Friday, August 8, 2025

Amid Pharma's US Investment Spree, FDA Unveils New Program to Streamline Domestic Plant Build-Outs

(8/7, Fraiser Kansteiner, Fierce Pharma) ...In line with the Trump administration's goal to curb the U.S.' reliance on overseas drug manufacturing, the FDA has deployed a new program designed to take some of the headache out of setting up domestic plants. The new FDA PreCheck program will leverage a two-phase approach to help ease the introduction of new pharmaceutical manufacturing facilities in the U.S., according to an Aug. 7 press release... Full

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

(8/7, Derrick Gingery, Pink Sheet) ...FDA PreCheck's facility readiness phase would include a pre-operational review where manufacturers could seek FDA feedback "at critical facility development stages including facility design, pre-construction, construction/equipment installation and qualification, and pre-production phases," the agency wrote in the FR notice. The FDA also could offer manufacturers "insight into whether their planned facility and manufacturing operations as designed are likely to comply with current Good Manufacturing Practice requirements," the agency said... Global Sub. Full

Amid MFN Talks, Lilly Chief Warns US Adoption of International Drug Prices Could Bring 'Worst of Two Worlds'

(8/7, Fraiser Kansteiner, Fierce Pharma) ...As the Trump administration seeks to align U.S. drug prices with lower reference costs in places like Europe, Eli Lilly's CEO has cautioned that deeper flaws in the American healthcare system, which "isn't built to function for patients," could complicate an otherwise commendable goal. "We support the administration's position that medical research costs need to be shared more equitably across developed countries," Lilly chief David Ricks said on the company's second-quarter earnings call Thursday. "It's also true that the U.S. pharmaceutical market has significant defects, which shift costs to consumers and increase red tape."... Full

Trump's Pharma Import Tariffs Threaten Drug Pricing, Generics

(8/7, Alivia Kaylor, TechTarget) ...Given that the pharmaceutical supply chain heavily relies on foreign-made ingredients and finished products, experts warn that implementing pharmaceutical import tariffs would sharply increase drug prices, destabilize the generic drug market and curb research and development (R&D) efforts. "The cost of medication will rise in the face of tariffs, especially for medications whose manufacturing largely occurs overseas," Kyle Faget, J.D., partner and co-chair of the Health Care Practice Group at Foley & Lardner, said in an interview... Full

Trump Plan for Tariffs On Imported Drugs Draws Criticism On All Sides

(8/7, Joyce Frieden, MedPage Today) ..."Domestic manufacturing matters, but doing it by taxing patients through tariffs is the wrong move," Natasha Murphy, MSPH, director of health policy at the Center for American Progress, a left-leaning Washington think tank, said in an email to MedPage Today. "These costs won't be eaten by drugmakers and instead will be passed on to families in the form of higher premiums and tighter formularies ... This is Trump's tariff-first playbook at work, and it puts affordability and access at risk."... Full

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

(8/8, Vibha Ravi, Pink Sheet) ...US imposes reciprocal and other tariffs on multiple countries, with 10% as the base. India and Brazil now have highest tariff rate of 50% and seek deeper commercial ties to counter US move. From fentanyl-related to threatened BRICS tariffs, levies seem designed to tilt trade balance in US favor and prompt investments in US. Pharmaceuticals under Section 232 investigation, but Trump threatens tariffs of up to 200%. US trade deficits appear to be behind tariffs but approach is not uniform and Trump statements create uncertainty and make forecasting difficult... Global Sub. Full

2 More Cases Challenging Medicare Negotiation Rejected in Federal Courts

(8/7, Joseph Choi, The Hill) ...In Connecticut, the U.S. 2nd Circuit Court of Appeals upheld a decision granted by U.S. District Judge Michael P. Shea last year against pharmaceutical company Boehringer Ingelheim. The company's diabetes medication Jardiance was among the first 10 drugs chosen for Medicare negotiations, and two more of its products were chosen for the following round of negotiations...In Texas, U.S. District Judge David Alan Ezra dismissed the lawsuit brought forward by the trade group PhRMA with prejudice, closing the case. As in Connecticut and other cases challenging Medicare negotiations, Ezra noted that drugmaker participation in Medicare is entirely voluntary... Full

IRA Suits Dismissed Back-To-Back By Two Appeals Courts

(8/7, Gabrielle Wanneh,Inside Health Policy) ...Patients for Affordable Drugs and other advocates for federal drug pricing reform are pleased with the back-to-back appellate decisions. The BI ruling further emphasizes that pharmaceutical companies cannot claim constitutional violations because they are opposed to the terms of doing business with the government, the advocates said... Sub. Req’d

Voices Across the Country Agree: PBMs Play a Critical Role in Making Drugs More Affordable

(8/7, PCMA) ...A multitude of policy analysts and economists have recently spoken out on the value of pharmacy benefit managers (PBMs). Satya Marar, visiting postgraduate fellow at the Mercatus Center at George Mason University, explains in a CounterPunch op-ed why PBMs are needed to push back against the high list prices that drug companies alone set: "We'd pay even more if private health plans didn't pool patients together and collectively bargain on drug prices through intermediary PBMs. Paradoxically, Big Pharma blames PBMs and their aggressive negotiating practices for higher drug prices even though drugs' list prices are set exclusively by drugmakers."... Full

State Providing $3M to Support Drugmaker's Insulin Development Project in Petersburg

(8/8, Jack Jacobs, Richmond Biz Sense) ...Civica Rx and Gov. Glenn Youngkin announced a $3 million grant from Virginia that would go toward Civica's effort to develop its own insulin aspart product, which is a type of rapid-acting medical insulin used to treat diabetes. The drugmaker plans to ultimately manufacture three insulin products at its plant at 1 Civica Way, a few miles south of Historic Old Towne Petersburg. Civica CEO Ned McCoy called the state funding an important step forward in the initiative in remarks during Thursday's announcement event... Full

Trump Medicaid Ozempic Plan Challenged by States' Budget Squeeze

(8/7, Celine Castronuovo, Bloomberg Law) ...A pilot project to be tested through the federal Center for Medicare and Medicaid Innovation would offer states options to experiment with coverage of GLP-1 drugs for obesity, people familiar with the matter told Bloomberg...These drugs, including Novo Nordisk A/S's Ozempic and Wegovy, can cost patients roughly $1,000 per month out of pocket without insurance. But word of the pilot program comes as some states that currently cover the drugs are re-evaluating those decisions, citing high costs and budget shortfalls. California lawmakers voted in June to end Medicaid coverage of weight-loss drugs as part of a bid to reduce the state's $12 billion budget deficit... Full

First CGRP Blocker Approved for Kids' Migraine Prevention

(8/7, Judy George, MedPage Today) ..."Pediatric migraine is a complex condition that can significantly impact a child's daily life, from school performance to emotional well-being," Jennifer McVige, MD, MA, of the Dent Neurologic Institute in Buffalo, New York, said in a Teva press release. "Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition," McVige added... Full

FDA Approves Ajovy for Childhood Migraine Prevention

(8/7, Logan Lutton, Managed Healthcare Executive) ..."Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood," Chris Fox, executive vice president and U.S. Commercial and Innovative Franchise Lead at Teva, said in the news release. "With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition."... Full

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

(8/7, Dave Wallace, Generics Bulletin) ...Civica has struck a deal with Fresenius Kabi to supply its unbranded ustekinumab-aauz biosimilar to Stelara in the US from January. The wholesale acquisition cost (WAC) for a 12-week supply will be $985 for the 90mg pre-filled syringes and $575 for the 45mg version. Civica's previous forays into biosimilars have mainly focused on insulins, including tie-ups with GeneSys, Ypsomed and Biocon Biologics... Global Sub. Full

Xanax-Maker Viatris Beats Quarterly Profit, Revenue Estimates; Shares Rise

(8/7, Puyaan Singh and Sriparna Roy, Reuters) ..."We delivered a strong second quarter and continued to make meaningful progress against our key 2025 strategic priorities," said CEO Scott Smith. Quarterly revenue fell 6% to $3.58 billion, but beat analysts' estimate of $3.47 billion, according to data compiled by LSEG. This was impacted by the restriction placed by the U.S. Food and Drug Administration on imports of certain products made at Viatris' facility in Indore, India following violation of federal requirements... Full

Biocon Gears Up to Ride Weight-Loss Drug Boom to Script Next Growth Chapter

(8/8, Viswanath Pilla, Moneycontrol) ...Managing director & CEO Siddharth Mittal says is de-risking supply chain as Trump tariffs loom. "We're scenario-mapping but there's a limit to how much we can do," he tells Moneycontrol...The company is preparing for a day-one launch of semaglutide in select markets, with filings underway and approvals expected by late 2026 or early 2027, managing director and chief executive officer Siddharth Mittal told Moneycontrol. He was referring to the expiry of semaglutide patent in India in 2026, which will pave the way for its generic versions... Full

Aurobindo Acquires US Drugmaker Lannett for $250M to Bolster 'Reshoring' Effort

(8/7, Joseph Keenan, Fierce Pharma) ...The deal, which is expected to be completed within the next 12 months, also gives Aurobindo an entry into the attention-deficit/hyperactivity disorder (ADHD) medication market, where it previously had no presence, the company said in a financial filing (PDF) last week. "The acquisition strengthens Aurobindo's ability to serve the U.S. generics space and provides strategic diversification into a specialized, high-value therapeutic category," the company said... Full

Celltrion in Talks to Buy Eli Lilly Plant in US for $504 Million

(8/8, Dae-Kyu Ahn and Yoo-Rim Kim, The Korea Economic Daily) ...If completed, the deal would give Celltrion its first drug manufacturing site in the US, a move aimed at avoiding tariffs that could reach up to 250% on its biosimilars. The US plant is expected to enable the Korean company to locally produce nearly all of its flagship biosimilars for the world's largest pharmaceutical market... Full

Pfizer's Integrated CMO Adopts 'Exclusive' Mindset as it Looks to Redefine Contract Manufacturing Partnerships: Exec

(8/7, Fraiser Kansteiner, Fierce Pharma) ...The company's goal is to move away from the sort of "transactional function" CMOs have traditionally performed in favor of stronger long-term partnerships with a narrower pool of customers, Jim Donovan, Pfizer CentreOne's vice president, said in a recent interview with Fierce Pharma. "We want a much deeper relationship with a lesser number of clients," he explained, referring to the goal as a recent strategic pivot for the company... Full

How Ozempic's Maker Lost Its Shine After Creating a Wonder Drug

(8/7, Eshe Nelson, The New York Times) ...Novo Nordisk had a huge head start. After Ozempic went on sale, it was another four and a half years before a serious competitor emerged: Eli Lilly's Mounjaro, the brand name for tirzepatide, a drug used to treat diabetes. Mounjaro proved to be more effective, leading to greater weight loss in clinical trials. Many patients said they preferred it. At the start of this year, Eli Lilly's Zepbound, which is tirzepatide marketed for weight loss, passed Wegovy in new prescriptions in the United States, according to IQVIA, an analytics company...Unlike Novo Nordisk, Eli Lilly also found ways to get its product to consumers more cheaply, and compete with telehealth companies offering compounded copycat versions, by selling its drug in vials with syringes instead of the more expensive pens with pre-filled doses. Novo Nordisk was further hampered by its slowness in introducing a direct-to-consumer sales platform. NovoCare Pharmacy launched in March, 14 months after LillyDirect... Sub. Req’d

SA Asks: How Could Higher India Tariffs Impact Drug Stocks?

(8/7, Val Brickates Kennedy, Seeking Alpha) ...If Trump goes all-in, which is unlikely, it will require Indian drugmakers to spend billions of rupees and at least three years to transfer production of active pharmaceutical ingredients, or APIs, to the U.S., which will, of course, harm Americans through higher prices and lead to temporary disruptions in the supply of vital drugs. Among the American stocks, I highlight Teva, Viatris, Perrigo and Amneal, which are also dependent on the export of APIs from India to their production facilities in the U.S. As a result, I believe that despite the ongoing uncertainty on Wall Street regarding the Indian pharmaceutical industry, Trump will hesitate to toughen his stance so as not to provoke a new round of inflation, as well as to avoid creating a shortage of cheap copies of branded drugs... Full

‘Worse Than Covid' US Levy Forces Indian Firms to Remap Options

(8/8, Satviki Sanjay, Bloomberg) ...While Indian drugmakers are awaiting clarity on sectoral tariffs imposed by the US, many of them have already begun scenario planning given Trump's dire threats...Alembic Pharmaceuticals Ltd., which earns about 30% of its revenue from the US, sees acquisitions there as a way of boosting manufacturing in the region, its Joint Managing Director Pranav Amin, told Bloomberg News...Firms elsewhere are also actively trying to lure non-American customers to diversify their customer base and market presence... Sub. Req’d

European Commission: Lack of Alternatives to TiO2 Precludes Ban in Drugs

(8/7, Joanne S. Eglovitch, Regulatory Focus) ...The European Commission has determined that there are no viable alternatives to titanium dioxide (TiO2) as an excipient in many pharmaceutical products. They also identified a risk of shortages if a ban were implemented, which could negatively impact patients due to the large number of medicinal products affected... Full

Fixing Antibiotics: How to Defuse the AMR Time Bomb

(8/8, The Pharma Letter) ...Drug-resistant infections now claim more lives each year than HIV/AIDS or malaria, and the toll is rising. The World Health Organization warns that without urgent action, antimicrobial resistance (AMR) could kill 10 million people annually by 2050 and drain 100 trillion dollars from the global economy...Governments must create predictable, long-term payment systems. Industry must stay in the fight, even when margins are thinner. Investors must accept that the value here is measured not only in profits, but in the preservation of modern medicine itself... Sub. Req’d

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