Wednesday, March 25, 2026

 

 

Jefferies Reiterates Buy Rating on Teva Pharma (TEVA)

(3/25, StreetInsider.com) ...The analyst comments: "TEVA has performed well in 2025 and in line with our (+) thesis on Austedo execution + IRA negotiations, which looked better than expected and lifted an overhang. With the stock trading at 9-10x EV/EBITDA, TEVA looks optically "expensive" going into 2026 vs spec pharma comps, but we'd argue there's still room for multiple expansion, especially if investors start looking at TEVA through a biopharma lens..."... Sub. Req’d

 

 

China's Threat To US Rx Sector Unifying Capitol Hill

(3/24, Michael McCaughan, Pink Sheet) ...A newer theme is the perceived threat from a surge of innovative therapy development in China. The focus on the country's sudden emergence as a leader in "first-in-human" trials clearly has the attention of the US Food and Drug Administration and the biotech sector... Global Sub. Full

 

In House Hearing, Unanimous Agreement on China Risks in American Rx Supply

(3/24, Kenneth Rapoza, CPA) ...A Section 232 tariff for generic drugs should operate as a dual-track tariff-rate quota (TRQ) system for both finished dose forms (FDF) and active pharmaceutical ingredients, with separate quotas and specific tariffs tied to U.S. demand and domestic capacity, adjusted periodically. Imports within quota enter at low or zero tariffs, while excess or high-risk supply faces steep per-dose or per-kilogram tariffs... Full

 

RAAP Releases New Policy Paper Warning States Against Adopting "Most Favored Nation" Drug Pricing Models

(3/24, Rare Access Action Project) ...The study concludes that importing Most Favored Nation (MFN) pricing benchmarks into state Prescription Drug Affordability Board (PDAB) frameworks could unintentionally jeopardize patient access while failing to address the root causes of affordability challenges... Full

 

SHARx: TrumpRx Platform Exposes Issues in Drug Pricing and Access

(3/24, Thorvardur de Shong, Chain Drug Review) ...SHARx argues that without addressing the rebate-driven economics and decision-making power embedded within the PBM system, efforts to reduce drug prices may have limited impact on patients... Full

 

What to Know About the BALANCE Model for GLP-1s in Medicare and Medicaid

(3/24, Meredith Freed, Juliette Cubanski, and Elizabeth Williams, KFF) ...CMS has proposed a two-step approach to expanding coverage of GLP-1s for obesity in Medicare - a temporary payment demonstration for 2026, known as the Medicare GLP-1 Bridge, and a new Center for Medicare and Medicaid Innovation (CMMI) model, known as the BALANCE Model, beginning January 2027... Full

 

Doctors for America Raises PDUFA, CNPV, Bayesian, Supply Chain Concerns With Lawmakers

(3/24, Maaisha Osman, Inside Health Policy) ...As negotiations over PDUFA reauthorization begin, DFA is calling on Congress to prioritize FDA independence, scientific integrity and supply chain resilience. The group argues that decisions made in the coming months will shape not only how quickly new drugs reach the market, but how safely and reliably they do... Sub. Req'd

 

US FDA Layoffs Did Not Curtail Some PDUFA Spending

(3/24, Derrick Gingery, Pink Sheet) ...Widespread layoffs and other departures at the US [FDA] did not reduce prescription drug user fee payroll spending in fiscal year 2025 and may not cut it as much as expected in FY 2026... Global Sub. Full

 

GDUFA IV: Negotiations Address DMFs, Internal Consultations, Imminent Actions

(3/24, Joanne S. Eglovitch, Regulatory Focus) ...During the meeting, FDA said the industry's request to expand prior assessments to include all DMFs was "not feasible." Instead, FDA offered to "clarify and standardize the process by creating a prior assessment cover letter template, presenting to industry on the process at least once per fiscal year, and by instructing DMF holders to request prior assessments using FDA Form 3938."... Full

 

Hatch-Waxman Needs Repair To Fight Against Serial Patent Litigations

(3/24, Urte Fultinaviciute, Generics Bulletin) ..."There is always value for the Congress checking in and asking, has this worked the way we intended it to 40 years later, the answer is no," Jon Potter, executive director of the Coalition Against Pharma Patent Abuse, told Generics Bulletin in an exclusive interview. The recently established CAPPA aims to bring light to one of the most prominent patent abuse tactics – serial patent litigations... Global Sub. Full

 

Inside USP's Strategy to Fortify Medicine Supply Chains

(3/23, Tony Lakavage, Susan Haigney, Zachary Zubulake, PharmTech.com) ...Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP), outlines the key pressures facing the pharmaceutical supply chain with particular focus on geopolitical risk, generic-drug pricing, and the infrastructure USP is building to support long-term resilience... Full

 

Kansas Lawmakers Take Aim at High Prescription Drug Prices With New Regulations

(3/24, Matthew Kelly, Kansas City Star) ...The Kansas Legislature sent a bill to Gov. Laura Kelly's desk on Tuesday that supporters say will protect independent pharmacies and ultimately drive down prescription drug prices. The bill would impose a new slate of restrictions on pharmacy benefit managers, or PBMs - the middlemen that process claims on behalf of insurance companies, decide which medications are covered by health plans, and how much they will cost patients... Full

 

IL Lawmakers Renew Push for Prescription Drug Affordability Board

(3/24, Mike Miletich, WAND News) ..."Illinois should learn from the lessons of the Inflation Reduction Act — patients facing higher out-of-pocket costs, fewer choices and more barriers to care — and focus on protecting patient access and affordability by addressing the abusive practices of insurers and PBMs," [PhRMA spokesperson Will May] said... Full

 

CVS, FTC Reach Proposed Settlement in Insulin Pricing Case

(3/24, Rebecca Pifer Parduhn, Healthcare Dive) ...The proposed settlement would "resolve all of the claims against the Caremark Respondents," and has already been approved by CVS, FTC attorneys and the FTC's competition and consumer protection bureaus, according to the filing. It still needs to be approved by FTC leadership, including Chairman Andrew Ferguson. CVS expects the settlement process to wrap up in the next few weeks, but final terms of the deal are still pending, the company told Healthcare Dive... Full

 

 

Generic Ozempic Is Coming to Canada. This Company Wants to Make it

(3/24, CBC) ...A Canadian pharmaceutical company, headed by two former executives with the company behind Ozempic, hopes to make a generic version of the weight-loss drug in Edmonton. Data protections on the GLP-1 receptor, semaglutide, expired in January... Full

 

Lupin Receives US FDA Tentative Approval for Pitolisant Tablets

(3/25, Pharmabiz.com) ...Lupin Limited announced that it has received tentative approval from the United States [FDA] for its Abbreviated New Drug Application for pitolisant tablets, 4.45 mg and 17.8 mg. This product would be manufactured at Lupin's Nagpur facility in India... Full

 

Cambrex Targets Complex APIs As Outsourcing Demand Rises

(3/24, Dean Rudge, Generics Bulletin) ...[Cambrex] said it had completed initial engineering studies for a new large-scale API facility in Charles City, Iowa, with groundbreaking slated for late 2026...Alongside its US plans, Cambrex is also investing $30m into its Milan, Italy site, where it is expanding analytical development and process R&D capabilities and upgrading multiple production plants. The European expansion is expected to complete in the second half of 2027, with the company also acquiring additional land to support future growth... Global Sub. Full

 

India Deal Strengthens Bio-Thera's Global Golimumab Strategy

(3/24, Dean Rudge, Generics Bulletin) ...Bio-Thera Solutions has extended its partnership with Intas Pharmaceuticals for its BAT2506 golimumab biosimilar to include India, adding another territory to a growing global commercialization network... Global Sub. Full

 

 

Merck Boosts Cancer Portfolio with $6.7 Billion Terns Deal

(3/25, Reuters) ...Merck said on Wednesday it would buy biotech Terns Pharma for $6.7 billion, as the drugmaker races to bolster its cancer pipeline ahead of the looming patent loss for blockbuster therapy Keytruda...The deal gives Merck access to Terns' experimental drug TERN-701, which is being tested to treat chronic myeloid leukemia, a cancer that starts in the bone marrow and causes the uncontrolled growth of leukemia cells... Sub. Req’d

 

Belgian Drugmaker UCB to Invest $2B in Suburban Atlanta Plant, Adding 330 Jobs

(3/25, Associated Press) ...The rapidly growing drugmaker said the plant, which would employ about 330 people upon completion, would anchor its effort to sell more drugs in the United States. "This decision reflects our confidence in UCB's long-term growth and our deep-rooted commitment to the United States," company CEO Jean-Christophe Tellier said in a statement... Full

 

Shionogi Will Pay $100M to Buy out Apnimed's Part of Their Sleep Disorder Partnership

(3/25, Kyle LaHucik, Endpoints News) ...The deal gives Shionogi full control of the pipeline under the joint venture named Shionogi-Apnimed Sleep Science, or SASS. That includes SASS-001 and SASS-002 (sulthiame). SASS-001 is a combo drug containing sivopixant, a P2X3 receptor antagonist, in Phase 2a for a type of sleep apnea. Meanwhile, the oral candidate SASS-002 was in-licensed from Germany-based company Desitin Arzneimittel last April. It is in Phase 2 for obstructive sleep apnea... Sub. Req’d

 

How Former Acorda CEO Ron Cohen Landed at a Parkinson's Cell Therapy Startup

(3/24, Jacob Bell, BioPharma DIVE) ...BioPharma Dive spoke to Cohen about lessons learned from the Acorda saga and why Oryon stood out amongst a handful of developers in the Parkinson's cell therapy space. The following conversation has been edited and condensed for clarity... Full

 

New Initiative to Support MS Treatment Decisions in Older Adults

(3/24, Margarida Maia, PhD, Multiple Sclerosis News Today) ...The Accelerated Cure Project for Multiple Sclerosis (ACP) has received funding to help interpret and share findings from the DISCO-MS study, which examined whether older adults with stable multiple sclerosis (MS) could stop disease-modifying medications, to support more informed treatment decisions... Full

 

AstraZeneca Reportedly Hit by Serious Cyberattack

(3/24, Phil Taylor, PharmaPhorum) ...A hacking group claims to have broken into AstraZeneca's IT systems and stolen confidential data, which they are now offering for sale. The group, known as LAPSUS$, maintain that they have stolen around 3GB of compressed AZ data, but somewhat unusually are trying to sell it on the Dark Web rather than threatening to release it publicly in an attempt to extort money from AZ to keep it under wraps... Full

 

Top Pharmaceutical Industry Trends Impacting R&D and Manufacturing

(3/25, Tony Lakavage, Susan Haigney, Zachary Zubulake, PharmTech.com) ...Tony Lakavage, executive vice president and head of Global External Affairs, US Pharmacopeia (USP), discusses how IRA negotiations, Most Favored Nation pricing, US manufacturing push, and new FDA biosimilar guidance are reshaping the industry... Full

 

Strides Recalls Nearly 90K Bottles of Children's Ibuprofen After Contamination Complaints

(3/24, Joseph Keenan, Fierce Pharma) ...The product, which was produced by Strides in India for Taro Pharmaceuticals' U.S. subsidiary, was recalled after complaints to the company flagged a "a gel-like mass and black particles" in the product, the FDA said in a posting on its website... Full

 

 

Israel's Healthcare Innovation Engine Is Maturing

(3/25, Adv. Ron Abelski, Globes) ...Over the past decade, Israel has evolved from a "Startup Nation" into a fully integrated healthcare innovation ecosystem. What makes it unique is not any single component, but rather the unusually tight combination of engineering talent, advanced clinical infrastructure and one of the most comprehensive health data environments in the world, all operating within a relatively compact geography... Full

 

Lilly to Remove Certain Insulin Products from European Markets by 2027

(3/24, Zoey Becker, Fierce Pharma) ...The company is removing several of its insulin presentations, including short- and rapid-acting, mixed-acting and long-acting iterations of its products containing human insulin, insulin lispro and insulin glargine across selected European countries, the European Medicines Agency (EMA) announced on Monday... Full

 

IGBA Welcomes Ana Gaunt as New Secretary General

(3/24, IGBA) ...The International Generic and Biosimilar Medicines Association (IGBA), has appointed Ana Gaunt as its new Secretary General with immediate effect, following the decision of Susana Almeida to step down from the role to pursue other opportunities... Full

 

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