Wednesday, July 8, 2026

 

 

Teva Reports Positive Skin Treatment Drug Results

(7/7, Shiri Habib-Valdorn, Globes) ...Teva Pharmaceutical Industries Ltd. has reported positive results for TEV-'408, an investigational anti-interleukin-15 monoclonal antibody, in an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV). The Israeli company will advance the antibody into a Phase 2b trial in the fourth quarter of 2026... Full

 

Teva Reports Early Vitiligo Data for Anti-IL-15 TEV-'408, Advances into Phase IIb

(7/7, AllSci) ...The decision positions Teva as one of the few large pharma companies pursuing a systemic biologic specifically engineered for vitiligo - a disease where the only approved pharmacological treatment remains a topical therapy restricted to limited body surface area... Full

 

Teva Advances TEV-'408 Into Phase 2b for Vitiligo

(7/7, Shannon Heaning, Dermatology Times) ..."TEV-'408 exemplifies the type of innovative, Teva-discovered program we are prioritizing as we continue to advance and strengthen our immunology pipeline," Richard Francis, president and chief executive officer of Teva, said in a news release... Full

 

Vitiligo Pipeline Update: Teva Set To Advance Its Anti-IL-15 Antibody Into Phase 2b Development

(7/7, The Dermatology Digest) ...The study showed improvements in skin pigmentation in patients with active or stable NSV... Full

 

Teva Draws Up Mid-Stage Study Plans for Vitiligo Asset on Phase Ib Success

(7/8, Annabel Kartal Allen, Clinical Trials Arena) ...In an investor call discussing the Phase Ib NSV results, Teva's head of R&D and CMO, Eric Hughes, noted that TEV-'408 could constitute a "pipeline in a product" opportunity for the company... Full

 

Teva Advances Experimental Vitiligo Drug after Encouraging Early Results

(7/7, Ynet Global) ..."Vitiligo can affect far more than the skin. It can shape how people see themselves, how they show up in the world, and the confidence they carry every day," said Dr. Eric Hughes, Teva's executive vice president, global R&D and chief medical officer. "These encouraging data strengthen our confidence in the IL-15 pathway and reflect the depth of Teva's scientific expertise."... Full

 

 

As US Lawmakers Increase Scrutiny of Chinese Trials, Industry Fears 'Huge Distraction and Expense'

(7/7, Will Maddox, Fierce Biotech) ...A spokesperson from a biotech industry group-who spoke on condition of anonymity for fear of political repercussions-pointed out that it's easier for Big Pharmas to absorb the costs of responding to changing political winds relative to their smaller biotech counterparts. "It is difficult for any business to deal with mass uncertainty and constant changing of goal posts and what's acceptable," they told Fierce. "If every time you turn around there's a new restriction and you have to start all over, that's wasting time and money."... Full

 

GOP Wants Price Transparency as Dems Ready Their Health Agenda

(7/8, Erin Durkin, Victoria Knight, Bloomberg Government) ...In conversations with a handful of Republicans on Capitol Hill before they departed for the July 4 recess, one common theme emerged as a target: healthcare price transparency policies. Democrats meanwhile argue their counterparts have slashed spending on crucial healthcare programs that are causing prices to rise, and they're readying their agenda to possibly reverse conservative policies... Sub. Req'd

 

Weakening Drug Patents Won't Lower Costs; It Will Slow Innovation | Opinion

(7/7, Anne Pritchett, The Detroit News) ...Witnesses spent much of the hearing urging lawmakers to pass the ETHIC Act, which would make it harder for drug companies to enforce valid patents, particularly those covering improvements made after a drug's initial FDA approval. That would naturally disincentivize companies from investing in additional lengthy and costly research. Such a drop-off in innovation couldn't come at a worse time. The United States still leads the world in the development of new medicines. But China has made biotechnology a strategic priority and is investing heavily to challenge U.S. leadership... Full

 

US FDA Saw PDUFA FY 2025 Payroll Costs Rise Despite Layoffs

(7/7, Derrick Gingery, Pink Sheet) ...The PDUFA program's payroll obligations, which primarily fall on CDER, increased from $918.2m in FY 2024 to $971.8m in FY 2025, the year the RIF occurred. The biosimilar user fee program saw a similar increase, from $32.8m in FY 2024 to $34.9m in FY 2025, according to user fee financial data... Global Sub. Full

 

FDA Revises Compliance Guide on Pre-Approval Inspections

(7/7, Joanne S. Eglovitch, Regulatory Focus) ...The US [FDA] revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions about the necessity of inspections and clarifies the agency's use of alternative methods instead of relying solely on onsite inspections... Full

 

US FDA To Clarify, Expand 'Significant Discretion' To Publish CRLs

(7/7, Sue Sutter, Pink Sheet) ...The US [FDA] believes it has "significant discretion" to disclose complete response letters, but is proposing to amend its regulations to "clarify and expand" it. The agency plans to issue a proposed rule on proactive disclosure of CRLs for drugs and biologics in October, according to the Trump Administration's most recent "unified agenda," an outline of upcoming regulations... Global Sub. Full

 

Industry Groups Press FDA for Transparency, Next Steps for CNPV Program

(7/7, Ferdous Al-Faruque, Regulatory Focus) ...Two major drug industry groups, PhRMA and the Biotechnology Innovation Organization (BIO), wrote to FDA requesting greater transparency and predictability regarding the program. PhRMA said taking such measures would ensure the program is credible, sustainable, and scalable. It emphasized that if the program is to move beyond the pilot phase, the agency should conduct notice-and-comment rulemaking to clarify aspects of the program, including voucher eligibility criteria, selection processes, operational expectations, and timelines. BIO made similar comments, noting that the program lacks transparency and predictability regarding the legal and regulatory framework that supports it... Full

 

Sen. Rick Scott Wants Pharmaceutical Tariff Carve-out Reversed Over China's Forced Labor

(7/7, Mary McCue Bell, The Washington Times) ...Sen. Rick Scott is lobbying the Trump administration to reverse forced-labor tariff carve-outs for pharmaceuticals, proposing placing duties on drugs linked to China's use of Uyghur forced labor. In the Florida Republican's Monday letter to U.S. Trade Representative Jamieson Greer, he suggested imposing duties on generic pharmaceuticals and ingredients produced with forced labor or state-supported market distortions, such as subsidies... Full

 

How PBMs Are Leading the Charge on Transparent Information for Patients

(7/7, PCMA Blog) ...As Washington searches for ways to improve transparency, it's worth reminding policymakers that pharmacy benefit managers (PBMs) have been investing in tools that do exactly that for years... Full

 

 

AstraZeneca Secures Ex-China License for Sino Biopharmaceutical's Experimental COPD Drug

(7/7, Andrew Silver, Reuters) ...The new partnership will "leverage AstraZeneca's deep clinical development experience and respiratory expertise," Sino Biopharmaceutical said in a filing to Hong Kong's stock exchange. "The Group is eligible to receive an upfront payment of $200 million, with additional development, regulatory and sales milestones, totalling up to $1.9 billion."... Full

 

Ferrer and Prilenia Begin Confirmatory Study of Pridopidine in Huntington's Disease

(7/7, John Pinching, PharmaTimes) ...New phase 3 trial to assess impact on disease progression, function and quality of life Ferrer and Prilenia have initiated the confirmatory PRECISE-HD study, a global phase 3 trial designed to evaluate the efficacy and safety of pridopidine in people living with Huntington's disease. Recruitment has begun in the US, with sites across the EU, UK and Canada expected to open later in the year... Full

 

Tiapride Shows Fewer Safety-Related Discontinuations Than Tetrabenazine for Huntington Disease Chorea, Real-World Analysis Suggests

(7/7, Isabella Ciccone, MPH, NeurologyLive) ...In a 25-year retrospective cohort study recently published in Clinical Therapeutics, researchers reported that tiapride was prescribed more frequently than tetrabenazine as first-line treatment for chorea in Huntington disease (HD) and was associated with significantly fewer adverse effect (AE)-related discontinuations.1 The findings offer clinicians one of the longest real-world comparative analyses available for these 2 agents in the DACH region of Europe (Germany, Austria, and Switzerland), where both have regulatory approval for HD-associated chorea... Full

 

Compass Says Psychedelic Helps Patients with Resistant Depression Go into Remission

(7/7, Elizabeth S. Eaton, FirstWord PHARMA) ...With a rolling review of its experimental psychedelic therapy for treatment-resistant depression (TRD) under way at the FDA, Compass Pathways shared updated Phase III data on Tuesday bolstering its argument that COMP360 could provide a durable benefit with infrequent dosing... Full

 

 

Aurobindo Receives FDA OK for Generic Vascepa

(7/7, Sandra Levy, Drug Store News) ...Aurobindo Pharma has received permission from the Food and Drug Administration for icosapent ethyl capsules, 1 gram, which are the generic of Amarin Pharmaceuticals Ireland's Vascepa capsules... Full

 

PharmaResearch Medicare Launches Teriment, Osteoporosis Biosimilar

(7/8, Yeom Hyun-a, The Chosun Daily) ...PharmaResearch's subsidiary PharmaResearch Medicare announced on the 8th that it has launched the osteoporosis treatment 'Teriment (active ingredient teriparatide).'... Full

 

Biosimilar ABP 654 Maintains Efficacy, Safety After Repeated Switching From Ustekinumab

(7/7, Skylar Jeremias, The Center for Biosimilars) ...Patients with moderate to severe plaque psoriasis who alternate between a reference biologic and its biosimilar counterpart don't have to worry that the change in manufacturer will compromise their treatment outcomes, according to new trial data supporting interchangeability between ABP 654 and the ustekinumab reference product... Full

 

 

Independent Pharmacies Hit Prime Therapeutics With Antitrust Suit Over Alleged Price Fixing

(7/7, Paige Minemyer, Fierce Healthcare) ...The lawsuit was filed July 2 in Washington federal court by Protecting Access to Retail Pharmacy, LLC, an organization that operates as TRUST, LLC. The group was formed in 2023 by the National Community Pharmacy Association to support pharmacies in investigations and potential litigation to recover controversial direct and indirect remuneration, or DIR, fees from pharmacy benefit managers... Full

 

Amphastar Receives Warning Letter from FDA for Facility's Manufacturing Practices

(7/8, Connor Hart, Dow Jones) ...Amphastar Pharmaceuticals said one of its subsidiaries received a warning letter from the [FDA] regarding one of its facilities, citing violations of current good manufacturing practices. The company on Wednesday said observations in the letter--concerning International Medication Systems' manufacturing facility in South El Monte, Calif.--relate to investigation procedures, environmental monitoring and handling procedures, as well as manufacturing equipment... Sub. Req'd

 

Launching Into an AI-Powered Future: A Prescription for Success

(7/8, Sarah Rickwood, Kirstie Scott, PMLiVE) ...What it takes to achieve launch excellence has always evolved, as the types of innovative medicines coming to market and the environments they face have changed. In the next ten years, however, the stakes are higher, and the environmental challenges more transformative... Full

 

 

'Crises And Challenges' - How An Embattled European Off-Patent Industry Is Fighting Global Pressures

(7/8, Dave Wallace, Generics Bulletin) ...Medicines for Europe's annual conference in Athens this year was a busy affair, with the event's central theme - the off-patent medicines industry as a strategic partner for Europe - applied to multiple topics, from jobs and growth to policymaking, health security, patient access and geopolitical uncertainty. However, amid the various discussions a few lightning rods emerged as the clear focus of concerns across the generics and biosimilars industry... Global Sub. Full

 

US Pricing Policy Behind Amgen's Danish Drug Withdrawal

(7/8, Monica Kleja, Euractiv) ...The dispute between Amgen and Amgros, the public Danish clinical medicines provider, has been unfolding since the pharmaceutical company decided in mid-February to stop supplying Denmark with the cholesterol-lowering drug Repatha...Amgen is rejecting Amgros' claim, citing the US's Most-Favoured-Nation (MFN) policy and Trump's administration's threat of increased tariffs... Full

 

Study: U.K. Could See 229,000 Avoidable Deaths From Pharma Trade Deal With U.S.

(7/7, Lauren Brensel, Inside Health Policy) ...A trade deal that was expected to serve as a formula for future negotiations in the United States could lead to 229,000 avoidable deaths over the next decade in the United Kingdom, where funding would be drawn from necessary health services to cover the costs of innovative medicines, a new analysis found... Sub. Req'd

 

UK MHRA Warns Data Access Hurdles Are Hindering Drug Safety Monitoring

(7/7, Eliza Slawther, Pink Sheet) ...At present, the MHRA "does not have default access to UK public health datasets, nor a fast-track governance pathway recognizing its legal remit and public health mandate," the agency said, adding that this was the case despite its "statutory duty" to monitor the safety of medicines and medical devices... Global Sub. Full

 

India Fat-Loss Drug Sales Slow After Early Spike From Generics

(7/8, Satviki Sanjay, Bloomberg) ...Monthly sales of GLP-1 drugs rose just 2.3% in June, data from market research firm Pharmarack showed. That's down from 12.1% growth in May and 58.4% in April. The slowdown marks a sharp deceleration from the initial rush that followed the expiry of semaglutide's patent in March... Sub. Req'd

 

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