Wednesday, April 15, 2026

 

 

Community Routes: Access to Mental Health Care Program Bolsters Services Across Three States

(4/14, Kim Ofilas, Direct Relief) ...Direct Relief, Teva Pharmaceuticals, and the National Association of Free and Charitable Clinics, or NAFC, today announced a second round of grant funding in the amount of $75,000 to each of 11 free and charitable clinics across Alabama, Mississippi, and Texas. At the end of 2024, Teva committed $2 million over two years to the program to support Mental Health services (for 2025 and 2026) at selected grantee clinics... Full

 

 

Congress Returns to a Packed Health Care Agenda

(4/14, John Wilkerson, STAT+) ...The Senate health committee will hold a hearing Thursday on how generics and biosimilars could lower drug prices. The Trump administration is trying to get Republicans to codify into law the voluntary deals that drugmakers have struck to lower U.S. prices to levels charged in other countries. Committee chair Bill Cassidy is one of the few Republicans to express openness to forcing drugmakers to lower U.S. prices. However, the hearing announcement does not mention so-called most-favored nation legislation, and a committee spokesperson did not respond to questions about whether the bill would be brought up... Sub. Req'd

 

Bill Would Force Payers to Apply DTC Drug Purchases to Patient Deductibles

(4/14, Paige Minemyer, Fierce Healthcare) ...North Carolina Republican Greg Murphy, M.D., on Tuesday unveiled the Every Dollar Counts Act, a bill that aims to lower patients' out-of-pocket costs for pharmaceuticals. Murphy, a consistent critic of insurers and pharmacy benefit managers, notes in an announcement that consumers have increasingly embraced DTC offerings as costs rise... Full

 

Consumers, Employers Make Joint Call For Price Transparency Reform

(4/14, Gabrielle Wanneh, Inside Health Policy) ...The National Alliance of Healthcare Purchaser Coalitions, Small Business Majority and Families USA want lawmakers to pass legislation that would ensure patients are immediately made aware of the real costs of treatments and prescription drugs, while also requiring patient costs and provider reimbursement be similar across all outpatient settings. The groups hosted staffers at a briefing Tuesday (April 14) pressing for the passage of legislation like the Patients Deserve Price Tags Act that would offer site-neutral payment reforms and greater billing transparency... Sub. Req'd

 

FDA Tells Eli Lilly to Round Up More Safety Info on Key Obesity Launch Foundayo

(4/14, Eric Sagonowsky, Fierce Pharma) ...In the FDA's approval letter (PDF) for GLP-1 pill Foundayo, the agency tasks Eli Lilly with obtaining more information about the med's potential link to major adverse cardiovascular events and drug-induced liver injury. In addition, the agency wants to gain more info about delayed gastric emptying associated with the drug and its potential effects in lactating women... Full

 

Editorial: Dr. Makary and Mr. Hyde at the FDA

(4/15, The Wall Street Journal) ...The FDA on Friday for the second time rejected a promising melanoma immunotherapy by the biotech firm Replimune. Drs. Makary and Prasad may not care if they kill a company, but what about the patients who will die as a result? The rejection will have a chilling effect on drug development by signaling that the FDA is slamming the door on accelerated approvals and requiring a level of evidence of efficacy that fewer cancer drugs could meet... Sub. Req'd

 

States' Efforts to Rein in PBMs Hit a Legal Roadblock

(4/15, Tina Reed, Axios) ...Beyond pricing, states may take aim at PBMs ownership structures, by preventing one company from owning retail pharmacies and PBMs... Full

 

Governor Pitches Amendments to Prescription Drug Affordability Board Bill That Some Say 'Nullify' it

(4/14, Charlotte Rene Woods, Virginia Mercury) ...Should they be signed into law, the bills would establish an advisory panel to examine data and ensure federal drug pricing caps are applied to state-regulated health insurance plans. The governor is now seeking amendments before she is fully on board with the idea. Advocates, however, caution that Spanberger's proposed reenactment clause, one of the amendments, prevents the bill from having the cost-savings teeth it was created to have... Full

 

 

Neurocrine Biosciences Presents First Real-World Head-to-Head Claims Analysis Demonstrating Greater Treatment Persistence with INGREZZA® (valbenazine) Capsules Compared to AUSTEDO XR

(4/14, Neurocrine Biosciences) ...Over a six-month follow-up period, patients treated with INGREZZA demonstrated statistically greater treatment continuation and lower switching rates than those receiving AUSTEDO XR. Differences in treatment persistence emerged early and were sustained throughout the six-month period, highlighting durable treatment continuation patterns... Full

 

Boehringer, Amgen Discard Early Immunology Candidates over Lack of Clinical Potential

(4/14, Darren Incorvaia, Fierce Biotech) ..."Boehringer Ingelheim has decided to stop the development of BI 3009947," a spokesperson for the pharma confirmed to Fierce Biotech. "The clinical data does not support further investigation and there were no safety concerns." Amgen likewise stopped a phase 1 study of oral small-molecule AMG 378 that had enrolled 48 healthy volunteers. "Amgen has decided to discontinue clinical development of AMG 378," the California company told Fierce through a spokesperson. "This decision reflects the low likelihood of clinical success and portfolio prioritization."... Full

 

Replimune Looks Ahead as Repeat CRL Speeds the Company's Decline

(4/15, Zachary Brennan, Endpoints News) ...Replimune's second complete response letter for its cancer therapy last week is already leading to multiple rounds of layoffs and existential questions about the company's future unless it can figure out a path forward with the FDA, CEO Sushil Patel told Endpoints News in an exclusive interview... Sub. Req'd

 

 

Amneal Launches First Two Respiratory Metered-Dose Inhalation Products in the U.S.

(4/15, Amneal Pharmaceuticals) ...Albuterol sulfate inhalation aerosol (90 mcg per actuation) is a generic equivalent of PROAIR® HFA. Beclomethasone dipropionate HFA inhalation aerosol (40 mcg and 80 mcg per actuation) is a generic equivalent of the original QVAR® Inhalation Aerosol, 40 mcg and 80 mcg. Both products utilize the hand-breath actuator device in which the cannister is depressed by the patient before inhaling. This option was previously discontinued for QVAR®, creating a potential gap in patient choice... Full

 

'Scale Matters And Portfolio Matters' – Biocon's Erick On The US Biosimilars Market

(4/14, Dave Wallace, Generics Bulletin) ...[Matt Erick, chief commercial officer for advanced markets at Biocon Biologics,] sets out how the recent merger between the Biocon Biologics biosimilars business and Biocon Ltd generics unit will offer synergies for both segments. The executive also looks ahead to what he sees as an upcoming wave of consolidation among US biosimilars players, while also explaining why partnerships will continue to be essential for firms who want to access all opportunities. He also discusses recent US moves towards a streamlined biosimilars pathway and how the market will evolve as a result... Global Sub. Full

 

J&J Loses Appeal to Block Samsung's Stelara Biosimilar Drug Copy

(4/14, Nyah Phengsitthy, Bloomberg Law) ...The US Court of Appeals for the Third Circuit wasn't convinced by the drugmaker's claims that it would face irreparable injury from Samsung Bioepis's move to launch another biosimilar to Stelara, in addition to the one it's allowed to launch under a separate agreement with J&J... Full

 

Orbicular Secures Tentative Approval for Semaglutide Generic in US

(4/15, ETPharma.com) ...The molecule's patent exclusivity is expected to lapse in 2030, after which Orbicular's therapy will be commercialized by the company's local partner and the ANDA applicant Apotex Corp... Full

 

Ofev Rivals Hit US As Five Firms Get FDA Nod

(4/14, Anabel Costa-Ferreira, Generics Bulletin) ...Five companies have secured approvals, including Apotex, Cipla North America, Dexcel, Dr Reddy's and Sandoz. All companies have either confirmed launch or plan to launch capsules in both strengths, 100mg and 150mg... Global Sub. Full

 

Organon Clears Legal Overhang In Crowded Denosumab Market

(4/14, Dean Rudge, Generics Bulletin) ...While the agreement removes legal uncertainty, Organon has cautioned that pricing pressure, payer dynamics and multiple competitors will limit its commercial upside... Global Sub. Full

 

Real-World Outcomes Mixed for Humira Biosimilars | AMCP Annual 2026

(4/14, Denise Myshko, Managed Healthcare Executive) ...Navitus Health Solutions saw both overall savings and reduced patient costs from the switch to the adalimumab biosimilars. Vanderbilt Health, however, experienced increased adverse events after the biosimilar conversation and further switching to other biosimilars or therapies... Full

 

 

Johnson & Johnson CFO Wolk on Q1 Earnings Results

(4/14, CNBC) ...CNBC's "Squawk Box" team breaks down Johnson & Johnson's latest earnings report with Johnson & Johnson CFO Joseph Wolk... Full

 

Shedding Caution, J&J Makes Bold Claims for Sales Growth. Will it Happen?

(4/15, Max Gelman, Endpoints News) ...On Tuesday morning's first-quarter earnings call, J&J leaders repeatedly and eagerly trumpeted the recent approval of Icotyde as a game-changing moment for the company. During the Q&A session, however, analysts pointed out Duato's claim about Icotyde's potential would assume at least $10 billion in annual peak sales, something that most prognosticators do not see happening. (J&J's own guidance projects at least $5 billion as an annual baseline at peak.) So what, if anything, has given Duato reason for such confidence?... Sub. Req'd

 

Cancer Drugs Boost J&J Revenue

(4/15, Peter Loftus, The Wall Street Journal) ..."There's a lot of macro uncertainty out there," J&J Chief Financial Officer Joseph Wolk said in an interview. "We think the fact that we're not only maintaining but raising" the forecast is a sign of the company's strength, he added... Sub. Req'd

 

Novo Taps OpenAI to Deploy AI Across R&D, Manufacturing and Corporate Functions

(4/14, Eric Sagonowsky, Fierce Pharma) ...Tuesday morning, the company unveiled a partnership with OpenAI, ChatGPT's parent company, to integrate AI "globally from drug discovery to commercial operations." The company aims to "bring new and better treatment options to patients faster" through the team-up, Novo said in an April 14 release. Specifically, this will involve tapping AI to analyze complex datasets, identify promising drug candidates and cut overall R&D timelines... Full

 

Sandoz Signs Landmark Agreement With Rwandan Government to Ensure Stable Provision of Critical Medicines Across Selected African Markets

(4/15, Sandoz) ...The agreement, signed at a ceremony in the Rwandan capital, Kigali, follows the publication last August of the Alpbach Communiqué in Tyrol, Austria: a cross-sectoral, multinational commitment to secure EU-based supply of antibiotics to both Europe and partner regions. The Communiqué was endorsed by Sandoz as the global leader in generic antibiotic production and supported by the government of Rwanda, which also hosts the African Medicines Agency... Full

 

Amazon launches AI Drug Discovery Tool for Speedy Antibody Design

(4/14, Marta Rybczynski, FirstWord PHARMA) ...The application, called Amazon Bio Discovery, gives scientists access to a catalogue of biological foundation models, trained on what it described as "vast" datasets, that can generate therapeutic candidates. The available models include open-source and commercial algorithms from partners such as Apheris and Boltz, with Biohub and Profluent coming soon, according to AWS... Full

 

Zantac Suits Tossed by Delaware Judge for Flawed Cancer Link

(4/14, Jef Feeley, Bloomberg) ...Superior Court Judge Francis "Pete" Jones concluded Monday lawyers for ex-Zantac users couldn't produce legitimate evidence backing up claims the over-the-counter product caused cancer. Zantac is currently made by French drugmaker Sanofi. Jones found the Zantac plaintiffs' were not entitled to a second chance at amending their claims because they failed to meet statutory requirements to prove allegations that the cancers were caused by the medication... Full

 

 

US Tariffs To Hit European Pharmaceutical SMEs Disproportionately

(4/14, Francesca Bruce, Pink Sheet) ...US tariffs mean significant complexities for European small and medium-sized drug companies, which face greater difficulties when it comes to mitigating strategies such as shifting production to the US, according to Alexander Natz, secretary general of EUCOPE, which represents innovative pharmaceutical SMEs in Europe... Global Sub. Full

 

Prolonged Iran Ports Blockade Risks Drug Shortages, Wider Supply Chain Woes

(4/15, Vibha Ravi, Manas Mishra, Pink Sheet) ...Peak season surcharges in areas outside the Middle and Far East like the US in May will soon add to freight re-routings, war-related surcharges and higher insurance premiums tied to the joint US-Israel offensive against Iran, heightening margin, and supply chain risks... Global Sub. Full

 

Hormuz Crisis Hits India Pharma: MSMEs May Face 40% Cost Surge

(4/15, Ashima Sharda Mahindra, Times Now) ...At the heart of the issue is a steep rise in petrochemical-derived pharmaceutical solvents, which have surged by 30 to 40 per cent within weeks. "Pharmaceutical solvents derived from petrochemicals have surged 30–40% within weeks, while vessel shortages are restricting the flow of goods from China, which remains the largest raw material supplier to Indian manufacturers," Hari Kiran Chereddi, MD and CEO of HRV Pharma, told Times Now... Full

 

Delay on Generic Ozempic in Canada Causing Concern for Some Patients

(4/14, Kevin Green, CTV News) ...Health Canada says it currently has nine submissions under review for generic semaglutide. "The submissions for generic semaglutide are complex," the department said in a statement. Unlike many traditional drugs, semaglutide is a biologic, produced using living cells through a yeast-based process. Proposed generics, however, are made synthetically, creating additional layers of scrutiny for regulators... Full

 

China to Improve Drug Price Formation Mechanism for Reasonable Pricing

(4/15, Xinhua) ...These guidelines, recently issued by the General Office of the State Council, stress the need to refine the market-oriented mechanism for drug price formation, support the high-quality development of the pharmaceutical industry, and ensure that the people have access to medicines that are both high in quality and reasonable in price... Full

 

Holding Pharma to Account

(4/15, Dinesh Thakur, Prashant Reddy Thikkavarapu, Frontline) ...While contaminated and adulterated drugs that cause deaths grab the headlines, an equally urgent problem in India is the rise in complaints about the quality of generic drugs manufactured in the country... Full

 

`Indian Pharma Must Balance Generics With Innovation'

(4/15, Rupali Mukherjee, The Times of India) ...``Given India's vast and diverse disease burden, this approach is necessary. At the same time, building a parallel market for reimbursement of innovative therapies through insurance, government support, or alternative financing models, will be critical to ensure that breakthrough treatments are developed'', Pankaj Patel, past president, Ficci and chairman, Zydus Lifesciences, said... Full

 

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