Friday, September 5, 2025

Trump Signs Order Sealing Japan Tariff Deal With 15% Rate

(9/5, Josh Wingrove, Hadriana Lowenkron, Skylar Woodhouse, Yoshiaki Nohara, Bloomberg) ...Trump's directive prevents the stacking of Trump's country-specific duties on top of existing levies. The 15% charge will apply retroactively to most products shipped starting Aug. 7, the date on which the US president's escalated tariffs on dozens of trading partners took effect...Under Thursday's agreement, the US will also lift certain tariffs on aircraft and aircraft parts as well as generic pharmaceuticals, ingredients and precursor chemicals... Sub. Req’d

RFK Jr. Blasts Pharma Industry, Touts mRNA Misinformation in Heated Senate Hearing

(9/4, Fraiser Kansteiner, Gabrielle Masson, Fierce Pharma) ...During a tense and at times incendiary senate hearing Thursday, Robert F. Kennedy Jr. blamed the pharmaceutical industry and fell back on vaccine misinformation as he sought to defend the tumult that has consumed the federal health apparatus during his first eight months as the nation's Department of Health and Human Services (HHS) secretary... Full

Kennedy: Administration In Talks With PBMs, Pharma Companies

(9/4, Luke Zarzecki, Inside Health Policy) ...HHS Secretary Robert F. Kennedy Jr. said pharmacy benefit managers (PBM) have agreed to some transparency protocols, and stressed most favored nation (MFN) negotiations with pharmaceutical companies include direct-to-patient marketing. Kennedy also said the administration is working on limiting pharmaceutical direct-to-consumer advertising and offered to talk privately about that with Sen. Chuck Grassley (R-IA), who has sought HHS' support for bipartisan legislation requiring price transparency in ads... Sub. Req’d

How PBMs Need to Respond to Government Policy Changes: More Lawyers, More Partnership, Lots of Flexibility | PBMI 2025

(9/4, Managed Healthcare Executive) ...With state and federal legislators and regulators casting a wider net of new laws and regulations over the pharmacy benefit management industry, pharmacy benefit managers (PBMs) need to get more involved in lawmaking, recruit allies, stay flexible and informed — and hire more lawyers, according to members of a panel about how PBMs are responding to government policy changes at the 2025 Pharmacy Benefit Management Institute Annual National Conference in Orlando, Florida... Full

PBMs Provide Tremendous Value; Without PBMs, It's Lost

(9/4, PCMA) ...PBMs are the only check against Big Pharma's pricing power. But PBMs do far more than negotiate rebates. PBMs also improve patient health outcomes, encourage generic drug use, and accelerate the pace of new drug development. The scope of services that PBMs provide equates to creating $145 billion in total value for Americans annually, according to research from the University of Chicago... Full

IQVIA Predicts Spending On Obesity Drugs Could Reach $60 Billion by 2029 | PBMI 2025

(9/4, Denise Myshko, Managed Healthcare Executive) ...Within the obesity market, spending could reach $60 billion in net manufacture costs by 2029 with a wide range of reimbursement and costs to patients. If there is significant expansion in usage and reimbursement, that number could reach $84 billion in net costs. There are 181 obesity medications in development, with GLP-1 drugs and combinations accounting for 85 of these. In phase 3 trials alone, there are 16 new obesity drugs being studied. "We're going to continue to watch how these perform," [Scott Biggs, director of supplier services at IQVIA] said... Full

Serial Patent Litigation: The Problem is Getting Worse

(9/4, AAM) ...The white paper outlines ten case studies of specific medications hindered by serial litigation. Serial patent litigation is a problem plaguing the pharmaceutical industry, delaying generic competition and inflating drug prices. Brand pharmaceutical companies leverage held-back or later-issued patents to file multiple successive actions against generic companies, giving them multiple opportunities to block competition. This greatly benefits brand companies, as they can readily obtain and assert a large number of related patents at a relatively low cost. Serial patent litigation significantly harms generic manufacturers, as well as patients and payors, as the availability of lower-cost, lifesaving generic medications is significantly delayed... Full

Latest AAM Report Calculates $467Bn In Annual Off-Patent Savings

(9/4, Dave Wallace, Generics Bulletin) ..."Generic medicines save money," said John Murphy, president and CEO of the AAM. "In fact, our industry is the only sector that consistently results in decreased spending across the US healthcare ecosystem."...With 90% of US prescriptions filled by generics at just 12% of the cost, generic medicines accounted for around 3.9 billion prescriptions and $98bn in spending in 2024. In comparison, brands made up just a tenth of prescriptions at around 435 million, but account for nearly nine-tenths of spending at $700bn. Putting it bluntly, the AAM said, "brand drugs drive costs. Generics drive savings."... Global Sub. Full

Drug Makers And Payers To Blame For Biosimilar Barriers In U.S. Market

(9/4, Joshua P. Cohen, Forbes) ...Broadly speaking, competitive markets have numerous sellers and buyers, all of whom have relevant information to make rational decisions about the products being bought and sold. There's market (information) transparency, and firms can freely enter or exit the market. Very few markets are perfectly competitive. But in a properly functioning economy, most markets for most goods exhibit a high degree of competitiveness. This isn't invariably the case with prescription pharmaceuticals and particularly with respect to biosimilars. Drug makers and payers are both to blame for entrance barriers, information asymmetry and often non-transparent pricing... Full

J&J, BMS IRA Suits Rejected By Divided Third Circuit Panel

(9/4, Gabrielle Wanneh, Inside Health Policy) ...A three-judge panel of the Third Circuit Court of Appeals on Thursday (Sept. 4) rejected separate cases filed by Johnson & Johnson and Bristol Myers Squibb aimed at thwarting further implementation of Medicare drug price negotiation, though one dissenting judge agreed with the drug companies that the program violates the companies' constitutional rights because it compels them to agree to lower their prices against their will and takes from them private patented property without justly compensating them in return... Sub. Req’d

J&J, Bristol Myers Lose Appeals Cases Challenging Medicare Price Negotiation

(9/4, Nicole DeFeudis, Endpoints News) ..."The program permits the government to acquire the companies' drugs only when it pays prices the companies have agreed to. If the companies dislike the prices the government is willing to pay, they are free to stop doing business with the government," the judges wrote in their opinion. The majority also determined that the process does not compel drugmakers' speech, in part because "participation in the program is voluntary, so the companies are not compelled to speak at all." "Notably, the companies also remain free to criticize the program outside of the contracts used to effectuate it," the majority wrote... Sub. Req’d

In a First, FDA Publishes Complete Response Letters for Ongoing Drug Applications

(9/4, Zachary Brennan, Endpoints News) ...The 89 letters include some recent high-profile — and sometimes contentious — rejections of drugs from Replimune, Capricor Therapeutics, Stealth BioTherapeutics and many others. And while the letters will add insight into why the FDA turned down the drugs, the action is almost certain to be controversial, or challenged legally, if some companies object to the release of what has long been thought of as proprietary and confidential information...Companies that spoke with Endpoints were generally neutral or supportive about the FDA's action... Sub. Req’d

Zydus Ties Up with Synthon BV for Multiple Sclerosis Drug Launch in US

(9/5, Press Trust Of India) ...Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Synthon BV for Ozanimod capsules (a generic version of ZEPOSIA) for the US market, the company said in a regulatory filing. Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules indicated for relapsing forms of multiple sclerosis... Full

Amneal Gets FDA Nod for Generic Version of Risperdal Consta

(9/4, Nilanjana Basu, Seeking Alpha) ...Amneal Pharmaceuticals has received approval from the U.S. FDA for its antipsychotic, risperidone extended-release injectable suspension, a generic version of Janssen's (JNJ) Risperdal Consta. The product is available in dosages of 12.5 mg, 25 mg, 37.5 mg, and 50 mg per vial. The company plans to launch this product in the fourth quarter of 2025... Full

‘Rugby In The First Half, Soccer In The Second': Aspen Lays Bare Its Challenges

(9/5, Dean Rudge, Generics Bulletin) ...Management acknowledged a "tough year" for the firm's Manufacturing segment and emphasized that Aspen's priority now is to boost free cash flow, driven by lower capital spending and tighter working capital management. The South African firm has put a plan into action to recover positive earnings before interest, tax, depreciation and amortization and cash flow in its Manufacturing division by FY2027, mainly geared towards turning around FDF - a sub-division within the Manufacturing business - after the setback... Global Sub. Full

Biocon Biologics' Bengaluru Facility Gets Five Observations from US FDA Inspection

(9/5, Jomy Jos Pullokaran, CNBC TV-18) ...The inspection, conducted between August 26 and September 3, 2025, covered drug substance manufacturing units, analytical quality control laboratories, microbiology laboratories, and warehouses. At the conclusion of the inspection, the FDA issued a Form 483 with five observations. Biocon said these observations are procedural in nature and do not relate to data integrity, systemic non-compliance, or quality oversight... Full

Health Canada Says it is Working to Reduce Backlog of Lower-Cost Biosimilar Drug Submissions

(9/4, Chris Hannay, Kelly Grant, The Globe and Mail) ...Health Canada says it is working to reduce a backlog of pharmaceutical submissions that is causing a delay in cheaper versions of high-cost biologic drugs coming to market. The pledge to speed up the reviews of the biosimilar class of drugs is part of a wider effort by the department to reduce red tape, which Health Minister Marjorie Michel has called a priority for the federal government... Sub. Req’d

Bulgaria Fears Brussels' Pharma Reform Will Drive Up Medicine Prices

(9/4, Krassen Nikolov, Euractiv) ...The health ministry told Euractiv that Sofia finds it unacceptable for the new legislation to dismantle functioning national mechanisms. The major concern is that if part of the sector's control is centralised in Brussels, Bulgaria could be forced to purchase medicines at the same prices as wealthier EU states...Deyan Denev, executive director of ARPharM-Bulgaria, told Euractiv, "For Bulgaria, the most important goal is to achieve a balance between patient access to medicines and encouraging innovation in the industry." He added that in its positions on the pharma package, Bulgaria has emphasised that the predictability and stability of the regime are essential for the industry and its member states... Full

Australian Govt To Start HTA System Overhaul – One Year After Major Review

(9/4, Eliza Slawther, Pink Sheet) ...The Australian government is taking steps towards a significant overhaul of its health technology assessment system in response to a major review released in September 2024. Health minister Mark Butler announced immediate actions to streamline medicine assessments and update guidelines for the Pharmaceutical Benefits Advisory Committee, among other changes. Butler said the new framework must meet the interests of industry as well as patients... Global Sub. Full

India's Drug Regulator Eyes Lighter Oversight, More AI to Boost Efficiency

(9/4, Rishika Sadam, Reuters) ..."We're trying to increase our efficiency, cutting down on regulations so that we create more and more resources within our system," the Central Drugs Standard Control Organisation's Rajeev Raghuvanshi said in an interview at the sidelines of an industry event...The agency said on Wednesday it has halved the processing time for drug test licences to 45 days and begun approving some studies with only an intimation, removing the need for prior licensing. It has also streamlined export certifications, which are now cleared in under seven days, Raghuvanshi said on Thursday... Full

Union Commerce Minister Emphasizes India's Critical Role in Global Healthcare at 11th Edition of the iPHEX

(9/5, Pharmabiz.com) ...Union Minister for Commerce and Industry Piyush Goyal at the inaugural session of 11th edition of the International Exhibition on Pharmaceuticals and Healthcare (iPHEX 2025) on September 4, 2025 emphasized India's critical role in global healthcare and its responsibility to ensure equitable access to affordable, quality medicines. He underlined India's position as the "Pharmacy of the World" and called for deeper global collaborations to strengthen healthcare systems worldwide... Full

To Ease Launch of Generics & Push Clinical Trials of Novel Therapies, Govt Moves to Amend Drug Rules

(9/4, Sumi Sukanya Dutta, ThePrint) ...The proposed amendment, according to a gazette notification issued last week, will allow pharmaceutical companies to start clinical trials of most experimental drugs or conduct comparative studies of generic formulations with innovative products by just intimating the apex drug regulator, instead of obtaining licences. "This initiative underscores the government's commitment to ongoing regulatory reforms in the pharmaceutical sector," the ministry said in a statement Wednesday... Full

Global Drugmakers Face Tougher Competition with Local Rivals in Russia

(9/4, The Pharma Letter) ...Global pharma companies supplying their drugs for the list of vital medicines in Russia may face with serious difficulties in the local market in the short term due to the ever tightening-requirements from the Russian state, The Pharma Letter's local correspondent reports... Sub. Req’d

Lee Vows to Ease Regulations in Bio Industry

(9/5, Kim Eun-jung, Yonhap News) ...President Lee Jae Myung said Friday the government will ease regulations in bio research and development (R&D) and speed up certification procedures to foster the bio industry as a new growth engine...Lee said the government will take "an open approach" to industry requests for regulatory easing, while working to build a fair ecosystem to prevent monopolies by certain sectors or companies. During the session, the government announced a plan to double biopharmaceutical exports and elevate South Korea into the world's top five bio industry powers by 2030... Full

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