Tuesday, June 10, 2025

No Drug Price Pledges by Pfizer, Others in Talks with US Government, Pfizer CEO Says

(6/9, Michael Erman, Reuters) ...Pfizer and other drug companies have met with the Trump administration to discuss lowering U.S. drug prices but no commitments have been made, Chief Executive Albert Bourla said on Monday..."I don't think we will remove our products from the markets there - we will just remove them from reimbursement," Bourla said. "We will leave them in open market."... Full

'Most Favored Nation' Price Controls Are the Path to Drug Shortages

(6/10, Justin Leventhal, RealClearMarkets) ...The dirty secret of price controls is that someone always pays in the end. If Medicaid prices are forced down via MFN, manufacturers will increase prices elsewhere to balance their books, most likely starting with the private market. Employers, insurers, and anyone with commercial insurance will pay the difference through higher list prices, fewer drug options, and tougher prior authorizations. While politicians brag about "beating Big Pharma," patients quietly get fleeced... Full

Will Drug Price Order Deliver On the Promise of Biosimilars?

(6/9, John Murphy III, DC Journal) ...Ultimately, this order represents a significant step toward establishing a sustainable and competitive biosimilar market. Successful implementation of these reforms will not only generate substantial savings for patients and the healthcare system but also encourage further investment and innovation in biosimilar products. Policymakers must act decisively to ensure these opportunities are realized, transforming potential savings into tangible economic and therapeutic benefits for millions of Americans... Full

Skinny Labels Save Dollars And Lives

(6/9, Henry A. Waxman, Inside Health Policy) ...This problem needs to be fixed now. If brand companies are successful in their legal challenges to the skinny label provision, the healthcare system will end up paying billions more for brand medications when there should be generic competition to drive down the cost of the drugs via the skinny label pathway... Sub. Req’d

Tariffs Are Raising Health Care Costs and Putting Patients at Risk

(6/9, Jack Buffington, The Hill) ...Pharmacy benefit managers and Group Purchasing Organizations need to work on behalf of the patients, hospitals and clinics to better manage costs, similar to processes in other supply chain systems. Overall, policymakers must understand that while tariffs may shift economic leverage, they also shift risk onto patients... Full

Former Big Pharma CEO: ‘PBMs Are Not The Bandits'

(6/9, PCMA) ..."I think that's a weak explanation. And I don't understand why they chose that approach," says Jesper Høiland. "It's not true to say that the products would be cheaper without the PBMs. They would rather become more expensive. But that's because Novo Nordisk doesn't want to be the bad guy — then they blame someone else."... Full

Generic Drug Office's Policy Staff Returning To US FDA

(6/10, Derrick Gingery, Pink Sheet) ...OGD policy staff were called back to work after being subject to the reduction-in-force, but whether the entire team will return is unclear. The OGD policy staff's return means product-specific guidance publication could return to a more normal schedule. The FDA now has reversed several policy staff cuts across multiple centers and offices... Global Sub. Full

FDA Reinstates Generic Drug Policy Group Let Go in April Firings

(6/9, Zachary Brennan, Endpoints News) ...The team's reinstatement was described by two FDA sources with knowledge of the decision, who spoke on condition of anonymity. One source told Endpoints that some of the team returned to the White Oak campus in Maryland on Monday, and that CDER leadership was pushing for the group to be reinstated prior to Monday. HHS, FDA and Nguyen didn't immediately respond to a request for comment... Sub. Req’d

Mark Cuban Calls Out Minnesota Bill On Prescription Drug Pricing

(6/9, Howard Thompson and Kelcey Carlson, FOX 9) ...Billionaire businessman and "Shark Tank" star Mark Cuban called out legislation being considered in Minnesota to regulate pharmacy benefit managers (PBMs), the companies that are currently under heavy scrutiny from the Federal Trade Commission for inflating the prices of prescription drugs... Full

Sarah Huckabee Sanders: Republicans Can Lead On This Health Care Issue

(6/10, Sarah Huckabee Sanders, The New York Times) ...Behind inflated prescription prices, complicated insurance plans and dying local pharmacies, there is a little-known culprit: pharmacy benefit managers that operate as self-serving middlemen between drug manufacturers, insurance companies and you. Now my home state, Arkansas, is taking action against them... Sub. Req’d

Exclusive: PBM Trade Group Sues Arkansas Over Pharmacy Law

(6/9, Maya Goldman, Axios) ...The trade group representing pharmacy benefit managers sued on Monday to overturn a first-in-the-nation state law that prevents them from owning pharmacies in Arkansas..."Rather than innovating and attempting to compete with PBM pharmacies on the merits, many independent pharmacies have turned to state lawmakers to manipulate the market with the heavy hand of government, to artificially tip the scales of competition in their favor," the complaint alleges. Arkansas Gov. Sarah Huckabee Sanders (R) has said the law is necessary to hold PBMs accountable for anticompetitive actions... Full

PCMA Files Lawsuit to Stop Dangerous Arkansas Pharmacy Closure Law

(6/9, PCMA) ..."Our lawsuit aims to protect patients in Arkansas from the implementation of this dangerous, misguided policy. If implemented, the Arkansas legislation mandating forced closures of pharmacies would have a devastating impact on patient access to critical medications and pharmacy services. Implementation of the law could eliminate convenient home delivery options for Arkansas patients, including seniors and veterans, severely jeopardize access to treatment for specialty pharmacy patients managing complex and serious conditions, like cancer, and close local retail pharmacies in the state, eliminating high-quality health care jobs and preventing patients from keeping their pharmacist."... Full

Drug Maker Sues Over New North Dakota Pharmaceutical Law

(6/10, Mary Steurer, North Dakota Monitor) ...In an April complaint filed against North Dakota, drug company AbbVie argued that Congress intended for manufacturers to be able to set additional requirements for 340B hospitals to access their products - so long as the medications are offered at the reduced costs mandated by the program... Full

Corapharm Deal Offers South-East Europe Opportunity For mAbxience

(6/10, Dave Wallace, Generics Bulletin) ...Serbia-based Corapharm has struck a licensing agreement with mAbxience to develop and commercialize a biosimilar candidate in south-east Europe. While mAbxience will hold the marketing authorization in Croatia and Slovenia, Corapharm will assume this role across Serbia, Bosnia and Herzegovina, North Macedonia, Montenegro, Kosovo, and Albania. Corapharm will lead commercialization efforts throughout these territories, with mAbxience overseeing the product's development and manufacturing... Global Sub. Full

Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

(6/10, Dean Rudge, Generics Bulletin) ...Lupin has settled US patent-infringement litigation with Harmony Biosciences over its proposed generic version of Wakix (pitolisant hydrochloride), which enjoyed sales of more than $700m last year. According to the settlement, Lupin will be allowed to launch its generic product no earlier than January 2030, or July 2030 if pediatric exclusivity is included. Lupin's agreement marks the third settlement for Harmony, including previous agreements with Novugen Pharma and Annora Pharma, allowing them to launch their generics beginning in January 2030... Global Sub. Full

7 Drugs in Shortage

(6/9, Alexandra Murphy, Becker's Hospital Review) ...Octreotide intramuscular injection kits: Teva Pharmaceuticals has all 10 mg, 20 mg and 30 mg octreotide kits on back order; the drug is used to manage symptoms of certain hormone-secreting tumors. The company estimates resupply date in mid- to late June...Scopolamine transdermal system: Baxter and Teva report shortages of scopolamine patches used to prevent nausea and vomiting. Baxter cannot estimate a resupply date, while Teva expects resupply of several presentations between July and October... Full

Zacks Industry Outlook Highlights Sandoz, Teva Pharmaceuticals and Viatris

(6/10, Zacks) ...Branded drugmakers, essentially big pharma, are better positioned to withstand these pressures due to market exclusivity and stronger pricing power. Generic drugmakers, on the other hand, are more vulnerable to cost inflation and pricing restrictions as they operate on tighter margins. In this regard, we highlight three generic drugmakers — Sandoz, Teva Pharmaceuticals and Viatris — which are well-positioned to navigate these headwinds due to their global scale, diversified portfolios and strategic emphasis on complex generics and branded generics. These firms are also undertaking cost optimization policies to improve margins and increase the efficiency of available resources... Full

Glenmark Pharma Announces India Launch of Blood Cancer Treatment Brukinsa

(6/9, Vipal Durge, CNBC TV-18) ...Globally, Brukinsa is approved in more than 70 countries and will be marketed in India under the same brand name. The drug, developed by BeiGene (now BeOne Medicines), a Basel, Switzerland-headquartered global oncology company, will be launched in the coming months... Full

US FDA Approves Merck's RSV Antibody for Infants

(6/10, Sneha S K, Mariam Sunny and Siddhi Mahatole, Reuters) ...Merck's monoclonal antibody, called clesrovimab and branded as Enflonsia, is the first and only preventive shot that can be administered as a single dose regardless of birth weight in healthy pre-term, full-term and at-risk infants to protect them against mild, moderate and severe RSV. The company told Reuters the therapy will be priced at $556 per dose... Full

Axsome Plots New Fibromyalgia Trial After FDA Refuses to Review Former Pfizer Candidate

(6/9, Darren Incorvaia, Fierce Biotech) ...Axsome Therapeutics has hit a costly snag in its mission to bring esreboxetine to market for fibromyalgia. The FDA has refused to review the CNS specialist's new drug application (NDA) for the asset, with the agency determining that one of the two trials in the filing was not up to snuff...This new trial will be a phase 3 study and will mimic the trial that the FDA found sufficient, with a 12-week endpoint and fixed dosing, an Axsome spokesperson told Fierce Biotech... Full

Acadia Pharmaceuticals Again Prevails in Appeal Upholding Patent for Parkinson's Drug

(6/9, MT Newswires) ...Acadia Pharmaceuticals ( ACAD ) late Monday said the US Court of Appeals for the Federal Circuit has upheld a trial court ruling that confirmed the validity of the patent allowing the company to be the sole producer of its Nuplazid medication to treat hallucinations in adults with Parkinson's disease through 2038...Acadia filed suit in federal court in Delaware in July 2020 against Aurobindo, MSN and three other drug makers, later settling with two of those firms while another, Teva Pharmaceuticals, agreed to accept the results of the cases against Aurobindo and MSN, which were heard during a bench trial in December 2024... Full

Growing Astellas Looks to Reap the Rewards of Uniting Commercial Strategy, Medical Affairs: Exec

(6/9, Zoey Becker, Fierce Pharma) ...After two years of quietly shifting its medical affairs and commercial strategy units under one roof, Astellas is entering a key growth year with one leader to unite the newly structured business. It's been two months since Claus Zieler picked up the medical affairs officer title along with his previously held role of chief commercial officer. The shake-up left the jobs of the company's chief medical officer and chief scientific officer defunct, but, according to Zieler, this was just the final step in a collaboration he's been fostering behind the scenes for years now... Full

83% of Americans Unwilling to Pay More Than $100 for GLP-1s, Survey Shows

(6/9, Logan Lutton, Managed Healthcare Executive) ...While Americans understand the benefits of GLP-1 agonist medications, 83% of Americans are unwilling to pay more than $100 in monthly health insurance premiums for them, even if they were covered, according to the results of the recent KPMG American Perspectives Survey. Willingness to pay differed across age groups. Gen Z was the most likely to pay at 27%, followed by 21% of Millennials, 14% of Gen X and just 6% of Baby Boomers, indicating a generational divide... Full

Health New England to Replace Humira Coverage with Lower-Cost Biosimilars

(6/9, John Budenas, WWLP) ...Health New England announced Monday that it will shift coverage of the biologic drug Humira to more affordable FDA-approved biosimilars starting next month for members of its commercial health plans. Effective July 1, the not-for-profit health insurer will cover Amjevita by Nuvaila and Hadlima instead of Humira, as part of a broader effort to manage rising health care costs while maintaining access to effective treatments... Full

Independent Pharmacies Can Now Directly Contract with GoodRx

(6/9, Anastassia Gliadkovskaya, Fierce Healthcare) ..."The impetus here is we want to extend this offering and what we've built with big retail into independent pharmacies, and make sure we can try to build long-standing relations with them," Aaron Crittenden, president of Rx Marketplace at GoodRx, told Fierce Healthcare. Community Link operates on cost-plus pricing, based on a NADAC (National Average Drug Acquisition Cost) dispensing fee plus a GoodRx admin fee. Entering into a direct agreement with the company does not waive a pharmacy's right to participate in ongoing litigation against GoodRx. "It's very straightforward on the cost-plus basis," Crittenden said. "In a world where multiple contacts are being played on by PBMs, this simplifies it drastically."... Full

Pharma Opportunity

(6/10, P Saravanan and A Paul Williams, The Hindu BusinessLine) ...Generic drugs constitute a significant portion of pharma exports, accounting for nearly 40 per cent of the generic drugs consumed in the US. Indian companies have a strong presence in the US generic market, with several firms holding a significant market share for various essential medicines. The trade in pharmaceuticals between India and the US is substantial and mutually beneficial... Sub. Req’d

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