Monday, August 18, 2025

Trump's Demand for Direct Drug Sales Stokes Industry Interest

(8/18, Lauren Clason and Nyah Phengsitthy, Bloomberg Law) ..."It looks like they're offering reduced prices, when, in fact, those prices are still unaffordable for people," said Anna Kaltenboeck, president of Verdant Research and a former adviser to the Senate Finance Committee under ranking member Ron Wyden (D-Ore.). If drugmakers were serious about lowering costs for consumers, Kaltenboeck said, they could simply lower their prices across the board...Drug pricing analysts—and some pharma executives—expect that direct sales will likely only have a major impact on certain drugs that aren't broadly covered—like weight-loss drugs—and for patients who are either underinsured or uninsured. Most patients who use their insurance will likely pay an amount similar to their current copay. Patients who don't use their insurance will likely pay more... Sub. Req’d

HHS To Launch Multi-Agency Working Group To Review Kids' Antidepressant Use

(8/15, Maaisha Osman, Inside Health Policy) ...HHS is forming a multi-agency working group to review whether mental health drugs -- including commonly prescribed antidepressants, antipsychotics and stimulants -- are overprescribed to children, and whether nutritional and other alternative interventions should be promoted, according to a draft Make America Healthy Again (MAHA) report leaked Friday (Aug. 15)... Sub. Req’d

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

(8/15, Sue Sutter, Pink Sheet) ...Manufacturers and the industry's trade group highlighted inconsistent or lacking communication practices, including the timing of information requests and discipline review letters. Viatris said the FDA's transparency pilot program should become a permanent fixture under GDUFA IV. Existing meeting opportunities do not provide the intended transparency about the FDA's expectations and offer limited opportunities for substantive dialogue, AAM said... Global Sub. Full

FDA Seeks Feedback On Ways to Bring Manufacturing Back to the US

(8/15, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration (FDA) is seeking public input on its PreCheck program, which aims to establish new pharmaceutical manufacturing facilities in the US to enhance the pharmaceutical supply chain...FDA expressed interest in other ideas to enhance or strengthen US pharmaceutical manufacturing. FDA encourages manufacturers to provide justification for these initiatives and submit relevant data and information... Full

FDA's New Post-Warning Letter Meetings

(8/15, Joseph Pham, Lachman Consultants) ...As part of user fee negotiations under the Generic Drug User Fee Amendments (GDUFA), which occur approximately every five years, the FDA commits to performance goals in reviewing ANDAs as well as other program enhancements. Under the most recent performance goals and program enhancements for GDUFA reauthorization for fiscal years 2023-2027—known as the GDUFA III Commitment Letter—the Agency agreed to the implementation of a Post-Warning Letter Meeting (PWLM), a program enhancement that offers generic drug manufacturers an opportunity to request feedback from the FDA regarding a facility's ongoing remediation efforts to address CGMP deficiencies that were the subject of a warning letter... Full

$160M War Chest Readied For Aquestive's Oral Epinephrine Film Launch

(8/18, Dean Rudge, Generics Bulletin) ...Aquestive Therapeutics is preparing to launch Anaphylm, a sublingual epinephrine film aimed at treating severe allergic reactions such as anaphylaxis. To support its planned commercialization, the company has secured $160m in funding, comprising $85m through a stock offering and $75m in a conditional agreement with RTW Investments, contingent on FDA approval. The FDA has set a review date of Jan. 31, 2026, for the New Jersey-based firm's 505(b)(2) NDA. Aquestive has conducted extensive clinical trials to validate Anaphylm's efficacy and safety... Global Sub. Full

Alembic Gets USFDA Nod For Generic Drug For Skin Condition

(8/18, Press Trust Of India) ...Alembic Pharmaceuticals has secured USFDA approval for its generic Tretinoin Cream USP (0.025%), a treatment for acne vulgaris. This ANDA is therapeutically equivalent to Bausch Health US, LLC's Retin-A Cream. The market size for Tretinoin cream USP (0.025%) is estimated at USD 94 million for the twelve months ending June 2025... Full

Marksans Pharma UK Arm Gets MHRA Nod for Metformin Hydrochloride Relonchem Prolonged Release Tablets in Three Strengths

(8/18, Ruchika Sharma, Medical Dialogues) ...Marksans Pharma Limited has announced that its wholly owned subsidiary Relonchem Limited in UK, has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for three strengths of its Metformin Hydrochloride Relonchem Prolonged Release Tablets... Full

Roche Sues Organon in First Case Over Biosimilar Copy of Perjeta

(8/15, Christopher Yasiejko, Bloomberg Law) ...Roche Holding AG subsidiaries accused Shanghai Henlius Biotech Inc. and Organon & Co.'s proposed biosimilar version of Perjeta of infringing two dozen patents for the blockbuster breast-cancer drug. Genentech Inc. and Hoffmann-La Roche Inc. seek to block the biosimilar's launch until the patents expire, the companies said in a complaint filed Thursday in the US District Court for the District of New Jersey. The suit appears to be the first over a proposed biosimilar of Perjeta... Sub. Req’d

Wall Street Sees New Obesity Pills as Priced Near Wegovy and Zepbound

(8/18, Maggie Fick and Bhanvi Satija, Reuters) ...U.S. prices for obesity-treatment pills that Eli Lilly and Novo Nordisk aim to launch next year likely will be on par with their weight-loss injections, analysts and investors say, in a departure from the usual practice of charging more for new medicines despite pressure to cut prices. Neither drugmaker has disclosed pricing plans for their new daily oral medications. With regulatory approvals and launches still months away, pricing plans could change. Denmark-based Novo expects approval later this year and to launch soon after, while Indianapolis-based Lilly expects to launch by August 2026... Full

Lundbeck Dials Up Migraine Drug's US Peak Sales Estimate, Stays Positive On Rexulti's PTSD Use

(8/15, Angus Liu, Fierce Pharma) ...The Danish company now expects the CGRP blocker to reach more than $1.1 billion in sales at peak in the U.S., a $100 million increase from its previous guidance. In the second quarter, Vyepti's sales were 1.83 billion Danish kroner ($287 million) in the States, representing 87% of the drug's global total... Full

Amgen Skirts $50M Payout in Blincyto Patent Litigation Tiff with Lindis

(8/15, Fraiser Kansteiner, Fierce Pharma) ...In a decision issued Thursday, U.S. District Judge Gregory Williams concluded that two patents held by Lindis Biotech "are unenforceable due to inequitable conduct." The development strikes down the $50.3 million jury verdict Lindis won in December over allegations that Amgen's Blincyto violated Lindis-held intellectual property. Amgen and Lindis now have two weeks to attempt to either reach an agreement or propose suggestions on how the case should proceed, the judge wrote in his decision... Full

USFDA: Glenmark, Alembic, Sun Pharma Recall Products

(8/18, Press Trust Of India) ...Drug makers Glenmark, Alembic Pharmaceuticals and Sun Pharma are recalling products in the US due to manufacturing issues, according to the US health regulator...Mumbai-based Glenmark is recalling two products in the market, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, is recalling Carvedilol tablets, used to treat heart failure, hypertension, and heart attack, in multiple strengths... Full

UK Patients Rush to Buy Obesity Jab Ahead of 170% Price Rise

(8/15, Hannah Kuchler, Financial Times) ...Asda Online Doctor said it had seen a 350 per cent increase in demand for Mounjaro since Lilly announced the price rise on Thursday, while London-based MedExpress said it had experienced a 40 per cent jump in orders, compared with a normal day. MedExpress's website slowed as customers rushed to buy the drug, because of the "significant uptick in traffic". Online weight loss programme CheqUp also reported patients looking to buy the drug in bulk, or offering to pay in advance for medication for the coming months... Sub. Req’d

Ozempic Sales ‘Rise by 500%' After Mounjaro Price Hike Announcement

(8/18, Charlie Moloney, The Times) ...Toby Nicol, chief executive at CheqUp, said: "As news of the Mounjaro price rise spreads, weight-loss jab patients are voting with their wallets and making the switch to Wegovy, which is nearly as effective but has a considerably lower cost. "We've been blown away by the huge spike in demand for Wegovy. It is too early to say for sure, but Wegovy will probably become the most popular weight-loss treatment in the UK as patients switch from Mounjaro following Thursday's news... Full

Wealthy Countries Pay More for Essential Medicines, But the Cost Burden Is Far Lower, Study Finds

(8/17, Gabriela Galvin, Euronews) ...Wealthy countries may pay steep prices for medicines, but once their purchasing power is factored in, they actually benefit from some of the lowest costs in the world, a new study has found. The analysis of 549 essential medicines across 72 markets worldwide reveals major disparities in affordability between wealthier and poorer countries – even though rich countries often pay higher list prices. While poorer nations often have lower list prices, people in those countries tend to shoulder a far greater financial burden, according to the study, which was published in the journal JAMA Health Forum... Full

Malaysia Clarifies Drug Shortage Reporting Rules And Penalties For Non-Compliance

(8/15, Neena Brizmohun, Pink Sheet) ...New guidance on how companies should report medicine shortages and discontinuations in Malaysia covers the timelines that must be met, mitigation plans and enforcement actions in the case of noncompliance...Among the measures for mitigating a shortage or discontinuation, a company may be given permission to import, sell and distribute a registered product in Malaysia with a different country's label, or they can request a priority review for a product currently under evaluation for registration or variation... Global Sub. Full

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