Tuesday, October 13, 2026

 

 

Teva Seeks To Shake Up Schizophrenia Market With Long-Acting Injectable Olanzapine Approval

(10/13, Dave Wallace, Generics Bulletin) ...In an analysts call taking place immediately after the approval was announced, Hughes set out the scale of the opportunity that Teva perceived for Weltruza. "This patient population is not insignificant," Hughes set out. "There's 2.2 million people [living with schizophrenia] in the US, about 1.5 million of them get treated and 20% of all those patients who get treated are on an oral olanzapine."... Global Sub. Full

 

FDA Approves Once-Monthly Olanzapine Injection for Adults with Schizophrenia

(10/12, Brian Nowosielski, Drug Topics) ...On Friday, FDA granted approval of the long-acting injectable (LAI) olanzapine (Weltruza) for the treatment of adults with schizophrenia, according to a news release.1 Once available, Teva Pharmaceuticals' newly approved LAI will be the first and only once-monthly, subcutaneous olanzapine for this population... Full

 

Teva Wins FDA Approval for Once-Monthly Olanzapine Injection

(10/12, Emily Letton, Manufacturing Chemist) ...Teva plans to launch WELTRUZA in the US in the coming weeks, in three strengths: 318 mg, 425 mg and 531 mg... Full

 

FDA Approves First Once-Monthly Subcutaneous Olanzapine LAI for Adults With Schizophrenia

(10/12, Gillian McGovern, Pharmacy Times) ...According to Teva Pharmaceuticals' announcement, the treatment requires no loading doses, no oral supplementation, and no postinjection monitoring... Full

 

Teva Wins FDA Nod for Monthly Olanzapine Shot That Ends Monitoring

(10/12, Heo Ji-yoon, ChosunBiz) ...The approval was based on the phase 3 SOLARIS study. In the trial, Weltruza improved schizophrenia symptoms and disease severity, and its safety profile largely aligned with that of oral olanzapine... Full

 

US FDA Approves Teva's Weltruza for Extended-Release Injectable Suspension, a New Once-Monthly Subcutaneous LAI for Adults with Schizophrenia

(10/12, Pharmabiz.com) ..."Weltruza offers the proven efficacy of olanzapine in an innovative long-acting subcutaneous injectable, helping to fill a major, long-standing gap in the schizophrenia treatment landscape," said Chris Fox, executive vice president, US commercial and head of innovative franchise at Teva. "Weltruza was developed with the patient in mind from day one and it is a powerful demonstration of what is possible when the needs of the patient guide the development of a truly innovative medicine. This important milestone also helps further Teva's Pivot to Growth strategy."... Full

 

FDA Approves Teva's Monthly Injection of Olanzapine for Schizophrenia

(10/12, Robert Barrie, Pharmaceutical Technology) ...Teva's chief medical officer Eric Hughes said: "Weltruza combines proven science and novel formulation innovation to eliminate the need for monitoring after each injection, addressing a significant barrier to treatment and advancing care for people living with schizophrenia."... Full

 

Drugmaker Corcept Seeks to Bar Ex-Judge's Views in Teva Antitrust Case

(10/12, Mike Scarcella, Reuters) ...Corcept Therapeutics is seeking to exclude testimony from a retired federal appeals court judge supporting Teva Pharmaceuticals in an antitrust lawsuit, arguing her opinions could sway jurors without shedding light on the facts of the case... Full

 

 

1 Big Thing: "Medicare for All" Support Surges

(10/13, Margaret Talev, Axios) ...The big picture: Two-thirds of all survey respondents — and half of Republicans — said the federal government should be willing to spend more tax dollars to lower health care costs for Americans. Why it matters: With three weeks to go before the midterm elections, and private health insurance premiums and prescription prices crushing voters, these findings suggest a path for swing-state candidates who embrace socialized medicine... Full

 

Medicare Drug Price Negotiations Yield Uneven Out-of-Pocket Savings

(10/12, Brooke McCormick, AJMC) ...Medicare beneficiaries using lower-priced negotiated drugs experienced out-of-pocket savings under the Medicare Drug Price Negotiation Program (MDPNP), whereas those whose spending exceeded the annual out-of-pocket cap saw no direct savings, according to a research letter published today in Annals of Internal Medicine... Full

 

Biosimilar Bills Would Automate Medicare Negotiation Delays

(10/12, Sabrina McCrear, The Center for Biosimilars) ...Under the MDPN program, drugs and biologics qualify for price negotiation if they are single-source brand-name products without a therapeutically equivalent generic or biosimilar that is approved or licensed and marketed on a "bona fide" basis. They must also be at least 7 years (small-molecule drugs) or 11 years (biologics) past FDA approval or licensure. Certain drugs are excluded from negotiation, including orphan drugs, low-spending drugs, plasma-derived products, and, from 2026 to 2028, "small biotech" drugs... Full

 

Biosimilars: FDA Finalizes Guidance on Postapproval Manufacturing Changes

(10/12, Ferdous Al-Faruque, Regulatory Focus) ...The agency said the changes are intended to harmonize with principles set in the International Council for Harmonisation (ICH) guidance for industry entitled "Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process."... Full

 

US FDA's NDA/BLA Approval Pace Back On Track, Slowdown Concerns Appear Averted For Now

(10/12, Derrick Gingery, Pink Sheet) ...The FDA cannot fully control the number of applications it can approve because submission times and review issues are not always predictable. But the agency now is on track to approve about 145 applications by the end of calendar year 2026, which would be less than the 2025 total of 168, but still be the sixth highest total in the previous 13 years... Global Sub. Full

 

 

First Tracks Climbs on 'Impressive' Celiac Study Data

(10/12, Delilah Alvarado, BioPharma DIVE) ...First Tracks, Argenx and Teva Pharmaceuticals all have drug prospects in clinical testing against celiac. First Tracks' drug ANB033 blocks the activity of CD122, a receptor component used by two immune-regulating proteins IL-2 and IL-15. Argenx's therapy, acquired in a recent buyout, also targets CD122. Teva's treatment homes in on IL-15 specifically. Teva and Argenx's drugs have already shown promise in early celiac trials. Their success heightened anticipation for the findings First Tracks reported on Monday... Full

 

Positive Clinical Profile of AstraZeneca's Tozorakimab in COPD

(10/12, The Pharma Letter) ...Caterina Brindicci, senior vice president and global h of R&D, respiratory, AstraZeneca, said: "These results reinforce tozorakimab's unique approach of inhibiting the signalling of two forms of IL-33 which translates to real clinical impact delivering durable and consistent benefits across a broad population. With these data, we further our understanding of the underlying drivers of COPD and how tozorakimab has the potential to help address how we treat this complex disease in a fundamentally new way," she noted... Sub. Req'd

 

A Newer Class of Migraine Drugs Is Linked to a 40% Rise in Miscarriage Risk

(10/13, Jess Cockerill, Science Alert) ...The new study, led by epidemiologist Anick Bérard of Centre Hospitalier Universitaire Sainte-Justine in Canada, suggests CGRP-blocking mAbs may interfere with a developing pregnancy, although the evidence is still quite limited at this stage. The study is observational, which means it can only identify associations, not establish a cause... Full

 

 

Zydus Lifesciences and Formycon Announces US FDA's Acceptance of BLA for Pembrolizumab Biosimilar

(10/13, Pharmabiz.com) ...Zydus Lifesciences Limited (Zydus), an innovation-led global life-sciences company, and Formycon AG (Formycon), an independent developer of biosimilars, today jointly announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda (pembrolizumab). To the best of the companies' knowledge, this is the first publicly announced acceptance by the US FDA of an application for a Keytruda biosimilar... Full

 

Accord BioPharma Launches FILKRI™ (filgrastim-laha); Now Offers Both Long- and Short-Acting G-CSF Options

(10/12, Accord BioPharma) ...Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim)... Full

 

Celltrion Promotes OMLYCLO at Japan Allergy Congress Ahead of Launch

(10/13, Hong Da-yeong, ChosunBiz) ...Celltrion(068270) said on the 13th that it will showcase OMLYCLO, which treats asthma and hives, at the World Allergy Congress. OMLYCLO is a biosimilar (biologic copycat drug) of XOLAIR, developed by Swiss drugmaker Novartis... Full

 

Novo's Semaglutide Patent Iceberg Keeps Shrinking In Europe

(10/13, Urte Fultinaviciute, Generics Bulletin) ...In an email to Generics Bulletin, the firm specified that the patent covered the use of semaglutide to reduce the risk of non-fatal stroke in patients with type 2 diabetes. Even though the patent was revoked, "this benefit, as well as additional cardiovascular benefits, remains in the label, and the compound patent still stands," Novo added. Novo told Generics Bulletin that the EPO's "decision is not expected to have a significant business impact."... Global Sub. Full

 

 

J&J Beats Earnings Estimates; Middle East Conflict Weighs on Medical Device Sales

(10/13, Reuters) ...Johnson & Johnson reported a slightly higher-than-expected profit on Tuesday, driven by strong sales of immune disease treatment Tremfya, but geopolitical issues including the Middle East conflict were a drag on its medical devices business... Full

 

Roche Strikes Obesity Drug Licensing Deal Worth up to $1.16 Bln with Chinese Rona Therapeutics

(10/13, Reuters) ...Roche, entered a licensing agreement worth up to $1.16 billion with Rona Therapeutics for its investigational obesity drug candidate, the Chinese biotech firm said on Tuesday...With the deal, Rona Therapeutics is set to receive an upfront payment of $100 million and is eligible to receive up to $1.06 billion in potential milestone payments, as well as tiered royalties on global net sales... Full

 

Piramal Pharma Cuts Exposure to Chinese Raw Materials to Reduce Supply Risk

(10/13, Satviki Sanjay, Aryan Gupta, Business Standard) ..."One of the things that we worked really hard on is limiting our exposure to China," Nandini Piramal, chairperson at Piramal Pharma told Haslinda Amin on the sidelines of Bloomberg's New Economy Forum in New Delhi on Tuesday. "We've gotten it down to single-digits," she said without elaborating... Full

 

BMS Doubles Up with Pivotal Wins in Lung Disease, Solid Tumor That Offer Hope for Post-Patent Cliff Growth

(10/12, Nick Paul Taylor, Fierce Biotech) ...One phase 3 trial, Aloft-IPF, tested the LPA1 antagonist admilparant in adults with idiopathic pulmonary fibrosis (IPF). The other study, Action-1, evaluated a radiopharmaceutical therapy, RYZ101, in people with SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Both trials met their primary endpoints, albeit without fully resolving doubts about the programs... Full

 

Parkinson's-Focused Aspen and Bispecific Biotech Bambusa Plan IPOs

(10/12, James Waldron, Fierce Biotech) ...Aspen's move comes off the back of promising phase 1/2a data for its Parkinson's asset. The autologous therapy, called sasineprocel, is designed to turn skin cells from patients into stem cells that are then prompted to become new neurons to be implanted into the brain... Full

 

Surviving the Adderall Shortage, Still, in 2026

(10/12, Psychology Today) ...The shortage has improved without ending. Teva currently lists amphetamine mixed salts extended-release 10 mg and 15 mg capsules on back order with release estimated in early September 2026, and the 20 mg capsule estimated in late October 2026. Immediate-release tablets remain inconsistent from strength to strength and from pharmacy to pharmacy... Full

 

The Bottlenecks That Slow Manufacturer Response to Increased Demand for Production

(10/13, Marc Wagner, Mike Hollan, Pharmaceutical Executive) ...Fox Rothschild's Mark Wagner on why scaling drug production is so slow — overseas API sourcing, supplier qualification, and FDA site approvals that take years... Full

 

 

Together Not Divided – How EU Member States Should Counter US Drug Policy Challenges

(10/13, Francesca Bruce, Pink Sheet) ...The terms of any deals made by individual EU member states to secure better terms from the US warrant scrutiny, while industry must make clear what it is offering in return for higher prices, said speakers at the forum... Global Sub. Full

 

Trump Wants Europe to Pay More for Medicines. Why Is Big Pharma Worried?

(10/13, Luciën Hordijk, Follow the Money) ...The Trump administration is also pressuring such companies to move production back to the United States. But this approach – the effects of which are already being felt in Europe – could leave everyone worse off, a number of experts told Follow The Money... Full

 

England Targets Local Budget Barriers To Quicken Uptake Of Reimbursed Drugs

(10/12, Dean Rudge, Pink Sheet) ...A six-to-eight-week call for participation from NHS regions is expected to open "this autumn," with participating regions selected before the end of 2026, NHS England said in an Oct. 9 guest article published by the Association of the British Pharmaceutical Industry (ABPI), which represents the UK research-based pharmaceutical industry... Global Sub. Full

 

'Stay Tuned for What Comes Next': US Envoy Says 'So Much Happening' in India-US Ties

(10/13, Mahima Sharma, The Times of India) ...Speaking at an event in Kolkata to mark the 250th anniversary of American Independence, [US ambassador to India Sergio Gor] highlighted the growing partnership across sectors, from military exercises and defence collaboration to technology and pharmaceutical trade. "India and the US have a great relationship, there's so much happening; pick any sector and we're working together in it," he said... Full

 

Beyond US: New Shores, New Bets

(10/12, Neha Aathavale, Express Pharma) ...So perhaps the question facing Indian pharma is not simply whether to look beyond the US, but which shores to reach next, how to make landfall, and how to build a business once there... Full

 

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