Monday, August 3, 2026
Top News
Why Teva Pharmaceutical Stock Surged This Week
(8/2, Keith Noonan, The Motley Fool) ...Teva Pharmaceutical stock closed out the last week of trading with significant gains, rising roughly 12.3% across the stretch... Full
Teva (TEVA) Stock Faces Earnings Shock Despite Strong Brand Growth
(7/31, Simply Wall St.) ...The bullish story on Teva Pharmaceutical Industries is that branded neurology and higher margin assets can steadily replace a shrinking generics base and lift earnings quality... Full
U.S. Policy & Regulatory News
Trump Slashes Medicare Drug Subsidies, Cutting Against Affordability Message
(8/2, Mallory Wilson, The Hill) ..."President Trump has had a lot of strong rhetoric on drug prices and negotiating deals with manufacturers to lower prices, and they've taken a lot of different steps to try to bring drug prices down," Juliette Cubanski, vice president and director of the Program on Medicare Policy at KFF, told The Hill. "But it's also true that this move to end these extra premium subsidies for some Medicare drug plans cuts in the other direction because it could translate to higher premium costs for millions of people with Medicare," she said... Full
The Trump Administration Is Ending a Medicare Drug Subsidy Program. Here's How it Could Affect Costs
(7/30, Ali Swenson, Associated Press) ...CMS Administrator Dr. Mehmet Oz on Tuesday said ending the subsidy program would prevent billions of taxpayer dollars from being funneled to insurance companies. It cost the agency an estimated $3.6 billion in 2026. He said most Medicare beneficiaries would see less than a $10-per-month increase, and some would even see lower premiums than beforehand... Full
Right Way to Fix Drug Prices
(8/2, Jack Kalavritinos, The Washington Times) ...I served in the Trump administration because I believe in using American strength and economic, diplomatic and legal resources to produce fair outcomes for American workers, patients and industries. Section 301 is exactly that: a proven mechanism for enforcing fair trade, not a blunt domestic instrument that punishes American innovators for a problem created abroad... Full
Trump's Tariffs Aren't Crushing Global Trade
(7/31, Matthew Lynn, The Washington Post) ...Global trade is now stronger than ever. The U.S. economy did not crash, inflation did not spiral out of control, and shelves at Walmart are not empty. Sure, that does not mean the tariffs were a good thing. It does mean, however, that they did not work the way the Econ 101 crowd expected them to... Full
Big Pharma's Tariff Countdown Begins
(8/2, The Economist: The World in Brief) ...Production in America has collapsed. The country makes less than a third of the generics it consumes, down from nearly three-quarters in 2002. The Coalition for a Prosperous America, a lobby group, reckons that supplies of over 200 drugs are currently running low in America... Full
Pharma Groups Back Changes to 340B Rebate Pilot as Earlier Version Remains Stuck in Court
(7/31, Zachary Brennan, Endpoints News) ...On Friday, in a 64-page Federal Register notice, HRSA said it has the statutory authority to use rebates, instead of the current upfront discounts. Hospitals have said that such a change could cause them to lose money because drugmakers could deny certain rebates. Drugmakers like the rebates for exactly that reason, since they give them more power to review the discounts... Sub. Req'd
Rand Paul's Biosimilar Drug Bill Could Cut Costs, Speed Patient Access
(7/31, Ronald Bailey, Reason) ...Under the act, the agency would approve biosimilars if analytical tests show that patients metabolize them in much the same way as comparator brand-name compounds. As Paul points out, no biosimilar that has passed such testing has failed to gain FDA approval. In other words, biosimilar clinical trials are unnecessary redundant expenses... Full
FDA Drafts Guidance on Container Closure Systems, Device Constituents for Biosimilars
(7/31, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) on Friday issued draft guidance to assist sponsors in providing necessary information for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar combination products, such as prefilled syringes and autoinjectable pens... Full
US FDA 'Simple Reform' Reorg Approved; Inspection 'Generalist' Changes Coming Later
(7/31, Derrick Gingery, Pink Sheet) ...The reorganization portion of the "Simple Reform" initiative at the US Food and Drug Administration has been set for implementation, but the move to a generalist approach for facility inspectors, which sparked stakeholder concerns, likely will occur later... Global Sub. Full
The Hollowing Out of America's Medicine Cabinet
(7/28, Andrew Rechenberg, Coalition for a Prosperous America) ...A country that cannot make its own medicine has surrendered a form of sovereignty as basic as the ability to feed or defend itself - and it has done so for a discount that evaporates the first time a pandemic, an export restriction, or a shuttered factory an ocean away leaves patients waiting. Rebuilding will take years and require long-term policy guidance, but the alternative is to keep gambling with American patients' health on a daily basis. That is a mistake the country cannot afford to keep making... Full
Innovative News
UniQure Welcomes Possible Adcomm for Huntington's Asset as Regulatory 'Jitters' Spread Through biopharma
(7/31, Trsitan Manalac, BioSpace) ...On uniQure's Thursday call, CEO Matt Kapusta said the company's recent interactions with the FDA "have been constructive and productive," insisting that the advisory committee meetings for Replimune and Capricor do not necessarily have spillover to uniQure... Full
AbbVie's Skyrizi Shrugs off New Competition as it Thrives in Growing Psoriasis Market
(7/31, Kevin Dunleavy, Fierce Pharma) ...In the second quarter, the IL-23 inhibitor generated sales of $5.55 billion, which were a virtual match for the most ever achieved by Humira in a single quarter. The result was a 24% increase for Skyrizi both sequentially and year over year... Full
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
Generics & Biosimilars News
Dr Reddy's Gets USFDA Nod for Rituximab Biosimilar
(8/2, The Hindu BusinessLine) ...Under a commercialisation agreement, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States, one of the world's most important pharmaceutical markets... Full
Polpharma and Fresenius Kabi's Vedolizumab Biosimilar PB016 Clears FDA, EMA Review Acceptance
(7/31, Emily Schoenthaler, BioPharmInternational.com) ...Regulatory momentum continued to build for biosimilar developers this week as two partner companies, Polpharma Biologics and Fresenius Kabi, announced parallel milestones for the same proposed vedolizumab biosimilar candidate, PB016... Full
Biocon's Yesafili Launch Leads Second Wave Of Eylea Biosimilars
(8/3, Dave Wallace, Generics Bulletin) ...Citing peak US sales for aflibercept of around $5.89bn in 2023 - "underscoring the growing need for effective treatment options" - Biocon said Yesafili offered a "potential benefit to the around 20 million adults in the US with age-related macular degeneration and other serious eye conditions."... Global Sub. Full
Celltrion Expands US PBM Coverage for Follow-on Biosimilars
(8/3, Lee Han-soo, Korea Biomedical Review) ...Celltrion said its follow-on biosimilars Avtozma and Stoboclo-Osenvelt have secured additional preferred formulary placements with major U.S. pharmacy benefit managers (PBMs), expanding reimbursement access and supporting prescription growth in the second half of the year... Full
Meitheal Pharmaceuticals Receives US FDA Approval for Garzulys Injection
(8/1, Pharmabiz.com) ...The collaboration initiated in 2023 between Tonghua Dongbao and NKF encompasses Garzulys and two additional insulin biosimilar candidates currently in development. Through its exclusive license agreement with Emerge, Meitheal holds exclusive US commercialization rights for Garzulys and the two additional product candidates... Full
Celltrion Expands US PBM Coverage for Follow-On Biosimilars
(8/3, Lee Han-soo, Korea Biomedical Review) ...Celltrion said its follow-on biosimilars Avtozma and Stoboclo-Osenvelt have secured additional preferred formulary placements with major U.S. pharmacy benefit managers (PBMs), expanding reimbursement access and supporting prescription growth in the second half of the year... Full
Sandoz Will Pay Another $480m to Settle US Antitrust Suits
(8/3, Phil Taylor, pharmaphorum) ...Sandoz reiterated its position that the settlements do not contain any admission of wrongdoing by its US subsidiaries Sandoz Inc and Fougera Pharma, adding that the deals "underscore the company's commitment to integrity, sound governance and resolving allegations of legacy conduct."... Full
Industry News
AstraZeneca Held Talks with Bristol Myers Squibb on $400 Billion Megadeal, Source Says
(8/2, Sabrina Valle, Michael Erman, Reuters) ...AstraZeneca Plc and Bristol Myers Squibb held preliminary discussions about a possible combination that would create one of the world's biggest pharmaceutical companies with a combined value of nearly $400 billion, according to a person familiar with the situation... Full
Editor's Corner: Why an AstraZeneca-Bristol Myers Squibb Merger Is a Bad Idea
(8/3, Angus Liu, Fierce Biotech) ...In reality, an AZ-BMS merger would likely be a disaster. Combining the two drugmakers would trigger severe regulatory concerns and significant pipeline disruptions, not to mention cost numerous jobs, all while damaging the broader biopharma ecosystem and hurting patients... Full
AbbVie Earnings Beat Forecasts as Skyrizi Sales Soar 24%. Why the Stock Is Falling.
(7/31, Mackenzie Tatananni, Barron's) ...The company's immunology portfolio commanded the lion's share of total second-quarter revenue at $8.8 billion. Blockbuster anti-inflammatory drug Skyrizi was a standout again -- bringing in $5.5 billion worldwide, up 24% from the prior year... Full
BREAKINGVIEWS-Eli Lilly is Pharma's Latest Victim of Success
(7/30, Robert Cyran, Reuters Breakingviews) ...The pressing question is what to do with all of it. Lilly's answer, increasingly, is to hand it back to shareholders. This is not a particularly compelling use of capital. Lilly is valued at some 12 times estimated revenue over the next 12 months. That's a huge premium over peers, such as Merck, at 5 times. Repurchasing stock is simply very expensive... Full
Novo Nordisk Shares Drop After Drug Candidate Fails in Trial
(7/31, Adrià Calatayud, The Wall Street Journal) ...The results of the trial for the drug, ziltivekimab, set the company back in its ambition to expand beyond its core obesity and diabetes business into adjacent cardiometabolic diseases... Sub. Req'd
Sun Pharma Misses Q1 Estimates as US Generics Drag Offsets India Growth
(7/31, Jessica Jani, Mint) ...The US business, however, remained under pressure. Sales fell 9.7% year-on-year to $427 million as pricing pressure and rising competition eroded generic drug sales. Growth from innovative medicines, including psoriasis treatment Ilumya, skin cancer drug Odomzo and chronic dry eye therapy Cequa, partly offset the decline. Generic products, including blood cancer drug lenalidomide, continued to weaken because of intensifying competition and pricing pressure... Full
Celltrion's Confidence Grows To Exceed Full-Year Guidance
(7/31, Urte Fultinaviciute, Generics Bulletin) ...Reporting its Q2 2026 earnings, Celltrion expressed confidence in not just meeting, but exceeding the full-year targets of KRW5.3tr ($3.7bn) in revenues and KRW1.8tr in operating profit. The Korean firm said that "second quarter results demonstrated Celltrion's cash-generating capability and business competitiveness, as we achieved an operating margin exceeding 30% while continuing to invest in R&D for future growth."... Global Sub. Full
Krka Raises Investments As It Looks To Expand Capacity
(7/31, Anabel Costa-Ferreira, Generics Bulletin) ...Krka says it is ramping up investment in production capacity both at home and abroad, after racking up 7% sales growth to €1.11bn ($1.27bn) in the first half of 2026. "Krka delivered an excellent performance in the first six months of the year, achieving record sales of more than €1.1bn, and further strengthening profitability...Growth was primarily driven by our prescription pharmaceuticals business, which remains the cornerstone of Krka's success, and accounted for most of the increase in sales," said David Bratož, member of the management board... Global Sub. Full
Hackers Steal Patient Data in Amgen Cloud Breach
(8/3, Ayisha Sharma, Endpoints News) ...The company said it noticed "unauthorized activity" affecting data stored on cloud platforms hosted by third-party providers in July, according to an SEC filing. It rolled out a cybersecurity response plan and has since discovered that the unnamed hackers accessed "proprietary data" and "patient protected health information." It is investigating the extent of the breach and exactly what other information may have been stolen, and is also assessing any potential impact on the company... Sub. Req'd
Stryker Catching up on Orders, Manufacturing after Cyberattack
(7/31, Elise Reuter, MedTech DIVE) ...The finance executive called out some ongoing challenges for Stryker. The company still faces costs related to the cyberattack, including losses from manufacturing and IT charges as it works through remediation, [CFO Preston] Wells said. The company is also managing costs around oil and raw materials... Full
Bausch & Lomb CEO: The AI Hysteria Is Nothing New
(7/31, Brent Saunders, Fortune) ...AI will continue to evolve. Today's leading model will eventually be replaced, and capabilities that seem extraordinary now will become familiar. No company can lock in a lasting advantage simply by choosing the right tool at one moment in time. What can endure is curiosity, adaptability and a culture where learning is understood to be part of the job... Full
International News
European Drug Manufacturers Under Threat From Proposed US Supply Chain Bill
(7/31, Pharmaceutical Technology) ...GlobalData data suggests that such an investigation could significantly impact Europe as the largest manufacturer of FDA-approved innovator and biosimilar products, potentially exposing the region to tariff and non-tariff actions as the Trump administration continues with its efforts to onshore pharmaceutical manufacturing... Full
Indian Drugmakers in No Rush to Shift to US Despite Tariff Threat
(8/2, Sohini Das Mumbai, Business Standard) ...Indian pharmaceutical companies are not rushing to move to the United States despite the Trump administration's renewed tariff threat. They are relying on existing US plants, contract manufacturers and selective investments in complex products while retaining India as their principal production base... Full
New Bulk Procurement Cycle Includes 65 Drugs
(8/3, Wang Ziaoyu, China Daily) ...The chosen medicines cover a broad range of therapeutic areas, including anti-infectives, oncology, treatments for blood clots, diabetes, hypertension, hyperlipidemia, rheumatology and immunology, as well as anti-inflammatory and pain relief therapies... Sub. Req'd
South Korea Cuts Generic Drug Prices as Pharmacies Strain and Supply Risks Rise
(8/2, Park Su-hyeon, Chosun Biz) ...The government will lower the insurance drug prices for generics and off-patent medicines starting in Aug., but some expect little change in what patients actually pay. Some also warn that pharmacies will face a heavier burden settling inventory and that supply disruptions could recur for essential medicines with low profitability... Full
From Abu Dhabi to Brazil, Every Region Is Vying for the 'New Emerging Economy' of Biotech
(7/31, Will Maddox, Fierce Biotech) ...Whether it's looming tariff threats or the rise of China as an innovation powerhouse, you need a truly global view to navigate today's biopharma industry... Full
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