Wednesday, December 10, 2025

NDA Submission: Olanzapine Extended-Release Injectable Suspension for Treatment of Schizophrenia

(12/9, Leah Kuntz, Psychiatric Times) ...The NDA for olanzapine long-acting injectable (LAI) is based on results from the phase 3 SOLARIS trial, including week 56 results studying its efficacy, safety, and tolerability in participants aged 18 to 64 with schizophrenia. These results demonstrate that olanzapine LAI meets efficacy and safety endpoints in a broad adult population of individuals living with schizophrenia... Full

Teva Files LAI Olanzapine With FDA, Paving Way for $2Bn Schizophrenia Franchise

(12/10, Dean Rudge, Generics Bulletin) ...Importantly, SOLARIS showed no suspected or confirmed post-injection delirium/sedation syndrome (PDSS) events for TEV-'749, easing a key safety concern linked to older olanzapine injectable formulations which has historically limited their use. TEV-‘749 leverages Teva's partner MedinCell's SteadyTeq copolymer technology to deliver a controlled and sustained release of olanzapine, a widely used second-generation antipsychotic, in a bid to overcome ongoing adherence in a population where relapse rates remain high and discontinuation is common... Global Sub. Full

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

(12/10, Chelsie Derman, HCP Live) ..."The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation," said Eric Hughes, MD, PhD, executive vice president, global R&D and chief medical officer at Teva, in a statement..."Teva is committed to working closely with the FDA on the review of this olanzapine LAI application as we seek to help address the critical unmet needs of people living with schizophrenia," Hughes continued... Full

Teva Submits FDA Application for Monthly Schizophrenia Injection

(12/10, StreetInsider.com) ...The drug is not currently approved by any regulatory authority for any use... Sub. Req’d

Teva Price Target Raised to $32 from $29 at BofA

(12/9, The Fly) ...BofA raised the firm's price target on Teva to $32 from $29 and keeps a Buy rating on the shares after having hosted fireside chats with management teams at the firm's CNS Therapeutics Conference... Sub. Req’d

"Innovation Is Not Exclusively the Preserve of Early-Stage Enterprises"

(12/10, Globes) ...The Conference, which was chaired by Adv. Stephen Rozen, partner and head of International Relationships and the Israel Innovation Authority (IIA) practice at APM, was also attended by innovation managers from major organizations in the Israeli economy, including Pazit Algoaz, head of innovations at the Phoenix Finance Group; Dr. Dana Bar-On, head of global academic collaborations at Teva Global R&D; Netta Benari, VP Business Development and Innovation, Bazan Group; and Natan Feldman, VP Marketing and Innovation at the Haifa Group... Full

Analysts Urge Stronger Pharmaceutical Trade Controls to Counter China

(12/10, David LaRoss, Inside U.S. Trade) ...Former Assistant Commerce Secretary Nazak Nikakhtar and others on Tuesday at an Atlantic Council event on biodefense argued that the White House's planned tariffs on patented and brand-name drugs will not go far enough to address what they contend is an urgent national-security threat from China's control of key links in the pharmaceutical supply chain. "We need to start limiting imports immediately, commensurate with the growth of the domestic industry -- and we need investment in domestic industry," Nikakhtar, who during the first Trump administration held a senior position at the International Trade Administration and was the acting head of the Bureau of Industry and Security. She is now a partner at Wiley Rein... Sub. Req’d

US and India Launch New Trade Talks Amid Tariff Tensions

(12/10, AFP) ...US and Indian trade negotiators began two days of talks on Wednesday seeking an elusive deal amid geopolitical turbulence...Deputy US Trade Representative Rick Switzer's visit comes a week after Prime Minister Narendra Modi hosted Russian President Vladimir Putin in New Delhi. India's foreign ministry described Switzer's meetings as a "familiarisation" trip... Full

Beyond the Numbers: Insights From The 2027 Medicare Drug Price Negotiation Cycle

(12/9, Kristi Martin and Rachel Sachs, Health Affairs) ...In this article, we consider five qualitative aspects of this negotiation cycle that go beyond the quantitative analyses others may offer. Some of our takeaways from this negotiation cycle reflect how it differs from the first, initial price applicability year (IPAY) 2026 cycle and the prices announced last year. Other takeaways relate to the drugs selected and/or the background circumstances while prices were being negotiated... Full

Medicare Modeling Shows Major Savings With Biosimilar Bevacizumab Use

(12/9, Skylar Jeremias, The Center for Biosimilars) ...Even with these constraints, the findings highlight the potential for biosimilars to extend access to oncology biologics within fixed budgets-an issue of growing importance as Medicare's oncology expenditures continue to rise. For bevacizumab, the model suggests that bevacizumab-bvzr may offer the most cost-efficient option among available biosimilars, allowing payers to treat more people with cancer without increasing overall spending... Full

Solicitor General Urges Supreme Court to Review ‘Skinny Labeling' and Generic Drug Access

(12/9, Ed Silverman, STAT+) ...The apprehension over the escalating legal skirmish reflects uncertainty about the direction the Supreme Court may now take. Its decision two years ago to allow an appeals court ruling to stand in a case between GSK and Teva Pharmaceuticals was interpreted by some legal experts as a possible one-off situation... Sub. Req’d

US FDA Continues Push For Rx-OTC Switches With New MaPP For Generics

(12/9, Malcolm Spicer, Pink Sheet) ...The Center for Drug Evaluation and Research's Office of Generic Drugs published the MaPP for prescription-to-nonprescription switches and abbreviated new drug applications on Dec. 8 to explain the regulatory responsibilities of ANDA holders when a reference listed drug is approved for an OTC switch. The document is the first MaPP on the subject since 2018... Global Sub. Full

 

FDA Finalizes Guidance on Biologic, Biosimilar Promotional Labeling

(12/9, Joanne S. Eglovitch, Regulatory Focus) ...The questions address several key topics, including: the general requirements for the content of promotional communications regarding reference and biosimilar products; how firms should identify reference products and biosimilar products in their promotional materials; what firms should consider when presenting information from studies that support the licensure of the reference product, especially if that information is included in the FDA-approved labeling for both the reference product and the biosimilar; and what firms should take into account when comparing a biosimilar product to its reference product in their promotional communications... Full

FDA Publishes PSGs For GLP-1 Giants Mounjaro, Wegovy, Victoza/Saxenda

(12/10, Urte Fultinaviciute, Generics Bulletin) ...The FDA's December batch of PSGs included 81 development recommendations, of which 44 were new and 37 were revised. Complex products were addressed in 28 PSGs, with seven being new and 21 recommendations being revised. Additionally, the agency provided its recommendations for products with no approved ANDAs in 54 PSGs, including 19 for complex products... Global Sub. Full

First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity

(12/9, FDA) ...The Augmentin XR application demonstrated clear alignment with the CNPV program's national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. This approval will also help address antibiotic shortages in the U.S. that have plagued the healthcare system over the past two decades... Full

Exclusive-US FDA Launches Fresh Safety Scrutiny of Approved RSV Therapies for Infants

(12/9, Dan Levine and Patrick Wingrove, Reuters) ...The preventive therapies - Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck - would be the latest called into question under U.S. Health Secretary Robert F. Kennedy Jr., a long-time promoter of anti-vaccine views who is presiding over a review of routine childhood immunizations... Full

WH Ignores Demands From Pro Life Lobby To Fire FDA Commissioner

(12/9, Philip Wegman, RealClear Politics) ...Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, called on Trump to fire Makary after news broke that the FDA had put the effort on the back burner despite multiple promises to Congress..."FDA Commissioner Marty Makary is working diligently to ensure that Americans have the best possible, Gold Standard Science study of mifepristone. The White House maintains the utmost confidence in Commissioner Makary," Trump spokesman Kush Desai told RCP in a statement, pointing to "one landmark victory for the American people after another" from his crackdown on artificial food ingredients to the first safety review of baby formula in decades... Full

Many CBER Leadership Posts Vacant, FDA Leans On AI To Fill Review Gaps

(12/9, Maaisha Osman, Inside Health Policy) ...On Dec. 1, FDA announced the deployment of agentic AI tools to assist with everything from pre-market reviews and validation to post-market surveillance, inspections, compliance, meeting management and administrative work. Agentic AI describes tools intended to accomplish tasks with limited human oversight, though exact definitions of the term vary. FDA Commissioner Marty Makary said the expansion is part of an effort to put "the best possible tools" in the hands of reviewers, scientists and investigators and to modernize the agency's operations to "accelerate more cures and meaningful treatments."... Sub. Req'd

AAM Urges ‘Steady Leadership' At FDA Following Pazdur's Abrupt Resignation

(12/9, Dean Rudge, Generics Bulletin) ...As the FDA navigates the latest senior leadership transition – with Tracy Beth Høeg, a senior advisor for clinical sciences at the agency, set to take on the CDER role on an acting basis – the AAM said it remained confident in the FDA's "deep bench" of scientific and regulatory expertise... Global Sub. Full

FDA Clears Amneal Epinephrine Injection

(12/9, Terrell Wright, Dow Jones Newswires) ...Amneal said that the Food and Drug Administration has approved its epinephrine injection in both single and multi-dose vials for hospitals... Full

ASH: Lilly Oncology Chief Sees Sweet Spot for Jaypirca in 2nd-Line CLL Despite 1st-Line Trial Wins

(12/10, Angus Lie, Fierce Pharma) ...Despite holding positive phase 3 data that position its BTK inhibitor Jaypirca for a first-line approval in chronic lymphocytic leukemia (CLL), Jacob Van Naarden, president of Lilly Oncology, maintained that the drug's primary value proposition remains in serving patients who require second-line treatment. "The main use case of the medicine, I think, remains in second-line," Van Naarden said in an interview with Fierce Pharma... Full

Zydus to Enter US Biosimilar Market via Keytruda Partnership with Germany's Formycon

(12/9, Viswanath Pilla, Money Control) ...Zydus Lifesciences on Tuesday said it has inked an exclusive licensing and supply agreement with Germany's Formycon AG to commercialize FYB206, a biosimilar of Merck's blockbuster cancer drug Keytruda (pembrolizumab), in the US and Canada... Full

Polpharma Biologics and Libbs Farmacêutica Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases

(12/10, Polpharma Biologics) ...Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, is thrilled to announce the signing of a landmark licensing agreement with the Brazilian company Libbs Farmacêutica! Through this strategic partnership, Libbs Farmacêutica will gain exclusive rights to commercialize a cutting-edge biosimilar for autoimmune diseases in the rapidly growing Brazilian market... Full

Looming GLP-1 Drug Patent Expirations Draw Generics Firms

(12/9, Aayushi Pratap, C&EN) ...The market is ripe in countries where semaglutide goes off patent next year, as close to one-third of the world's adults with obesity live in those countries, says Aurelio Arias, director of thought leadership at Iqvia, a health-information company..."Among those markets, India and China alone represent about a quarter of the world's adult obese population, and the availability of generic semaglutide will be a big shift in how these countries manage these populations," Arias says... Full

Pfizer Boosts its Obesity Plans with $2bn GLP-1 YaoPharma Deal

(12/10, European Pharmaceutical Review) ...The deal with China-based manufacturer YaoPharma will focus on development, manufacture and commercialisation of its phase I GLP-1 drug YP05002. YaoPharma will receive $150 million upfront and is eligible for milestone payments plus tiered royalties on sales, if the deal is approved... Full

Roll Tide: Lilly Selects Alabama Site as Location for $6B API Facility

(12/9, Kevin Dunleavy, Fierce Pharma) ...The drugmaker has selected Huntsville, Alabama, as the site of a $6 billion plant that will produce active pharmaceutical ingredients (APIs) for peptide and small-molecule medicines, including the highly anticipated GLP-1 weight-loss pill, orforglipron. Lilly plans to employ 450 at the complex, including engineers, scientists, operations personnel and lab technicians. The Indianapolis-based company expects to begin construction in 2026 and complete the facility in 2032. Lilly estimated that the project will also generate 3,000 construction jobs... Full

CVS Boosts Profit Outlook in Sign of Momentum as 2026 Nears

(12/9, Ike Swetlitz, Bloomberg) ...The outlook suggests CVS expects to manage a volatile environment that has posed challenges for all three of its businesses. Health insurance plans are facing greater government scrutiny and drug benefit managers are changing their business practices while retail pharmacies are struggling to increase their profits... Sub. Req’d

Novartis Pens $1.7B Immuno-Dermatology Pact with AI-Enabled British Biotech

(12/10, James Waldron, FierceBiotech) ...What caught the Swiss pharma's eye is the so-called Lab-in-the-Loop platform developed by London-based Relation Therapeutics. The biotech has touted the platform as a way to "integrate state-of-the-art AI with patient-derived multi-omic data and proprietary experimental systems to uncover causal genes and refine target hypotheses."... Full

AI Shows Potential Against Resistant Bacteria

(12/10, Patrick Temple-West, Financial Times) ...With these superbugs advancing, the antibiotics needed to kill them must punch back. As the pandemic worsened in 2020, some scientists turned to machine learning tools to design and develop antibiotics. Their project, named Phare Bio, was started with US government funding and a grant from Google's philanthropic division... Sub. Req’d

Shooter Claiming Adderall-Fueled Psychosis Wins New Murder Trial

(12/9, Holly Barker, Bloomberg Law) ...The district court botched its instructions on voluntary intoxication when it told the jury that Robert Rainford couldn't have been involuntarily intoxicated if he knew of Adderall's possible intoxicating effects or had used illegal drugs while taking his prescription. Those factors might be probative of whether intoxication was involuntary, but they aren't dispositive, the US Court of Appeals for the Tenth Circuit said... Sub. Req’d

Big Pharma's Patent Cliff Puts China in Spotlight: Juliana Liu

(12/9, Juliana Liu, Bloomberg Law) ...For pharmaceutical firms, watching the lucrative patents on their top-selling drugs expire has long been part of the business cycle. There's enormous pressure to find ways of covering the shortfall. For the first time, China has something to offer. Its prolific biotech companies are now in the mix as a potent remedy for the upcoming so-called "patent cliff" facing the industry... Sub. Req'd

UK Pilot On Clinical Trial Modifications Delivers Approvals In Under A Week

(12/9, Anabel Costa-Ferreira, Pink Sheet) ...The UK's new pilot process for approving certain low-risk substantial modifications to already approved clinical trials is delivering impressive results, with an average response time of under seven days and some approvals taking just two days, according to the Medicines and Healthcare products Regulatory Agency... Sub. Req'd

Belgian Regulator Presses Roche Further Over Biosimilar Abuse Allegations

(12/9, Dave Wallace, Generics Bulletin) ...The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab... Sub. Req'd

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