Wednesday, October 14, 2026

 

 

Could Medicare Price Negotiation Tip The Scales Toward Part B Drug Payment Reform?

(10/13, Cathy Kelly, Pink Sheet) ...Beginning in 2028, the average sales price plus 6% formula will be replaced with a Medicare maximum fair price plus 6% formula for negotiated Part B drugs. The reimbursement decrease could mean providers avoid prescribing drugs with negotiated prices in favor of more expensive products considered therapeutically equivalent to maintain their margins... Global Sub. Full

 

Advocates To CBP: Let FDA Step In To Maintain Patients' Drug Imports Come Oct. 22

(10/13, Gabrielle Wanneh, Inside Health Policy) ...The new CBP entry procedures are set to become effective Oct. 22 for certain international mail shipments that are subject to requirements by federal agencies like FDA, and the changes are expected to significantly disrupt patient access to crucial medicines from abroad under the FDA's longstanding case-by-case approach to permitting imports of personal items... Sub. Req'd

 

Wide Range of Parties Ask FDA to Be Flexible, Protect Patients When Regulating Psychedelic Drugs

(10/13, Ferdous Al-Faruque, Regulatory Focus) ...Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket... Full

 

Study Pushes for Greater Adoption of a Cloud-Based Regulatory Environment

(10/13, Joanne S. Eglovitch, Regulatory Focus) ...Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the Journal of Pharmaceutical Sciences... Full

 

Estrogen Patches: How Generic Manufacturers Have Ramped Up Production

(10/13, Shana Christrup, AAM Blog) ...According to an AAM analysis of IQVIA data, in a year in a half (from January 2025 to June 2026), the number of prescriptions for dispensed estrogen patches has doubled – from 1.8 M prescriptions to 3.6 M prescriptions. A large majority of that increase was met by AAM member companies – Amneal, Sandoz, and Zydus. Generic manufacturer Mylan/Viatris has increased supply as well... Full

 

To Lower the Cost of Medicine, the Backbone of Affordable Healthcare Must Grow Stronger

(10/13, John Murphy III, DC Journal) ...The fixes are known, and none of them require new spending. Streamline FDA review so approved medicines reach patients faster by deeming all biosimilars interchangeable and stop requiring redundant clinical studies. Curb patent abuse by limiting the thickets that brand manufacturers use to protect their monopolies... Full

 

 

Formulations Matter: The Approval of Olanzapine Extended-Release Injectable Suspension for Schizophrenia

(10/14, Peter J. Weiden, MD, Psychiatric Times) ...The apparent reluctance to change practice routines is a complicated topic, but there are a few key points that matter, and these key points explain why the arrival of Weltruza could be a major opportunity to revisit what is standard practice... Full

 

AbbVie Presents New Phase 3 AFFIRM Data Showing Clinical and Endoscopic Outcomes With Subcutaneous SKYRIZI® (risankizumab-rzaa) in Patients With Moderately to Severely Active Crohn's Disease

(10/13, Abbvie) ...Presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, the findings build on the previously reported efficacy results of subcutaneous (SC) SKYRIZI® treatment, showing new endoscopic remissionii and ulcer-free endoscopyiii outcomes for patients receiving SKYRIZI subcutaneously... Full

 

NEMLUVIO Data Show Sustained Three-Year Responses in Atopic Dermatitis

(10/14, John Pinching, PharmaTimes) ...Galderma has announced new NEMLUVIO data to be presented at Fall Clinical 2026, including a post-hoc analysis from the ARCADIA LTE study showing that most adults and adolescents aged 12 and older who responded at Week 16 maintained deep and lasting improvements in skin lesions and itch for up to three years. The findings add to growing evidence supporting long-term efficacy in moderate to severe atopic dermatitis... Full

 

J&J's New Pharma Chief Expects Icotyde's Psoriasis Launch Momentum to Repeat Across Indications

(10/13, Fraiser Kansteiner, Fierce Pharma) ...J&J has yet to report out discrete sales for Icotyde, or icotrokinra, though the company on Tuesday cited the medicine's uptake in the U.S. as one driving factor in the 1.3% year-over-year increase in immunology revenue it posted for Q3, during which the unit collectively brought home (PDF) more than $4.2 billion... Full

 

 

Alvotech and Advanz Pharma Announce First Known Regulatory Submission Worldwide for Proposed Biosimilar to Eylea® 8 mg

(10/14, Alvotech) ...Based on publicly available information, this marks the first regulatory submission worldwide for a proposed biosimilar to Eylea® 8mg... Full

 

Zydus and Formycon: FYB206 Becomes First Publicly Announced Keytruda® Biosimilar Accepted for Review by USFDA

(10/13, Zydus) ...Under the Biosimilar User Fee Amendments (BsUFA), the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. Based on this timeline, a decision could be expected in the third quarter of 2027. The regulatory dossier for FYB206 has also been submitted to Health Canada... Full

 

Formycon Breaks New Ground In More Ways Than One With US Keytruda Biosimilar Filing

(10/13, Dave Wallace, Generics Bulletin) ...While the development represents a significant first for such a high-value target, it also represents a major test of the FDA's new streamlined approach to biosimilar regulation that will not typically require comparative efficacy studies as standard, given that Formycon chose not to conduct a full Phase III trial program for its FYB206 candidate after reaching agreement with the agency on the development pathway... Global Sub. Full

 

Ascend Laboratories And Mayne Pharma Settle For $1M Over Generic Price-Fixing

(10/13, Anabel Costa-Ferreira, Generics Bulletin) ...Under the terms of the settlement, Mayne has been ordered to pay $650,000 and Ascend will pay $400,000. The companies have also individually agreed to a series of internal reforms, including providing an annual antitrust compliance training... Global Sub. Full

 

Xbrane Edges Closer To Opdivo Biosimilar Finish Line With Completed Trial Recruitment

(10/14, Urte Fultinaviciute, Generics Bulletin) ...Describing the update as a "significant milestone" in the development of the Xdivane biosimilar, the Sweden-based firm said that approximately 340 patients with melanoma were enrolled in the study... Global Sub. Full

 

Biocon Settles Patent Dispute with Genentech Over Breast Cancer Drug

(10/14, P B Jayakumar, FORTUNE India) ...Biocon and Genentech executed the patent settlement agreement to resolve all pending disputes between the companies, including in the U.S., Canada, and other jurisdictions. This global patent settlement and license agreement enables Biocon to launch Pebrilzo in Q1 of calendar year (CY) 2027 in the European Union and UK, Q3 of CY 2028 in the U.S., and in CY 2026-2028 in other Rest of the World (RoW) countries or earlier in certain circumstances. The other terms of the agreement are confidential, said a company release... Full

 

 

Aurobindo Joins Speciality Pharma Race as Indian Drugmakers Return to Branded US Play

(10/14, Viswanath Pilla, Money Control) ...Aurobindo Pharma has joined a growing group of Indian drugmakers seeking to build a presence in the US speciality medicines market. The company has launched ADQUEY (difamilast 1 percent) ointment in the US through its subsidiary Acrotech Biopharma and also established a dedicated dermatology business, underscoring its ambitions beyond traditional generics... Full

 

CVS Agrees to Pay $315 Million to Settle Justice Department Case Over Opioid Prescriptions

(10/13, Alanna Durkin Richer, Associated Press) ...CVS said in a statement that its pharmacists were trained "in the safe and appropriate use of all medications" and that it had implemented "best-in-class" programs to help them "make the best decisions on behalf of patients." The company said it strongly disagreed with the claims made in the lawsuit and that the settlement admits no wrongdoing... Full

 

Sanofi Escapes Fine in EU Mismarketing Case

(10/14, Phil Taylor, pharmaphorum) ...Sanofi will not be fined for disparaging an influenza vaccine sold by rival CSL in a marketing campaign that ran in the EU, after the European Commission accepted its remediation commitments... Full

 

Celltrion Targets PBM Formulary Listings by Q4

(10/14, Yeom Hyun-a, ChosunBiz) ...Celltrion announced on October 14 that it is negotiating with a major U.S. pharmacy benefit manager (PBM) to list its high-margin follow-on products in the formulary. The company aims to secure additional contracts within the fourth quarter... Full

 

Pharma's Manufacturing Boom Has a Workforce Problem

(10/12, Pharma Voice) ...That strategy of investing in both production facilities and local colleges will be more necessary than ever as the demand for domestic manufacturing jobs surges, especially since life sciences companies won't just be competing with each other for talent. They'll also be vying for the same workforce as industries like engineering, defense, semiconductor and energy... Full

 

 

India Must Shift Pharma Industry From Generics to Innovation-Led Growth: Kiran Mazumdar-Shaw

(10/13, ANI) ...Speaking virtually at the Indian Foundation for Quality Management (IFQM) Symposium 2026, Mazumdar-Shaw said India had the talent and capabilities to take innovations from laboratories to clinical development and commercial markets, but needed a credible ecosystem to compete with global leaders. Generics is a great success story for India but we need to follow this with innovation and an innovation led strategy, she said, adding that the country should benchmark its progress against China... Full

 

Indian Pharma Companies Look for Options Beyond US Amid Tariff Threat: GlobalData

(10/13, Greg Slabodkin, Pharma Manufacturing) ...As uncertainty grows over its long-term foothold in the U.S. market, India is gaining improved access to other major overseas markets, according to the firm. Indian pharma companies are diversifying into Europe, emerging markets, and specialty segments to offset U.S. generics pressures... Full

 

Korea Moves to Restructure Generic Drug Industry

(10/14, Park Hong-yong, Seoul Economic Daily) ...The Ministry of Health and Welfare said it held the third meeting of its public-private council on pharmaceutical innovation on the 14th at Sangyeonjae, a conference venue near Seoul Station, where participants discussed ways to strengthen the competitiveness of generic-focused drugmakers and turn them into exporters. Government officials, public agencies, industry representatives and outside experts attended... Full

 

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