Tuesday, September 16, 2025

Drugmaker Corcept Must Face Teva Lawsuit Over Mifepristone 'Monopoly' for Rare Disorder

(9/15, Mike Scarcella, Reuters) ...In a ruling on Friday, U.S. District Judge Noël Wise in San Francisco said Teva had presented enough information for now to press ahead with claims that Corcept and specialty pharmacy Optime Care, the sole distributor of Korlym, violated antitrust law. Teva's lawsuit, filed last year, alleged that Corcept stifled competition "at every turn" through exclusive agreements that suppressed Teva's generic version of Korlym. Teva also accused Corcept of "paying bribes and kickbacks" to physicians to keep them prescribing Korlym... Full

Hill Staff Gets Briefed On Implications of Trump's Drug Pricing Plan

(9/15, Daniel Payne, STAT+) ...Congressional staffers and health policy experts from major think tanks held a closed-door meeting to discuss policy options that would peg U.S. prices for drugs to what other countries pay, called most-favored nation pricing. The discussions are the latest example of growing interest among Republicans in more aggressive measures to lower drug prices, including the most-favored nation plan that has been a top priority for President Trump... Sub. Req’d

Trump's Reshoring Drive Raises Questions About Supply Resilience

(9/15, Nick Paul Taylor, BioSpace) ...John Murphy, president and CEO of the Association for Accessible Medicines (AAM), told BioSpace that the generic drug trade group has cautioned against relying exclusively on domestic manufacturing on the grounds that it could harm supply chain resilience. If U.S. plants are hit by natural disasters, the country may need supplies from overseas. A strategy focused solely on domestic supply would not establish trade routes with foreign partners that could provide APIs and finished products in the event the U.S. is unable to meet its own needs, Murphy said... Full

Trump's Drug Ad Crackdown May Get a Reality Check

(9/16, Tina Reed, Axios) ..."The FDA is not banning prescription drug advertisements — the First Amendment prohibits such action," FDA commissioner Marty Makary wrote in an opinion piece in JAMA. "But the First Amendment does not protect deceptive and misleading advertisements that have flooded the media, strained the health care system, and driven unnecessary spending that could have been avoided with proper regulatory oversight."... Full

Biosimilars Are the Future of Medicine

(9/15, Jerry Rogers, RealClearHealth) ...Biosimilars are the future of medicine – they are often at the most cutting edge of their biologic counterparts and offer a huge revenue opportunity of the U.S. economy. With a combined focus of removing unnecessary barriers to access to incentivize greater investment in the continued development of biosimilars, we are in a position to generate a lot of economic growth for the U.S. economy while also saving the healthcare system billions of dollars. The reasons to support biosimilars are many, but the best reason is offering patients greater access to the health care they need... Full

Putting Americans First: International Prices in Context

(9/15, Biotechnology Innovation Organization) ...The cost of medicine in the U.S. must be viewed in a broad context, including how the high prices of other medical products and services compare to international prices and how those differences boost the value of medicines in the U.S. market. The role of generic medicines in creating budgetary headroom for breakthroughs can't be underestimated and is at the core of a compromise that allows American patients both the most innovative new medicines and the lowest-cost generics... Full

Tidmarsh: Surprise Foreign Inspections ‘Essentially Impossible'

(9/15, Jessica Karins, Inside Health Policy) ...FDA officials sent mixed messages on the agency's foreign inspections at the Consumer Healthcare Products Association conference last week. While one official said FDA is expanding its surprise inspections of foreign facilities, drug center director George Tidmarsh acknowledged it's "essentially impossible" to do unannounced inspections outside the United States... Sub. Req’d

FDA Unveils Plan To Continue Using Remote Inspections

(9/15, Luke Zarzecki, Inside Health Policy) ...FDA plans to continue to use remote evaluation tools from the COVID-19 pandemic to evaluate drug manufacturing facilities, including overseas, the agency revealed in new guidance released last week (Sept. 12). The guidance says FDA will continue to request records directly from facilities and other entities subject to inspection, perform remote interactive evaluations (such as livestreaming video of operations) and request inspection reports from "trusted foreign regulatory partners through mutual recognition agreements and other agreements."... Sub. Req’d

Why States Struggle to Deliver Savings: Middlemen and 340B Siphon Dollars from Patients and States

(9/15, Reid Porter, PhRMA) ...Any state seeking savings in the health care system should fully understand and account for the complex dynamics impacting affordability—including the interplay of 340B hospital markups and PBM abuses—and the role of different supply chain entities in determining what patients pay. Delivering patients real change demands comprehensive reform to curb exploitation by middlemen and federal reform of the 340B program, not government price-setting... Full

AstraZeneca Wins MHRA Approval for New Use of Symbicort

(9/15, The Pharma Letter) ...The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has approved AstraZeneca's Symbicort (budesonide/formoterol) Turbohaler 100/6 for use as a maintenance and reliever therapy (MART) in the treatment of asthma in children aged 6-11 years. This approval, effective from September 4, brings the first licensed MART regimen for pediatric asthma in the 6-11 age group, the company noted... Sub. Req’d

Sandoz Dodges Injunction To Line Up Australia's First Aflibercept Biosimilar

(9/16, Dean Rudge, Generics Bulletin) ...Justice Helen Rofe ruled that restraining Sandoz was not justified, stating that any financial losses incurred by the originators could be compensated through damages, whereas blocking Sandoz's entry would delay important competition in the anti-VEGF market. Although Bayer and Regeneron are pursuing an expedited infringement trial, the court did not set a firm date. Sandoz plans to supply Afqlir starting in October 2025, and it has another aflibercept biosimilar, Enzeevu, registered for potential future market entry... Global Sub. Full

BMS Sells Controlling Stake in Historic US-China Pharmaceutical Joint Venture

(9/15, Fraiser Kansteiner, Fierce Pharma) ...BMS has inked an agreement to sell a 60% ownership stake in its China-based joint venture Sino-American Shanghai Squibb Pharmaceuticals (SASS), a BMS spokesperson told Fierce Pharma in an emailed statement. The move is primarily related to manufacturing of older medicines and consumer products in China and doesn't affect Bristol's core business in the country. An internal email circulating online suggests Hillhouse Capital is on the other end of the transaction... Full

Fosun's Henlius Said in Talks With J&J, Roche On Cancer Drug

(9/16, Shirley Zhao, Manuel Baigorri and Amber Tong, Bloomberg) ...Shanghai Henlius Biotech Inc. is in talks with multinational pharmaceutical firms including Johnson & Johnson and Roche Holding AG about selling them the rights to an experimental cancer drug, people familiar with the matter said. An agreement could fetch the subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. at least several hundred million dollars up front and then more in milestone payments down the line based on the drug's performance, the people said, asking not to be identified because the discussions are private... Sub. Req’d

Lilly Weight-Loss Pill Could Be FDA-Approved by Year-End

(9/16, Deena Beasley, Reuters) ...Analysts speculate that the drug, orforglipron, is a viable candidate given the growing cost burden of expensive injectable weight-loss drugs and the fact that Lilly is expanding its U.S. manufacturing - issues the Trump Administration has prioritized...The FDA is reviewing an oral version of Denmark-based rival Novo Nordisk's GLP-1 obesity drug, with a decision expected in the fourth quarter. Goldman Sachs recently estimated that if orforglipron were to launch one quarter earlier than expected, it would bring in another $1 billion in revenue to Lilly... Full

GLP-1 Drugs: IQVIA Research Shows ‘Pivotal Role' For Wellness Industry

(9/15, David Ridley, HBW Insight) ...Reviewing recently published clinical evidence, IQVIA Consumer Health finds that GLP-1 users often fail to meet recommended dietary intakes for several key nutrients, presenting an opportunity for the dietary supplements industry to create targeted and research-backed wellness products. The current trend for weight-loss drugs presents an unmissable opportunity for dietary supplement manufacturers, argues IQVIA Consumer Health in a recently published white paper... Full

Pharma Firms Pile Pressure On the UK as Trump's Drug Pricing Order Looms

(9/16, Karen Gilchrist, CNBC) ..."We think that this is, at this point, a negotiating tactic and many of these companies will not walk away completely and will kind of redesign their investments," Jimmy Muchechetere, global healthcare & industrials equity research analyst at Investec, told CNBC's "Europe Early Edition" on Monday. Since the new U.S. administration came to office, "production locations, innovation and price are all under discussion," Diederik Stadig, healthcare economist at ING Research, told CNBC by email...ING's Stadig said the U.K. appeared to be an early casualty of pharma firms repositioning their investment strategies in response to the Trump administration, but cautioned that may also follow suit in other countries. "Pharma companies will allocate an increasing portion of their capital towards the U.S., at the cost of investment into competing geographies," Stadig said... Full

Big Pharma Firms Have Paused Nearly £2Bn in UK Investments This Year

(9/16, Julia Kollewe, The Guardian) ...Pharma companies have accused the government of not spending enough on new medicines, arguing that there is little incentive for them to develop drugs and test them in a country that does not value innovation sufficiently. More recriminations are expected when MPs on the science, innovation and technology committee question MSD's UK and Ireland managing director, Ben Lucas, about its decision on Tuesday afternoon. He will appear alongside AstraZeneca UK president Tom Keith-Roach, Association of the British Pharmaceutical Industry chief executive Richard Torbett and representatives of the government, including the science minister Lord Vallance, a former GSK executive... Full

‘A Concerning Pattern': Pharma Mulls UK Divestments as Government Action Lags in Life Sciences

(9/15, Anna Brown, Endpoints News) ...The potential divestments add to a broader financial dilemma for the UK government, which is facing roughly a £50 billion gap in public finances, according to the National Institute for Economic and Social Research. "My biggest worry is that we're almost sleepwalking into this £50 billion black hole and these kind of issues that we're having with pharma, which are one of the biggest contributors to spiking growth in the economy," Peel Hunt healthcare analyst Miles Dixon said in an interview... Sub. Req’d

Sanofi Becomes Latest Pharma to Hold Fire On UK R&D Investments as Funding Fallout Continues

(9/15, James Waldron, Fierce Biotech) ...This morning, French pharma Sanofi told Fierce that it is taking a similar stance. "The U.K. is a world-class hub for science, and we are always looking at opportunities to work more closely with world-leading universities, scientists and clinicians to research and develop tomorrow's medicines," a Sanofi spokesperson said. "However, we need to see tangible improvements in the current commercial environment and appropriate recognition of the value of innovation before we consider any substantial investment into U.K. R&D," the spokesperson added...Not all pharmas are ready to shake up their U.K. plans—at least not yet. Roche told Fierce this morning that it "has no current plans for disinvestment in the UK."... Full

Who Benefits if NHS Drug Prices Soar? Donald Trump and Big Pharma. Just One More Way He's Menacing Britain

(9/16, Polly Toynbee, The Guardian) ...Industry leaders warn that the NHS's low prices and strict Nice controls are making Britain "un-investable". They claim that the NHS under-prescribes medicines, spending 9% of its annual budget, compared with Spain's 18%. But is that a bad thing? Ahead lies an explosion of new drugs and vaccines: some will save the NHS, but some, such as genome sequencing for every baby, which aims to identify rare and treatable genetic conditions early, will ignite huge demands to treat slight risks... Full

Dutch Patients ‘Waiting Too Long' for Medicines

(9/15, The Pharma Letter) ...Patients in the Netherlands want faster access to new medicines and prioritize their availability over controlling costs, research shows. The findings come from a Samhealth survey of 1,128 people at five patient associations in the Netherlands, commissioned by trade group the Association of Innovative Medicines (VIG). A majority is willing to pay higher health insurance premiums for proven effective treatments, the survey finds. Patients also want a greater voice in the decision-making process regarding reimbursement... Sub. Req’d

First-In-Class Bronchiectasis Treatment Among 14 Drugs Awaiting EMA Verdict

(9/16, Vibha Sharma, Pink Sheet) ...The European Medicines Agency's human medicines committee is this week set to decide whether to recommend pan-EU marketing approval for 14 new products. Opinions are expected on brensocatib, clesrovimab, elinzanetant and insulin icodec/semaglutide. The remaining products are biosimilars, generic or hybrid products... Global Sub. Full

WHO Backs Weight-Loss Drugs for Obesity and Urges Change in Mindset

(9/15, Jennifer Rigby, Reuters) ...The WHO's expert committee concluded that the popular GLP-1 drugs, first developed by Novo Nordisk and Eli Lilly, are part of the solution for the long-term treatment of obesity for patients with a body mass index (BMI) of 30 or above, alongside counselling on lifestyle and behaviour changes... Full

In Major Move, Patent of Novartis' Blockbuster Cardiac Drug Revoked by India

(9/16, The Economic Times) ...The Indian Patent Office revoked Novartis' patent for Vymada, a heart failure drug, citing a lack of novelty and inventive step. This decision paves the way for generic versions, potentially lowering treatment costs for Indian patients. Domestic pharmaceutical companies had challenged the patent, arguing it violated Section 3(d) of the Patents Act, which prevents 'evergreening'... Full

Patient and Pharmacist Groups Criticize Health Authorities' Lenience Toward Pharma Firms

(9/16, Kim Jung-hyun, Korea Biomedical Review) ...The Ministry of Health and Welfare has postponed the reevaluation of drug reimbursement appropriateness scheduled to begin next year and is showing signs of easing sanctions against pharmaceutical companies with a history of illegal rebates, prompting strong backlash from patient groups and other critics. The reimbursement appropriateness reevaluation system originated when the Korean Pharmacists for Democratic Society requested a public interest audit from the Board of Audit and Inspection... Full

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