Monday, June 30, 2025

Teva's CEO Shares 'Pivot to Growth' Progress

(6/27, Ayla Ellison, Fraiser Kansteiner, Fierce Pharma) ...On this week's episode of "The Top Line," Fierce Pharma's Fraiser Kansteiner sits down with Francis to talk about the progress made so far on Teva's "Pivot to Growth" strategy and what comes next. They dig into the strategies behind the company's chief commercial medicines, its pipeline darlings and the way Teva's generic and biosimilar backbone is expected to evolve through the end of the decade... Full

Teva Leads Call to Secure Europe's Access to Critical Medicines and Protect Health Sovereignty

(6/27, Pharmaceutical Manufacturer) ...Speaking at the Medicines for Europe Annual Conference, Michal Nitka, SVP head generics Europe & global head OTC at Teva Pharmaceuticals, highlights the essential role of a resilient, competitive, and environmentally sustainable pharmaceutical industry in safeguarding patient access to medicines and strengthening Europe's healthcare sovereignty... Full

Sandoz Board Chair ‘Convinced That Common Sense Will Ultimately Prevail' On US Pharma Tariffs

(6/28, Philippe Monnier, Swissinfo.ch) ...Pharmaceuticals have so far been excluded from the sweeping new tariffs announced by the United States, but the sector may not be spared for long. The pharma industry, including generics, could be hit with 25% tariffs or more...Swissinfo met Sandoz board chair Gilbert Ghostine at the company's headquarters in Basel. In an exclusive interview, he analyses the impact that US tariffs would have on the company, the pharma sector's dependence on certain regions for sourcing, and ways to avoid future drug shortages... Full

Trump Officials Met With Walmart On Direct-to-Patient Drug Sales

(6/27, Rachel Cohrs Zhang and Jaewon Kang, Bloomberg) ...US health officials met with with Walmart Inc., Amazon.com Inc. and other retailers this week as part of an effort to help Americans get their medicines more directly from companies that make them, according to people familiar with the talks. The conversations between the Trump administration and experts from the nascent straight-to-consumer drug industry are intended to explore streamlining the way Americans get their medicines and therefore lower costs, said the people, who weren't authorized to speak publicly on the matter... Sub. Req’d

Congress Should Reconsider Breaking Up Pharmacy Benefit Managers, Experts Say

(6/27, Rebecca Pifer, Healthcare Dive) ...Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy benefit managers' chokehold on the U.S. drug market, experts said during a drug pricing transparency forum in Washington, D.C. this week... Full

J&J Suffers a Loss Over 340B Drug Discount Program

(6/27, Ed Silverman, STAT+) ...The decision marks the second time in as many months that a federal court sided with the U.S. Health Resources and Services Administration, which last year pushed back against plans by several drug makers to alter their payment models for the 340B Drug Discount Program. Last month, a different judge reached the same decision in lawsuits brought by Eli Lilly, Bristol Myers Squibb, and Novartis... Sub. Req’d

US Senator Probes GSK's Halt of Children's Asthma Inhaler

(6/27, Ahmed Aboulenein, Reuters) ...U.S. Senator Maggie Hassan said on Friday she is launching an investigation into British pharmaceutical giant GlaxoSmithKline's decision to discontinue a widely used asthma inhaler for children... Full

Senator Launches Investigation into GSK's Asthma Inhaler Maneuvers

(6/27, Ed Silverman, STAT+) ...In a letter sent to the company, the lawmaker maintained that the decision to discontinue its inhaler in January 2024 has since had "life-threatening consequences for patients" and contributed to a spike in hospitalizations. And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators... Sub. Req’d

CMS Continues to Make a Bad Law Worse

(6/27, Matthew Norawong, PhRMA) ...Yesterday, PhRMA submitted comments in response to the Centers for Medicare & Medicaid Services (CMS) draft guidance for implementation of the prescription drug price-setting program established under the Inflation Reduction Act (IRA). Unfortunately, rather than using their authority to mitigate the program's harmful impact on patients and innovation, CMS has doubled down on the previous administration's misguided approach... Full

NCPA Submits Comments to CMS On Draft Guidance to Medicare Drug Price Negotiation Program

(6/30, NCPA) ...NCPA submitted comments to CMS on its draft guidance to the Medicare Drug Price Negotiation Program (MDPNP). Among other things, NCPA stressed that manufacturers should pay pharmacies timely, meaning within 14 days of the pharmacy adjudicating the claim with the plans/PBMs. NCPA argued that CMS must ensure that neither plans, PBMs, manufacturers, wholesalers, CMS, nor any other entity be allowed to assess any fee on pharmacies to effectuate any aspect of the MDPNP whatsoever, and that any EFT fees should be borne by the manufacturer and not the pharmacy... Full

CSRxP Statement On Big Pharma Giveaway in Reconciliation Bill Text

(6/28, The Campaign for Sustainable Rx Pricing) ..."The Big Pharma-supported policy added to the reconciliation bill would cost seniors and taxpayers billions of dollars in higher prescription drug prices," said CSRxP executive director Lauren Aronson. "Congress should remove this Big Pharma giveaway from the reconciliation tax bill."... Full

America's Pharmacy Benefit Managers Support Reforming Prescription Drug Rebate System

(6/27, PCMA) ..."We applaud Sen. Paul for introducing legislation to modernize the Robinson Patman antitrust statute. The Robinson Patman Act currently requires pharmacy benefit managers (PBMs) to use rebates as the pathway to achieve savings on prescription drugs. Updating the law could allow for upfront discounting on prescription drugs as one alternative approach, which could lower out-of-pocket costs for patients, especially for patients enrolled in high-deductible health plans. A reexamination of the law could also give additional transparency to employers, patients, and policymakers on the amount drug companies are lowering costs as a result of negotiations with PBMs."... Full

Orders of Magnitude: Gauging Future Pricing-and-Policy Reverberations in Pharma

(6/27, Michael Christel, PharmExec.com) ...Q&A with Model N's Michael Grosberg drills deeper into the new US drug pricing directives, including challenges in implementation, the potential unintended consequences, and how these actions could spark the shift to outcomes-based contracting in healthcare... Full

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

(6/27, Derrick Gingery, Pink Sheet) ...One potential theme of the upcoming user fee reauthorization talks could be removing the perceived conflict of interest in the program. Attorney Barrett Tenbarge said one way to address the issue could be moving PDUFA to depend more on program fees compared to application fees. The FDA's Grace Graham said it is too soon to determine whether user fee programs will generate less funding in the next cycle... Global Sub. Full

FDA Gives Drugmakers More Time to Submit Impurity Data

(6/27, Zachary Brennan, Endpoints News) ...In an update on its website, the agency said that while applicants should conclude confirmatory testing for drugs at risk of nitrosamine impurities and submit necessary changes to their applications by Aug. 1, FDA "is allowing additional time for submission of required changes" to remove the impurity, as mitigation "may vary depending upon the specific strategy, for example adding a specification or reformulation."... Sub. Req’d

Digital Inhaler Captures Changes in Physiologic Metrics Before COPD Exacerbation

(6/27, Isabella Hornick, Healio) ...The ProAir Digihaler captured peak inspiratory flow, inhalation volume, inhalation duration, time to peak inhalation and inhaler use. Three metrics changed significantly before an acute COPD exacerbation..."This study demonstrates that digital inhalers can provide real-time physiologic and medication use data that may allow clinicians to identify acute exacerbations of COPD (AECOPDs) earlier, potentially improving outcomes through earlier intervention," M. Bradley Drummond, MD, MHS, professor of medicine in the division of pulmonary diseases and critical care medicine at the University of North Carolina, Chapel Hill School of Medicine, told Healio... Full

Exploring TL1A for IBD Relief

(6/30, Aimee Molineux, News Medical Life Sciences) ...In its current stage, Duvakitug requires medication every two weeks, whereas both competitors provide a more convenient four-week dosing schedule. To compete with PRA023 and RVT-3101, Sanofi and Teva pharmaceuticals need to expedite Phase III trials and adjust dose regimens to increase patient adherence. Overall, the emergence of TL1A-targeting treatments present new opportunities for IBD treatment, accelerating progress in the field. The competitivity of the autoimmune disease therapy market will ultimately benefit IBD patients, improving their lived experience... Full

UK Pharma Group Hikma Ploughs $1Bn into US Manufacturing as Tariff Threat Lingers

(6/30, Mike Sheen, This is Money) ...The London-headquartered firm told investors on Monday the investment would expand its domestic capabilities 'to develop, produce and deliver a broad range of medicines needed by the US healthcare system to treat patients nationwide'...Hikma said: 'This next phase of expansion will help to strengthen Hikma's portfolio of more than 800 medicines and increase the company's US-based capacity to produce large volumes of high-quality and affordable medicines for American hospitals, providers and patients.'... Full

Alembic Pharma Gets USFDA Nod for Generic Cancer Treatment Injection

(6/30, Press Trust Of India) ...The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement... Full

An Acid Reflux Drug Got Recalled. The Bottles Might Have Different Meds

(6/29, David J. Neal, Miami Herald) ...One lot of reflux medicine got recalled when fluid retention tablets were discovered in the medicine bottles. Teva Pharmaceuticals pulled lot No. 5420094 of 10 mg Metoclopramide tablets in 100-count bottles after "a single 20 mg Torsemide tablet that does not belong was discovered in each of three individual sealed bottles of 10 mg Metoclopramide tablets."... Full

India's Torrent Pharma to Acquire Controlling Stake in JB Chem and Pharma

(6/29, Abu Sultan, Mrinmay Dey, Reuters) ...India's Torrent Pharmaceuticals said on Sunday it will acquire a 46.39% controlling stake in smaller peer JB Chemicals and Pharmaceuticals from New York-based investment firm KKR, and plans to merge the two drugmakers... Full

Teva Launches Startup Challenge Program

(6/30, Gali Weinreb, Globes) ...Teva intends to launch new challenges twice yearly on set dates. In addition to the call for proposals, Teva will actively look for companies that could be appropriate for participation. As mentioned, the challenges will concern the integration of innovations in all areas of Teva's business...Yossi Ofek, general manager of Teva Israel, said, "Two years ago, we launched our Pivot to Growth strategy, the aim of which was to place a greater emphasis on innovative products and to grow faster in the coming years. So far, that strategy has been very successful. We are now at the acceleration stage... Full

The Politics of Health: Ideology Over Life

(6/28, Bepi Pezzulli, The Times Of Israel) ...The mayor, Lorenzo Falchi, a far-left extremist, has decided to prohibit the sale of Teva Pharmaceutical products within the town, aligning with a broader campaign to economically pressure the Israeli government. This includes a ban on all Israeli-manufactured products: medications, medical devices, and cosmetics alike. It's an ideological stand, but one that sacrifices a fundamental pillar of society: public health... Full

New EFPIA President Hopes ‘Sanity Will Prevail' In EU Pharma Reform Dialogs

(6/27, Eliza Slawther, Pink Sheet) ...Stefan Oelrich, the new president of the European pharma industry federation EFPIA, expressed concerns regarding the EU pharma reform. He said that he hopes "sanity will prevail" during discussions between the European Commission, the European Parliament and Council of the EU, and does not want negotiations to fail. Oelrich emphasized the need for a favorable intellectual property environment to encourage investment in Europe, as the industry has been falling behind... Global Sub. Full

Drug Shortages Causing ‘Unprecedented' Issues for Patients

(6/29, Jane Kirby, The Independent) ...Community Pharmacy England said that, in the last year alone, the Government has issued serious shortage protocols (SSPs) for key medicines used to treat schizophrenia, bipolar disorder, angina, HRT, antibiotics such as cefalexin and clarithromycin, and medicines for cardiovascular disease and pancreatic enzyme replacement therapy. There are also ongoing shortages of drugs for ADHD, diabetes and epilepsy, it said... Full

Poland's Overhaul of Drug Reimbursement System Opens for Public Consultation

(6/27, Paulina Mozolewska, Euractiv) ...Poland's Ministry of Health unveiled a comprehensive draft amendment to the drug reimbursement law on May 22, 2025; it's now open for public consultation. The reform, which introduces over 100 changes, aims to simplify procedures, improve access to medicines and medical devices, and strengthen the role of patients in the reimbursement process... Full

Greece Accelerates Digital Health Plan with New Infrastructure and Drug Pricing Reforms

(6/20, Vasiliki Angouridi, Euractiv) ...Greece is advancing its digital health agenda with the rollout of a comprehensive digital health data infrastructure, part of a broader push to modernise its healthcare system. The Ministry of Health is also developing a transitional compensation framework for high-cost, innovative medicines, expected to launch later this year... Full

Pharmexcil, USP Discuss Collaboration On Biosimilar Accessibility, Building Resilient Supply Chain

(6/30, Pharmabiz.com) ...The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has discussed synergies with the United States Pharmacopoeia (USP) to ensure access to biosimilars particularly in low-and middle-income countries, identify high-risk APIs prone to shortages and global best practices as part of the USP resolutions for 2025-2030... Full

Delhi Drugs Control Department Cracks Down On Sale of Fake Cholesterol Medicines

(6/28, The Indian Express) ...The Delhi drugs control department recently uncovered a multi-level distribution network involved in the sale and circulation of spurious Rosuvas F 20 tablets, a prescription drug used to manage cholesterol and triglyceride levels, officials said on Friday. The action followed a complaint from Sun Pharmaceutical Industries Ltd, which reported that fake versions of its Rosuvas F 20 tablets were being sold by a retail outlet in central Delhi. The complaint mentioned a multi-level supply chain involving multiple wholesalers and distributors across the city... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.