Wednesday, April 8, 2026

 

 

From Netanya Labs to Global Race: Teva Develops Antibody Targeting Celiac and Autoimmune Diseases

(4/7, Eitan Gefen, Ynet Global) ...Providing a rare look behind the scenes is Inbal Ben-Eliezer, a director and team leader in Teva's preclinical department, where early-stage science is gradually translated into therapeutic potential. At the center of the effort is TEV-53408, an experimental antibody currently being developed for two conditions: celiac disease, a chronic intestinal disorder, and vitiligo, an autoimmune skin condition with limited treatment options... Full

 

Jefferies on Teva Pharma (TEVA): 'Early, But Investors Should Pay Attention'

(4/7, StreetInsider.com) ...Jefferies analyst Dennis Ding reiterated a Buy rating and $40.00 price target on Teva Pharma...The analyst commented, "TEVA has an IL13 x TSLP bispecific entering the clinic in early 2027, but gets zero credit. We appreciate TEVA is early, but investors should still pay attention given (+) SNY IL13 x TSLP bispecific data in asthma / CRSwNP (missed on atopic derm) + signals from PFE's IL13 x TSLP x IL4 trispecific in atopic derm. TEVA is taking a fast follower approach to its antibody portfolio, & we view competitor readouts as partially derisking & impt given low expectations."... Sub. Req’d

 

 

Pharma Industry Laments Trump's Tariff on Branded Drugs

(4/8, Robert barrie, Pharmaceutical Technology) ...In a research note, ING senior economist Diederik Stadig commented: "The key countries involved include Singapore, India, and China -none of which currently export a substantial volume of branded pharmaceuticals to the US. The economic impact will therefore be negligible. Rather, the tariff is geopolitical in nature and should be seen as a shot across the bow for more intense competition between the US and China in biotech and pharma."... Full

 

Bayer US Head Says Tariffs Will Not Affect Its 2026 Forecasts

(4/7, Reuters) ..."We feel that we've appropriately anticipated tariffs as we think about our 2026 guidance," Bayer Pharmaceuticals Chief Operating Officer and Bayer U.S. President Sebastian Guth told Reuters. Guth said Bayer was particularly comfortable with its forecast as the U.S. has committed to honoring the trade deal it signed with the European Union last year that caps tariffs on most goods from those countries - including medicines - at 15%... Sub. Req’d

 

Editorial: The Backward Logic of Pharmaceutical Tariffs

(4/7, The Washington Post) ...[U]nsurprising are the enormous carveouts in the tariff announcement. The administration has exempted generic and biosimilar drugs from the levies and said it would spare drugs for rare diseases from certain countries or that "meet an urgent public health need." Judging by the stock market's lack of reaction to Trump's announcement, those loopholes probably are enough for most companies to get by unscathed... Sub. Req'd

 

The Price Americans Pay for Medicine Has Gotten Horribly Out of Control. Here's How to Fix It.

(4/7, Paul Markovich, MarketWatch) ...We need federal legislation that prohibits PBMs and their affiliated companies from collecting fees based on drug prices, volume of drugs sold, or placement on a formulary. Providers and patients must know the net price of a drug and have copays tied to that price rather than the inflated list prices. That means any discounts offered by drug companies would benefit patients, not PBMs... Full

 

PDUFA VIII: US 'Anchored' Phase I Clinical Studies Could Mean Millions In Fee Discounts

(4/7, Derrick Gingery, Pink Sheet) ...The US [FDA] and industry have agreed to halve the application user fee for sponsors that "anchor" Phase I clinical trials in the US as part of the prescription drug user fee reauthorization. The discount could be a substantial incentive to increase domestic drug development. Applications requiring clinical data mandate a $4.7m fee in fiscal year 2026... Global Sub. Full

 

FDA Lays Out Policy Wish List, Including New Trial Pathway and New Enforcement Powers

(4/7, Angus Liu, Eric Sagonowsky and Zoey Becker, Fierce Pharma) ...One year into his tumultuous tenure as the FDA's commissioner, Marty Makary, M.D., has laid out ambitious internal goals and perhaps a more ambitious legislative wish list in his fiscal year 2027 budget proposal to Congress. Alongside the justification of a $7.2 billion budget request, including $3.3 billion from congressional appropriations and $3.9 billion in industry-paid user fees, Makary is asking for a broad set of legislative actions... Full

 

PCMA Partners With Groups on Letter Urging Congress to Advance Legislation to Stop Drug Patent Abuse

(4/7, PCMA) ...The Pharmaceutical Care Management Association (PCMA) joined nearly 20 other organizations that support patients and affordable health care to call on Congress to speed generic and biosimilar market entry by ending Big Pharma's use of patent thickets and protecting the use of skinny labels... Full

 

Kansas Bill Aims to Regulate Pharmacy Benefit Managers, the Middlemen in Prescription Drug Pricing

(4/7, Blaise Mesa, The Beacon) ...[Joel Kurzman, director of state government affairs at the National Community Pharmacists Association,] said PBM legislation has been debated in virtually every state. Three hundred bills this year were introduced to regulate the companies. Kansas is not alone in its issues, and Kurzman said that while it is not leading the charge, the state is a fast follower of reform...West Virginia passed a similar bill, and while some insurance plans did rise, they didn't rise as much as they could have. Some plans were 5.5% lower because of PBM reform, state officials say... Full

 

 

Sanofi Immune Drug Hopeful Posts Mixed Results in Mid-Stage Tests

(4/7, Ben Fidler, BioPharma DIVE) ...One therapy Sanofi has put considerable resources into, amlitelimab, hasn't been as effective or safe in testing as investors had hoped, leading analysts to significantly pare down financial projections. Now Sanofi has delivered mixed results with lunsekimig, a bispecific drug that targets two known drivers of inflammation, TSLP and IL-13. Ahead of the results, R&D chief Houman Ashrafian noted that biologics for asthma were increasingly producing similar effects on symptom flare-ups, suggesting "the field may be nearing a biological ceiling," Leerink Partners analyst David Risinger wrote in a Tuesday note... Full

 

 

Biocon Launches Two Denosumab Biosimilars, Aukelso and Bosaya, in US

(4/7, Patrick Lavery, Contract Pharma) ...Both are available in their most common presentations. For Aukelso, that means a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use, in a single-dose vial. Bosaya, comparatively, is available in a 60 mg/mL injection for subcutaneous use in a prefilled syringe... Full

 

Apotex Strengthens Osteoporosis Care in Canada with Health Canada's Approval of DENOZA™, a Denosumab Biosimilar

(4/7, Apotex) ...Apotex...today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications... Full

 

Phase III Success Puts Aurobindo In Xolair Biosimilars Race

(4/7, Dean Rudge, Generics Bulletin) ...The study met all primary endpoints, demonstrating "high comparability" to the reference product, Roche's Xolair (omalizumab), in patients with chronic spontaneous urticaria at the 300mg dose, according to the company... Sub. Req’d

 

Aeon Finances Creak As Biosimilar Momentum Builds

(4/8, Dean Rudge, Generics Bulletin) ...Aeon Biopharma is advancing its ABP-450 (prabotulinumtoxinA) proposed biosimilar to Botox (onabotulinumtoxinA) with encouraging regulatory feedback and analytical data, even as the company faces mounting financial strain and stock exchange compliance challenges. The California-based group has disclosed that recent interactions with the US [FDA] have provided a "clear framework" for progressing its biosimilar development program... Global Sub. Full

 

Hikma And Glenmark's Ryaltris Break-Up Illustrates Shifts In Strategies

(4/7, Dave Wallace and Anju Ghangurde, Generics Bulletin) ...Industry sources tracking the development maintained that Glenmark's decision to go solo was not perhaps a sudden or event-driven change. "The partnership with Hikma played an important role in establishing Ryaltris in the US, particularly in the early phase post-launch," sources told Generics Bulletin sister publication Scrip. However, "as the brand has evolved, there was a natural shift in how Glenmark is approaching the US." And in future, "Glenmark could be more selective like this going forward, owning commercialization where it aligns with the strategy, while continuing to partner in other situations," the sources suggested... Global Sub. Full

 

 

Gilead Pays $3.1B Upfront for Tubulis to Bolster Oncology ADC Pipeline

(4/7, Nick Paul Taylor, Fierce Biotech) ...In Tubulis, Gilead has identified a biotech capable of expanding the ADC foothold it secured in 2020 by acquiring Immunomedics for $21 billion. The earlier deal gave Gilead control of the anti-TROP-2 ADC Trodelvy... Full

 

Eli Lilly's Latest Acquisition Could Preview Another Booming Market

(4/8, Max Bayer, Endpoints News) ...But what if narcolepsy is just scratching the surface? Interviews with Wall Street analysts suggest that's a possibility, and with Lilly in control, a lot more money could be poured into widening the drugs' development scope — specifically, testing whether they broadly help with focus or fatigue... Sub. Req’d

 

Merck Got a Peek at Terns' Leukemia Data During its Deal Talks — and Decided to Lower its Bid by $1B

(4/7, Kyle LaHucik, Endpoints News) ...The SEC filings don't spell out the exact clinical data update that Merck and Party C received. The documents reveal that the "MMR achievement rate was lower, potentially due to more patients being pre-treated with asciminib [Scemblix] in the evaluable population." But the regulatory filing doesn't detail the new achievement rate, other than saying it "stayed within Terns' disclosed confidence interval after the ASH Annual Meeting, with no overlap with the asciminib interval."... Sub. Req’d

 

Vertex Taps Halozyme and its Recently Acquired Elektrofi Tech in $15M Drug Delivery Deal

(4/7, Frasier Kansteiner, Fierce Pharma) ...Vertex is licensing Halozyme's Hypercon, a microparticle, high-concentration formulation technology developed by Elektrofi. Halozyme paid $750 million in cash to acquire its subcutaneous drug delivery peer Elektrofi last fall... Full

 

A High Dose of Wegovy Will Cost $50 less than Zepbound

(4/8, Jaimy Lee, MarketWatch) ...For patients paying cash, Wegovy HD has a price of $399 per month. That's compared to $449, the cash price for the four highest doses of Lilly's Zepbound that are sold as a pen... Full

 

Novo Nordisk's Explosive Wegovy Pill Launch Draws a New Wave of Patients into GLP-1 Weight Loss Treatment

(4/7, Annika Kim Constantino, CNBC) ...CNBC spoke with five U.S. patients who recently started the pill following its launch and have varying initial experiences with the drug... Full

 

Biocon Bets on Global Markets as Rivals Fight India's Semaglutide Price War

(4/8, Neetu Chandra Sharma, Business Today) ..." We are looking beyond the Indian market. The opportunity is in the US and emerging markets," said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon. "Biosimilars will be the key growth driver for us going forward."... Full

 

 

A ‘Fundamental Shift': What The EU Pharma Reform Means For Orphan Drugs

(4/7, Eliza Slawther, Pink Sheet) ...One "major shift" for orphan medicines that will be introduced under the new pharma reform package is a global orphan marketing authorization (GOMA), Anna Wawrzyniak, special counsel at the law firm Covington & Burling, told the Pink Sheet... Global Sub. 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.