Wednesday, July 9, 2025

JPMorgan Reiterates Overweight Rating On Teva Pharma (TEVA)

(7/9, StreetInsider.com) ...JPMorgan analyst Chris Schott reiterated an Overweight rating and $23.00 price target on Teva Pharma..."Ahead of TEVA's 2Q earnings, we wanted to update our estimates and share some quick thoughts on the story. We are roughly in-line with consensus for Q2 and are modeling revenues of $4.3bn, EPS of $0.63 and EBITDA of $1.2bn. We are expecting ~2% growth for the US generics business in the qtr (with roughly flat contribution from Revlimid and unfavorable comps for gVictoza) but are expecting strong growth from Austedo (JPMe $499mm) and Uzedy (JPMe $42mm)...."... Sub. Req’d

J&J Defeats Generic Drugmakers in US Appeal Over Schizophrenia Treatment

(7/8, Blake Brittain, Reuters) ...Johnson & Johnson convinced a U.S. appeals court on Tuesday to reject a bid from generic drugmakers Teva and Viatris to invalidate a patent covering its schizophrenia medication Invega Sustenna. The U.S. Court of Appeals for the Federal Circuit ruled that Teva and Viatris failed to demonstrate that the patent's innovations were obvious, blocking their path to manufacturing a cheaper generic version of J&J's blockbuster drug... Full

Trump Plans 50% Copper Tariff, Will Wait Year On Drug Duties

(7/8, Joe Deaux and Stephanie Lai, Bloomberg) ...Trump told reporters during a Cabinet meeting on Tuesday he was still planning tariffs on select industries, including drugs, semiconductors, and metals...Trump said he expected to offer pharmaceutical manufacturers some time to bring their operations to the US before slapping tariffs of as much as 200% on their products... Sub. Req’d

Trump Threatens to Impose Up to 200% Tariff On Pharmaceuticals ‘Very Soon'

(7/8, Annika Kim Constantino, CNBC) ...Details on pharmaceutical tariffs "will come at the end of the month," Commerce Secretary Howard Lutnick told CNBC after the Cabinet meeting. "With pharmaceuticals and semiconductors, those studies are being completed at the end of the month, and so the president will then set his policies then, and I'm going to let him wait to decide how he's going to do it," Lutnick said... Full

Trump Hints at Tariff Grace Period for Pharma Companies to Bring Manufacturing to US

(7/8, Max Bayer, Endpoints News) ...A grace period would give companies at least some time to shift manufacturing — though it often takes years to build and bring new drug plants online, far longer than Trump is proposing. "We are going to give people about a year, year and a half to come in, and after that they are going to be tariffed if they have to bring the pharmaceuticals into the country," Trump said at a Cabinet meeting on Tuesday. "They are going to be tariffed at a very, very high rate, like 200%. We'll give them a certain period of time to get their act together."... Sub. Req’d

Zuellig Pharma On Tariff Threats

(7/9, Bloomberg) ...John Graham, CEO at Zuellig Pharma, says he expects most industry peers to be scrambling to understand the potential impact of US tariffs on supply chains. He speaks exclusively with Haslinda Amin on "Bloomberg: The China Show" from the Techcombank Investment Summit 2025... Full

Advocacy Groups, Health Networks and Others Back Bill Seeking to Nix 'Interchangeable' Biosim Tag

(7/8, Fraiser Kansteiner, Fierce Pharma) ...As biosimilars struggle to live up to their promise of cutting costs and improving access to biologic medicines for U.S. patients, more than 39 advocacy groups are championing recent bipartisan efforts to cut through the bureaucracy that they believe has kept adoption at bay..."Interchangeability is a designation that doesn't exist anywhere else in the world and there is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines," John Murphy III, president and CEO of AAM, said in a release detailing the HELP committee letter. "The number of groups who've joined us in support of this bill shows how impactful cleaning up this confusion will be for patients."... Sub. Req’d

Industry Groups Renew Push To Drop Interchangeable Distinction

(7/8, Luke Zarzecki, Inside Health Policy) ...The groups say the current statutory language generates confusion on the distinction between biosimilars and interchangeable biosimilars, and they note FDA has said there is no scientific difference between the two. Some groups are opposed to the bill, including the major lobbying organization for brand-name drugs, with Pharmaceutical Research and Manufacturers of America spokesperson Andrew Powaleny saying the change would lower drug standards... Sub. Req’d

A Brave New World: Medicare's $2,000 Cap, A Tectonic Shift Pharma Can't Afford to Miss

(7/8, Aanam Mahmood, Sayantan Niyogi, Luke Greenwalt and Jamie Cattell, IQVIA) ...Medicare's $2,000 cap is more than a policy update. It's a market reset, and may be the most significant near-term consequence of the Inflation Reduction Act. Pharma companies that treat it like a temporary rebate shift will be left behind. Those that engage deeply, with data, empathy, and strategic agility, will unlock new patient growth while preserving margin... Full

DIA Aims To Facilitate Collaboration Between FDA, Global Regulators

(7/8, Jessica Karins, Inside Health Policy) ...As FDA makes major policy changes and withdraws from participation in some international organizations, Drug Information Association (DIA) President Marwan Fathallah says he wants his organization to be a neutral platform for FDA to engage with leaders around the globe -- and he says agency leadership is interested in taking advantage of that opportunity... Sub. Req’d

US FDA Staff Stability Should Be A Congressional Priority, Former Chief Of Staff Says

(7/8, Derrick Gingery, Pink Sheet) ...Anything Congress can do to create some stability for the FDA staff and combat departures in the near- and long-term would be helpful, former agency Chief of Staff Elizabeth Jungman said. CBER Director Vinay Prasad told staff he is talking with former FDA employees who left in the last few years about potentially returning. The FDA continued to lag behind its FY 2025 PDUFA hiring goal after adding only two people in the second quarter... Global Sub. Full

A Breakthrough On The Horizon: Teva's TEV-53408 Fast Tracked for Celiac Disease (+Video)

(7/8, Scott Adams, Celiac) ...In a hopeful development for the celiac disease community, Teva Pharmaceutical Industries has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational drug TEV-53408...With TEV-53408 now in a Phase 2a clinical trial, this designation marks a significant milestone—not only for Teva's innovative pipeline but for the millions around the world seeking relief beyond the gluten-free diet...Teva's investment in this space could pave the way for other biotech companies to explore similar or complementary approaches... Full

Southwest Airlines Sues Dozens of Generic Drugmakers for Alleged Price-Fixing Scheme

(7/8, Zoey Becker, Fierce Pharma) ...In a 730-page lawsuit filed in federal court in Pennsylvania, the airline targets dozens of drugmakers and argues the companies "deprived the public" of the benefits of cheaper generic drugs by fixing the price of their meds since at least 2009. Among the generic defendants named are Teva Pharmaceutical Industries, Sandoz, Dr. Reddy's Laboratories, Lupin and Apotex... Full

Corcept v. Teva Oral Argument: Infringement by Drug Label, Again

(7/8, Dennis Crouch, Patentlyo) ...On Monday of this week, the Federal Circuit heard oral argument in Corcept Therapeutics, Inc. v. Teva Pharmaceuticals USA, Inc., which involves Corcept's patent on a method of administering particular doses of mifepristone along with a "strong CYP3A inhibitor" to treat Cushing's syndrome. (Cushing's syndrome is a rare but debilitating endocrine disorder.) After a bench trial, Chief Judge Renée Bumb of the District of New Jersey rejected Corcept's induced infringement claim, finding that no doctor had actually practiced the patented method and that the generic's label didn't encourage the co-administration of mifepristone and a strong CYP3A inhibitor—it actually cautioned against it... Full

Three's A Crowd? Celltrion Launches Denosumab In US

(7/8, Dave Wallace, Generics Bulletin) ...Celltrion has launched its Stoboclo and Osenvelt denosumab biosimilar rivals to Prolia and Xgeva in the US, under the terms of a settlement with originator Amgen...The firm has not yet commented on an expected launch date, but remains embroiled in litigation with Amgen, with the originator having also filed further lawsuits against other biosimilars developers in recent weeks... Global Sub. Full

Lupin Inks $50 Million Licensing Deal with Zentiva for Global Biosimilar Rollout

(7/9, Financial Express) ...Under this agreement, Zentiva will be responsible for marketing and distributing the biosimilar in Europe and CIS (Commonwealth of Independent States) countries. Lupin, on the other hand, will handle commercialization in the rest of the world, including key markets like the United States and Canada...Lupin clarified that the agreement does not involve any acquisition and does not fall under the category of a related-party transaction. Lupin said the partnership is expected to enhance its reach and ensure wider availability of cost-effective biologics globally... Full

Alvotech Expands its Capacity in Assembly and Packaging with the Acquisition of Ivers-Lee in Switzerland

(7/9, Alvotech) ..."Ivers-Lee has been an Alvotech preferred partner in assembly and packaging for several years. We know and trust each other very well, having worked closely together. As Alvotech prepares for the launch of three new biosimilars in 2025 and sales growth in global markets, the integration of Ivers-Lee into our Technical Operations, provides added flexibility and capacity to meet increased global demand for our biosimilars, maintaining the highest level of quality and service," said Robert Wessman, founder, chairman and CEO of Alvotech... Full

Merck to Buy Verona Pharma in $10 Billion Deal

(7/9, Golin Kellaher, The Wall Street Journal) ...Merck & Co. has struck a roughly $10 billion deal to buy Verona Pharma, bolstering its lineup with the chronic obstructive pulmonary disease treatment Ohtuvayre as it braces for the 2028 loss of patent exclusivity for the blockbuster cancer drug Keytruda... Sub. Req’d

Johnson & Johnson Seeks Expanded FDA Approval of Caplyta for Relapse Prevention in Schizophrenia

(7/8, Don Tracy, PharmExec.com) ...Johnson & Johnson announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA, seeking an expanded indication for Caplyta (lumateperone) to include relapse prevention in schizophrenia. According to the company, the sNDA is based on positive data from a Phase III randomized withdrawal trial, which demonstrated that Caplyta significantly prolonged time to relapse compared to placebo... Full

Novo Nordisk Submits Higher Wegovy Dose to the European Medicines Agency for Approval

(7/8, Anna Ringstrom, Reuters) ...Denmark's Novo Nordisk said on Tuesday it had submitted a new, higher dose of its obesity treatment Wegovy to the European Medicines Agency for approval, with one in three trial participants achieving 25% or more weight loss... Full

CVS Caremark Drops Coverage of Popular Weight Loss Drug

(7/8, Daniella Genovese, FOX Business) ...GLP-1 products, originally developed to treat type 2 diabetes, but are now FDA-approved specifically for obesity under brand names like Wegovy and Zepbound, are "significantly contributing to overall plan costs", CVS spokesperson Phillip Blando told FOX Business. Removing coverage of the drug will result in an estimated client savings of 10% to 15% year over year in the anti-obesity medication space for its clients who choose to cover these medications for weight loss, according to Blando...Eli Lilly told FOX Business that the company is committed to ensuring patients have access to the treatment they need... Full

The Looming ‘Patent Cliff' Facing Big Pharma

(7/8, Hannah Kuchler and Patrick Temple, Financial Times) ...The blockbuster drugs going off patent are almost all biologics - infusions derived from biological, not chemical, processes - and they are harder to replicate than pills. Lichtenberg thinks it could take five years for sales to slump as much as 75 per cent, far longer than the months it took for some best-selling tablets to be replaced by generics last time... Sub. Req’d

Judge Orders CVS' Omnicare Unit to Pay $949 Million Over Invalid Prescriptions

(7/8, Jonathan Stempel, Reuters) ...A federal judge ordered CVS Health's Omnicare unit to pay $948.8 million in penalties and damages, in a whistleblower lawsuit claiming it fraudulently billed the U.S. government for invalid drug prescriptions...CVS plans to appeal the judgment. The Woonsocket, Rhode Island-based drugstore chain and pharmacy benefits manager bought Omnicare in 2015. Omnicare has asked McMahon to throw out the case or grant a new trial... Full

Trump's Latest Threat of 200% Pharma Tariffs Raises Big Questions for Ireland

(7/9, Cliff Taylor, The Irish Times) ...Donald Trump has made so many threats of tariffs that it is hard to know what to take seriously. But his latest outburst on the pharma sector will have been very uncomfortable news in Dublin, for a few key reasons...The wider context here is that the EU wants to sign a deal in principle with the US - and may be close to doing so - but reports on Wednesday said that this would be on worse terms than the UK deal. The UK has been promised preferential treatment on the Section 232 tariffs. This will be of concern to Ireland on pharma, while Germany will wait to see the current 25 per cent levies on cars reduced... Full

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

(7/8, Francesca Bruce, Pink Sheet) ...A top-level European Commission official says that no better proposition than transferable exclusivity vouchers for incentivizing the development of new antibiotics has been proposed. Subscription models are limited due to costs. Clarity on what the vouchers will look like in practice could be on the way as the new Danish presidency of the Council of the EU is prioritizing negotiations on the pharma reform package... Global Sub. Full

Australia ‘Urgently Seeking' Detail On Trump's Drug Tariff Threat

(7/8, Swati Pandey, Bloomberg) ...Australia is "urgently seeking" more detail on President Donald Trump's threat to impose 200% tariffs on pharmaceutical imports to the US, Treasurer Jim Chalmers said. "These are obviously very concerning developments," Chalmers told Australian Broadcasting Corp. radio in an interview on Wednesday. "Our pharmaceutical industry is much more exposed to the US market. And that's why we're seeking – urgently seeking – some more detail on what's been announced."... Full

India Must Secure Fair Trade Terms, Say Experts Amid Trump's Tariff Warnings

(7/9, Prashant Nair and Surabhi Upadhyay, CNBC TV-18) ...Even as concerns grow over high tariffs proposed by the US administration, experts believe there is still room for progress on a possible India-US trade deal. Former Commerce Secretary Anup Wadhawan and Professor Biswajit Dhar, Head of the Centre for WTO Studies, both expressed cautious optimism about a potential agreement, though they flagged several areas of concern. Wadhawan said it appears a deal has already been worked out at the official level and is now waiting for US President Donald Trump's approval... Full

Chinese Pharma Companies May Be Less Affected by Latest Trump Tariff Threat -- Market Talk

(7/9, Dow Jones) ...Chinese pharmaceutical companies may not be affected by President Trump's latest sectoral tariff threat, says Kai Wang, Asia equity market strategist at Morningstar. The pharma tariffs referenced by Trump have more to do with generic drugs, and China's generic drug consumption is mostly domestically driven, Wang says. South Korea could instead be more affected in Asia, while India also has a significant export percentage to the U.S., Wang notes... Full

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

(7/9, Xu Hu, Pink Sheet) ...16 measures announced by China's NHSA and NHC on July 1 aim to remove barriers between R&D, the clinic and medical insurance to support the entire drug life cycle. Such barriers are a key reason for the recent underperformance of innovative therapies in the country, one expert told the Pink Sheet. One highlight is a proposed list of innovative drugs to be reimbursed by commercial insurance, which is linked to official announcements earlier this year... Global Sub. Full

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