Monday, September 14, 2026

 

 

Trump's Secretive Pharma Deals May Undermine 'Most-favored Nation' Pricing, an Analysis Suggests

(9/14, Ed Silverman, STAT) ...Without any exemptions, the researchers estimated Medicare could save $5.2 billion under the GLOBE program and $6.4 billion under the GUARD program. But by exempting so many medicines from the pilots, the potential savings to Medicare would be reduced by up to 80%, according to the modeling study, which was published in The Lancet... Sub. Req'd

 

Trump's Drug-Pricing Push to Cut Access Outside US, Study Finds

(9/13, Naomi Kresge, Bloomberg) ...As a result, drugmakers might raise prices in some countries or pull out of markets altogether, according to the study published Sunday in The Lancet... Sub. Req'd

 

Medicare Tackles Pharmacy Rebate Obstacles in Drug Price Program

(9/14, Nyah Phengsitthy, Bloomberg Law) ...Under the negotiation program, drugmakers must offer providers with the lower of the negotiated price or the 340B ceiling price of a selected drug, prohibiting stacked discounts on the same product. But some 340B pharmacies aren't getting reimbursed due to manufacturers struggling to identify which products are subject to a refund... Full

 

Chris Klomp Begins Confirmation Battle With Most Favored Nation Questions In Tow

(9/11, Maaisha Osman, Pink Sheet) ...Democrats plan to press Klomp on secrecy, expiration dates and questionable math associated with the MFN deals during the confirmation hearings, while Republicans will question whether the policy can co-exist with efforts to encourage pharmaceutical innovation. He will appear before the Senate Finance Committee on Sept. 15 and the Senate Health, Education, Labor and Pensions Committee on Sept. 16... Sub. Req'd

 

Community Health Advocates Appalled J&J's New 340B Claims Data Policy Includes CHCs

(9/11, Gabriellee Wanneh, Inside Health Policy) ...Advocates for Community Health (ACH) has yet to hear that other companies are considering applying their claims data policies to CHCs, but ACH CEO Amanda Pears Kelly worries that unless the government or lawmakers step in, more drug makers are likely to launch new policies or extend their existing ones to include CHCs... Sub. Req'd

 

California Attempts to Crack Down on Health Spending

(9/14, Caitlin Owens, Axios) ...California recently adopted steep penalties for hospitals, physician groups and insurers that exceed previously set caps on health spending. Violators will pay up to 125% of the amount they spend over the limit, with the earliest fines in 2028, CalMatters reports... Full

 

Officials, Advocates Seek Funds to Soften Blow of Rising Healthcare Costs

(9/11, Danielle J. Brown, Maryland Matters) ..."The biggest challenges that we are having in Maryland, around the changes … at the federal level, is how are we going to make sure our residents have the healthcare that they need - and that means being able to afford it," Del. Bonnie Cullison, a Montgomery County Democrat and co-chair of the Maryland Health Insurance Coverage Protection Commission, said Friday... Full

 

Gone From The Shelf: The Hidden Danger of Drug Price Caps

(9/11, Dominique Daniels, Maryland Matters) ...Here is the economic reality that everyone tends to ignore. Specialty biologic drugs, the kind used to treat conditions like my disease are expensive for pharmacies to stock. They must be acquired upfront, often at significant cost, long before any reimbursement arrives... Full

 

States Should Not Adopt Laws That Close Drugstores

(9/13, Ernest Istook, Washington Examiner) ...Too many lawmakers are jumping on the bandwagon to declare PBMs as villains who must be punished, thereby creating competitive advantages for non-PBM pharmacies. States should follow the medical maxim of "first do no harm" and not pass laws that could close many drugstores. That would only hurt consumers who want to keep the same pharmacy... Full

 

 

AbbVie Aims to Expand Qulipta's Label into New Migraine Market

(9/10, Elizabeth S. Eaton, FirstWord PHARMA) ...AbbVie reported Thursday that the oral CGRP inhibitor met its primary endpoint and all eight ranked secondary measures in the Phase III LUNA study, which evaluated the use of Qulipta as a preventative treatment for menstrual migraine in adults. With the top-line findings in hand, AbbVie is readying submissions to global regulators and will share the detailed data at an upcoming medical meeting... Full

 

A New Drug Lifts the Fog of Sleepiness for Those With Narcolepsy

(9/9, Carolyn Y. Johnson, The New York Times) ...The new drug developed by Takeda Pharmaceutical Co., called Orzeyful, marks a long-sought success in the quest to mimic an essential brain peptide called orexin, which is missing in people with type 1 narcolepsy. About 120,000 people in the United States suffer from this type of narcolepsy, which causes pervasive sleepiness and episodes of cataplexy. Other companies, including Alkermes and Eli Lilly, are chasing close behind... Sub. Req'd

 

Teitur Reports Positive Early Data for Parkinson's Peptide TT-P34

(9/14, John Pinching, PharmaTimes) ...The study, conducted in healthy volunteers and patients with early-stage Parkinson's, showed the therapy was safe and well tolerated, with pharmacokinetic data confirming robust central nervous system exposure. The company said the findings support plans to begin a phase II trial in 2027. TT-P34 is designed to improve both mitochondrial and lysosomal function, targeting a pathway implicated in multiple neurodegenerative conditions... Full

 

 

Health Canada Is Recalling this Generic Acetaminophen

(9/11, Uday Rana, Global News) ...A recall was issued for Novo-Gesic Forte 500 mg acetaminophen tablets sold by Teva Canada Limited. The company is issuing a recall for one lot of its medication due to "the potential presence of phenolic resin or epoxy."... Full

 

These Acetaminophen Tablets Are Being Recalled in Canada Over 'Foreign Material.' Here's What You Need to Know

(9/11, Samm Mohibuddin, Toronto Star) ...The recall is limited to lot 100083040, which has an expiry date of Jan. 31, 2029 and has a Drug Identification number (DIN) of 00482323... Full

 

Urgent Nationwide Recall Issued for Common Painkiller

(9/11, Irish Mae Silvestre, DH National) ...Canadians are urged to report any possible side effects or complaints to Health Canada. Customers can also contact Teva Canada Customer Care... Full

 

Lupin Receives FDA Nod for Generic Provigil

(9/11, Sandra Levy, Drug Store News) ...Lupin has received approval from the Food and Drug Administration for modafinil tablets, 100 mg and 200 mg, which is the generic of Nuvo Pharmaceutical's Provigil tablets... Full

 

Amgen Leads The Pack With First Filing For US Opdivo Biosimilar

(9/14, Dave Wallace, Generics Bulletin) ...Speaking at the recent Wells Fargo Healthcare Conference in Boston, Amgen's chief financial officer Thomas Dittrich said that the firm was advancing its "third wave of biosimilar candidates" that included the Opdivo and Keytruda rivals as well as biosimilars to Ocrevus (ocrelizumab) and Eylea HD (aflibercept) 8mg... Sub. Req'd

 

Henlius Sees Overseas Profits Quadruple In H1 As Collaborations Expand

(9/11, Anabel Costa-Ferreira, Generics Bulletin) ...The company is executing a deliberate biotech to biopharma transition via its "C-MNC" China-headquartered multinational biopharmaceutical company model, targeting 10 new products worldwide by 2030, with five or more targeted to reach both US and European markets... Sub. Req'd

 

Lupin to Bet Big on Biosimilar Sales in Mid Term, Ramp Capacity Expansion

(9/14, Business Standard) ...Pharma major Lupin is stepping up its focus on biosimilars, with plans to expand its portfolio and presence across key global markets, Executive Director and Global Chief Financial Officer (CFO) Ramesh Swaminathan told Business Standard in an interaction..."Pegfilgrastim is set to enter the United States (US) market, while ophthalmic drug Ranibizumab is lined up for launches across the US, Europe and Japan," Swaminathan said. He added that the company expects turnover from biosimilars to be close to $500 million over the next five years... Full

 

Sun Pharma Subsidiaries Settle US Generic Drug Pricing Antitrust Case for Confidential Amount

(9/14, Jomy Jos Pullokaran, CNBC TV-18) ...Under the agreement, the subsidiaries will make the settlement payment in exchange for a full release of all claims asserted against them in the action. The release also covers their current and former parents, affiliates, predecessors and successors, as well as their current and former directors, officers, employees and representatives. Other terms of the settlement remain confidential. Sun Pharma said the agreement was entered into without admission of any wrongdoing in the action... Full

 

Lack of Biosimilar Development Could Cost Billions in Lost Savings, Report Warns

(9/14, Max Bayer, Endpoints News) ...The findings underscore one of the hard truths of the US drug market: Cheaper options can only reach patients if they're made. The biosimilars market specifically has tried to warn regulators that current constraints limit the viability of developing them... Sub. Req'd

 

 

Big Pharma Is Pouring Billions Into China's Biotechs

(9/14, Bill Alpert, Barron's) ...China's biotech engine is fueled by Western-trained entrepreneurs and government planning. Scientific research and clinical trials there are gaining global respect. But domestic sales in China don't allow for great profits, so the country's start-ups have needed Big Pharma's money to take their innovations abroad... Full

 

AstraZeneca Breast-Cancer Drug Misses Goal in Late-Stage Trial

(9/14, Adrià Calatayud, The Wall Street Journal) ...The U.K. drugmaker evaluated its Etcamah medicine, in combination with Pfizer's Ibrance, as a first-line treatment for patients with a type of advanced breast cancer that hadn't received any systemic treatment for advanced disease, it said late Friday... Sub. Req'd

 

Lonza to Build New Manufacturing Hub in Oregon

(9/11, Elizabeth S. Eaton, FirstWord PHARMA) ...At the planned Oregon plant, Lonza will be capable of the integrated, end-to-end manufacturing of small molecules, biologics and mRNA-based therapies. The facility, expected to be completed in 2029, will have two SDD units, which will enable Lonza to increase its capacity in the future if demand grows... Full

 

Novo Nordisk Rebrands to 'Novo,' Unveils Corporate Changes as it Fights for Obesity Market Share

(9/14, Annika Kim Constantino, CNBC) ...The Danish drugmaker called the changes the beginning of a new chapter, as it has been grappling with stiff competition from chief rival Eli Lilly and investor pressure to deliver new blockbuster products and chart a path toward long-term growth. Novo is preparing to detail its business strategy changes during its Capital Markets Day event on Sept. 21... Full

 

Heart Disease Is Tripping Up Big Pharma Making Further Advances in Cardiovascular Drugs Is Getting Harder and Costlier

(9/14, David Wainer, The Wall Street Journal) ...Cardiovascular drug development is starting to look a bit like the modern oil industry. The easy wells have been tapped. What's left is in deep water: expensive, technically perilous and less likely to strike oil... Sub. Req'd

 

 

Germany Explores Pharma Proposal With Team Trump as Tariff Threat Looms

(9/11, Caroline Hug, Stefanie Bolzen, Politico) ...Berlin is under increasing pressure to pay more for medicines after the U.S. launched a Section 301 trade probe in June, alleging Germany persistently underpays for innovative pharmaceutical products. A hearing for the investigation will take place on Sept. 22, after which the investigation could pave the way for new tariffs targeting German industry... Full

 

Alcon CEO Says US Drug Pricing Deal May Limit European Products

(9/14, Fabienne Kinzelmann, Bloomberg) ..."Every market is going to develop its own reimbursement system, its own negotiation, and we do that around the world," [Alcon Inc. Chief Executive Officer David Endicott] said. "We'll continue to push around the world to figure out what that implication means as we negotiate prices as we always have."... Sub. Req'd

 

US Drug Pricing Could Push EU Prices Higher, Study Finds

(9/14, Emma Pirnay, Euractiv) ...The researchers found that for three-quarters of the medicines, the estimated US revenue loss from matching a lower price in a reference country – France, for example – would exceed sales in that country. That means "manufacturers would have a strong incentive to raise prices outside the United States," the authors explained... Full

 

Industry Seeks Clear Rules For Resolving Filing Date Disputes With EMA

(9/11, Vibha Sharma, Pink Sheet) ...The pilot will test a revised pre-submission meeting model, under which companies and the EMA will have to agree on MAA submission dates in advance of the filing. It is intended to help prepare for a system that will be introduced by the EU's forthcoming pharmaceutical reform legislation... Sub. Req'd

 

EU Lawmakers Back Unlimited Biosimilar Stockpiling Under SPC Waiver

(9/14, Dean Rudge, Generics Bulletin) ...European biosimilars manufacturers could gain significantly more freedom to build up stocks ahead of originator protection expiry after the European Parliament's Legal Affairs Committee (JURI) backed the removal of the six-month limit on manufacturing for EU market entry under the supplementary protection certificate (SPC) manufacturing waiver... Sub. Req'd

 

Pharma Wins a Battle Over The Cost of Wastewater Treatment in Europe

(9/11, Ed Silverman, STAT+) ...In a boost for the pharmaceutical industry, a European Union Advocate General recommended annulling part of a directive that requires drug and cosmetics manufacturers to finance at least 80% of the costs of wastewater treatment... Sub. Req'd

 

India Wants to Buy Fewer Chinese Imports, but Keeps Needing More

(9/12, Alex Travelli, The New York Times) ...As India hosts China at the BRICS summit this weekend, analysts expect trade to loom large as a source of tension, alongside the two countries' disputed border. Both sides seem to prefer quiet along the border for now. The harder problem may be their economic relationship... Sub. Req'd

 

India Should be an AI Powered Innovation Hub and Not Just a Low-Cost Hub: Dr Mahesh Bhalgat

(9/14, Nandita Vijayasimha, Pharmabiz.com) ...India must move beyond its traditional positioning as a low-cost pharmaceutical hub and emerge as an AI-powered innovation hub. With its talent pool, scientific capabilities, digital infrastructure, and entrepreneurial ecosystem, India has the potential to harness AI across drug discovery, clinical development, manufacturing, and commercialisation creating a differentiated, innovation-led model that competes on science, speed, and value rather than cost alone, said Dr. Mahesh Bhalgat, founder and CEO, AAPM Therapeutics... Full

 

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