Wednesday, September 9, 2026

 

 

'Patients Pay the Tariff': Swiss Pharma CEO Warns of Trump's Generic Drug Tariff Threat

(9/8, Elsa Ohlen, CNBC) ..."Patients pay the tariff," Sandoz CEO Richard Saynor said in an interview with CNBC during its Capital Markets Day. "Any business is not going to systematically continue to supply a product at a material loss," he said on Tuesday. "So you either then have a choice of putting the price [up] or not supplying the product."... Full

 

Drug Pricing Policy 'Earthquake' Forcing Rethink of Global Commercialization Plans: Survey

(9/9, Nick Paul Taylor, Fierce Pharma) ..."While there has always been change throughout the industry, the past 24 to 36 months have felt more exponentially transformative than anything I have seen over the last 30 years," an executive said. "What we may experience over the next five years could exceed the cumulative level of change we saw over the previous several decades." Another executive characterized the policy environment as an "earthquake" that is "not going to settle down soon," while a third person predicted that the need for politicians to try to address the cost of healthcare will ensure ongoing change... Full

 

Ominous Outlook for Medicare Drug Spending

(9/9, Adriel Bettelheim, Axios) ...Why it matters: The upward trajectory could threaten some seniors' coverage for outpatient prescription drugs — and it could force painful tradeoffs over the next decade as Medicare consumes a growing share of the nation's debt. Follow the money: The IRA limited what seniors have to pay for outpatient drugs and shifted the remaining cost to taxpayers, insurers who provide stand-alone Medicare drug plans and drug manufacturers... Full

 

A Drug Discount Program Meant to Help Patients Is Enriching Hospitals Instead | Opinion

(9/8, Dr. Moshe Chasky, Penn Live) ...The 340B program has become a tool for corporate profits and market consolidation through an unintended loophole that encourages hospitals to acquire private physician practices and convert them into hospital outpatient departments. These converted practices can then buy medications at 340B rates, which boosts hospital revenue. In addition to limiting patient choice, hospital outpatient facilities often charge higher fees than independent practices, placing a financial burden on patients... Full

 

Smaller Application Package Among US FDA IND Reform Goals

(9/8, Derrick Gingery, Pink Sheet) ...Among the US Food and Drug Administration's goals for its IND reform pilot is to thin out the submissions, which often include later-stage information that is not necessary. The pilot is intended to streamline the IND approval process, which agency officials and others believe has become outdated and slow. In addition to helping sponsors avoid submission mistakes that could cause delays or clinical holds, the FDA also wants them to recognize the information that is needed in an IND... Global Sub. Full

 

US FDA Names Permanent CDER, CBER Directors, Creates AI Deputy Commissioner Post

(9/8, Sue Sutter, Derrick Gingery, and Elizabeth Orr, Pink Sheet) ...Michael Davis and Karim Mikhail get permanent titles after months in acting roles, but their tenure may hinge on whether commissioner nominee Heidi Overton is confirmed and whether there are other leadership changes at the top... Global Sub. Full

 

NORD Asks Dems To Keep Orphan Drug Exemption As They Craft Expanded Drug Negotiation Plan

(9/8, Lauren Brensel, Inside Health Policy) ...As Senate Democrats start crafting a drug pricing agenda anticipating their party could take control of both Houses of Congress in the midterms and potentially the White House in 2028, a key advocacy group for rare disease patients is pushing back against Democrats' calls to expand Medicare drug negotiation by basing prices on international benchmarks and rolling back the expanded orphan drug exemption... Sub. Req'd

 

OGD Releases Official July 2026 Monthly Statistical Report

(9/8, Bob Pollock, The Lachman Blog) ...We are coming up to the end of another Fiscal Year and the OGD has just 2 months of official stats to report. Here is what Happened in July. OGD approved 68 new ANDAs and issued 18 tentative approval actions in July. Of the 68 newly approved ANDAs, 6 were for first-time generics and 11 (16.2%) were approved in the first review cycle. Of the 18 tentative approvals, 3 (16.7%) were acted upon in the first review cycle. As for other OGD actions, there were 126 complete response letters issued, which represents the highest number in any month this FY... Full

 

Illinois Law to Lower Prescription Drug Prices Struck Down

(9/8, Brian Weckerly, Fox2Now) ...A federal judge has struck down an Illinois state law meant to bring prescription drug prices down. The Illinois Prescription Drug Affordability Act (House Bill 1697) was signed into law in July 2025 and took effect January 1. The law was to regulate pharmacy benefit managers, but a coalition of those managers sued... Full

 

 

FDA Approves Stelara for Pediatric Ulcerative Colitis

(9/8, Megan Brooks, MedScape) ...The safety and effectiveness of Stelara in children with UC was supported by evidence from studies in adults with UC, pharmacokinetic and safety data from children as young as 2 years with CD, as well as additional data from the phase 3 UNIFI Jr study, which enrolled 112 children aged 3-17 years with moderate-to-severe UC. At week 52 in the UNIFI Jr study, 32 of 79 (40.5%) clinical responders achieved clinical remission and 52 (65.8%) achieved symptomatic remission... Full

 

 

The Biosimilars Market Is Projected to Nearly Double — Here's Where the Growth Is Coming From

(9/8, Lauren Gordon, Managed Healthcare Executive) ...Biosimilars are on just about everyone's radar, and if recent market projections come to fruition, that is going to be truer than it ever has been. MarketsandMarkets projects the biosimilars market will be worth $70.79 billion by 2036, up from its 2026 value of $37.39 billion. That means in just 10 short years, the industry's value will nearly double, with a compound annual growth rate (CAGR) of 6.6%... Full

 

Sandoz Unveils Plan for Biosimilar Expansion and New $300M Factory in Slovenia

(9/8, Anna Brown, Endpoints News) ..."Today we stand at the beginning of our golden decade of opportunity, with an unprecedented number of loss of exclusivities. The originators talk about a patent cliff. Their patent cliff is our golden opportunity," CEO Richard Saynor said in a media briefing at the London Stock Exchange on Tuesday. The Swiss drugmaker's plan — dubbed "Bio100" — would grow its portfolio from 13 biosimilars to over 100 by 2040, and double its net sales between 2025 and 2035, according to a Tuesday release. The company currently has at least 39 biosimilars in development, according to its website... Sub. Req'd

 

LI Pharma Expanding; Maker of Generic Drugs Wants to Build New Site

(9/9, James T. Madore, Newsday) ...A Hauppauge manufacturer of generic prescription drugs wants to build a 60,000- square-foot factory and warehouse on Motor Parkway where up to 200 people could eventually work. ScieGen Pharmaceuticals Inc. already has facilities nearby but needs more space to meet increased consumer demand. The company also wants to add to its product portfolio, which totals more than 85 drugs, executives told Newsday. "We need the building because everything is getting congested," said Pailla Malla Reddy... Full

 

Fresenius Kabi Latest To Launch Generic Bridion As Merck Prepares US Market Exit

(9/8, Urte Fultinaviciute, Generics Bulletin) ...Dr Reddy's claimed the "first-to-market launch" of sugammadex injection of 200mg/2ml and 500mg/5ml single-dose vials. Same administration products were also launched by Glenmark, Gland Pharma, B. Braun, and Lupin. Meanwhile, Hikma set itself apart from other generic companies by launching a 200mg/2ml pre-filled syringe version. Yet, this differentiation did not last long... Global Sub. Full

 

 

Roche Sweeps Neurology Corporate Reputation Rankings Once Again

(9/8, Nick Paul Taylor, Fierce Pharma) ...PatientView surveyed 352 neurology patient groups about individual drugmakers and pharma in general. Respondents named Roche, including its Genentech and Chugai units, as the best company that they worked with and that they were familiar with. Claiming the top spots on those two rankings meant Roche also placed first on lists of Big Pharma companies that groups worked with or were familiar with. The results extend Roche's dominance of the neurology rankings... Full

 

Novo Shutters 2 More Heart Disease Studies, Indicating IL-6 is 'Invalid Target'

(9/8, Gabrielle Masson, BioSpace) ...After the failure of Novo Nordisk's IL-6 inhibitor ziltivekimab sent waves through the industry, the company has terminated two other studies of the asset, bringing the total number of high-profile cardiovascular flops to six over nine weeks. Novo Nordisk is ending two more late-stage studies for its investigational IL-6 inhibitor, citing expected futility and dimming prospects for the class as a whole in cardiovascular disease... Full

 

Novartis RNA Drug Falls Short in Rare Muscle Disease Study

(9/8, Jacob Bell, BioPharma DIVE) ...An experimental medicine that Novartis acquired in a $12 billion buyout has failed a key clinical trial, an outcome at least one analyst believes could sow doubt not only about the technology platform behind the treatment, but Novartis' dealmaking strategy as well. Without providing many details, Novartis on Tuesday said the medicine failed to hit the main goal of a late-stage study that evaluated it in people with a muscle-weakening disease known as myotonic dystrophy type 1... Full

 

The Largely Hidden Force Helping Drive America's Craze for Weight-Loss Drugs

(9/9, Christopher Rowland, Lydia Sidhom and Ariana Eunjung Cha, The Washington Post) ...Whether speaking in a private dining room at a fancy steakhouse or over bags of Chick-fil-A in a primary care office, Campos is part of a vast effort by drug companies to build sales of their revolutionary weight-loss drugs by targeting the prescribers who act as the gatekeepers to the American health care system, according to an analysis of public federal government data by The Washington Post and interviews with six physicians involved in the marketing program. The analysis shows that Eli Lilly and Novo Nordisk, the largest manufacturers of the weight-loss drugs, have made at least one payment to more than a quarter of a million individual doctors and other prescribers including nurse practitioners since 2018... Full

 

 

India's Speciality Pharma Push to Depend on Scientific Innovation and Effective Manufacturing Processes

(9/9, Nandita Vijayasimha, Pharmabiz.com) ...Pooja Rokade, director, Star Bio Pharma Global, said that Indian pharma leaders now face a clear imperative which is that manufacturing scale alone is no longer sufficient. To compete in the speciality pharmaceuticals market, companies must consistently deliver products that meet stringent international quality and regulatory standards. The next phase of growth will therefore be shaped by the ability to combine scientific innovation with robust, compliant, and cost-efficient manufacturing processes. Companies that can successfully integrate these capabilities will be better positioned to capture high-value opportunities, strengthen global competitiveness, and create sustainable long-term value... Full

 

Mounjaro Becomes India's Top-Selling GLP-1 Drug as Diabetes, Weight-Loss Medicines Surge

(9/9, Purnima Sah, The Indian Express) ...Mounjaro, the blockbuster diabetes and weight-loss drug from Eli Lilly, has emerged as the biggest-selling brand in India's rapidly expanding GLP-1 medicines market, underscoring the growing demand for newer treatments for diabetes and obesity. The GLP-1 segment grew 74 per cent in units in August, while its market value for the 12 months ended August reached Rs 2,333 crore, according to Pharmarack's PharmaTrac data... Full

 

EMA Issues Guidance on Submitting ePI Ahead of Upcoming Requirement

(9/8, Ferdous Al-Faruque, Regulatory Focus) ...The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications (MAA) should provide electronic product information (ePI) for products under the EU's centrally authorized review process. The agency noted that submitting ePI is voluntary until the general pharmaceutical legislation fully goes into effect. "During the voluntary phase, ePI can be submitted in English and submission of any EU language translations (including Icelandic and Norwegian) of ePI is optional," said EMA. "Submission of ePI in all languages is expected to become mandatory in future... Full

 

Beyond China: Five Other Overseas Destinations for Biopharma Dollars

(9/9, Tristan Manalac, BioSpace) ..."Biopharma companies are looking harder at established alternatives as China becomes more competitive and geopolitically complicated," Cody Powers, principal at the consulting firm ZS, told BioSpace in an email. The economics of picking these alternatives is "straightforward," Powers continued—drug development is simply cheaper overseas. The U.S. remains the most important end market for most biopharma companies, but the upstream question is simply: "What is the fastest, most efficient and most cost-effective way to get an asset from idea to market?"... Full

 

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