Tuesday, December 16, 2025

Teva Price Target Raised to $35 from $28 at JPMorgan

(12/16, The Fly) ...JPMorgan analyst Chris Schott raised the firm's price target on Teva to $35 from $28 and keeps an Overweight rating on the shares. The firm upped 2027 estimates to reflect the Centers for Medicare and Medicaid Services Austedo announcement... Sub. Req’d

Hickenlooper, Bennet, Democratic Colleagues Demand Answers from Trump Admin and Drug Companies as Health Care Costs Skyrocket

(12/15, U.S. Senator John Hickenlooper) ...The letters, sent to Pfizer, AstraZeneca, Novo Nordisk, and Eli Lilly ask for specific pricing information on which drugs will be affected by the announcements, what the "most favored nation" price is for those drugs, and what state Medicaid programs will pay in the wake of these announcements... Full

Miller-Meeks Says Her Health Care Bill Would Address ‘Root Causes' of High Premiums

(12/15, Robin Opsahl, Iowa Capital Dispatch) ...The legislation contains multiple proposals that Miller-Meeks said would reduce premium costs, including providing funding for cost-sharing reduction payments under the ACA beginning in 2027. "Cost-sharing reductions" lower deductibles, copayments and out-of-pocket maximums for one of the ACA plans, depending on income. The bill also adds new requirements for pharmacy benefit managers (PBMs) to share information on prescription drug costs and other decisions... Full

The High Price of False Security in Drug Policy

(12/15, Justin Leventhal, RealClearHealth) ...America faces growing pressure to secure its pharmaceutical supply chains, but protectionist policies—especially those centered on tariffs and strongarming domestic production—offer the illusion of safety while threatening affordability, access, and global competitiveness... Full

Why Trump's Second Term is Different for the MFN Drug Pricing Policy

(12/15, Brian Nowosielski, Drug Topics) ...Ron Lanton III, Esq, discusses the revamped version of the Trump Administration's MFN drug pricing policy and why his second term may yield different outcomes...In part 1 of our interview with Lanton, he introduced the idea of the MFN drug pricing policy, why the administration continues to go after this lofty goal, and how it is different and expected to overcome previous policies of a similar ilk... Full

FDA Wants to Use More Real-World Data and Calls Again for Early-Phase Trials Reform

(12/16, Max Bayer, Endpoints News) ...As part of the FDA's data plans, the agency announced Monday that it will allow the use of data that don't include "private, confidential information at the individual patient level," a broadening of its current standard that could include large, real-world datasets from insurers, hospitals or patient registries, for example. The new guidance is first aimed at medical device makers, but the agency says it intends to release similar advice for drugs and biologics... Sub. Req’d

FDA Rolls Back 'Red Tape' in Move Aligned With Trump Push to Speed Up New Cures

(12/15, Kristen Altus, Fox Business) ...Echoing President Donald Trump's call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from submitting real-world data in drug and device applications. He says the shift will cut costs, reduce delays and open the door to faster cures... Full

US FDA Commissioner Makary Continues Pushing Boundaries With Novartis Photo-Op

(12/15, Sarah Karlin-Smith, Pink Sheet) ...US [FDA] Commissioner Martin Makary's participation in recent groundbreaking ceremonies for Novartis' new North Carolina manufacturing hub is the latest example of his bucking the norms for agency leadership...In the video with Narasimhan, Makary said Novartis is "doing a phenomenal job in this broader goal of domestic manufacturing."..."We're going to continue to promote these efforts at the FDA," Makary said in the second video, where he appeared alone and touted President Trump's "America first agenda," to bring manufacturing back to the US... Global Sub. Full

Big Pharma Pushes FDA To Decouple Inspections From Drug Approval Applications

(12/16, Nick Paul Taylor, BioSpace) ...Establishing clearer inspection timelines is one of the ways the PreCheck program could benefit the industry, Guggenheim Securities analysts said in a note to investors. Under the current process, manufacturers can lack the forewarning they require to ensure a production run is active when the FDA visits. Karen Wolfrom, global head of regulatory affairs at Lonza, told the FDA the alignment problem has a particular impact on contract manufacturers because they commonly make batches of different products for different clients at different times... Full

FDA ‘Proactively' Awards J&J A National Priority Review Voucher for Multiple Myeloma Drug Combo

(12/15, Angus Liu, Fierce Pharma) ...The voucher was granted to J&J for its proposed combination of Tecvayli and Darzalex for previously treated multiple myeloma. With the voucher, the FDA aims to deliver a decision within one to two months following submission of an application... Full

FDA Greenlights Enhertu's Move into First-Line Breast Cancer

(12/15, Elizabeth S. Eaton, FirstWord PHARMA) ...The latest label expansion covers the use of Enhertu in combination with Roche's Perjeta (pertuzumab) to treat adults with treatment-naïve, unresectable or metastatic HER2-positive breast cancer... Full

Sanofi Broadens Alzheimer's Pipeline with $1B Bet on ADEL's Tau Antibody

(12/16, Pavan Kamat, FirstWord PHARMA) ...Seeking to scale its dementia pipeline beyond a newly-acquired asset from Vigil Neuroscience, Sanofi forged a licensing pact, potentially worth over $1 billion, for global rights to develop and commercialise South Korean biotech ADEL's investigational Alzheimer's disease antibody and related backup candidates... Full

Amphastar Cracks Forteo With FDA Approval After Years of Delays

(12/16, Dean Rudge, Generics Bulletin) ...Amphastar has secured a significant regulatory milestone with US Food and Drug Administration approval of its substitutable generic version of Eli Lilly's Forteo (teriparatide) injectable, marking the company's entry into one of the most technically challenging generic drug-device markets. The California-based player plans to launch its abbreviated new drug application product by the end of 2025 – ahead of a recent projection setting out potential market entry in the first half of 2026... Global Sub. Full

Sandoz Asserts ‘Biosimilars Leadership' As It Completes Just-Evotec Acquisition

(12/15, Dave Wallace, Generics Bulletin) ...Sandoz says it is "asserting biosimilars leadership" after completing a deal to acquire partner Just-Evotec Biologics's Toulouse development and manufacturing site, as well as an indefinite licence to the firm's continuous manufacturing technology for biosimilars... Global Sub. Full

Stada-Bio-Thera Chase Alvotech-Advanz In Early EU Golimumab Biosimilar Market

(12/16, Dean Rudge, Generics Bulletin) ...Ian Henshaw, global head of Stada's Specialty unit, said the firm was positioning Gotenfia as a means to expand patient access to a well-established anti-TNF therapy with reported European annual sales of approximately €700m ($823m), while leveraging its prior experience in biosimilars across immunology... Global Sub. Full

Celltrion Launches Eylea Biosimilar Eydenzelt in Europe, Notches Early NHS Tender Wins

(12/16, Kim Ji-hye, Korea Biomedical Review) ...The Korean drugmaker said Tuesday it began rolling out Eydenzelt earlier this month and that its U.K. unit won National Health Service (NHS) tenders across three administrative regions at launch. Celltrion said the wins included Northern England, which it described as the largest U.K. tendering region by market size, and added that Eydenzelt was the only biosimilar officially listed there... Full

Pfizer Sees Flat 2026 Sales as It Rebuilds Drug Pipeline

(12/16, Madison Muller and Robert Langreth, Bloomberg) ...Revenue in 2026 will be $59.5 billion to $62.5 billion, roughly in line with Wall Street's estimate, Pfizer said Tuesday in a statement. Sales this year are expected at $62 billion, within the range the company projected in early November. The company expects next year's adjusted profit to reach $2.80 to $3 a share... Sub. Req’d

The Plan to Rescue Denmark's Weight-Loss Pioneer

(12/15, The Economist) ...That narrower focus is meant to clear the way for two new drug launches next year. One is an oral version of Wegovy that, in trials, produced better weight-loss results than Lilly's competing pill. Some analysts worry that patients may balk at the requirement to take it on an empty stomach and wait half an hour before eating (Lilly's pill carries no such strictures). But Martin Lange, Novo's chief scientist, dismisses the concern, noting that diabetics are already taking oral semaglutide without fuss. The second launch is a higher-dose Wegovy injection that achieved weight loss comparable with Zepbound in trials...The company adds that, this time around, it will have ample capacity in place for the drugs... Sub. Req'd

Hikma Signals Reset With Abrupt CEO Change As Injectables Margins Slide

(12/15, Dean Rudge, Generics Bulletin) ...Mishlawi's abrupt exit is the second high-profile departure from Hikma in the space of six weeks. The company is already in the middle of looking for a new leader for its Injectables division, after announcing in November that Bill Larkins had stepped aside from the position and would leave the company at the end of the year... Global Sub. Full

Civica Secures Federal Supply Schedule Deal With US Veterans Health System

(12/16, Dean Rudge, Generics Bulletin) ...Civica has secured a significant foothold in US federal healthcare after being awarded a federal supply schedule contract by the Department of Veterans Affairs, opening the door to supply essential generic medicines across the Veterans Health Administration... Global Sub. Full

EU Commission's Long-Awaited Biotech Act Sparks New Incentive Debate

(12/15, Thomas Mangin, Euractiv) ...On Tuesday, the Commission is set to present the first part of the Biotech Act. In the version seen by Euractiv, that would extend the supplementary protection certificate (SPC) for medicines developed using biotechnological processes by 12 months...That proposal confirms rumours that Adrian Hoven, director general of the generics industry association Medicines for Europe, addressed in an interview with Euractiv on Monday. He warned that, according to the organisation's calculations, extending additional intellectual property protection to biological medicines would cost health systems around €7.7 billion for the top three biologics alone... Full

We Must Stay Vigilant on False Patent Extensions and The Non-Clinical Use of Weight-Loss Drugs

(12/16, Mint) ...For drugs, India now follows product patents in line with World Trade Organization norms, but does not indulge Big Pharma the way the US and EU often do by allowing patent extensions on flimsy grounds. The original molecule of Ozempic lost its patent monopoly last year and its specific formulations will go off-patent in March 2026. The court has let Dr Reddy's make and export a generic version of semaglutide to markets where the drug has no patent shield, while barring sales in India until that point... Full

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