Friday, October 3, 2025

Teva Pharma (TEVA) PT Raised to $26 at JPMorgan

(10/3, StreetInsider.com) ...JPMorgan analyst Chris Schott raised the price target on Teva Pharma to $26.00 (from $23.00) while maintaining a Overweight rating... Sub. Req’d

Teva Price Target Raised to $26 from $23 at JPMorgan

(10/3, The Fly) ...JPMorgan raised the firm's price target on Teva to $26 from $23 and keeps an Overweight rating on the shares as part of a Q3 earnings preview. The firm expects no surprises in the quarter... Full

Mark Cuban Says Trump's New Drug Platform Could Succeed if it Forces Pharma Managers to Change: ‘If that Happens, Trump Gets All the Credit'

(10/2, Sasha Rogelberg, Fortune) ..."I think it could be impactful," Cuban told Fortune in an email. "Their challenge is going to be who has more power and influence over the industry: the PBMs/insurance companies and the contracts they have with brand manufacturers, or the president. That has not been determined yet."...Cuban gave the TrumpRx platform a grade of B, he said on social media Tuesday, giving the Trump administration credit for bringing on "great people" for the project, such as Chris Klomp, the director of Medicare and deputy administrator of the Centers for Medicare & Medicaid Services within the Department of Health and Human Services... Sub. Req’d

FDA Commissioner Says TrumpRx is a "Major Step" Toward Making Prescription Medications Affordable

(10/2, Nikki Battiste, Aparna Zalani, CBS News) ...The head of the Food and Drug Administration on Thursday praised a plan announced by the White House earlier this week that President Trump said is designed to lower the cost of prescription drugs, calling it a "major step" toward making medication more affordable for Americans...Makary argues the Trump administration's agreement with Pfizer will help in addressing health care costs across the board. "By reigning in egregious drug prices, we're actually addressing the larger issue of healthcare costs in the United States, which is something no one has really be able to get a handle on until now," Makary said... Full

Inside Pfizer's Drug-Pricing Deal With the Trump Administration

(10/2, Liz Essley Whyte, Jonathan D. Rockoff and Peter Loftus, The Wall Street Journal) ...During a 90-minute call on Wednesday with executive members of PhRMA, the trade group representing the pharmaceutical industry, some other CEOs were angry and felt blindsided, according to people familiar with the meeting. Genentech's CEO Ashley Magargee discussed whether Bourla should be removed as chair, one person said...Bourla pushed back, telling the executives that Trump made clear he wanted better pricing for the American public and that the deal showed how companies could avert tariff threats and have certainty to invest in their businesses... Sub. Req’d

Pfizer Will Eventually Need To Disclose Rx Deal Under Securities Law, For Now Experts View It As Trump Campaign Tool

(10/2, Maaisha Osman, Inside Health Policy) ...However, industry experts note that these deals are being struck outside the regulatory process and without congressional approval, meaning they may generate political buzz but may have little real-world impact on drug pricing. Duane Wright, senior analyst at Bloomberg LP, told IHP the lack of details about the arrangement raises questions about whether U.S. consumers will actually pay less. "You have to assume that if the CEO of the drug company is in the Oval Office smiling while the president is speaking, the impact to his company is manageable," Wright said. "The worst outcome is avoided, and maybe there's some marginal hit, but it's not meaningful."... Sub. Req’d

Editorial: America's Pharmacist in Chief

(10/1, The Wall Street Journal) ...The comedy portion of this show debuted this week with Mr. Trump's announcement of a new government website dubbed (of course) TrumpRx. The plan is to sell medicines directly to consumers at discount prices. Details are vague, though the business theory is supposedly to bypass insurance "middlemen." Someone should have told the President that private businesses already do this... Sub. Req’d

Trump Administration Delays Effort to Address Medicare Drug Price Negotiation Loophole

(10/3, John Wilkerson, STAT+) ...Some Wall Street analysts and Washington insiders have said they think the Trump administration's Medicare officials are negotiating prices more aggressively than the Biden administration. On the other hand, this is the latest example of the administration showing lenience to drugmakers, after Trump's tax bill exempted from negotiation drugs that treat multiple rare diseases, known as orphan drugs, and delayed Medicare negotiation for drugs first approved as orphans and later approved for wider use... Sub. Req’d

New Orphan Drug Protections Could Shield Blockbusters from Medicare Negotiations, Experts Say

(10/2, Nicole DeFeudis, Endpoints News) ...The guidance describes how CMS will implement the third cycle of Medicare drug price negotiations, including how it will expand protections for certain orphan drugs in accordance with President Donald Trump's recently enacted tax and spending package. The move is a win for the pharmaceutical industry, which has lobbied for those extra protections. But Anna Kaltenboeck, who co-authored the Inflation Reduction Act's drug negotiation section, told Endpoints News it could result in missed savings on expensive, widely-used drugs... Sub. Req’d

Despite Shutdown, Companies Still Plan to Submit Upcoming FDA Applications

(10/2, Zachary Brennan, Endpoints News) ...While Democrats and Republicans have yet to work out a deal for funding the government, companies including Moderna, Viridian Therapeutics, Cogent Biosciences and Avidity Biosciences told Endpoints News that the shutdown isn't expected to affect their upcoming filings, all of which are planned before the end of the year. A Cogent spokesperson told Endpoints that its application for its lead candidate, the tyrosine kinase inhibitor bezuclastinib, is still planned for sometime this year. Avidity said it's also still preparing its submission for its Duchenne muscular dystrophy treatment delpacibart zotadirsen by year's end, and "will communicate if something changes."... Sub. Req’d

US FDA's Prescription And Generic Drug User Fee Collections May Miss FY 2025 Targets

(10/2, Sue Sutter, Pink Sheet) ...The PDUFA and GDUFA programs were expected to slightly under-collect fees in FY 2025. The FDA's capacity planning adjustment methodology is accurately forecasting the financial needs for PDUFA, GDUFA and BsUFA, a consultant found. However, the CPA tends to under-forecast biosimilars program workload due to the small volume of submissions and lack of historical data... Global Sub. Full

How Tariffs Could Disrupt Health Care—And What States Can Do About It

(10/2, Geeta Minocha, Health Affairs) ...Tariff policy is often discussed in the context of manufacturing and trade deficits. But it also has critical implications for health equity, chronic disease management, and the financial sustainability of public health programs. In this context, state governments can play a proactive role in mitigating the health harms of economic policy decisions made in Washington... Full

Maryland PDAB Moves Closer To UPLs, Suggests Other Policies To Pair

(10/2, Luke Zarzecki, Inside Health Policy) ...The Maryland Prescription Drug Affordability Board (PDAB) directed its staff not only to further develop policies on upper payment limits for Boehringer Ingelheim's Jardiance and AstraZeneca's Farxiga, but also other policies to bring drug costs down in the state. Meanwhile, the Colorado PDAB is set to vote Friday (Oct. 3) on whether an upper payment limit should be placed on Amgen's Enbrel... Sub. Req’d

Drug Discount Program Regulations in RI Go into Effect After Judge Denies Big Pharma Suit

(10/2, Jonny Williams, The Providence Journal) ...A new law regulating a federal drug discount program in Rhode Island went into effect on Wednesday, Oct. 1, after a District Court judge denied a preliminary injunction requested by a pharmaceutical manufacturer. The law prohibits reimbursement discrimination against organizations, including contract pharmacies, covered by the 340B Drug Pricing Program... Sub. Req’d

Third US Settlement Secured In Eylea Biosimilar Battle As Formycon Strikes Deal

(10/3, Dean Rudge, Generics Bulletin) ...Formycon, along with its commercial partner Valorum Biologics, has reached a settlement agreement allowing for the US launch of its Eylea biosimilar, Ahzantive, in the fourth quarter of 2026. This agreement resolves all patent-infringement litigation with Regeneron concerning Eylea, making Formycon the third firm to secure such a deal following Biocon Biologics and Sandoz. Although specific financial terms of the settlement remain undisclosed, the deal is considered a significant achievement for Formycon, emphasizing their commitment to providing affordable biosimilar options... Global Sub. Full

Celltrion Launches Avtozma IV Formulation in the U.S.

(10/2, Rachel Klemovitch, Contract Pharma) ...Avtozma IV will be available in all the same formulations currently provided by Actemra IV. The available presentations are 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) in single-dose vials. Avtozma IV will be supported by a comprehensive patient support resources for healthcare providers and patients, and copay support for eligible commercial patients prescribed Avtozma IV... Full

Polpharma Biologics Splits Into Separate Biosimilars And CDMO Units

(10/2, Urte Fultinaviciute, Generics Bulletin) ...Polpharma Biologics has restructured its business by splitting into two independent units: a biosimilars firm and a contract development and manufacturing organization. Polpharma Biologics will be based in Switzerland and will solely focus on developing and commercializing biosimilars. Meanwhile, newly launched CDMO Rezon Bio will leverage Poland's local talent and cost structure, while seeing itself as a disruptor in the region... Global Sub. Full

Lotus Enters License and Supply Agreement With Adalvo for Semaglutide Injection (Wegovy® & Ozempic® 2mg Generic)

(10/3, Lotus Pharmaceutical) ...Lotus Pharmaceutical Co., Ltd...today announced that it has entered into a License and Supply Agreement with Adalvo to commercialise its Semaglutide injection for obesity (Wegovy® generic) and diabetes (Ozempic® 2mg generic) in multiple Asian markets, including South Korea, Taiwan and a number of Southeast Asian countries. In particular, Lotus will hold the exclusive rights to the Wegovy generic to be commercialised in South Korea, Taiwan, Thailand, Singapore and Vietnam. Lotus will initiate the registration processes in these markets with the aim to launch as first generic in their corresponding markets... Full

Alkermes Hit With Antitrust Suit Over Opioid Use Treatment

(10/2, Katie Arcieri, Bloomberg Law) ...Alkermes Plc was sued by a wholesale drug distributor alleging the biopharmaceutical company conspired to delay the generic version of its Vivitrol medication used to treat opioid and alcohol use disorder. Alkermes induced Teva Pharmaceutical Industries Ltd. to delay until 2027 Teva's generic version of Vivitrol, an injection treatment used to treat alcohol dependence and to prevent relapse into opioid dependence, according to a proposed class action filed Thursday by Value Drug Co. in the US District Court for the District of Massachusetts... Sub. Req’d

US FDA Approves Another Generic Version of Abortion Pill

(10/2, Siddhi Mahatole, Reuters) ...The FDA said in a letter dated September 30 it has approved Evita's generic version of Danco Laboratories' mifepristone, which is used to terminate pregnancy at up to 10 weeks. The drug is manufactured by the privately held company that describes its mission as being to "normalize abortion" and make it "accessible to all."...U.S. Health Secretary Robert F. Kennedy Jr. said in a post on X that "the Biden administration removed mifepristone's in-person dispensing rule without studying the safety risks. We are filling that gap." "U.S. FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug," he added... Full

Pricing Depends On the Country, Bayer Looks at Affordability: Executive

(10/2, Teena Thacker, The Economic Times) ...Ashraf Al-Ouf, head of pharmaceutical commercial operations, Apac at Bayer spoke to Teena Thacker about the company's moves towards innovation and clinical research for the region. He said the company is poised to address healthcare needs and offer new therapeutic options to patients across the Apac... Full

Cease Fire: Vanda, US FDA Agree To Pause Hetlioz, Tradipitant Disputes

(10/2, Sue Sutter, Pink Sheet) ...Vanda will pause or dismiss several legal challenges and administrative proceedings related to Hetlioz (tasimelteon) and the investigational drug tradipitant. In return, the FDA will conduct expedited re-reviews of Hetlioz for a jet lag indication by early January and a partial clinical hold for long-term tradipitant studies by November. Vanda's CEO says the agreement resulted from a recent federal appeals court decision in a Hetlioz case and the new agency leadership's receptiveness to talks... Global Sub. Full

AbbVie, BeOne End BTK Blood Cancer Drug Patent Fight

(10/2, Angus Liu, Fierce Pharma) ...BeOne Medicines and AbbVie's Pharmacyclics have decided to voluntarily dismiss the patent lawsuit the Big Pharma firm brought against its competitor over their BTK inhibitors...The patent covers a method of use for a BTK inhibitor developed under a certain chemical structure for treating chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), the most important indication of the drug class. Filing of the lawsuit was not a good look on AbbVie because it was initiated right after the '803 patent was issued, nearly 10 years after the FDA approval for the company's Johnson & Johnson-partnered Imbruvica in CLL/SLL... Full

Europe Sounds The Alarm Over US Tariffs

(10/2, Francesca Bruce, Pink Sheet) ...The European Commission says that US tariffs on pharmaceuticals would stick at 15%, in line with the EU-US trade agreement struck earlier this year. Some industry groups in Europe have expressed concern that 100% tariffs could be applied. The tariffs would be here to stay if they generate an income stream for the government, according to one expert in geopolitics... Global Sub. Full

Better, Faster, Quicker: EUCOPE's Natz Urges EU Drug Regulators To Act Now – Not Wait For New Laws

(10/2, Eliza Slawther, Pink Sheet) ...EUCOPE's secretary general, Alexander Natz, emphasized the need for improvements within the existing EU drug regulatory framework despite promising new legislation like the Critical Medicines Act and the Biotech Act. Natz also highlighted aspects of the EU pharma reform package that could be beneficial for companies but stressed that the legislation was not yet finalized and argued for changes to be introduced sooner. He said that clinical trials were an area the EU could look at improving now, given that there has been a decline in trial activity despite the introduction of the new Clinical Trials Regulation... Global Sub. Full

EU Health Chief Faces Pushback Over Fast-Tracked Biotech Proposal

(10/2, Emma Pirnay, Sarantis Michalopoulos and Thomas Mangin, Euractiv) ...The long-awaited EU Biotech Act proposal, aimed at boosting Europe's innovation capacity, will be submitted by the end of the year, EU Health Commissioner Olivér Várhelyi said on Thursday. "I will propose this year a Biotech Act that will simplify clinical trials, speed up authorisation procedures for various health applications, and enable European industries to innovate and scale their activities up in Europe," Várhelyi said at the European Health Forum Gastein... Full

Groups Accuse Drugmakers of Conspiring to Pressure UK Over Drug Prices

(10/2, Anna Brown, Endpoints News) ...The CMA received the letter on Sept. 26 from UK-based patient advocacy groups Balanced Economy Project, Just Treatment and Global Justice Now, which alleged that companies are working with the US administration and a UK pharma trade group, the Association of the British Pharmaceutical Industry, to pressure the UK government...An AstraZeneca spokesperson told Endpoints News that the accusations in the letter are "categorically untrue."... Sub. Req’d

Drugmakers Divided Over Poland's New Pharma Litigation Rules

(10/2, Aneta Zachová, Euractiv) ...At the end of August, an amendment to the Polish Code of Civil Procedure (KPC) was announced, with key provisions addressing patent litigation, injunctions, and intellectual property rights protection, which will come into effect on March 1, 2026..."Intellectual property protection forms the foundation for investing in the lengthy, complex, risky, and costly process of bringing innovative medicines to patients, which improves healthcare efficiency and contributes to economic growth by enhancing public health," Michal Byliniak, Director General of INFARMA, told Euractiv... Full

Bulgaria's Rebate Policy Risks Limiting Medicine Access

(10/2, Krassen Nikolov, Euractiv) ...The Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharm) argues that the policy threatens the availability of innovative therapies, puts pressure on the long-term sustainability of the healthcare system, and could leave Bulgarian patients further behind their EU peers. Bulgaria must increase medicine budgets and reduce the financial burden it places on pharmaceutical companies, said Deyan Denev, Executive Director of ARPharM-Bulgaria, in an exclusive interview with Euractiv... Full

US Tariffs On India a Wrong Approach: Phil Murphy, New Jersey Governor

(10/2, The Economic Times) ...On a recent visit to India, Murphy's delegation focused on economic growth, government-level relations and collaboration for higher education. He emphasised India's strong position as a key business ally for the US."While tariffs are beyond New Jersey's direct control, we have built a strong and dynamic business environment, to help companies succeed despite global headwinds," a spokesperson from Murphy's team told ET in a statement. US President Donald Trump imposed a 50% reciprocal tariffs on goods imported from India but has so far spared generic drugs from the ambit of tariffs... Sub. Req’d

India's CDMO Moment: Scale, Quality, and the Climb Up the Value Chain

(10/3, The Pharma Letter) ...India's pharmaceutical industry has long been cast as the world's pharmacy, churning out affordable generics and APIs at industrial scale. That narrative still holds, but a new one is taking shape: the rise of Indian contract development and manufacturing organizations (CDMOs) as credible global partners. Scale remains the foundation, yet the story is no longer only about volume and price. It's about quality, credibility, and the climb toward innovation-driven value... Sub. Req’d

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