Tuesday, August 4, 2026

 

 

12 Questions with Kim Innes

(8/4, pharmaphorum) ...Kim Innes is General Manager of Teva UK...At Teva, I'm particularly motivated by the scale of our impact. We supply medicines that the NHS and patients rely on every day, but also have the opportunity to contribute to the future of care through biosimilars and innovative treatments. That combination of practical everyday impact and long-term shaping is what keeps the work meaningful for me... Full

 

Teva's Re-Rating Still Has Room To Run

(8/4, Seeking Alpha) ...Teva's specialty and innovative drugs, AUSTEDO, AJOVY and UZEDY, are picking up speed in a way that's clearly different from the company's old days focused on generics... Full

 

 

US Officials Want to Counter China's Pharma Rise, But Pricing Policies May Be Doing The Opposite

(8/3, Maaisha Osman, Pink Sheet) ...When US and other Western companies avoid European markets that could lower their US prices, a potential consequence of President Trump's Most Favored Nation pricing policy, they would leave a void Chinese companies could fill. Having largely licensed their US rights to American partners, Chinese companies can price freely in Europe without worrying about increasing prices there, Neal Masia, a health economist at Columbia University, told the Pink Sheet... Global Sub. Full

 

Trump Has Another Tariff Plan to Reshore Generic Drug Production. Will it Work?

(8/3, Kelly Bilodeau, PharmaVoice) ...There is broad agreement that reshoring generic drug manufacturing is a worthwhile goal...But substantial barriers could limit the effects of this tariff-driven push for reshoring, [Tinglong Dai, the Bernard T. Ferrari professor of business at Johns Hopkins Carey Business School,] said, including labor challenges, regulatory disparities and cost... Full

 

Single, Public PBM Suggested To Crack Down On Excess Market Power

(8/3, Gabrielle Wanneh, Inside Health Policy) ...A publicly owned pharmacy benefit manager transparent about the lower prescription drug prices it negotiates with drug companies and operated under a strict fee-for-service basis could serve as a unique policy intervention to achieve meaningful cost savings and improve the supply chain for stakeholders, policy experts at the progressive think tank Groundwork Collaborative say. The group is proposing the government either create a near-term, federal PBM for the Department of Veterans Affairs (VA) under existing executive authority, or a legislated national public option available to Medicare, Medicaid and commercial plans... Sub. Req'd

 

FDA Updates TDS Guidances on Adhesive Performance, Skin Irritation and Sensitization Studies

(8/3, Ferdous Al-Faruque, Regulatory Focus) ...The US Food and Drug Administration (FDA) has published two guidances on transdermal or topical delivery systems (TDS) for generic drugs, including a final guidance on assessing adhesives for TDS products and a draft guidance on assessing skin irritation using in vivo studies in TDS products... Full

 

Expert Sees Shift to 'Ecosystem-Centric Assurance' Under FDA's Distributed Manufacturing Rule

(8/3, Jeff Craven, Regulatory Focus) ...Under the proposed rule, distributed manufacturers with multiple sites could create a single drug establishment under a "hub-and-spoke" model that manages distributed manufacturing units (DMUs), rather than registering each individual site. The rule change would also close a loophole that allows active pharmaceutical ingredient (API) manufacturers that ship products only to foreign sites to avoid registering with the agency by applying changes made by the PREVENT Pandemics Act that specify these manufacturers must register with FDA... Full

 

Investing in FDA's Inspectional Enterprise

(8/3, Elizabeth Miller, Lowell Zeta, FDA Voices) ...As part of the FDA's broader transparency efforts, we are taking steps to modernize how we communicate, how we make decisions, and how we carry out regulatory responsibilities. A critical component of that effort is the transformation of our inspectional enterprise, including how we plan, coordinate, and execute inspections across the agency... Full

 

California's Highest Court Rules for Gilead, Says Drugmakers Don't Have 'Duty to Innovate'

(8/3, Reuters) ...Justice Joshua Groban said imposing a "duty to innovate" and holding drugmakers to a negligence standard would require juries to second-guess complex scientific judgments in hindsight, including when the underlying science is in flux... Full

 

Gov. Healey Targets Premiums, Drug Prices in Health Affordability Push

(8/3, Alison Kuznitz, NBC Boston) ...Massachusetts Gov. Maura Healey unveiled long-promised healthcare affordability recommendations Monday to expand MassHealth's investment in primary care, slash premiums, rein in out-of-network costs, mitigate "low-value" care, leverage state buying power to reduce prescription drug costs, initiate an artificial intelligence regulatory process and more... Full

 

 

Merck's $11B Anti-TL1A Bet Delivers 1 Win, 1 Loss in Midphase Inflammatory Disease Trials

(8/4, Nick Paul Taylor, Fierce Biotech) ...Merck acquired the antibody, tulisokibart, when it bought Prometheus Biosciences in 2023. Racing Roche's afimkibart and Sanofi and Teva's duvakitug,..In its second-quarter earnings update, the drug developer revealed that the SSc-ILD study missed its primary endpoint. As a result, Merck is ending the SSc-ILD trial, although the company pointed out that no new safety concerns were seen in the failed study... Full

 

Nurix Therapeutics Announces First Patient Enrolled in Registrational Phase 3 DAYBreak CLL-306 Trial of Bexobrutideg in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

(8/4, Nurix Therapeutics, Inc.) ...Nurix Therapeutics, Inc. today announced that the first patient has been enrolled in the global Phase 3 DAYBreak CLL-306 study (NCT07516093) evaluating bexobrutideg, a potential best-in-class targeted protein degrader of Bruton's tyrosine kinase (BTK), in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor... Full

 

Pathos AI Expands Pipeline via Pair of Oncology Deals with Alphamab, AstraZeneca

(8/4, Pavan Kamat, FirstWord Pharma) ...Under the first deal, potentially worth as much as $2.2 billion, Alphamab granted Pathos exclusive rights to JSKN016, a TROP2/HER3 bispecific antibody–drug conjugate (ADC) for solid tumours, in regions outside Greater China. The drug was identified through Foundry, Pathos' AI-driven decision platform for oncology drug development... Full

 

Looking Back and Moving Forward: Questions and Lessons 4 Weeks out from Roche's Disappointing News

(8/3, Dr Rachel Harding, HDBuzz) ...Across multiple clinical programmes, including Roche's tominersen studies, hundreds of people have received therapies that reduce huntingtin levels. While every drug has its own safety profile and side effects, there is now little evidence that partial lowering of huntingtin itself is inherently unsafe in adults with HD... Full

 

Gene Editing Tool Could Pave Way for New Huntington's Treatments

(8/4, Neuro Rehab Times) ...Unlike other gene-based treatments that aim to switch off the gene, the experimental method changes how cells read it... Full

 

Tardive Dyskinesia a 'Silent Driver' of Healthcare Spending

(8/3, Kristen Monaco, MedPage Today) ...While the risk of TD is lower with newer, second-generation agents, the threat still remains. "TD is not something from the 1980s," Rubio told MedPage Today. "It is still prevalent even with second-generation antipsychotics, stigmatized, and perhaps more under-recognized than in the 1980s."... Sub. Req'd

 

 

Dr Reddy's Labs Receives US FDA Approval for Rituximab Biosimilar

(8/3, Pharmabiz.com) ...Dr Reddy's Laboratories Ltd. announced that the US [FDA] has approved its rituximab biosimilar, a biosimilar to Rituxan (rituximab), for the US market...Under a commercialization 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

 

Dr Reddy ' s Laboratories Launches Sugammadex Injection in US

(8/4, The Hindu BusinessLine) ...The company has launched Sugammadex injection 200 mg/2 mL and 500 mg/5 mL single-dose vials, a generic equivalent of Bridion, in the US, Dr Reddy's Laboratories Ltd said in a statement... Full

 

Slow And Steady: FDA Chalks Up Two More Biosimilar Approvals

(8/3, Dave Wallace, Generics Bulletin) ...Meitheal CEO Tom Shea said the approval of Garzulys "represents an important milestone in Meitheal's continued expansion beyond our established generic injectable business and into a broader portfolio of biologics and branded products."... Global Sub. Full

 

 

Supernus, Individor Merge to Beef up Brain Drug Portfolio

(8/3, Jonathan Gardner, BioPharma DIVE) ...The transaction will bring under a single company 11 different products for psychiatric, neurologic and addiction conditions, many with steady but sub-blockbuster sales. The biggest seller is Individor's Sublocade, a long-acting injection that treats opioid-use disorder, and its only drug recording sales growth in 2025 as it shifts away from the oral products that have led to legal problems... Full

 

Curium Strikes Up to $8B Deal for Radiopharma Rival Lantheus

(8/3, Ayla Ellison, Fierce Biotech) ...Curium has agreed to buy all outstanding Lantheus shares for $102.50 apiece in cash at closing. Shareholders could receive up to another $12 per share through contingent value rights tied to sales milestones for Lantheus' prostate cancer, neurology and Definity franchises through 2030. The companies expect to close the transaction in the first half of 2027, subject to approval from Lantheus shareholders and regulators. If the deal is completed, Lantheus will become a privately held company... Full

 

Pfizer Beats Quarterly Profit Estimates on Strong Demand for Blood Thinner Eliquis

(8/4, Reuters) ...blockbuster drugs, while investors look for signs that its $10 billion purchase of Metsera can help establish a meaningful presence in the fast-growing obesity market. The drugmaker, whose shares have fallen more than 50% from their pandemic-era peak, expects to return to stronger growth after 2028... Full

 

Merck Posts Better-than-Expected Second-Quarter Results on Keytruda Strength

(8/4, Reuters) ...Sales of immunotherapy Keytruda, the world's top-selling prescription medicine, rose 5% to $8.37 billion in the quarter, including $463 million from its newer subcutaneous formulation, Keytruda QLEX. That exceeded analysts' estimates of $8.07 billion... Full

 

India's Alembic Pharma Posts Quarterly Profit Rise on Strong Generics Demand

(8/4, Reuters) ...[Alembic Pharmaceuticals] revenue from its U.S. generics business jumped nearly 49% to 7.78 billion rupees... Full

 

Sun Pharma Maintains FY27 Growth Outlook, Says Organon Deal Remains on Track

(8/3, Ekta Batra, CNBC TV18) ...Jayashree Satagopan, Chief Financial Officer of Sun Pharma, said it is too early to assess the potential impact of proposed US tariffs on generic medicines, noting that the company will continue engaging with the US administration and industry stakeholders. She added that Sun Pharma's existing manufacturing footprint in the US provides strategic flexibility should policy changes materialise... Full

 

An AstraZeneca-Bristol Myers Megamerger? Wall Street Isn't Thrilled

(8/3, Jacob Bell, BioPharma DIVE) ...To Michael Leuchten, an analyst at Jefferies who covers AstraZeneca, a buyout of Bristol Myers would be a "head scratcher," namely because, under the direction of CEO Pascal Soriot, AstraZeneca has notched a series of major wins over the past several years. At the end of 2025, the company had 16 products generating $1 billion or more in annual sales. By 2030, it expects that number to surpass 25 and sales to exceed $80 billion... Full

 

More Biotech M&A Is Coming, Whether an AstraZeneca-Bristol Myers Deal Happens or Not

(8/4, Barron's) ...But the excitement around a possible merger is just the latest sign that M&A activity in the broader biopharma sector is taking a front seat -- and that's good for pharma stocks and shareholders themselves. When a company as large as Bristol Myers can be a takeover target, everyone in the sector gets a takeover premium baked into their valuation. "Large companies are signaling an appetite to continue to make deals," Goldman's [Asad] Haider said. "That includes companies like Eli Lilly and AbbVie that aren't sitting on the cusp of a patent cliff."... Full

 

How a Pharma Megamerger Could Squelch R&D

(8/4, Tina Reed, Axios) ...Combining two drug giants with overlapping portfolios could put cost efficiencies ahead of innovation... Full

 

Eli Lilly to Offer Early Access to Next-Gen Obesity Drug to Some Patients

(8/3, Sneha S K, Deena Beasley, Reuters) ..."For a limited number of patients who meet specific medical criteria and cannot enroll in a clinical trial, we believe it is medically appropriate to make authentic retatrutide available before FDA approval, consistent with FDA's guidance," a company spokesperson said. The spokesperson added that Lilly has built an expanded access program "that does that and are actively reviewing requests from health care providers."... Full

 

'Arrogance Kills': Novo Chief Injects Risk-Taking Into Ozempic Maker

(8/4, Aaron Kirchfeld, Aanu Adeoye, Financial Times) ..."You know, if you do not like failure, then you should not get into a pharma business," [Novo Nordisk's chief executive, Mike Doustdar,] told the FT at Novo's headquarters in the suburbs of Copenhagen. "I actually think success for us will be to have more shots at goal because we're dealing with science and research that has, inevitably, failure attached to it."... Sub. Req'd

 

Amgen Says Patient Health Data, IP Stolen in Cybersecurity Breach

(8/3, Angus Liu, Fierce Pharma) ...According to a securities filing (PDF), Amgen identified unauthorized activity in its cloud storage systems hosted by external service providers in July. The California company activated its cybersecurity response plan and initiated containment measures. Still, a subsequent forensic investigation confirmed that attackers had stolen that data. Although Amgen stated that it "has not identified any impact" to its products, manufacturing operations, financial reporting or delivery to patients to date, it has determined that the incident is "material."... Full

 

 

India Pharma Sector to Miss 2030 Sales Target Amid Tariff and Shipping Woes, Trade Body Says

(8/4, Rishika Sadam, Reuters) ...The sector is now expected to reach $80 billion to $90 billion by 2030, well below an industry target of $130 billion set in April last year, Namit Joshi, chairman of the Pharmaceuticals Export Promotion Council of India, said... Full

 

UK, US And Canada Making Pharmacovigilance Inspections Less Burdensome For Companies

(8/3, Vibha Sharma, Pink Sheet) ...A working group established by regulators in the UK, the US and Canada to align how they identify and prioritize drug manufacturers for pharmacovigilance inspections is beginning to influence inspection planning. The initiative has the potential to reduce the burden on multinational drugmakers while enabling regulators to make more efficient use of limited resources, according to Claire Longman, of the UK's Medicines and Healthcare products Regulatory Agency... Global Sub. Full

 

Trade War Triggers Calls To Reform Canada's Drug Regulation And Reimbursement Systems

(8/3, Eliza Slawther, Pink Sheet) ...The Canadian government said it would "carefully consider" 39 recommendations on reforming the nation's pharmaceutical regulations, reimbursement and pricing policies, and clinical trials framework in response to geopolitical volatility and trade pressures... Global Sub. Full

 

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