Tuesday, July 1, 2025

  U.S. Policy & Regulatory News

Orphan Cures Act Re-Added to Trump Tax Bill as Senate Prepares to Begin Vote-A-Rama

(6/30, Angus Liu, Fierce Pharma) ...The massive domestic policy bill that passed a Senate procedural vote Saturday night now includes provisions that would allow drugs with multiple rare disease indications to be exempt from Medicare price negotiations. Currently, under the Inflation Reduction Act, such exemptions are only available to drugs that treat just one rare disease... Full

Trump's Threat of More Tariffs Slows Trade Deals

(6/30, Ana Swanson, The New York Times) ...Governments around the globe are racing to negotiate trade deals with the United States in order to forestall President Trump's punishing tariffs, which could kick in on July 9. But the discussions have been slowed because Mr. Trump has threatened to impose more tariffs even if those deals are in place..."We have countries that are negotiating in good faith, but they should be aware that if we can't get across the line because they are being recalcitrant, then we could spring back to the April 2 levels," Treasury Secretary Scott Bessent said in an interview with Bloomberg Television on Monday... Sub. Req’d

How US Tariffs Could Disrupt the Generic Drugs Supply Chain

(7/1, Vittoria Vardanega, Swissinfo.ch) ...The introduction of new tariffs could reduce dependence on foreign suppliers by encouraging domestic production, but it's a risky strategy – one that might drive up costs and potentially push some manufacturers out of key markets, experts warn. For the generics industry, tariffs could lead to manufacturing discontinuations and shortages, said Ronald Piervincenzi, CEO of the United States Pharmacopeia (USP), a non-profit group that sets drug quality standards, in an interview in April with Fierce Pharma, a news website focused on the pharma industry... Full

Pharma Lobby Threads Needle as Trump Agenda Challenges Industry

(7/1, Nyah Phengsitthy and Kate Ackley, Bloomberg Law) ...The Association for Accessible Medicines also finds itself in a battle to do more lobbying, but the industry's revenue has been fairly flat in recent years, according to tax filings. That's a concern because generics and biosimilars account for roughly 90% of the market for patient drugs, said John Murphy III, president and CEO of AAM. "I'm trying to use the noise around the brand industry as an opportunity for us," he said. "It's going to be a very active year for the voice of the generic and biosimilars industry."... Sub. Req’d

PCMA Statement On Today's Federal Trade Commission/Department of Justice Listening Session On Big Pharma's Anti-Competitive Behavior

(6/30, PCMA) ..."Today's session, ‘Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition,' should provide an opportunity to learn more about some drug companies' egregious abuse of the patent system. There is irrefutable evidence of some drug companies repeatedly abusing the patent system to block competition by keeping more affordable alternatives from entering the marketplace..."... Full

Supreme Court Declines to Review Oklahoma Law Regulating PBMs

(6/30, Ed Silverman, STAT+) ...The U.S. Supreme Court has declined to review an appeals court ruling that struck down key parts of an Oklahoma law regulating the retail networks created by pharmacy benefit managers, a victory for the controversial middlemen in the pharmaceutical supply chain that may create uncertainty across the country... Sub. Req’d

NCPA Laments SCOTUS Decision to Punt On Oklahoma PBM Reform

(6/30, NCPA) ...A lower federal court upheld the law, but the 10th Circuit Court of Appeals overturned it in a poorly reasoned decision that directly conflicts with the law of the land as outlined in Rutledge. States contemplating PBM reform should not be dissuaded – they should look to Rutledge and the Wehbi decision from the 8th Circuit. Other challenges are winding their way through the federal courts. But yesterday's Supreme Court decision likely means the 10th Circuit decision will remain in force for now, but for only 10th Circuit states (Colorado, Kansas, New Mexico, Oklahoma, Utah, and Wyoming)... Full

PCMA Statement on U.S. Supreme Court Declining Review of PCMA v. Mulready

(6/30, PCMA) ..."We applaud the Supreme Court's decision to decline review," said Jack Linehan, General Counsel, PCMA. "As the Mulready case reaffirms, ERISA and the Medicare Part D statute are the primary laws governing health care benefits organized under these federal frameworks. In particular, ERISA preemption has been the cornerstone of the American system for employer-sponsored health care benefits, and it is vital to maintain the statute's authority to allow plan sponsors to administer uniform health benefits across state lines and control costs for their workers."... Full

  Generics & Biosimilars News

Advanz Claims Cimzia Biosimilar In Europe Following Alvotech-Xbrane Deal

(7/1, Dean Rudge, Generics Bulletin) ...Advanz Pharma has partnered with Alvotech to commercialize a biosimilar to UCB Pharma's Cimzia (certolizumab pegol) in Europe. The AVT10 candidate is currently the only one in development globally for Cimzia, which is utilized in treating various inflammatory conditions, particularly in women of childbearing age, Alvotech noted. Following a flurry of agreements for Alvotech-developed biosimilars, the companies plan to launch their first biosimilars in Europe by Q4 2025... Global Sub. Full

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

(6/30, Susan Haigney, PharmTech.com) ...In other company news, Hikma published its 2024 Sustainability Report, detailing the company's approach to sustainability. "Access to medicines remains at the heart of everything we do at Hikma," said Tim Brooks, the company's vice-president of Sustainability, in a press release..."This key objective is supported by our commitment to our people, our planet, and our suppliers. Additionally, we have introduced metrics for each of these areas to demonstrate our performance and ensure sustainability remains embedded throughout our corporate strategy," Brooks added... Full

Biocon Biologics' Yesafili Approved And Ready To Launch In Canada

(7/1, Urte Fultinaviciute, Generics Bulletin) ...The approval announcement was accompanied by the news that Biocon Biologics' Yesafili will launch in a matter of days. The Indian firm has already settled with the originators Bayer and Regeneron last year, which allowed a mid-2025 market entry. In the US, Yesafili will be commercialized in the second half of 2026, while competitor Amgen is already enjoying the biosimilars market to itself after an at-risk aflibercept launch last year... Global Sub. Full

Generic Zantac Makers Again Win Negligence Claim Dismissal

(6/30, Megan Crepeau, Bloomberg Law) ..."Plaintiff cannot avoid preemption here merely by arguing that the generic ranitidine was misbranded under federal law and unreasonably dangerous under state law," First District Appellate Justice Mary Rochford wrote. The appeal stemmed from a Cook County Circuit Court case against the makers of name-brand Zantac, including GlaxoSmithKline LLC, as well as several manufacturers of the generic, including Dr. Reddy's Laboratories, Inc. and Teva Pharmaceuticals USA Inc. The plaintiff, Angela Valadez, was diagnosed with colorectal cancer after taking the drug for years... Sub. Req’d

MSN Says Novartis Recycles Arguments to Delay Generic Entresto

(6/30, Christopher Yasiejko, Bloomberg Law) ...MSN Laboratories Ltd. urged a federal judge to reject Novartis AG's renewed bid to block its launch of Entresto copies, arguing it recycles rejected arguments and flawed science. "Novartis's motion is a regurgitation of its post-trial briefing and last year's failed preliminary-injunction motion," MSN said in its June 27 response to Novartis' second injunction request based on US Patent No. 11,096,918 in the US District Court for the District of Delaware... Sub. Req’d

  Industry News

Novartis Sues Aurobindo to Block Copies of Tasigna Leukemia Drug

(6/30, Christopher Yasiejko, Bloomberg Law) ...Novartis is seeking an order blocking Eugia's generic version of the oral chemotherapy treatment until the patents have expired, and cash compensation if it makes copies before then, according to a complaint filed June 27 in the US District Court for the District of Delaware. The patents cover the composition and use of the pharmaceutical compound nilotinib—specifically, its various forms and methods of treating certain types of cancer... Sub. Req’d

How Novo Nordisk Misread the US Market for its Weight Loss Sensation

(7/1, Jacob Gronholt-Pedersen, Maggie Fick, Reuters) ...Novo Nordisk's top executives ignored internal warnings that the company was not sufficiently prepared for the launch of its weight-loss drug Wegovy, leaving the Danish drugmaker in a more vulnerable position when rival Eli Lilly entered the market, six former employees involved in the discussions told Reuters...In heated internal discussions, sales and marketing executives urged Langa to first secure more supply and health insurance coverage, the two former employees said. Without robust coverage, many patients could not afford Wegovy's monthly cost of up to $1,300. Lilly wasn't expected to enter the market for at least two years and Novo could have been better prepared, they said... Full

AbbVie to Buy Capstan for Up to $2.1 Billion in Immunology Push

(6/30, Christy Santhosh, Reuters) ...AbbVie said on Monday it would acquire privately held cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, expanding its product pipeline with experimental treatments for autoimmune diseases. The U.S. drugmaker has spent over $20 billion on acquisitions since 2023 as its flagship rheumatoid arthritis drug, Humira, lost patent protection... Full

Building a Stronger Pharma Industry for Patients and Providers

(7/1, Generics Bulletin) ...By embracing different perspectives, it enables a better understanding of the needs of diverse patient populations around the world and develops more inclusive solutions. Creating an inclusive environment in which people feel as though they belong is the catalyst for great change, both internally and externally. Remaining flexible in a constantly changing world is essential to the pharmaceutical industry's long-term sustainability and success... Global Sub. Full

Finding The Right Leadership In A Fast-Moving Industry: Parsity Group's Nathan Talks Recruitment

(6/30, Dave Wallace, Generics Bulletin) ...Parsity Group founder and managing director Dan Nathan talks to Generics Bulletin about how the firm sources talent for the global off-patent industry. Distinguishing features of the generics and biosimilars sector include the need for fast-paced decision-making, resource optimization and IP awareness. Wider off-patent industry factors are shaping the landscape for recruitment in 2025, including portfolio rationalization and restructuring. In the biosimilars and complex generics space, a major challenge is the current scarcity of talent... Global Sub. Full

Sandoz Recalls One Lot of Antibacterial Drug Cefazolin Due to Mispackaging

(6/30, Joseph Keenan, Fierce Pharma) ...The company initiated the lot pull after a customer complained of finding four injectable penicillin G potassium vials in a cefazolin carton. As of Friday, Sandoz said it hadn't received any adverse event or injury reports tied to the mix-up, though it did receive a complaint that the incorrect product was administered to a patient. The recall covers a single batch of injectable cefazolin that was slated to expire in November 2027. Sandoz did not specify where the product was packaged in its recall notice... Full

Smoking Cessation Pill Champix Returns to Market Four Years After Withdrawal Over Carcinogen

(7/1, Corrinne Burns, The Pharmaceutical Journal) ...In October 2021, Pfizer recalled Champix owing to the presence of unacceptable levels of nitrosamine compound N-nitroso-varenicline, a probable human carcinogen. In May 2024, Pfizer said it intended to resupply the medicine, but said this would not happen until at least the end of 2024. However, in November 2024 it was announced that generic varenicline was being made available in England, following a deal with the generic's manufacturer, Teva. In a press release issued on June 30, 2025, Pfizer said that Champix was available again for prescription by GPs and independent prescriber pharmacists... Full

Adalimumab Double Take: The Unexpected Return to Reference Humira

(6/30, Skylar Jeremias, The Center For Biosimilars) ...The launch of adalimumab biosimilars in the United States in 2023 marked a pivotal moment for health care cost savings and patient access, promising to disrupt the long-standing dominance of the originator biologic, Humira. However, a recent analysis from Truveta, spanning data through April 2025 unveils a concerning trend: more than 13% of patients who initially switched to an adalimumab biosimilar ultimately reverted to the reference drug... Full

  International News

EU to Accept Trump Universal Tariff But Seeks Key Exemptions

(6/30, Jorge Valero and Alberto Nardelli, Bloomberg) ...The European Commission, which handles trade matters for the EU, views this arrangement as slightly favoring the US but still something it could agree to, said the people, who spoke on the condition of anonymity. The EU has until July 9 to clinch a trade arrangement with Donald Trump before tariffs on nearly all of the bloc's exports to the US jump to 50%. The US president has imposed tariffs on almost all its trading partners, saying he wanted to bring back domestic manufacturing, needed to pay for a tax-cut extension and stop other countries from taking advantage of the US... Sub. Req’d

No ‘Doomsday' For US Pharma Despite Political Uncertainties, EU Industry Chief Says

(6/30, Eliza Slawther, Pink Sheet) ...Stefan Oelrich, the new president of the European pharma industry federation, EFPIA, said that industry does not view political and regulatory uncertainties in the US as a "doomsday" for pharma. He said the EU needs to improve its pharmaceutical framework to support innovation, accelerate drug development, and ensure equitable drug pricing. Trump's most favored nation policy, which would lower drug pricing in the US, was described by Oelrich as a threat to jobs and industry... Global Sub. Full

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

(6/30, Sue Sutter, Pink Sheet) ...Pharmaceutical sponsors who suspect clinical trial fraud should move quickly, but quietly, to investigate, UK and US regulators said. If sponsors unwittingly alert wrongdoers that fraud is suspected, evidence likely will disappear before regulatory authorities can get involved, said Jason Wakelin-Smith, expert good clinical practices investigator at the UK's Medicines and Healthcare products Regulatory Agency... Global Sub. Full

US Tariff Overhang Weighs On Chinese API Exports

(6/30, Dexter Jie Yan, Generics Bulletin) ...Chinese customs data show that in May, domestic firms' API exports to the US fell by 24% year-on-year to $255m, as tariff effects came into play. The downward trend is predicted to extend to June and July. One Hangzhou-based, peptide-focused CRDMO has seen its order backlog shrink in the ongoing uncertain bilateral trade environment... Global Sub. Full

US Pharma Industry Urges Trade Pressure On South Korea Over Drug Pricing

(7/1, Kim Dong-young, AJP) ...In comments submitted to the Office of the U.S. Trade Representative on June 27, the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's primary lobbying group, urged Washington to take a tougher stance on what it described as "unfair pharmaceutical policies" in foreign markets. PhRMA singled out South Korea, along with Australia and Canada, as particularly problematic. All three are high-income countries with strong demand for prescription drugs, yet the group contends they routinely underpay for American pharmaceutical products... Full

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