosimilars are a strategic tool to free up NHS resources... Full

Amid Tariff Wars, Canada's Pharma Services Industry Sees Opportunity

(9/3, Aayushi Pratap, Chemical & Engineering News) ...Although the Canadian government has boosted funding for the pharmaceutical manufacturing sector, most of the money has gone toward biologics and vaccines. "Investors need to pay more attention to setting up commercial-scale manufacturing of small molecules in Canada," says John Yao, founder of Hermay Labs, a Canadian contract research organization. "We need to remember that small molecules are a significant share of drugs consumed in the world."...Despite the growing opportunity to expand their US business, industry insiders are well aware of the challenge of emulating the well-established manufacturing hubs in China, India, and Europe... Full

India Launches National Biomanufacturing Hubs to Propel Bioeconomy

(9/3, The Pharma Letter) ...India's new BioE3 (Biotechnology for Economy, Environment and Employment) policy, spearheaded by minister Dr Jitendra Singh, aims to reduce the nation's reliance on imports by building a robust, domestic biomanufacturing ecosystem. The initiative directly addresses India's heavy reliance on foreign sources for critical active pharmaceutical ingredients (APIs), fermentation-based drugs, and enzymes. India aims to transform from a generics powerhouse to a full spectrum biomanufacturing leader, with the initiative set to supercharge the country's biotechnology sector... Sub. Req’d

FDA Streamlines Biosimilar Development to Enhance Public Health and Accessibility in Korea

(9/4, Heo Ji-yoon, ChosunBiz) ...Sarah Yim, Director General of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, noted on the 4th at the Global Bio Conference (GBC 2025) hosted by the Ministry of Food and Drug Safety at the Grand InterContinental Parnas in Gangnam, Seoul, that "the approval process for the development of biosimilar antibody therapeutics will be streamlined."... Full

Taiwan To Phase Out Paper Drug Package Inserts By 2027

(9/3, Eliza Slawther, Pink Sheet) ...Taiwan is the latest country to move away from paper drug package leaflets in favor of electronic inserts accessed via a QR code on the medicine box, lawyers have said. Companies must submit electronically formatted versions of their information leaflets by the year-end. Electronically structured drug package inserts are to be fully adopted by the end of 2026... Global Sub. Full

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