Tuesday, October 6, 2026

 

 

Who's Hired? Teva Finds A New Leader For TAPI

(10/5, Dave Wallace, Generics Bulletin) ..."As the pharmaceutical industry increasingly focuses on supply chain resilience and geographic diversification, TAPI is uniquely positioned to support its customers," [Serge] Rogasik stated. "Few companies can match one of the industry's broadest technology platforms and an integrated manufacturing and R&D network spanning India, the Middle East, Europe and the Americas. I am excited by the momentum in the business and see significant opportunities ahead to further strengthen TAPI's position as a leading integrated API and CDMO partner."... Global Sub. Full

 

 

HHS To Develop Drug Price Transparency Schema With May 2027 Publication Target

(10/5, Jalen Brown, Inside Health Policy) ...HHS will begin developing a standardized format for health plans to disclose their negotiated prescription drug prices next month, CMS official Peter Nelson announced Monday (Oct. 5), with CMS Administrator Mehmet Oz adding that the agency hopes to publish it by May 2027... Sub. Req'd

 

New Trump Regulations Would Clean up Health Care Pricing Disclosures

(10/5, Bob Herman, STAT) ...The main audience for this health care price data isn't the average American, as Trump officials suggested. It is researchers who want to understand pricing trends, employer benefit leaders and attorneys who want to know what companies are paying for health care, and data scientists and consultants who want to dig into the numbers and create a product to sell... Sub. Req'd

 

Europe's Price Controls on Drugs Are Becoming a National Security Threat

(10/5, Eli Bremer, DC Journal) ...It's not difficult to imagine a nightmare scenario in which an adversary holds a significant edge in pharmaceutical research. Dependency on a foreign government for vaccines, treatments for new and deadly diseases, or critical biopharma supply chains is not a place we want to find ourselves... Full

 

Naloxone Prescribing Remains Rare Among Medicaid Beneficiaries

(10/5, Kwamesha Joseph, Clinical Pain Advisor) ...Naloxone remains underprescribed for Medicaid beneficiaries following nonfatal opioid poisoning, according to study results published in the Journal of the American Pharmacists Association... Full

 

Democratic Women Ask FDA To Act On Estrogen Patch Shortage

(10/5, Jessica Karins, Inside Health Policy) ...The Democratic Women's Caucus asks FDA to provide information including a detailed explanation of the factors contributing to the shortage, a timeline for when demand is expected to stabilize, what interim guidance FDA is providing to prescribers and pharmacists, whether FDA is recruiting additional manufacturers of the patch products and whether FDA is considering adding the patches to its drug shortage list... Sub. Req'd

 

Transparency Growing: US FDA Plans Reg Allowing NDA, BLA Filing Disclosure

(10/5, Derrick Gingery, Pink Sheet) ...In an Oct. 2 blog post, Lowell Zeta, FDA Acting Chief of Staff, deputy commissioner for strategic initiatives and special counsel, wrote that the agency intends to develop rulemaking "to increase transparency surrounding New Drug Applications (NDAs), Biologics License Applications (BLAs), Abbreviated New Drug Applications (ANDAs), and related applications through public disclosure of the fact of submission of all major applications."... Global Sub. Full

 

Mark Cuban Offers Fix for NJ's Health Care Cost Crisis

(10/5, The Press of Atlantic City) ...Cuban, the co-founder of Cost Plus Drugs and former owner of the Dallas Mavericks and "shark" on the TV show "Shark Tank," volunteered over the weekend to serve on a new state task force created as part of a deal between the Sherrill administration and public employee unions... Full

 

 

Ecopipam Shows Early and Sustained Tic Reduction in New Pediatric Tourette Syndrome Analyses

(10/5, Louie Pasculli, NeurologyLive) ...The new data come as ecopipam remains under FDA priority review for pediatric patients with Tourette syndrome. The FDA accepted Teva's new drug application (NDA) in August 2026 and established a Prescription Drug User Fee Act target action date for late in the first quarter of 2027... Full

 

Lundbeck Presents Phase Ib data for Lu AF28996 in Advanced Parkinson's Disease, as Phase II Trial Begins

(10/6, Lundbeck) ...Descriptive changes from baseline in motor fluctuations were observed with Lu AF28996, including increases in Good ON-time and reductions in OFF-time, alongside reductions in dyskinesia severity... Full

 

Roche Licenses Alector's Brain-Penetrant Parkinson's Therapy for up to $1.3B

(10/5, Anna Bratulic, FirstWord PHARMA) ...Alector will pocket $100 million upfront as part of the deal, and could eventually receive another $1.17 billion potentially tied to various milestones, plus tiered royalties on net sales. Genentech will take on development, regulatory, manufacturing and commercialisation responsibilities across all indications, though the biotech retains ownership of its ABC delivery platform and full rights to apply the technology across its wholly owned pipeline... Full

 

LRRK2 Inhibitor BIIB122 Fails to Slow Early-Stage Parkinson Disease

(10/5, Marco Meglio, NeurologyLive) ...Full results from the phase 2b LUMA showed that investigational BIIB122/DNL151 did not slow confirmed clinical worsening in early-stage Parkinson's disease compared with placebo... Full

 

Bial Showcases Parkinson's Research at MDS 2026

(10/5, Bial) ...The first is the Patient Endpoint Preference Project (PEPP), an ongoing multinational observational study that seeks to identify and prioritise the symptoms and outcomes that matter most to people living with Parkinson's. The second is the TRACK-PD study, which provides insights into treatment routines and adherence behaviours, contributing to a better understanding of the challenges experienced in real-world settings... Full

 

Lilly's BTK Drug Jaypirca Joins First-Line Options in US

(10/5, Phil Taylor, pharmaphorum) ...The new approval for Jaypirca (pirtobrutinib) covers use of the drug in CLL and SLL patients without 17p deletions, making it an alternative to other BTK inhibitors with frontline labelling, i.e., AbbVie/Johnson & Johnson's Imbruvica (ibrutinib), AstraZeneca's Calquence (acalabrutinib), and BeOne Medicine's Brukinsa (zanubrutinib)... Full

 

Kither Begins Dosing in COPD Trial of KIT2014

(10/5, John Pinching, PharmaTimes) ...KIT2014 is a proprietary cell-permeable peptide designed to enhance bronchodilation and reduce lung inflammation through balanced dual PDE3/4 inhibition. This mechanism increases local concentrations of cAMP, a key signalling molecule. The company said the therapy's multimodal action may offer benefits in debilitating lung conditions... Full

 

 

Glenmark Enters $45.8 million US OTC Market with New Adapalene Pump Packs

(10/6, Financial Express) ...The gel will be sold in 15 g and 45 g pump packs. Both sizes are listed on Amazon and Walmart.com. Glenmark said the product can be compared to the active ingredient of Differin Gel, 0.1%... Full

 

Lupin Plans To Cut The Generic Eliquis Line In The US With Differentiated Oral Suspension

(10/5, Urte Fultinaviciute, Generics Bulletin) ...As a liquid oral formulation, the drug will offer an "alternative administration option for adult patients requiring anticoagulation therapy, including those who may have difficulty swallowing tablets," Lupin said. Once Lupin secures a final approval, the apixaban oral suspension will be manufactured at the firm's Somerset, New Jersey, facility to leverage its US-based manufacturing... Global Sub. Full

 

Celltrion Launches First Omalizumab Biosimilar in US, Targets PBM Access

(10/6, Yeom Hyun-a, ChosunBiz) ...OMLYCLO is the first biosimilar to "XOLAIR," an antibody therapy jointly developed by Novartis of Switzerland and Roche. Upon launch, it was listed as a preferred drug in the private insurance formulary of Optum, a major U.S. pharmacy benefit manager (PBM). Celltrion said it is also negotiating formulary listings with other major PBMs, with some talks nearing contract signing... Full

 

Alvotech Wins FDA Nod for 2nd Simlandi Manufacturing Suite

(10/5, Feliza Mirasol, BioPharm International) ...FDA has approved a supplement to the biologics license application (BLA) for adalimumab-ryvk (Simlandi), Alvotech's biosimilar to Humira (adalimumab), the company announced October 5, 2026, enabling AVT02 drug substance for US commercial supply to be manufactured in a 2nd production suite at Alvotech's Reykjavik, Iceland, facility... Full

 

Christine Johnston on Why Biosimilars Are Losing Formulary Ground

(10/5, Lauren Gordon, Managed Healthcare Executive) ...Biosimilar versions of Humira and Stelara arrived in 2023 and 2024, promising major savings for payers. But much of that early uptake has since shifted toward newer branded alternatives such as Skyrizi, Rinvoq, and Tremfya, according to Christine Johnston, president and co-founder of Foundational Pharmacy Strategies. The reason, she said, has less to do with clinical performance than with how pharmacy benefit managers are paid... Full

 

 

Astra Doesn't Need a Deal for Growth Beyond 2030, CEO Says

(10/5, Madison Muller, Bloomberg) ...The UK drugmaker has medicines in development across oncology, metabolic and rare diseases. Astra assumes roughly a 60% probability of success across its entire pipeline, [CEO Pascal] Soriot said, compared with about 75% in recent years with late-stage clinical trials that typically have a higher success rate. "If everything was to work, we would completely explode our turnover post 2030," he said... Sub. Req'd

 

AbbVie Updates 2026 Earnings Guidance with Q3 R&D Charges

(10/5, StreetInsider.com) ...The charge is expected to reduce both GAAP diluted earnings per share and adjusted non-GAAP diluted earnings per share by $0.11 for the quarter ended September 30, 2026. The company noted that results for that period have not been finalized and remain subject to financial statement closing procedures... Sub. Req'd

 

Piramal Pharma Solutions Launches New Microbiology Laboratory at Its Lexington, KY Sterile Injectable Facility

(10/6, Piramal Pharma Solutions) ...The new lab more than triples the site's existing microbiology testing space, supporting improved laboratory workflow and providing additional capacity to accommodate future growth. The added space features three new biosafety cabinets, allowing PPS to run concurrent tests and reduce sample queue times. All incubators have also been consolidated within the new lab, further streamlining workflow and improving monitoring and accessibility across testing activities... Full

 

Sectors Up Close: Big Pharma 'Needs to Replace Drugs Coming Off Patent'

(10/5, Reuters) ...The pharmaceutical industry is facing a problem - more than $400 billion of its annual revenue comes from drugs whose patents will expire by 2033. Leah Bennett of Concurrent told Reuters that means they are buying up smaller biotech companies developing new drugs, and those tie-ups could be good news for investors... Full

 

 

India's BioPharma Has Opportunity to Evolve from Manufacturing Powerhouse to Global Innovation Partner

(10/6, Yash Ved, Pharmabiz.com) ...As biopharma moves from conventional biologics towards precision and advanced therapies, India has an opportunity to evolve from a manufacturing powerhouse into a more integrated global innovation partner, according to B G Barve, joint managing director, Blue Cross Laboratories Private Limited... Full

 

Asia-Pacific Roundup: TGA Starts 5-Year Transition to New Australian Medicine Labeling Standards

(10/5, Nick Paul Taylor, Regulatory Focus) ...The old standards, TGO 91 and TGO 92, were revoked automatically on 1 October. TGA used the sunsetting of the standards to update and improve Australia's labeling requirements. The agency brought the new standards, TGO 115 and TGO 116, into effect when the old documents were sunsetted. However, TGA deferred enforcement to give sponsors time to interpret the requirements and update their labels... Full

 

Managing Post-Marketing Pharmacovigilance Across Global Markets

(10/5, Quintin van Wyk, The Pharma Letter) ...In this week's Expert View, Quintin van Wyk of global contract research organization ICON (Nasdaq: ICLR) looks at what happens to drug safety monitoring once a product reaches the market. A medical doctor with more than 24 years in pharmacovigilance and drug safety, Dr van Wyk sets out the case for outsourcing post-marketing safety obligations, and the role of the local qualified person for pharmacovigilance in meeting them... Sub. Req'd

 

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