Wednesday, May 28, 2025

Teva Receives FDA Fast Track Designation for TEV-53408, An Anti-IL-15 Antibody

(5/27, The Fly) ...Teva Pharmaceutical Industries announced that the FDA granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet... Full

Teva Gets FDA Fast Track Designation For Investigational Celiac Disease Drug TEV-53408

(5/27, RTT News) ...TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat serious conditions and address unmet medical needs... Full

Truist Securities Starts Teva Pharma (TEVA) at Buy

(5/27, StreetInsider.com) ...Truist Securities analyst Les Sulewski initiates coverage on Teva Pharma with a Buy rating and a price target of $25.00. The analyst comments "We initiate coverage on TEVA ahead of its upcoming investor day with a BUY rating and $25 PT. We think the company is well positioned to rival big pharma with its long-term durable growth strategy. With stock trading 25% off recent highs, we urge investors to accumulate."... Sub. Req’d

Teva Initiated with a Buy at Truist

(5/27, The Fly) ...Teva's dual focus on cultivating its high-margin brands while strengthening generics continues to de-risk the topline and margin profile, says the analyst, who sees management executing well against the company's "Pivot to Growth" plan. The firm sees potential line of sight to 30% operating margin by 2027, the analyst added... Full

10 Drugs in Shortage

(5/27, Alexandra Murphy, Becker's Hospital Review) ...Imatinib acetate tablets: Several manufacturers, including Major, Strides Pharma, Teva Pharmaceuticals and Upsher-Smith Laboratories, have reported shortages of imatinib tablets, used in oncology for chromic myeloid leukemia and other cancers. Apotex estimates resupply in late 2025, Teva anticipates a release of early to mid-July and Upsher-Smith has tablets on allocation for primary customers... Full

Seven Top Pharmas Posted Revenue Declines in Q1. The Common Thread? All Are US Firms

(5/27, Kevin Dunleavy, Fierce Pharma) ...The companies that took the biggest hits were in the United States, where there is already considerable angst in the industry over the tariff threats and drug price-slashing aspirations of President Donald Trump, along with the unsettling prospects of having a pharma adversary, Robert F. Kennedy Jr., heading up the Department of Health and Human Services... Full

Paracetamol Maker Granules India's Profit Drops as Lower Prices in US, Europe Pinch

(5/28, Kashish Tandon, Reuters) ...Granules India reported a drop in fourth-quarter adjusted profit on Wednesday, hurt by weak pricing and stiff competition in its key European and North American markets...Granules, which holds a 30% share of the global paracetamol market, supplies the drug as an active pharmaceutical ingredient (API) and as a ready for consumption form in Europe, Canada, and South Africa. APIs are the active and key components in a drug that produce the intended therapeutic effects. Indian API makers have been grappling with weak pricing in key European and North American markets due to tough competition, even as global drugmakers turn to India to limit their reliance on Chinese contractors... Full

Hikma Gears Up To Enter US Biosimilars Market With Ustekinumab Nod

(5/27, Dave Wallace, Generics Bulletin) ...Hikma is set to enter the US biosimilars market after its Bio-Thera-partnered Starjemza (ustekinumab-hmny) rival to Stelara was approved by the US FDA. As part of its commercialization strategy the firm will aim to build on its position as a leading US injectables supplier. Starjemza represents the third Bio-Thera-developed biosimilar to be approved by the US FDA after Tofidence (tocilizumab-bavi) and Avzivi (bevacizumab-tnjn)... Global Sub. Full

Formycon and Fresenius Kabi Announce the Commercial Launch of FYB202/Otulfi™, An Approved Ustekinumab Biosimilar in Canada

(5/27, Formycon AG) ...Following Health Canada's Notice of Compliance (NOC) end of December 2024, Otulfi™ is now available as a high-quality and cost-effective treatment option for adult patients with moderate to severe active Crohn's disease, moderate to severe active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis...To support patients transitioning to Otulfi™, Fresenius Kabi provides access to its KabiCare® patient support program... Full

Hadlima Designated Interchangeable Biosimilar to Humira

(5/27, Diana Ernst, Rph, MPR) ...Findings showed similar pharmacokinetics between participants receiving Humira continuously and those who alternated between Humira and Hadlima. Efficacy, safety, and immunogenicity results were also found to be comparable. "As our data show, on average, patients paid more than 4 times as much out of pocket per month for Humira compared to Hadlima," said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon... Full

Alvotech and Advanz Pharma Extend Strategic Partnership to Commercialize Three Additional Biosimilars in Europe

(5/28, Alvotech) ...The new agreement covers the supply and commercialization in Europe of biosimilar candidates to Ilaris® (canakinumab), a human antibody interleukin-1ß blocker indicated for the treatment of various inflammatory diseases, and Kesimpta® (ofatumumab), a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis, in addition to a third undisclosed biosimilar candidate. Alvotech will be responsible for development and commercial supply and Advanz Pharma will be responsible for registration and commercialization in Europe... Full

Novartis Expands Strategic Collaboration with Shanghai Pharma in China to Cover Eye Drugs

(5/27, Angus Liu, Fierce Pharma) ...Novartis will leverage Shanghai Pharma's omni-channel integrated marketing services and broad market coverage capabilities to accelerate the reach of some Novartis drugs for ocular infections and glaucoma in smaller territories not currently targeted by Novartis, according to the Chinese company... Full

Axsome and Hetero Settle Patent Fight Over Sleep Disorder Drug

(5/27, Nicole DeFeudis, Endpoints News) ...The settlement, announced Tuesday, resolves patent litigation between Axsome and Hetero in the New Jersey federal district court. Axsome alleged that Hetero's generic version of its "wakefulness" drug Sunosi would infringe several patents. The agreement grants Hetero a license to launch its own version of Sunosi on the US market in March 2040, or September 2040 if Axsome receives pediatric exclusivity for the drug... Sub. Req’d

Novartis Keeps MSN's Entresto Copy Off Market During Appeal

(5/27, Christopher Yasiejko, Bloomberg Law) ...The US Court of Appeals for the Federal Circuit denied MSN's motion for a stay and to expedite the appeal because the company failed to show it was "likely to succeed in demonstrating that the district court abused its discretion in declining to allow amendment of the complaint to state a delisting counterclaim," Circuit Judge Timothy B. Dyk wrote for a three-judge panel in an order issued May 23 in the US Court of Appeals for the Federal Circuit... Sub. Req’d

Mark Cuban Does It Again: Reshuffling the Deck of Front-Line CML Therapy

(5/27, Hagop M. Kantarjian, MD, FASCO; Shilpa Paul, PharmD, BCOP and Fadi G. Haddad, MD, The ASCO Post) ...The availability of generic imatinib and of generic dasatinib, through Cost Plus and similar generic companies that bypass the intermediaries (pharmacy benefit managers, group purchasing organizations, and pharmacy outlets), now offers the best treatment value for front-line CML therapy. One issue that remains to be resolved is whether Cost Plus can charge the insurers directly or the patients can be reimbursed by the insurers for the amounts they pay to Cost Plus. This appears to be a nonissue, were it not for the "vertical integration" of the different health-care entities into conglomerates... Full

What's the Price Outlook for Weight-Loss Drugs?

(5/27, Cheryl Winokur Munk, The Wall Street Journal) ...Newer drugs tend to cost more because of the upfront research and development, as well as patent laws that limit competition and keep prices higher due to exclusivity, says Cynthia Cox, vice president at KFF, a health-policy nonprofit formerly known as the Kaiser Family Foundation and based in San Francisco. Also, the U.S., unlike some other countries that routinely negotiate drug prices, hasn't stepped in to negotiate lower prices for these drugs. Supply and demand is another factor. "There's a lot of demand for these drugs, and for a while there was a shortage too," Cox says... Sub. Req’d

US FDA's Familiar Drug Pricing To-Do List

(5/27, Michael McCaughan, Pink Sheet) ...President Trump's April executive order on drug pricing gives the agency 180 days to deliver a list of recommendations to "accelerate approval of generics, biosimilars, combination products, and second-in-class brand name medications." The to-do list mirrors the agenda former FDA Commissioner Scott Gottlieb set for the agency during President Trump's focus on drug pricing during his first term... Global Sub. Full

US FDA Makary's Pharma CEO Tour Goes Against Transparency Rhetoric

(5/27, Sarah Karlin-Smith, Pink Sheet) ..."This is deeply ironic given the administration's claimed concern about industry capture," said Peter Lurie, president of the Center for Science in the Public Interest and former FDA associate commissioner for public health strategy and analysis. "The hypocrisy is … just astounding," said Reshma Ramachandran, co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, pointing to Makary's recent announcement to reduce conflicts of interest by removing some industry representatives from advisory committees... Global Sub. Full

Trump's 340B Request Could Further Convolute Existing Program Issues

(5/27, Gabrielle Wanneh, Inside Health Policy) ...President Donald Trump's demand for health centers to make insulin and injectable epinephrine available at low prices offered under the 340B drug discount program is unlikely to solve any of the existing operational issues within the program that stakeholders want resolved, health policy experts tell Inside Health Policy... Sub. Req’d

EMA: ‘Sad To See' Member States Against Patient Engagement Under EU Pharma Reform

(5/27, Eliza Slawther, Pink Sheet) ...Steffen Thirstrup, the European Medicines Agency's chief medical officer, has expressed concern over signs that some EU member states are pushing back against provisions in the European Commission's proposed overhaul of Europe's pharmaceuticals legislation that seek to strengthen the patient voice in the drug regulatory process... Global Sub. Full

IDA Consults Pharma Firms Over EU Retaliatory Tariffs On the US

(5/28, David Murphy, RTE) ...The European Union published a list of imports from the US which could face tariffs as part of the trade war with the Trump administration in March. Shortly after the 99-page list was published the IDA's Head of Life Sciences and Food Rachel Shelly circulated it to companies supported by the IDA. In her email, Ms Shelly asked if pharmaceutical companies had views and said the IDA "will feed them back into the Government system to inform Ireland's response to the EU consultation"... Full

India Puts Big Pharma Concessions On Table as US Trade Deal Nears Finish Line

(5/28, Dhirendra Kumar , Priyanka Sharma, Mint) ...According to two people familiar with the matter, India's proposals include supply of low-cost complex generic medicines at sharply reduced costs, patent reforms to allow earlier entry of generics in the US, increased US-based manufacturing by Indian pharma firms of active pharmaceutical ingredients (APIs) and fixed dosage forms (FDFs), and tariff exemptions for life-saving and critical medicines imported into India from the US... Sub. Req’d

Novartis Offers Payment Plan for High-Cost Heart Medicine

(5/27, Rica Bhattacharyya and Vikas Dandekar, The Economic Times) ...In a first-of-its-kind pricing strategy in the pharmaceutical industry, Swiss drug major Novartis has introduced a financing scheme for its cholesterol lowering drug brand Sybrava (inclisiran) in India, as the company looks to expand the adoption of the new generation heart drug that has so far been restricted due to its high pricing. Novartis has tied up with Indian payment technology company Pine Labs to offer a monthly instalment scheme for the twice-a-year treatment of the injectable drug used to reduce levels of low-density lipoprotein cholesterol (LDL-C), commonly called bad cholesterol... Full

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