Friday, September 18, 2026

 

 

Teva Launches LongActingImpact.com to Advance Understanding of Earlier, Effective and Uninterrupted Schizophrenia Care

(9/17, Chain Drug Review) ..."Long-acting injectables can help address one of the most persistent challenges in schizophrenia care – consistent medication adherence – but their potential cannot be fully realized if they are not considered as a treatment option. We've heard from physicians that systemic hurdles, along with the complexities of navigating treatment conversations, can create barriers to care," said Verena Ramirez Campos, VP of U.S. Medical Affairs and Global Innovative Strategy at Teva. "LongActingImpact.com is our commitment to helping remove those barriers by empowering clinicians with the right resources to ensure that people living with schizophrenia have a better chance at a life free from relapse."... Full

 

 

Exclusive-US Weighs Allowing Most Pharma Licensing Deals with China, Sources Say

(9/18, Michael Erman, Reuters) ...The US is working on rules for pharmaceutical companies investing in China that would likely preserve their ability to strike most licensing deals for Chinese drugs, according to three people who have been briefed on the process...The rules – being drafted by the US Treasury Department – are likely to allow US pharmaceutical companies to invest in promising new drugs being developed by Chinese companies as long as they are not related to pathogens or biotechnology that could be weaponized, the sources said... Full

 

Exclusive / White House Claims Drug Pricing Progress

(9/18, David Lim, Semafor) ...President Donald Trump is focusing on drug pricing today, with his administration set to announce all 50 states will see most-favored-nation pricing for certain drugs in Medicaid programs, according to Trump administration plans shared first with Semafor... Full

 

US Plans Medicaid Most-Favored-Nation Pricing for Some Drugs in All States, Semafor Reports

(9/18, Anusha Shah and Sriparna Roy, Reuters) ...President Trump will host the governors of South Dakota, Mississippi and Arkansas in the Oval Office "to tout work on lower drug prices," Semafor said. Reuters could not immediately verify the report... Full

 

MedPAC, Democrats Searching For Answers To Post-Redesign Part D Spending

(9/17, Gabrielle Wanneh, Inside Health Policy) ...Adjusting the calculation of average monthly bids for standalone prescription drug plans and placing more financial responsibility on drug companies when a patient reaches their personal spending limit are a part of the handful of policies listed in the senators' June 16 request for information as potential policies to stabilize Part D market premiums... Sub. Req'd

 

Exclusive: Internal CMS Email Confirms Globe and Guard Exemption Strategy

(9/17, Max Bayer, Endpoints News) ...Emails obtained by Endpoints News through a Freedom of Information Act request show a top CMS official, Corinne Alberts, soliciting feedback from other colleagues when asked by a consultant whether participating in Generous could lead to exemptions in the other two programs, Globe and Guard... Sub. Req'd

 

Graham: PDUFA VIII Reflects 'America First' Principles

(9/17, Joanne S. Eglovitch, Regulatory Focus) ...During the public meeting, regulators outlined the performance goals and program enhancements contained in the PDUFA VIII proposal spanning premarket drug review, postmarket safety, and chemistry, manufacturing, and controls (CMC) enhancements. Representatives from industry supported many of the changes proposed in the commitment letter... Full

 

GDUFA IV Deal Gives Contract Manufacturers More Say, Defuses 'Potential OAI' Pain Point

(9/17, Sue Sutter, Pink Sheet) ...At a September 17 public meeting on the GDUFA IV agreement, representatives from the Association for Accessible Medicines (AAM), Pharma and Biopharma Outsourcing Association (PBOA), and Bulk Pharmaceuticals Task Force (BPTF) highlighted a new opportunity for facilities to discuss inspection findings with the FDA, and a new clearly defined goal date extension when an inspection results in a "potential Official Action Indicated" tag. The provisions are among several in the commitment letter aimed at increasing communication and improving the first-cycle approval rate... Global Sub. Full

 

Convergence: Califf Says Regulations 'Need an Update,' Sees AI Assistants in Regulatory Future

(9/17, Jeff Craven, Regulatory Focus) ...Califf said he sees a future in regulating devices similar to current food regulation, rather than traditional drug and device regulation... Full

 

Patient Assistance Program Gets OIG Thumbs Up - But Only For Two Years

(9/17, Cathy Kelly, Pink Sheet) ...The check-in will also allow the OIG to assess the program in light of the Inflation Reduction Act's redesign of the Medicare Part D benefit, including an annual cap on beneficiary out-of-pocket spending, and the IRA's price inflation rebates and reduced coinsurance in Part B, the advisory said... Global Sub. Full

 

 

U.S. Women Seeking Hormone-Free IUDs Come Up Short

(9/18, Annie Burns-Pieper, The New York Times) ...Thousands of lawsuits have been filed against the makers of Paragard, claiming the device can break during removal and cause injuries, sometimes requiring surgery...Grace Ann Arnold, vice president of global corporate affairs at Teva Pharmaceuticals, said Paragard was a "safe, effective," nonhormonal option and that the "possibility of breakage and the potential need for surgical removal" were included in its labeling... Sub. Req'd

 

 

Aurobindo Gets FDA Nod For Second Generic QVAR Inhaler

(9/17, Anabel Costa-Ferreira, Generics Bulletin) ...The regulator has currently approved the product across two strengths, 40mcg and 80mcg, providing exact generic equivalents of Teva's branded QVAR inhalation aerosol indicated for the same dosages... Global Sub. Full

 

Sandoz Approved for Semaglutide Sales in Canada

(9/18, Adrià Calatayud, The Wall Street Journal) ...The company doesn't anticipate any material earnings contribution this year from any potential launches of generic versions of semaglutide and the approval in Canada has no effect on its 2026 guidance, it said... Sub. Req'd

 

Sandoz Partners With MAbxience On Hemophilia Biosimilar Program

(9/18, TajSabreen Ahamed, RTT News) ...Under the agreement, the companies will collaborate on a proposed Emicizumab biosimilar that is currently in early-stage development. Sandoz will hold exclusive global commercialization rights, excluding Argentina, Uruguay and Paraguay, while mAbxience will be responsible for development and manufacturing. The financial terms of the agreement were not disclosed... Full

 

Opdivo Biosimilar Competition Ramps Up With Dr Reddy's Launch In India

(9/17, Dave Wallace, Generics Bulletin) ...Marketed as Nivorz, Dr Reddy's biosimilar is approved across 12 indications – spanning both solid and hematological malignancies – and was developed entirely in-house by the Indian firm at its biologics facility in Bachupally, Hyderabad... Global Sub. Full

 

Generic Drugs Get a Legal Boost From Supreme Court Ruling, Law Firm Analysis Finds

(9/17, Todd Shryock, Medical Economics) ...Ballard Spahr says the Hikma v. Amarin decision makes it harder for brand-name drugmakers to sue over "skinny label" generics — a shift likely to speed generic competition and lower costs for patients... Full

 

 

'Still a Bull': Novo's CEO on Honoring Heritage and Planning for the Future Amid Corporate Rebrand

(9/17, Fraiser Kansteiner, Fierce Pharma) ..."Internally and externally, there is a recognition that Novo Nordisk needs to rethink and revise some parts of its strategy," [CEO Mike] Doustdar said of how he's framed the decision to colleagues. "Some parts are actually still very intact," he said of Novo's existing business. "Diabetes, obesity are very core to what we do, and we need to strengthen and continue that leadership." That said, "there is more to that than we thought," the Novo CEO admitted... Full

 

When Weight Loss Isn't the Goal of Taking a GLP-1

(9/18, Sumathi Reddy, The Wall Street Journal) ...Dr. Louis Cohen, a gastroenterologist and associate professor at Mount Sinai in New York City, is studying whether tirzepatide—the active ingredient in Eli Lilly's Zepbound and Mounjaro —can improve symptoms in patients with Crohn's disease, a type of inflammatory bowel disease...While there is a decent amount of data showing that Crohn's patients can tolerate GLP-1s, Cohen says he's not yet prescribing them off-label for patients who don't meet the criteria. He's holding off until he sees trial data but is encouraged by reports that GLP-1s helped improve outcomes in patients with psoriasis, which has similar medical characteristics to Crohn's... Sub. Req'd

 

 

China May Follow US To Limit Biotech Deals, Pfizer CEO Warns

(9/17, Andrew McConaghie, Pink Sheet) ...Pfizer's CEO Albert Bourla told the Morgan Stanley investor conference on Sept. 15 that he had been speaking out against moves for new US laws to allow federal agencies to "screen" licensing deals, joint ventures and equity investments between US and Chinese companies. But he also flagged similar new restrictions coming from the Chinese administration: "The political risk is from both sides," he said, adding voices in both countries were looking to slow down or query deals... Global Sub. Full

 

Convergence: EU Officials Tout Pending Pharmaceutical Reforms

(9/17, Ferdous Al-Faruque, Regulatory Focus) ...Antonios Rodiadis, a policy officer at the European Commission's Directorate-General for Health and Food Safety (DG SANTE), noted the reforms proposed in the new EU pharmaceutical legislation are intended to revise two decades of EU pharmaceutical rules. It includes a new Directive and Regulation to update and simplify the region's pharmaceutical rules and regulatory framework and added that the reforms are also intended to complement the proposed Critical Medicines Act, Biotech Act, Medical Device Regulation (MDR), and more... Full

 

UK Government Committees Call for Probe into US Pharma Deal

(9/18, Anna Brown, Endpoints News) ...Six UK government committees have called for an investigation into the cost of the UK's pharmaceutical trade deal with the US. The letter, published Wednesday, demands that the UK's watchdog, the National Audit Office, launch an investigation into the costs of the UK-US deal and the long-term impacts on the country's National Health Service... Sub. Req'd

 

Delhi High Court Says Payments to Overseas Units Aren't Automatically Taxable in India

(9/18, Krishna Yadav, Mint) ...The court said the tax department must establish a sufficient nexus between India and the income-producing right or activity, or bring the receipt within a specific statutory provision. In Teva's case, the pharmaceutical rights, US regulatory process, litigation, settlement and market from which the economic return arose were substantially outside India. The court therefore held that "mere payment by an Indian resident to a non-resident ipso facto does not constitute an income accruing or arising in India."... Full

 

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