Friday, June 6, 2025

A Decade after its Ill-Fated $40.5B Megadeal, Teva Pivots from Generics to Innovation

(6/5, Andrew Dunn, Endpoints News) ...Francis is pitching Teva as a mature drug company that doesn't have to worry about aging blockbusters. Its former top-selling multiple sclerosis drug Copaxone went generic a decade ago. "Because there are no major LOEs in the future, I like to sometimes think of this as a biopharma company that starts, but it skips straight [over] adolescence and then straight into its 30s," Francis said. "We have the ability to do that."... Sub. Req’d

Teva Canada Brand Seasonale Tablets Recalled for Extra Placebo Pills

(6/5, The Canadian Press) ...Health Canada has issued a recall for a brand of birth control pills after some packages were packed with extra placebo tablets. The agency says the recall covers Seasonale Tablets made by Teva Canada with 0.03 milligrams of ethinylestradiol and 0.15 milligrams of levonorgestrel... Full

Formycon And Fresenius Launch Partnered Stelara Rival In Canada

(6/5, Adam Zamecnik, Generics Bulletin) ...And Abhi Bhoite, senior director and head of commercial for Fresenius Kabi Biopharma in Canada, said "the high demand for biosimilars in Canada highlights the necessity for accessible and cost-effective biologics, which helps to ensure healthcare in Canada is accessible and affordable for all patients. We are proud to be introducing a cost-effective and European-manufactured alternative ustekinumab treatment for patients living with inflammatory and immune diseases."... Global Sub. Full

PBM Serve You Rx to Add 2 Stelara Biosimilars to Its Specialty Formulary

(6/5, Paige Minemyer, Fierce Healthcare) ...The PBM will add the biosimilar drugs Otulfi, dispensed by Mark Cuban Cost Plus Drugs, and Yesintek. Access to both drugs will be powered by Waltz Health's specialty pharmacy network, according to an announcement. Serve You Rx will also make "robust" copay assistance programs available to ensure members can secure the medications if they need them... Full

Xbrane Sets Date For Latest Run At Ranibizumab In US

(6/6, Dave Wallace, Generics Bulletin) ...The latest word from the US Food and Drug Administration suggests that a decision will be made on the filing by 21 October this year, although the Swedish biosimilars developer indicated that approval would be contingent on passing agency reinspections of its manufacturing sites... Global Sub. Full

Novartis Aims to Block MSN's Entresto Copy Launch Until 2026

(6/5, Christopher Yasiejko, Bloomberg Law) ...If a final decision finding MSN's generic version infringes US Patent No. 11,096,918 is issued before July 15—when Entresto's pediatric exclusivity on another patent ends—the US Food and Drug Administration will have to push back its final approval for MSN's generic to Nov. 9, 2026, according to Novartis' request filed Wednesday in the US District Court for the District of Delaware... Sub. Req’d

Novo's Ozempic, Wegovy Linked to Rare Cases of Dangerous Eye Disorder, EMA Says

(6/6, Reuters) ...The European Medicines Agency's safety committee has concluded that the use of Novo Nordisk's popular weight-loss drug Wegovy and its treatments for type 2 diabetes may cause rare occurrences of a potentially dangerous eye condition. Called non-arteritic anterior ischemic optic neuropathy (NAION), the condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and Novo's diabetes drugs Ozempic and Rybelsus, the regulator said on Friday... Sub. Req’d

U.S. Imports Drop, Hurt By Tariffs

(6/6, Ana Swanson, The New York Times) ...Much of the 16.3 percent drop from March reflected the fact that importers had rushed to bring many goods into the United States at the beginning of the year, before President Trump could impose tariffs that would raise the price of foreign products. That resulted in a record surge in imports and in the trade deficit in the first three months of the year... Sub. Req’d

Drug Imports Plummeted in April Despite Tariff Threat

(6/6, Tina Reed, Axios) ...Imports of goods to the U.S. decreased $68.9 billion to $277.9 billion in April, the Commerce Department's Bureau of Economic Analysis and the Census Bureau reported on Thursday... Full

Despite Trade War, U.S. Drug Companies Turn to China for Key Cancer Treatments

(6/6, Josh Nathan-Kazis, Barron's) ...The deals could one day result in new options for sick patients, but they also pose a major risk to U.S. biotech firms. The domestic drug pipeline relies on capital from Big Pharma, and now those funds may be going to start-ups in Shanghai, rather than Cambridge, Mass... Full

The Biosimilar Council Applauds Bipartisan Senate Legislation to Eliminate the Arbitrary Distinction between Interchangeable Biologics and Biosimilars

(6/5, Biosimilars Council) ...The Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, today applauded the bipartisan introduction of the Biosimilar Red Tape Elimination Act in the United States Senate. The legislation, sponsored by Senators Lee (R-UT) and Luján (D-NM), removes the arbitrary and unscientific distinction between biosimilars and interchangeable biologics... Full

Breaking Down the Interchangeability Barrier Blocking Patients to Lower-Cost Medicines

(6/5, Biosimilars Council Blog) ...The commonsense bill does a simple but powerful thing: it removes outdated Food and Drug Administration requirements that block approved biosimilars from being automatically substituted for brand-name biologics at the pharmacy counter, just like generic drugs are today... Full

Trump's FTC Continues The Mission Of Eliminating Orange Books' Improper Patent Listings

(6/6, Urte Fultinaviciute, Generics Bulletin) ...For the third time, the Federal Trade Commission has sent out warning letters to drug companies, disputing improperly listed patents in the US Food and Drug Administration's Orange Book. In this round, the agency targeted over 200 listings across 17 different products that shield brand-name asthma, diabetes, epinephrine autoinjector, and COPD drugs from "prompt generic competition."... Global Sub. Full

FDA Updates Generic Drugs Program Monthly and Quarterly Activities Report—Big Time

(6/5, Bob Pollock, The Lachman Blog) ...Approvals of original ANDAs in February, March, and April were 53, 54, and 62, respectively. Through the end of April, the OGD had approved 419 new ANDAs. Thus, the average number of ANDAs is just under sixty per month. Projecting that out for twelve months, we can expect the OGD to approve about 718 ANDAs in FY 2025, which would be higher than FY 2024's 694... Full

FDA's Makary Looks at Ways to Speed Drug Approvals, Talks About Cutting User Fees

(6/5, Zachary Brennan, Endpoints News) ...In a series of recent talks, Makary has said he would like to shorten the 10 years that it takes on average to develop and bring a drug to market; would like to make more use of AI technology in reviews; and to rely less on industry dollars that, through application and other fees, currently make up more than half of the agency's budget... Sub. Req’d 

House Gives US FDA More Non-User Fee Funds Than Requested

(6/5, Sue Sutter, Derrick Gingery, Pink Sheet) ...A US House appropriations bill would give the US Food and Drug Administration $33.1m more in budget authority funding than requested by the Trump Administration for fiscal year 2026. The measure proposes $3.2bn in budget authority for the agency, a 1% increase over the administration's request for $3.17bn... Global Sub. Full

House FDA Panel Advances Approps Bill In Line With Trump Ask

(6/5, Jessica Karins, Inside Health Policy) ...Mirroring the president's budget request, the House bill includes decreased appropriations for FDA's drugs and biologics centers, while appropriations for food and medical devices would increase... Global Sub. Full

Dose of Reality: Big Pharma Pushes for Policy to Keep Drug Prices High in Reconciliation Tax Bill

(6/5, CSRxP) ...In the version of the legislation recently passed by the U.S. House, Big Pharma was able to successfully insert a provision based on a bill called "The Optimizing Research Progress Hope And New (ORPHAN) Cures Act." While purportedly meant to protect and foster pharmaceutical innovation, this misguided legislation would help brand name drug manufacturers keep prices high on a whole category of their products... Full

Indian Drug-Makers Heave a Sigh of Relief as API Prices Fall

(6/6, Teena Thacker, The Economic Times) ...We are seeing a huge impact on the prices of antibiotics, steroids, hormones, statins, among others," confirmed Mehul Shah, who tracks the Chinese pharmaceutical industry. Shah said he is foreseeing this trend to continue this year. The move is perceived as a predatory strategy to maintain market dominance by industry experts... Full

EU Council Adopts Compromise Position on Pharma Reforms

(6/5, Joanne S. Eglovitch, Regulatory Focus) ...One of the most significant changes in the Council's position has to do with market protections awarded to drugmakers. In contrast with the Parliament's package, which would provide seven and a half years of regulatory data protection for newly authorized drugs (with the ability to extend that protection to a maximum of eight and a half years) and an additional two or three years of market protection, the Council's proposal would provide eight years of regulatory data protection and up to two years of market protection... Full

Ireland's Economy Grew Much Faster Than Expected on Tariff Stockpiling

(6/5, Paul Hannon, The Wall Street Journal) ...In a news conference Thursday, ECB President Christine Lagarde said an upgrade in the growth estimate for the eurozone is likely, referring to Ireland without naming the country. "It's the buildup in inventories in fear and anticipation of tariffs," she said. "I would not exclude that the number will be revised up given the volume of trade we are seeing out of some countries in particular."... Sub. Req’d

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 and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.