Tuesday, September 8, 2026

 

 

What's the Damage From the IRA's Drug Price Controls?

(9/8, Dan Crippen, DC Journal) ...While it is still early, we no longer have to depend exclusively on models and forecasts. We now have four years of data on how the IRA is affecting research and development investment. The bad news is that even now the early data strongly suggests reductions in R&D, especially for certain types of drugs for particular diseases. Congress and the White House would be wise to re-evaluate the effects of the IRA prior to considering efforts to expand it... Full

 

The FTC Didn't Just Save You Money on Prescription Drugs. They Got Outsmarted

(9/7, Eric Wargotz, Washington Examiner) ...The Federal Trade Commission (FTC) just finalized settlements with corporate giants Express Scripts and CVS Caremark, with OptumRx soon to follow. The agency promised these deals would smash out-of-pocket drug costs and bring transparency to a broken system. Do not buy the hype... Sub. Req'd

 

Americans Aren't Divided on Health Care. Washington Is. | Opinion

(9/8, Steven Kull, USA Today) ...The debate over expanding government health insurance is often framed as a litmus test of ideology. Our findings suggest Americans are less interested in the ideological debate than in the practical question of how more people can get covered. Premiums for Affordable Care Act policies spiked this year after Congress let the enhanced subsidies put in place during the COVID-19 era expire, leading to major increases for millions of Americans... Full

 

The Market Forces Quietly Adding Thousands to Patient Bills

(9/8, Elisabeth Rosenthal, KFF Health News) ...The FTC has brought eight actions or suits against healthcare mergers and acquisitions in President Donald Trump's second term. "The FTC has made healthcare competition one of our top priorities," said Daniel Guarnera, director of the FTC's Bureau of Competition. Nonetheless, he said the agency relied on complaints and news reports to learn about smaller mergers... Full

 

US FDA Tightening Foreign Clinical Trial Enforcement Amid Phase I Re-Shoring Campaign

(9/7, Maaisha Osman, Pink Sheet) ...The agency is adding resources for Bioresearch Monitoring inspections at foreign sites and will inspect more Phase I and early-stage trials. The agency also will update risk criteria used to select sites for inspection to reflect compliance risks tied to specific countries and regions, the officials wrote in a Sept. 2 blog post. The post does not name China, which is growing its influence in the early-stage clinical trial space... Global Sub. Full

 

US FDA Hiring Binge Reversing Losses, But Only Slightly

(9/7, Derrick Gingery, Pink Sheet) ...The FDA reported an increase in overall employment in July, ending a string of several months where staffing totals declined. Overall employment at the US Food and Drug Administration ticked up slightly in July, breaking a trend of several months of staff declines under the Trump Administration and offering a potential signal that hiring efforts are finally showing progress... Global Sub. Full

 

Bad Medicine: Why New York's Drug Fix Is the Wrong Prescription

(9/7, Sam Raus, Washington Examiner) ...The New York state legislature has sent a bill to Gov. Kathy Hochul's (D-NY) desk that would require pharmacy benefit managers to reimburse pharmacies at a minimum rate tied to a federal benchmark, plus a $10.18 dispensing fee for each prescription. The proposal is expected to cost roughly $576 million, which lawmakers insist pharmacies and PBMs will absorb rather than pass on to consumers. It's another piece of legislation in a long list of state and federal proposals to scapegoat PBMs for the high cost of various prescription drugs... Sub. Req'd

 

Texas Has Momentum to Tackle Healthcare Prices

(9/7, The Dallas Morning News) ...State lawmakers have an opportunity in the next legislative session to enact reforms to tackle healthcare affordability. There is growing support for price transparency and stronger oversight on healthcare consolidation, the poll shows. For the question above, 90% of respondents agreed that Texans should have the right to know who owns their hospitals, doctors' offices and health insurers. This concern should not be surprising... Full

 

Michigan Hospital Sues US Over Access to Drug Discount Program

(9/4, Nyah Phengsitthy, Bloomberg Law) ...The lawsuit filed by Corewell Health William Beaumont University Hospital alleges the US Health Resources and Services Administration unlawfully denied discounts when it rejected the healthcare provider's designation as a disproportionate share hospital (DSH). Such a classification would allow for access to hefty drug concessions from manufacturers under the federal 340B Drug Pricing Program... Sub. Req'd

 

 

Biocon CEO Says Biosimilars Can Reach $1 Billion Revenue Soon, Insulin Demand Strong

(9/8, Ekta Batra, CNBC TV18) ...Biocon is confident that its biosimilars business can reach the $1 billion revenue mark soon. The company is seeing strong demand for insulin and traction for newer products such as aflibercept supporting growth. However, it is not committing to a specific timeline for achieving the target. MD & CEO Shreehas P Tambe said, "Clearly, the opportunity [in biosimilars] is now and here. It's not so much limited by whether we can do it. The question really is that how soon can we get there?"... Full

 

'It's Time to Put The Muttering to Rest' - Samsung Bioepis Rebuts Biosimilar Drift Concerns

(9/8, Dave Wallace, Generics Bulletin) ...Product drift was among early concerns raised about biosimilars when regulatory approval pathways were first being considered, referring to the idea that a biosimilar and its reference product could 'drift apart' over time and diverge through changes to either product. And while concern over drift "has been somewhat dormant over the recent years," the article notes, the hypothetical risk of divergence has resurfaced as leading regulators such as the US Food and Drug Administration and European Medicines Agency move towards streamlined biosimilars pathways that typically do not require comparative clinical efficacy studies... Global Sub. Full

 

Cipla Joins The US Keytruda Biosimilar Line Up With Qilu Alliance

(9/7, Urte Fultinaviciute, Generics Bulletin) ...Cipla's US subsidiary Invagen Pharmaceuticals has gained commercial rights to Qilu Pharmaceutical's pembrolizumab biosimilar candidate in the US. The pair signed an exclusive licensing and supply agreement to the Keytruda rival, marking another biosimilar competitor in an already heated race ahead of the originator's key patent expiry in 2028... Global Sub. Full

 

Sandoz Focuses on Biosimilars to Help Double Group Sales by 2035

(9/8, Bhanvi Satija, Marleen Kaesebier, Reuters) ...Sandoz said it wants to increase its biosimilars portfolio to 100 drugs by 2040, from 13 currently, and said it targets mid-to-high single-digit percentage growth in total group annual net sales at constant currencies from 2025 to 2030... Full

 

Formosa Files European Trial Application For Roche's Kadcyla Biosimilar

(9/7, Urte Fultinaviciute, Generics Bulletin) ...The pivotal trial will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of the biosimilar compared with the reference product. Without providing further details, the Taiwan-based firm said that the pivotal trial was designed following regulatory guidance from both US and EU authorities... Global Sub. Full

 

The Launch Letter: How Generics and Biosimilars Should Write to Avoid UPC Urgency

(9/8, Matthieu Dhenne, Kluwer Patent Blog) ...A launch letter is written to reassure. The wholesaler wants a date, the payor wants availability, the investor wants momentum. The Unified Patent Court opens the same document with a colder question: what does it prove? Rather a lot, as it turns out, and often for both sides. A sentence drafted to calm the market can end up showing that only the last commercial step remains to be taken. The same sentence, routed through a regulatory channel, can end up showing that the patent proprietor knew, or should have known, enough to move for a preliminary injunction... Full

 

 

Novo Nordisk Says Wegovy Shot Helped Children Lose Weight in Trial

(9/7, Adrià Calatayud, The Wall Street Journal) ...The Danish drugmaker said Monday that the study showed 40.4% of children aged 6 to under 12 years with obesity who were treated with Wegovy in combination with a lower-calorie diet and increased physical activity reduced their body mass index to levels considered normal or overweight after 68 weeks... Sub. Req'd

 

Cholesterol Drug Setback Casts Doubt over Multibillion-Dollar Race

(9/8, Elsa Ohlen, CNBC) ...The pelacarsen drug, developed jointly with Ionis Pharmaceuticals, reduced a particularly harmful form of cholesterol in a late-stage clinical trial, but failed to significantly improve cardiovascular outcomes, Novartis said after the bell on Friday. The stock fell 3% on Monday... Full

 

Novartis India Acquires Pfizer Brands for $132m

(9/8, Salong Debbarma, Pharmaceutical Technology) ...Novartis India has agreed to pay Rs12.5bn ($132m) to acquire the Minipres and Minipress trademarks in India, along with certain associated intellectual property rights, from Pfizer and Pfizer Products. The purchase adds an established hypertension brand to Novartis' cardiovascular range. Novartis India's board cleared the deal, after which the company signed an asset purchase agreement and trademark assignment deeds with the two Pfizer entities... Full

 

Novo Nordisk Stops Two Cardiovascular Trials of Drug Aimed at Lowering Inflammation

(9/7, Andrew Joseph, STAT News) ...Novo Nordisk has stopped two trials of a drug that aims to tame inflammation as a way to improve cardiovascular health, another blow for the approach. The company said it had halted the HERMES and ATHENA trials of its drug, ziltivekimab, after a data monitoring committee found they were unlikely to succeed. Novo informed trial investigators on Friday. The move follows the earlier failure of the drug in the ZEUS trial... Sub. Req'd

 

Major Trial of Roche Alzheimer's Drug Kicks off in Europe

(9/7, Phil Taylor, pharmaphorum) ...An NHS trust in the UK has become the first site in Europe to offer Roche's experimental drug trontinemab to patients enrolled in a large-scale trial to see if it can delay or prevent Alzheimer's disease. The phase 3 PrevenTRON study – which gets underway in World Alzheimer's Month – will recruit around 1,600 people aged 55 to 80 around the world who have no symptoms of Alzheimer's or memory problems, but who are at high risk of developing the disease... Full

 

AbbVie-Backed ADARx Plans IPO to Bankroll Array of Clinical-Stage siRNA Therapies

(9/6, James Waldron, Fierce Biotech) ...ADARx Pharmaceuticals has reinvigorated its ambitions to go public as the AbbVie-backed biotech looks to fund ongoing clinical trials of a range of next-gen small interfering RNA (siRNA) medicines. The San Diego-based company has yet to set out how much stock it's planning to offer—or at what price—but the lion's share of the proceeds will go towards advancing three clinical-stage medicines... Full

 

Trailing Rivals, AbbVie Scores Win with Dual-Acting Myeloma Drug

(9/4, Jonathan Gardner, BioPharma DIVE) ...The drug, called etentamig, could be safer than rival drugs launched by Johnson & Johnson, Pfizer and Regeneron, with low rates of two kinds of serious immune responses common to other drugs of its type. AbbVie said its safety profile could enable greater use in community oncology centers because of reduced need for post-treatment patient monitoring... Full

 

 

After Credit Upgrade, Teva Plans to Recycle Debt

(9/7, Shiri Habib-Valdhorn, Globes) ...Last week, when S&P raised Teva's debt rating, CFO Eli Kalif said, "Three rating upgrades in just a few months reflect the successful implementation of the 'return to growth path' strategy, and the significant progress we have made in reducing debt and strengthening Teva's financial profile. This significant milestone strengthens our financial flexibility and allows us to continue investing in growth and creating long-term value."... Full

 

 

India Must Build on Its Strength in Generics to Become a Global Leader in Complex & High-Value Medicines: Piyush Goyal

(9/7, Pharmabiz.com) ...He said, "With the active and hard work of the pharma industry over the years on generics, India has become quite a success story. But we cannot rest our case with generics. We will have to promote more and more R&D, patent our own products, and put pharma at the forefront of research and innovation. Biosimilars and biotech should become our next frontier. We need a regulatory environment where R&D and innovation become attractive in India, with greater openness to investments in clinical trials, patenting, research and new product development."... Full

 

Piyush Goyal Calls for Resilient Pharma Supply Chains, Global Investment and Stronger R&D

(9/7, Pharmabiz.com) ...The Minister also urged Indian pharmaceutical companies to invest outside India to establish local access to international markets. He said companies would need to combine talent, technology and artificial intelligence to remain competitive as major economies and markets including the United States, Canada, South Korea, Singapore and the European Union compete to attract investments... Full

 

Intl Buyer Participation Provide Indian Pharma MSMEs Direct Access to Global Markets: Pharmexcil

(9/7, Shardul Nautiyal, Pharmabiz.com) ...Namit Joshi, chairman, Pharmexcil said, "The growth in pharmaceutical exports reflects the strength of Indian companies across products and markets. The opportunity now is to build on this base by expanding our engagement with international customers and identifying areas where Indian capabilities can meet demand across geographies. iPHEX 2026 is designed to facilitate that engagement and create opportunities for Indian companies to develop business relationships with overseas customers."... Full

 

EU Legal Opinion Offers Industry Reprieve On UWWTD

(9/4, Dave Wallace, Generics Bulletin) ...The pharmaceutical industry has registered a significant victory in its long-running battle to push back against the EU's controversial Urban Waste Water Treatment Directive, after Juliane Kokott – advocate general of the Court of Justice of the EU – issued an opinion urging the annulment of a key tenet of the UWWTD's controversial extended producer responsibility scheme. European off-patent industry association Medicines for Europe said that although the decision was not binding for the CJEU's final judgment, it "materially strengthens the case for pausing implementation of the EPR scheme."... Global Sub. Full

 

Industry Warns EMA's Role In Filing Dates Could Erode EU Market Protection Incentive

(9/7, Vibha Sharma, Pink Sheet) ...A new approach the European Medicines Agency is testing to improve the quality and predictability of drug marketing authorization applications (MAAs) has raised concerns within industry because of its potential to inadvertently undermine one of the flagship incentives in the EU's pharmaceutical reform package. At issue is an additional year of market protection that will be available to companies that meet certain conditions under the forthcoming pharmaceutical legislation... Global Sub. Full

 

EU Pharma Industry Pushes for Expansion of Barcodes on Medicines

(9/7, Robert Barrie, Pharmaceutical Technology) ...New guidance published on September 7 by the European Association of Hospital Pharmacists (EAHP) and the European Federation of Pharmaceutical Industries & Associations (EFPIA) supports the utilisation of barcodes to individual doses, marking an expansion to the current framework that places them on multi-packs of medication... Full

 

England's New QoL Measurement Triggers Drug Access Warning From Industry

(9/4, Neena Brizmohun, Pink Sheet) ...Britain's drug industry association, the ABPI, has called for close monitoring of England's newly adopted, more sensitive value set for measuring quality of life in health technology assessments (HTAs), arguing that additional mitigations may be needed if the change prevents access to new medicines. The new EQ-5D-5L value set is replacing the EQ-5D-3L value set, the HTA institute, NICE, confirmed in an interim methods statement it published on Aug. 27 to explain how to use the new value set in HTA submissions... Global Sub. Full

 

Mexico Acknowledges Anvisa's Regulatory Decisions and Establishes a Simplified Procedure for Drug Registration

(9/8, Agro News) ...The decision applies to drugs containing new molecules, generics, innovative biotechnological drugs, biosimilars, as well as biological products and vaccines. To undergo this procedure, the product submitted in Mexico must have essential characteristics identical to those authorized by Anvisa, and the Brazilian authorization must be currently valid. The required legal, technical, and scientific documentation must also be submitted to the Mexican authority... Full

 

Korea Drugmakers Hire Law Firms to Secure Innovation Status, Blunt Price Cuts

(9/5, Park Su-hyeon, Chosun Biz) ...With price cuts for generic drugs looming, small and midsize drugmakers are knocking on law firms' doors. If they earn certification as "innovative" or "quasi-innovative" pharmaceutical corporations, they can delay for several years the point at which prices fall to a final 45%. Because the paperwork is complex and the evaluation criteria are strict, drugmakers are willing to pay legal advisory fees running into tens of millions of won... Full

 

Pharmaceutical Firms and CSOs Navigate Rising Complexity in Sales Outsourcing

(9/8, Heo Ji-yoon, The Chosun Daily) ...The council plans to discuss improvements in CSO management, strengthening control over subcontracting tiers, and enhancing pharmaceutical companies' responsibilities. The council includes the vice minister of the Ministry of Health and Welfare and the head of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association as co-chairs, along with 21 participants from relevant government departments, industry, experts, and public institutions. Earlier, the ministry conducted a survey in May, requesting pharmaceutical companies to submit details of their CSO contracts... Full

 

Is Korea Slipping Down Global Pharma's Drug Launch Priority List?

(9/7, Kim Yun-mi, Korea Biomedical Review) ...Physicians and industry officials, however, say warning signs are already emerging before they appear in official statistics, including companies scaling back marketing of high-priced drugs in Korea, slower dissemination of product information and global headquarters reconsidering Korea's place in launch sequences... Full

 

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