Monday, July 14, 2025

From Protocol To People: Teva's Patient-First Clinical Trials Approach

(7/14, Eran Harary, MD, Clinical Leader) ...At Teva, this patient-focused mindset isn't just a trend; it's fundamental to how we develop therapies that we hope will be life-changing, and it stems from a culture of care. Looking back on my almost 20 years in drug development, I'm struck by the sheer pace of progress and improvements to clinical studies for both researchers and participants. The processes we rely on today are vastly different from those of the past and are designed to drive greater efficiencies that accelerate the drug development process while simultaneously creating improved patient experiences and enhanced treatment outcomes... Full

Trump Says 200% Pharma Tariffs Are Coming. Wall Street Shrugs.

(7/13, David Wainer, The Wall Street Journal) ...A year and a half is a long runway—and it could turn out to be even longer in practice. In a note titled "Tariffs Schmariffs," Jefferies analyst Akash Tewari argues that if the grace period begins some time this year and lasts for a year and a half, companies could continue importing drugs tariff-free until 2027. They could buy even more time if they stockpile during that period to cover demand at least until some time in 2028. That might give them time to build entirely new U.S. manufacturing facilities, which typically takes around four years... Sub. Req’d

Trump's First Drug Negotiation Move Sparks Combo Medicine Fight

(7/14, Nyah Phengsitthy, Bloomberg Law) ...Drugmakers have long opposed the government's definition because it determines that two or more drugs approved under distinct FDA applications should be treated as one qualifying single source drug. Novo Nordisk A/S challenged the agency when it deemed six of its insulins as a single product subject to price controls, and Teva Pharmaceuticals Inc. sued the CMS when it grouped two of its drugs that treat movement disorders as one product... Sub. Req’d

ANDA User Fees: Complex Generics, Transparency, Communications Are Early Negotiation Targets

(7/11, Sue Sutter, Pink Sheet) ...Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting...The GDUFA IV agreement should include "a dedicated complex generic development program to enable enhanced engagement between FDA and the applicant during development and review," said Nimi Chhina, Teva Pharmaceutical Industries' VP of global regulatory affairs, operations, policy and intelligence...In addition, Teva wants more opportunities for engagement between industry and the FDA... Global Sub. Full

FDA Kicks Off Latest Reauthorization of Generic Drug User Fee Legislation

(7/11, Zachary Brennan, Endpoints News) ...FDA Commissioner Marty Makary on Friday opened up the first public meeting that kicked off negotiations for the next generic drug user fee agreement between the FDA and industry, explaining the importance of generic drugs to the US and the need to onshore more manufacturing...Teva VP Nimi Chhina said during the open public hearing that first-cycle reviews should still be a major priority for the FDA. In the current iteration of GDUFA, the FDA sought to use enhanced FDA-industry communications to reduce the average number of review cycles for generic drugmakers, which is significantly higher than for new drug applications... Sub. Req’d

Senate Approps Report Calls Out FDA Staffing, Science, User Fee Concerns

(7/11, Jessica Karins, Inside Health Policy) ...The report accompanying the Senate Appropriations Committee's fiscal 2026 FDA funding bill outlines several concerns with the agency's operations since the beginning of the Trump administration, warning FDA needs to ensure it has enough staff amid a White House decision this week to continue the hiring freeze through Oct. 15, user fee activities are being maintained and proper procedures for advisory committees are being followed... Sub. Req’d

Makary Lauds User Fees as FDA Begins GDUFA IV Reauthorization Process

(7/11, Michael Mezher, Regulatory Focus) ...Giuseppe Randazzo, senior vice president of sciences and regulatory affairs for the Association for Accessible Medicines said GDUFA has "played an essential role in strengthening the generic drug review process and helping to ensure that patients have timely access to safe, effective, and affordable medicines." "Continued investment in the generic drug program is critical in maintaining both access and affordability in the American healthcare system," he added... Full

Makary: FDA Will Offer PRV Vouchers To Drug Makers That ‘Equalize' US, Foreign Prices

(7/11, Gabrielle Wanneh, Inside Health Policy) ...By offering faster reviews in exchange for lower prices, FDA is for the first time taking on a key role in the national drug pricing pricing debate that, until now, has largely fallen outside the agency's jurisdiction. "We're talking to industry constantly to figure out how we can be helpful, which of their products being proposed are in line with our national priorities -- that is, meeting a large unmet public health need, domesticating drug manufacturing as a national security issue, increasing the affordability of drugs, which is an access issue," Makary said... Sub. Req’d

Why I'm Retroactively Making FDA Drug Decisions Public

(7/14, Marty Makary, The Washington Post) ...The letters the Food and Drug Administration sends to pharmaceutical companies explaining its decisions on drugs are a treasure trove of valuable information. They detail how the agency thinks and reveal patterns of where companies fall short in trying to bring new drugs to the market. But for too long, the contents of these letters have been seen, for the most part, only by the individual applicants. The result: Companies stumble - making common mistakes because of the lack of a road map - and cures and meaningful treatments are delayed for the American people... Sub. Req’d

FDA Announces Workshop On Biosimilar Development Priorities

(7/11, Jessica Karins, Inside Health Policy) ...FDA is planning a public workshop in September focused on the development of interchangeable biosimilar products, coming as both FDA officials and lawmakers seek to deemphasize the distinction between interchangeables and other biosimilars, and perhaps eliminate the legal distinction. The meeting will form the basis for a draft strategy document on FDA's plans to facilitate the development of interchangeable biosimilar products, which will be available for public comment within 12 months following the meeting. A final document will be issued within nine months after the public comment period closes... Sub. Req’d

Minnesota Pushes Rehearing of Court Pause On Drug Pricing Law

(7/11, Celine Castronuovo, Bloomberg Law) ...A three-judge panel of the US Court of Appeals for the Eighth Circuit misread US Supreme Court precedent when it determined in June that the trade association representing generic and biosimilar manufacturers showed it's likely to succeed on its claim that the Minnesota law violates the dormant commerce clause of the US Constitution, Minnesota Attorney General Keith Ellison (D) wrote in a petition for rehearing filed Thursday... Sub. Req’d

Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines

(7/14, Samsung Bioepis) ...Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024). However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade. The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines... Full

Wockhardt Turns Focus to Biosimilars and Innovation, Targets Stronger Margins

(7/14, Ekta Batra and Vinnii Motiwala, CNBC TV-18) ...Wockhardt's exit from its loss-making US generics business is expected to improve margins and support its broader pivot toward innovation and biologics, Chairman Habil F. Khorakiwala said...Growth will now come from Wockhardt's portfolio of new drugs and biogenerics, particularly its insulin-based diabetes therapies and upcoming anti-obesity treatments. The company also plans to file for US approval of its new drug candidate Zaynich in August, with hopes for a green light by mid-next year. Out-licensing options are on the table for international markets, depending on interest and valuation... Full

Hikma Launches Morphine Sulfate Injection, USP, in a Prefilled Syringe in the US

(7/14, Hikma) ...Hikma Pharmaceuticals PLC, the multinational pharmaceutical company, has launched Morphine Sulfate Injection, USP, in 2mg/mL and 4mg/mL doses in the US. The product has been launched in a prefilled syringe form and is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. According to IQVIA, US sales of Morphine Sulfate Injection, USP, 2mg/mL and 4mg/mL, were approximately $75 million in the 12 months ending May 2025... Full

Biocon's Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

(7/11, Urte Fultinaviciute, Generics Bulletin) ...Biocon Biologics has received approval from the UK's health agency for its two denosumab biosimilars, Vevzuo and Evfraxy. This follows formal approval from the European Commission, alongside competitors mAbxience and Gedeon Richter. Fresenius Kabi has disclosed a settlement with originator Amgen, securing an H2 2025 launch date in Europe, while Sandoz has indicated a Q4 2025 launch... Global Sub. Full

Cipla Eyes Entry into India's Weight Management Market Amid Rising Demand and Global Competition

(7/13, Press Trust Of India) ...Cipla is set to enter India's weight management market, addressing the increasing demand for obesity solutions, while also strengthening its central nervous system portfolio through strategic in-licensing deals and acquisitions, particularly in ADHD and Parkinson's disease. The company is also focusing on innovation-led solutions to combat antimicrobial resistance and aims to be a global, patient-centric healthcare leader... Full

MSN Labs Swerves 2026 US Entresto Patent Ahead Of Separate July 15 Expiry

(7/14, Dean Rudge, Generics Bulletin) ...MSN Laboratories is on the verge of potentially selling a US generic version of Novartis' Entresto treatment for heart failure following a favorable ruling from a US District Court in Delaware. The court found that MSN's sacubitril/valsartan ANDA product does not infringe Novartis' US patent 11,096,918 and denied Novartis' request for injunctive relief. This ruling allows MSN to gain final FDA approval as early as July 16, 2025, and launch its product after the expiration of another patent in July... Global Sub. Full

GSK Seeks FDA Nod for Expanded Use of RSV Vaccine in Adults

(7/14, Pushkala Aripaka, Reuters) ...British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to extend the use of its respiratory syncytial virus (RSV) vaccine to adults under the age of 50 at a higher risk of the disease. If approved in the world's biggest pharmaceuticals market, GSK's vaccine, Arexvy, would be competing for a market share in the 18-49 age group with Moderna's and Pfizer's Abrysvo... Full

EURneffy/neffy Emerging as Serious EpiPen Alternative—and the Data Keeps Coming

(7/12, The Pharma Letter) ...Data presented on the EURneffy/neffy adrenaline (epinephrine) nasal spray at the European Academy of Allergy & Clinical Immunology Congress last month highlights a comparable clinical pharmacological response to intramuscular adrenaline injection, despite congestion associated with allergic rhinitis... Sub. Req’d

J&J Sues Sun to Block Invega Sustenna Copies After Patent Win

(7/11, Christopher Yasiejko, Bloomberg Law) ...Johnson & Johnson's Janssen units filed lawsuits in two federal courts alleging Sun Pharmaceutical Industries Ltd.'s proposed copies of the schizophrenia drug Invega Sustenna infringe a patent the Federal Circuit upheld earlier this week...The patent is the only one listed for Invega Sustenna in the US Food and Drug Administration's registry of approved drugs, the Orange Book, and expires in 2031. The US Court of Appeals for the Federal Circuit on July 8 rejected efforts by units of Teva Pharmaceutical Industries Ltd. and Viatris Inc. to invalidate the patent, finding that skepticism in the field and unexpected results supported its nonobviousness... Sub. Req’d

Glenmark Pharma Receives Warning Letter from USFDA for Indore Facility

(7/14, Business Standard) ...In an official filing, the company stated that it does not anticipate the warning letter will disrupt supply chains or affect revenues generated from the Indore facility. Glenmark emphasized its commitment to addressing the FDAs concerns promptly and working closely with the regulator to resolve the issues. The company further clarified that there were no observations related to data integrity during the inspection... Full

Canada Relies On Foreign Regulators for the Majority of Drug Manufacturer Inspections — But One of its Biggest Partners is Falling Behind

(7/12, Annie Burns-Pieper, CP24) ...New data obtained by CTV News from Health Canada shows that 85 per cent of inspections of drug manufacturing sites supplying the Canadian market were conducted by international regulators — not Health Canada. Given the scale and complexity of the global pharmaceutical supply chain for both brand name and generic drugs, reliance on partners is necessary. But the United States, which Canada relies on for 70 per cent of these inspections, has been facing an inspection backlog and remains behind its pre-pandemic inspection levels. Experts are raising concerns about how well the system can safeguard Canadians from substandard or dangerous medications... Full

Water Pressure: How European Industry Is Pushing Back On The UWWTD

(7/11, Dave Wallace, Generics Bulletin) ...Industry concerns are mounting over the EU's Urban Wastewater Treatment Directive, given the disproportionate cost impact on the generics sector. Implementing the UWWTD in its current form could make some narrow-margin generics economically unviable, leading to supply interruptions. Legal challenges over the UWWTD are ongoing, and Medicines for Europe has just intervened over what it calls a "discriminatory and disproportionate levy."... Global Sub. Full

More Pharmacy Drugs Will Receive Subsidies – to the Benefit of Danish Patients

(7/14, The Pharma Letter) ...New figures in Danish pharma trade group Lif's Medicine Reimbursement Meter show a slight increase in the number of pharmacy medicines for which companies applied for reimbursement in 2024 - and the development for 2025 is positive. The Lif notes that it continuously monitors the Danish Medicines Agency's processing of applications for drug reimbursement and updates the status of both case processing times and new decisions... Sub. Req’d

UK Agrees Deal with Vietnam to Remove Pharmaceutical Trade Barriers

(7/13, Alistair Smout, Reuters) ...Britain launched the new strategy last month, promising a nimbler approach compared to the emphasis it placed on full-fledged free trade agreements following its departure from the European Union. Vietnam will hasten the registration of new medicines and vaccines, while recognising approvals from more regulators, including Britain's Medicines and Healthcare products Regulatory Agency, the British government told Reuters in a statement. The deal is expected to be confirmed later on Monday... Full

Biosimilars to Usher New Growth, Lead $ 1 Trillion Drug Exports by 2030

(7/12, Teena Thacker, The Economic Times) ...The country's biosimilars market has the potential to exceed $60 billion by 2030, according to Namit Joshi, chairman of Pharmexcil, an authorised export promotion agency under the commerce and industry ministry. That would be about half of the whole pharma exports, which is expected to grow to $120-130 billion by 2030 from $50-$55 billion at present. "Large Indian pharmaceutical companies such as Biocon, Dr Reddy's, and Cipla have already begun to make considerable strides in biologics and biosimilars, with product launches in advanced markets like the US and Europe," Joshi said... Full

Pharmexcil Warns New Online Portal Threatens 45% of India's Pharma Exports

(7/11, Priyanka Sharma, Mint) ...A certificate of pharmaceutical product (COPP) is mandatory to ship drugs to a foreign country. It certifies that the product is manufactured in compliance with good manufacturing practices and is of appropriate quality, safety, and efficacy. Last week, the Central Drugs Standard Control Organization (CDSCO) said all COPP applications must be submitted solely through a single licensing portal. This could severely disrupt India's pharmaceutical exports, said officials at Pharmexcil, which works to promote Indian pharmaceutical and healthcare exports worldwide... Full

US FDA's Enhanced Oversight Signals Long-Term Gains for Indian Pharma

(7/14, The Pharma Letter) ...Even as the US Food and Drug Administration (FDA) has unveiled a strategic expansion of its oversight mechanisms for foreign manufacturing facilities supplying the American market, aiming to bolster product safety and ensure consistent quality for US consumers, the intensified oversight presents significant long-term benefits for the Indian pharmaceutical sector as a whole, reports The Pharma Letter's India correspondent... Sub. Req’d

China Biotech's Stunning Advance Is Changing the World's Drug Pipeline

(7/13, Amber Tong, Jinshan Hong and Spe Chen, Bloomberg) ...The number of novel drugs in China — for cancer, weight-loss and more — entering into development ballooned to over 1,250 last year, far surpassing the European Union and nearly catching up to the US's count of about 1,440, an exclusive Bloomberg News analysis showed...The findings, gleaned from an analysis of a database maintained by pharma intelligence solutions provider Norstella, show a fundamental shift in medical innovation's center of gravity... Sub. Req’d

China Has 60 Drugs Under Trial to Rival Ozempic in US$150 Billion Weight-Loss Market

(7/12, Eric Ng, South China Morning Post) ...Over 60 novel drug candidates are in late-stage clinical trials in China, and these will potentially compete directly with US drugmakers...Analysts said cheaper generic versions of the drug could then be launched by rivals, bringing down prices. Up to 20 generic drug players in China will vie for market share and exert downward pressure on prices, according to a report published in May by Boston-based L.E.K. Consulting. In addition, over 60 novel GLP-1 drug candidates were undergoing late-stage clinical trials in China, and these would potentially compete directly with semaglutide and rival product tirzepatide developed by US-based Eli Lilly, the report added... Full

South Korea to Fast-Track Biosimilar Approvals Starting Next Year

(7/14, M. H. Lee, Korea Bizwire) ...In a move expected to accelerate the rollout of biosimilars — often referred to as a next-generation growth engine — South Korea's drug regulator plans to streamline the approval process for these cost-effective biologic drugs beginning in 2026. According to pharmaceutical industry sources on Sunday, the Ministry of Food and Drug Safety (MFDS) is developing a new review and approval framework specifically for biosimilars. The initiative, currently under government review and consulting, aims to reduce time-to-market and encourage domestic production... Full

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