Friday, July 31, 2026

 

 

Teva Lifts Risperidone Forecast Ahead Of Cautious Olanzapine Rollout

(7/30, Dean Rudge, Generics Bulletin) ...Chief medical officer Eric Hughes said the application remained on track for its fourth-quarter action date, while reminding investors that an EU marketing authorization application had also been accepted. "All things are go right now on olanzapine LAI," Hughes summarized... Global Sub. Full

 

 

Trump's Pharma Tariffs Won't Kick in Friday Because There's No One Left to Kick

(7/30, Anna Brown, Endpoints News) ...When setting up its initial tariff targets, the White House had specified this first round would only hit 17 specific large drugmakers, including AbbVie, AstraZeneca and Johnson & Johnson. But all 17 have since reached "most favored nation" and US onshoring deals with the administration - meaning they're exempt from any levies for the next three years. No targets? No tariffs to impose... Sub. Req'd

 

The Trump Administration's Deals With Pharma: Policy Progress Or Political Theater?

(7/30, Matthew Vogel, Sanam Rangaraj, and Olivier J. Wouters, Health Affairs) ...The bilateral MFN agreements are more than political theater. They reflect a real shift in the federal government's prescription drug strategy: Rather than relying only on Medicare's limited purchasing power, the administration leveraged drug companies' exposure to tariffs and other executive actions to extract concessions that companies likely would not have offered on their own... Full

 

The Question We Should Be Asking About Drug Costs

(7/30, Mostafa Kamal, RealClear Health) ...Company structure is where alignment starts: structure creates the incentives that shape a health care company's behavior, decisions, investment priorities, and outcomes. No ownership structure is inherently right or wrong, but different structures incentivize different things. A company built to deliver quarterly returns to shareholders will, over time, make different choices than one built to return value to health plans, plan sponsors such as employers and unions, and the patients whose coverage they support. In other words, the people who pay for care... Full

 

FDA Unveils FY 2027 User Fee Rates

(7/31, Ferdous Al-Faruque, Regulatory Focus) ...FDA estimates the base revenue for FY 2027 for the Generic Drug User Fee Amendment (GDUFA III) at $670,899,031 before considering inflation and other factors. The new estimate is more than a 5% increase compared to its FY 2025 estimate of $638,961,803...Based on what was agreed to under the Biosimilar User Fee Amendments (BsUFA III), FDA estimated that its base revenue from the program for FY 2027 needs to bring in $58,926,749 before being adjusted for inflation, hiring, operating costs, and other factors. That's a 5.2% increase from the $56,011,943 base revenue that was projected by the agency for FY 2026... Full

 

FDA Updates Product-Specific Guidelines for Injectable Peptides

(7/30, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide products. These PSGs focus on peptide drugs used to treat conditions such as obesity, type 2 diabetes, osteoporosis, and macular degeneration... Full

 

Proposals to Lower Health Costs Get Broad Support in Battlegrounds

(7/30, Lia DeGroot, Roll Call) ...Voters in battleground states and congressional districts tend to voice support for proposals in Congress that would expand access to health care or lower drug costs - often irrespective of their party affiliation - according to new polling from the University of Maryland... Full

 

The Real Antidepressant Crisis

(7/30, Richard A. Friedman, The Atlantic) ...Kennedy's desire to reduce Americans' reliance on antidepressants fits in with his larger antipathy toward pharmaceuticals, especially vaccines. He generally seems to believe that eating and exercising well is all that is necessary for health...Taking an antidepressant after you have tried exercise, a healthy diet, and psychotherapy isn't a sign of weakness or a character flaw. It's a recognition that disease has an underlying biological basis—and that sometimes, you need medication to get better... Full

 

 

Takeda, Regeneron, Sanofi and Bristol Myers Trim Pipelines

(7/30, Elizabeth Cairns, Endpoints News) ...On Wednesday, Takeda, Regeneron, Sanofi and Bristol Myers Squibb all announced program cuts as part of their quarterly updates. Some of the terminations were for early-stage programs...But at least one drug - a Bristol Myers cancer therapy - made it to a Phase 3 test before being trimmed. Takeda made a change to its inflammation pipeline, dropping its mid-stage celiac disease program, TAK-101, which was notable for having been in the company's hands for nearly seven years... Sub. Req'd

 

Replimune's Oncolytic Immunotherapy Clears FDA Panel Despite Trial Flaws

(7/30, Anna Bratulic, FirstWord PHARMA) ...The company is seeking an accelerated approval for RP1 with Opdivo in advanced melanoma patients. Thursday's vote is a much-needed win for Replimune, which has already received two complete response letters from the FDA for RP1... Full

 

Pfizer Takes Litfulo to Regulators in Vitiligo Challenge to Incyte, AbbVie

(7/30, Fraiser Kansteiner, Fierce Pharma) ...With positive results in hand, Pfizer said it now plans to submit regulatory filings around the world in vitiligo, with the aim to target an approval in adults. The New York pharma also intends to share additional data from the two studies at an upcoming medical meeting... Full

 

 

Decline Accelerates For Biogen's Biosimilars

(7/30, Dave Wallace, Generics Bulletin) ...With sales from its biosimilars business declining by 8% to $335 in the first half of the year – after second-quarter turnover alone fell to $153m, down 16% compared to the prior-year period – Biogen said that its biosimilars results for the full year of 2026 "are expected to continue to decline by [a] low double-digit percentage vs. FY 2025."... Global Sub. Full

 

Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate

(7/31, Polpharma Biologics) ...Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda's reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease... Full

 

Roche Sues Biocon Over Proposed Breast-Cancer Drug Copy

(7/30, Blake Brittain, Reuters) ...Genentech has sued Indian biopharmaceutical company Biocon, in New Jersey federal court, alleging its proposed biosimilar of Genentech's blockbuster breast-cancer drug Perjeta would infringe Genentech's patents..A Biocon spokesperson declined to comment on the lawsuit on Thursday, citing pending litigation..."We respect the legal process and will defend our patents," a Genentech spokesperson said... Full

 

Fresenius Announces FDA and EMA Acceptance for Review of Vedolizumab Biosimilar Candidate

(7/31, Fresenius Kabi) ...The applications were submitted by Polpharma Biologics S.A., with Fresenius Kabi holding exclusive commercialization rights globally, excluding the Middle East and North Africa, pending regulatory approvals... Full

 

 

Sanofi Needs Less 'Dreaming' and More Science, New CEO Says

(7/30, Ashleigh Furlong, Bloomberg Law) ...Going forward, Sanofi will use rigor, due diligence and fact-based decision making to decide which medicines should move into costly late stage studies..Analysts have said Sanofi could lean on its partnership with Regeneron, which developed Dupixent, to discover new medicines. That's indeed the plan, [Chief Executive Officer Belén] Garijo said, with talks ongoing about expanding the alliance. Yet, here too there are challenges, with a need to rebuild trust, she said. Regeneron has sued Sanofi over its sharing of information... Full

 

Sanofi Shares Slide After CEO Signals Challenges to Fill Drug Pipeline

(7/30, Adrià Calatayud, The Wall Street Journal) ...Sanofi Chief Financial Officer Francois Roger said the company would have a greater appetite for buying drugs already on the market or at a late stage of development, instead of focusing mainly on early-stage assets as it has recently... Sub. Req'd

 

BMS Pushes Key Readouts for Cobenfy, Milvexian to 2027

(7/30, Anna Bratulic, FirstWord PHARMA) ..."As a reminder, [LIBREXIA-AF1] is being monitored by an independent data monitoring committee, which continues to endorse the study, and with the passage of time as the study progresses, we are increasingly encouraged about milvexian," CEO Chris Boerner said on an earnings call with analysts. Chief Medical Officer Christian Massacesi suggested the delay increases his confidence that milvexian can achieve both the primary endpoint of non-inferior efficacy to Eliquis and secondary endpoint of superior bleeding outcomes... Full

 

AbbVie Q2 Earnings Preview: Analysts Eye Immunology Growth, Pipeline

(7/31, Investing.com) ...Goldman Sachs analysts expect AbbVie to deliver a modest beat on both revenue and adjusted earnings, with investor attention centered on blockbuster drugs Skyrizi and Rinvoq. The brokerage forecasts Skyrizi to slightly exceed Visible Alpha consensus on stronger prescription trends, while Rinvoq is expected to miss consensus by about 2% because of pricing headwinds... Full

 

Neurocrine Biosciences Reports Second-Quarter 2026 Financial Results

(7/30, Neurocrine Biosciences) ..."Our second quarter performance demonstrates the power of a strategy designed to compound over time," said Kyle W. Gano, Ph.D., Chief Executive Officer of Neurocrine Biosciences..."With multiple important clinical milestones in 2027, including Phase 3 readouts for osavampator in major depressive disorder and direclidine in schizophrenia, we are building an enduring company poised to deliver meaningful value for patients and shareholders for years to come."... Full

 

Lilly, Resilience Commit $750m to Boost US Diabetes, Obesity Med Production

(7/30, Kevin Dunleavy, Fierce Pharma) ...The investment will fund upgrades to Resilience's site in Ohio, which has been manufacturing Mounjaro and Zepbound since the companies first teamed up in 2023. The outlay will create at least 400 new jobs at the site, bringing Resilience's headcount in the Buckeye State to more than 1,400, the company said in a July 30 release... Full

 

Eli Lilly Is Pharma's Latest Victim of Success

(7/30, Robert Cyran, Reuters) ...Lilly will throw off some $17 billion of excess cash this year, according to analyst estimates collected by LSEG. That's over three times as much as it produced prior to U.S. regulators' approval of tirzepatide, the company's marquee diabetes and weight loss drug. In 2027, Wall Street assumes this figure will soar past $31 billion. The pressing question is what to do with all of it. Lilly's answer, increasingly, is to hand it back to shareholders... Full

 

India's Sun Pharma Posts Higher Quarterly Profit on Strong Demand

(7/31, Reuters) ...Sun Pharma has been expanding in higher-margin specialty medicines, including treatments for skin disease, cancer and obesity, to offset pressure in its U.S. business. The specialty segment accounted for 21.9% of total revenue, with sales rising 12.8% to $351 million, supported by 16% growth in India, the company's largest market. U.S. sales were flat... Full

 

Cigna Raises Annual Profit Forecast on Strength in Specialty Drug Unit

(7/30, Sneha K, Kunal Das, Reuters) ...Specialty pharmacy was boosted by higher use of specialty drugs for complex conditions such as cancer, multiple sclerosis and rheumatoid arthritis, the company said... Full

 

Celltrion Expands Direct Sales in Italy

(7/31, Choi Mun-hee, BusinessKorea) ...According to the industry on July 31, Celltrion's allergy treatment 'Omlyclo' has currently started sales in 15 regions in Italy. In 7 of these regions, it has secured an exclusive position by signing a sole supply contract with the provincial government, making it the only one among suppliers of omalizumab-based products to do so... Full

 

Rising Oil Prices Can Boost the Cost of Some Medicines. One Expert Says It's Time to Lower Reliance on Fossil Fuels

(7/30, Ed Silverman, STAT+) ...That's why for now, we don't see any direct impact on the medicine prices because there's buffering embedded in the system. Again, the large manufacturers are sitting on huge inventories. But at some point, that inventory will deplete and they will need to buy products that are based on petrochemicals that would be more expensive. So at some point, those oil price increases will impact the medicine production value chain... Sub. Req'd

 

 

India Takes Action Against 90% of Inspected High-Risk Pharmaceutical Facilities, Regulator Says

(7/30, Rishika Sadam and Kashish Tandon, Reuters) ...India has taken enforcement action against about 90% of inspected pharmaceutical facilities identified as high-risk under a nationwide quality drive, the drug regulator's chief said, as authorities step up oversight following global scrutiny of Indian-made drugs... Full

 

India Tightens Drug Quality Norms, Eyes Biopharma Push: Pharma Secretary

(7/30, Ankita Upadhyay, The Hindu BusinessLine) ...The Centre has begun cracking down on pharmaceutical manufacturers that fail to meet revised quality standards, with non-compliant companies being asked to shut down unless they upgrade their facilities, said Manoj Joshi, Secretary, Department of Pharmaceuticals. In an interview with businessline, Joshi said restoring confidence in India's pharmaceutical manufacturing through stricter regulation is the government's immediate priority... Full

 

Experts to Deliberate on Quality and Safety of Biosimilars to Strengthen India's Biopharma SHAKTI Vision

(7/31, Shardul Nautiyal, Pharmabiz.com) ...Leading experts from the government, regulatory bodies, industry, academia and the biopharmaceutical sector will come together to deliberate on the quality, safety and regulatory landscape of biosimilars at a two-day national programme, "Quality and Safety of Biosimilars: Strengthening India's Biopharma SHAKTI Vision," scheduled between September 10 and 11, 2026, at the Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru... Full

 

US Tariffs: Indian Pharma to Push for Continued Exemption for Generics at Trade Talks

(7/31, Abhijeet Singh, ETPharma) ..."The issue of tariffs has been under discussion since last year, but generics have so far remained exempt from such levies. The matter is likely to come up during the ongoing bilateral trade agreement (BTA) talks, and will make a strong case for maintaining the status quo, as Indian generic medicines provide significant savings to the US healthcare system and patients," a senior industry representative involved in the discussions told ETPharma... Full

 

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