Tuesday, April 14, 2026

 

 

Teva's LATAM Strategy: Branded Generics and APIs

(4/14, Rafael Suarez, Mexico Business News) ...Teva has historically been recognized as the world's largest generics company; actually generics contribute to more than US$40 billion global savings in healthcare systems. However, the company is now expanding beyond that foundation to incorporate innovation as a core pillar of growth. Globally, we are advancing innovative therapies across key areas such as migraine, schizophrenia, and Huntington's disease among others. This reflects a deliberate shift toward a more balanced portfolio that combines generics, branded generics, and innovative medicines. In Latin America, the implementation of this strategy varies by country, as each market is at a different stage of development... Full

 

Teva Must Face Mylan Lawsuit Over Generic Competition for Copaxone

(4/13, Blake Brittain, Reuters) ...U.S. District Judge Julien Neals denied the company's bid to dismiss allegations by generic drugmaker Viatris' (VTRS.O) Mylan subsidiary that Teva broke federal antitrust law by encouraging its sales representatives to spread false information about generic Copaxone and pressuring pharmacy benefit managers (PBMs) to exclude generics from their plans... Full

 

 

Merck, Sanofi Are Latest Companies to Add Medications to TrumpRx

(4/13, Edward Lawrence, Fox Business) ...Merck added three popular Type 2 diabetes medications, cutting the cost by 74%. Januvia, Janumet and Janumet XR will all cost $84.57, down from $330. Meanwhile, Sanofi will become the 13th company to offer the discounts, listing diabetes, tuberculosis and blood medications on the website... Full

 

Exclusive: GOP Pushes Sweetener for Cash-Pay Drugs

(4/14, Maya Goldman, Axios) ...Rep. Greg Murphy (R-N.C.) is unveiling a plan Tuesday that would require commercial insurers to apply prescription drug purchases from cash-pay platforms toward deductibles and out-of-pocket maximums, he told Axios first... Full

 

Dems Press More Companies For Terms Of MFN Deals, Tariff Exemptions

(4/13, James Jarvis, Inside Health Policy) ...House and Senate Democratic committee leaders, including Energy & Commerce ranking Democrat Ranking Member Frank Pallone (D-NJ) and Senate Finance ranking Democrat Ron Wyden (OR), are asking the companies to detail the terms of the agreements - including which drugs are covered, how prices are set and whether the arrangements apply to Medicare or Medicaid - and gave them until April 27 to respond... Sub. Req'd

 

More Tariff Uncertainty For Chinese Companies with US FDA-Approved Drugs

(4/13, Dexter Jie Yan, Pink Sheet) ...The administration has not made clear whether tariffs will be imposed or the amount that will be charged on the six Chinese innovative medicines that have been approved by the US Food and Drug Administration since 2023... Global Sub. Full

 

SHARx: Drug Pricing Isn't Just Broken, It's Protected

(4/13, SHARx) ...Growing regulatory scrutiny and industry reporting suggests that high drug prices persist not just because of cost, but because of a system designed to protect pricing benchmarks, according to industry insider, Paul Pruitt of SHARx. As lower-cost, clinically viable alternatives emerge, they threaten to reset expectations—and disrupt the economics of the pharmaceutical market... Full

 

Skinny Labels at the Supreme Court—Generic Competition, Patent Inducement, and Affordable Medicines

(4/09, S. Sean Tu, PhD, JD, Frazer A. Tessema, MD, Aaron S. Kesselheim, MD, JD, MPH, JAMA) ...The skinny labeling pathway is now under serious threat, with the Supreme Court poised to consider whether its scope has been improperly narrowed by recent decisions by the US Court of Appeals for the Federal Circuit. The implications are substantial for patients, clinicians, and the health care system. The stakes are highest in therapeutic areas in which multi-indication drugs are common, such as cardiovascular disease, oncology, and neurology... Sub. Req'd

 

FDA Urges Clinical Trial Sponsors to Report the Results of Their Studies

(4/13, Kevin Dunleavy, Fierce Biotech) ...An FDA review of records in the U.S. clinical trials database shows that results have not been reported for 30% of clinical studies, the agency said on Monday. To remedy this shortfall, the U.S. regulator has sent messages to 2,200 drug companies, medical device manufacturers and researchers urging them to report their results... Full

 

Another QMSR Town Hall – What Changes and What Stays the Same in FDA's Inspection Process

(4/14, Adrienne R. Lenz, FDA Law Blog) ...In the opening remarks, FDA summarized the two inspection models and noted that unlike prior inspections under the Quality System Inspection Technique (QSIT) that each inspection will include evaluation of each area of a company's Quality Management System (QMS). After the summary, FDA turned to a panel of experts who responded to frequently asked questions related to FDA inspection under QMSR and the new CP... Full

 

US FDA's CDER, CBER Continue Hiring Staff, But More Continue To Leave

(4/13, Derrick Gingery, Pink Sheet) ...The continued overall decline in employee count likely will increase industry and stakeholder concerns about the FDA's ability to meet its application review and other responsibilities. Review goals still largely seem on track, but stakeholders have warned that the consequences of the reduction-in-force and other departures soon will impact the agency... Global Sub. Full

 

New CBER Director Candidate Could Signal Industry Cred Important Again

(4/13, Derrick Gingery, Pink Sheet) ...Houman David Hemmati, a biotech company founder and former big pharma executive, is reportedly among the candidates for CBER director... Global Sub. Full

 

Pfizer Rebuked by FDA for Misleading Adcetris Ads on Facebook

(4/14, Nick Paul Taylor, Fierce Pharma) ...Continuing a wave of actions against drug ads in recent weeks, the FDA sent (PDF) Pfizer an untitled letter outlining its issues with promotional materials for the CD30-directed antibody-drug conjugate Adcetris. The FDA ruled the Facebook ads misbrand Adcetris and make distributing the drug a violation of the Federal Food, Drug and Cosmetic Act... Full

 

Maryland State Affordability Board Sets Its First Price Cap for a Medicine

(4/13, Ed Silverman, STAT+) ...The board, which is designed to function like a state utility commission, will now oversee a process to lower the cost of the type 2 diabetes medicine Jardiance for the state and local governments by January 2027. At that time, the price will be capped at $204, or $6.80 a pill, for a 30-day supply. The move is estimated to save $320,000 a year... Sub. Req'd

 

White House Urges Mississippi To Reject Rx Fee Bill Over Drug Price Concerns

(4/13, Maaisha Osman, Inside Health Policy) ...White House officials, in a memo to state legislators, argued the amended bill HB 1665 risks undermining broader federal goals of lowering prescription drug prices and expanding access to affordable medications. The memo was made public by Mississippi Today... Sub. Req'd

 

 

Lilly's Jaypirca Shows Fixed-Duration Power in 'Ambitious' Phase 3 CLL Trial Win

(4/13, Angus Liu, Fierce Pharma) ...Monday, Lilly said its phase 3 Bruin CLL-322 trial in patients with previously treated CLL or small lymphocytic lymphoma (SLL) has met its primary endpoint. In an industry first, the study showed that adding Jaypirca to a fixed-duration regimen of venetoclax and rituximab significantly extended progression-free survival (PFS) compared with the standard combo alone... Full

 

IDEAYA's Darovasertib Combo Succeeds in Key Uveal Melanoma Trial

(4/13, Matthew Dennis, FirstWord PHARMA) ...Findings showed that for the primary endpoint, median progression-free survival (PFS) in the darovasertib combination arm was 6.9 months, a statistically significant improvement over 3.1 months for ICT, representing a 58% reduction in the risk of disease progression... Full

 

Allogene's Off-the-Shelf CAR-T Erases Lingering Lymphoma Cells in Early Slice of Data

(4/13, Darren Incorvaia, Fierce Biotech) ...The small slice of data includes 24 patients out of a planned enrollment of around 220 for the phase 2 ALPHA3 trial, all of whom still had minimal residual disease (MRD) following six first-line rounds of chemotherapy. Seven of the 12 patients given Allogene's donor-derived CAR-T therapy cema-cel tested negative for MRD at day 45, compared to two of 12 patients in the control arm... Full

 

Spyre Drug for Inflammatory Bowel Disease Shows Promise in Early Study

(4/13, Delilah Alvarado, BioPharma DIVE) ...Spyre said the findings were "clinically meaningful" and support SPY001's "best-in-class profile." The drug is one of multiple therapies the company is evaluating in Phase 2 trials in inflammatory bowel disease. Proof-of-concept data for two other therapies in the trial are expected later this year. Data from a placebo-controlled portion of the study are on track for 2027... Full

 

Bristol Myers Squibb Evolves and Expands Multiple Myeloma Programme

(4/13, PMLiVE) ...Now, Standing in the Gaap aims to respond to the needs of a broader range of populations across the MM ecosystem by reinforcing culturally responsive, community-informed approaches to care. Through the survey, BMS hopes to centre voices from across the MM community to show daily real-world challenges, reflect how care is experienced and highlight when additional support is needed most... Full

 

Revolution Medicines Says its Potential Breakthrough Pancreatic Cancer Drug Succeeds in Late-Stage Trial

(4/13, Angelica Peebles, CNBC) ...RevMed said its daily pill, daraxonrasib, met all primary and secondary endpoints in a trial of people whose cancer had already progressed on another treatment. People who took daraxonrasib typically lived for 13.2 months versus 6.7 months for people who took chemotherapy, an increase of 6.5 months, RevMed said in a press release... Full

 

Allogene's Off-the-Shelf CAR-T Strikes at Residual Lymphoma Cells in Phase II Win

(4/13, Anna Bratulic, FirstWord PHARMA) ...An interim futility analysis of the Phase II ALPHA3 study found that 58.3% (7/12) of patients receiving cema-cel achieved MRD-negativity, compared with 16.7% (2/12) in the observation arm, a 41.6-percentage-point difference that Allogene said exceeds benchmarks of 25-30% in the literature often associated with clinical benefit... Full

 

Symptoms in Early Parkinson's Disease Improve with Tavapadon

(4/13, Richard Gawel, Healio) ...Long-term use of oral levodopa, which is the current initial treatment, has been linked to motor complications, Angelo Antonini, MD, PhD, professor, Padova Neuroscience Center, University of Padova, and colleagues wrote... Full

 

 

Celltrion Sees Growth Opportunities As Lingering Uncertainty Over US Tariffs Is Resolved

(4/13, Urte Fultinaviciute, Generics Bulletin) ...In an announcement celebrating the new tariff exemption, Celltrion particularly highlighted its Zymfentra (infliximab-dyyb). Even though Zymfentra is an off-patent rival to Johnson & Johnson's Remicade, the drug is sold as a new medicine due to its subcutaneous formulation. As such, it is not excluded from tariffs as a biosimilar, but Celltrion is bidding on a domestic manufacturing and R&D exemption, which was part of Trump's tariff announcement... Global Sub. Full

 

Apotex Breakthrough Sets Stage For Future Semaglutide Competition

(4/13, Dean Rudge, Generics Bulletin) ...Announcing the milestone, Apotex chief corporate development officer Barry Fishman said it was "a clear demonstration of what true partnership can achieve," adding that the approval "reflects Apotex's leadership in bringing together complementary strengths, a shared purpose, and an unwavering commitment to execution excellence."... Global Sub. Full

 

How Serious is the Biosimilar Void?

(4/14, Mike Hollan, PharmExec.com) ...Pharmaceutical Executive spoke with Thomas Newcomer, SVP and head of US commercial at Samsung Bioepis about the biosimilar market in the United States. While FDA's draft guidance may alleviate some of the pressures when biosimilar developers, there are still other significant factors impacting the market... Full

 

 

J&J's First-Quarter Profit Beats Estimates Even as Stelara Sales Disappoint

(4/14, Reuters) ...The drug and device maker reported first-quarter revenue of $24.1 billion, up nearly 10% from a year earlier. That exceeded analysts' estimates of $23.6 billion, according to LSEG data. Adjusted earnings came in at $2.70 per share, above the consensus estimate of $2.66... Full

 

Merck Transforms Itself Through Dealmaking as Clock Ticks on Top-Selling Drug

(4/14, Patrick Temple-West, Oliver Barnes, Financial Times) ...Merck chief executive Rob Davis has turned the pharmaceutical company into the industry's most aggressive dealmaking machine. The group has spent nearly $26bn on acquisitions over the past year — more than any of its competitors — as Davis leads the oncology and vaccines powerhouse into medicines for infectious diseases and respiratory conditions. "We have as rich a phase 1, phase 2 and phase 3 pipeline as we've ever had in this company and that . . . is not appreciated," Davis told the FT... Sub. Req'd

 

How Merck Keeps Prices for Its Blockbuster Cancer Drug Sky High

(4/14, Ken Alltucker, Austin Fast, Sydney P. Freedberg, USA TODAY) ...But a joint investigation by the International Consortium of Investigative Journalists and USA TODAY found that Merck has employed several tactics to keep Keytruda's price high – along with its profits... Full

 

Novo Taps OpenAI to Speed Development of New Obesity Drugs

(4/14, Naomi Kresge, Bloomberg) ...The OpenAI deal is not "about replacing the scientist, it's about supercharging them," Novo's Chief Executive Officer Mike Doustdar said in an interview. "The same would go for many of our employees."... Full

 

GSK CEO's 'Scientific Courage' Propels Plans for Medley of Phase 3 Trials for Hansoh-Partnered ADC

(4/12, James Waldron, Fierce Biotech) ...Speaking to Fierce at the European Society for Medical Oncology (ESMO) Congress in Berlin at the time, GSK's Hesham Abdullah, M.D., described the 48.5% overall response rate (ORR) seen in a Hansoh trial of patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal cancer as "extremely encouraging."... Full

 

Big Pharma Is Thinking Small on Deals. That's a Boon for Biotech.

(4/13, David Wainer, The Wall Street Journal) ...Deal sizes are smaller, valuations are reasonable and buyers are walking away from megadeals when sellers push too hard on price... Sub. Req'd

 

Mapping the Vertical Integration of Insurers, PBMs, GPOs, Specialty Pharmacies, and Healthcare Services: DCI's 2026 Update

(4/14, Drug Channels) ...The chart below provides an updated illustration of the major vertical business relationships among insurers, PBMs, specialty pharmacies, healthcare services, and other companies within U.S. drug channels. The companies are listed alphabetically by insurer name... Full

 

 

Iran War: How Companies Can Mitigate Higher Costs And Supply Chain Disruption

(4/13, Francesca Bruce, Pink Sheet) ...[I]n an interview with the Pink Sheet, Alexandre Regniault, a partner at the law firm Simmons and Simmons, offered some advice on how companies can mitigate some of the risks through a thorough review of contracts and making difficult decisions on prioritizing certain supply channels, or even certain medicines... Global Sub. Full

 

New Biosimilar Guidelines to Ease Bioequivalence Study Norms: DCGI

(4/14, Abhijeet Singh, ETPharma.com) ...Speaking to the media at the sidelines of the 9th edition of 'India Pharma 2026', Union Minister of State for Chemicals & Fertilizers and Health & Family Welfare Anupriya Patel highlighted the critical nature of this industrial evolution. She noted that the Department of Pharmaceuticals is actively working to expand the domestic industry's influence through dedicated platforms and policy support... Full

 

India Poised to Lead Global Pharma Landscape with Focus on Biosimilars and Specialty Medicines, Says Minister J P Nadda

(4/13, Pharmabiz.com) ...While India has long been recognized as the "Pharmacy of the World" due to its leadership in affordable generic medicines, the global landscape is now rapidly shifting towards biologics, biosimilars, and specialty medicines and India is well positioned to emerge as a global leader, said Union minister of health & family welfare and chemicals & fertilizers, J P Nadda... Full

 

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