Wednesday, July 2, 2025

Amid Pricing Squeeze and Market Withdrawals, Europe Must Prioritize Generic Manufacturing, Teva Exec Says

(7/1, Fraiser Kansteiner, Fierce Pharma) ...Now, as trade pressures and geopolitical uncertainties mount—and as certain generics manufacturers pull back from the market—it's imperative that the EU swiftly strengthen and adopt new policies that provide "targeted support for sustainable and resilient manufacturing," Michal Nitka, chief of Teva's Europe generics and global over-the-counter businesses, said in a recent email interview... Full

‘Skinny Label' Legislation Is a Solution in Search of a Problem

(7/2, Irena Royzman and Dana Sublett, Bloomberg Law) ...Proposed legislation to change the process adjudicating patent infringement in cases involving "skinny labels" is a solution in search of a problem, as two Federal Circuit cases in recent years have shown the legal framework for assessing patent infringement remains stable and balanced...The first case to prompt calls for reform, GlaxoSmithKline LLC v. Teva Pharm USA Inc., featured GSK suing Teva for induced infringement of a patent covering a method of treating congestive heart failure. Teva launched a generic with a purported skinny label, omitting the congestive heart failure indication but including two others...Following trial, the district court overturned the jury's finding of induced infringement due to Teva's skinny label... Full

Senate Passes Reconciliation Bill in 51-50 Vote

(7/2, Dave Muoio, Fierce Healthcare) ...Following a record-breaking "vote-a-rama" session and a tie-breaker vote from Vice President J.D. Vance, the Senate has passed its version of the massive reconciliation bill that includes healthcare industry-opposed changes to federal health programs...The bill now goes back to the House for another sign-off before heading to President Donald Trump's desk, though reports suggest opposing contingents of Republican representatives will take issue with the Senate's increased healthcare cuts and budget impacts. Republicans have a self-imposed deadline of July 4 for the bill to be signed into law... Full

PBM Reforms Fail to Make the Cut as Senate Passes Trump's Megabill

(7/1, Max Bayer, Endpoints News) ...Efforts to rein in pharmacy benefit managers, for which drugmakers have been building bipartisan support over the years, were left out of the Senate-passed version of President Donald Trump's megabill...It was not all disappointment for drugmakers, however. Senators added back language tweaking a portion of the Inflation Reduction Act — former President Joe Biden's signature legislation — that stakeholders said limited rare disease development. This language was included in the House's version of the bill, but removed by the Senate Finance Committee... Sub. Req’d

Trump Administration Closer to Unprecedented Drug Price Transparency Requirements

(7/1, Tim Casey, Pink Sheet) ...New requirements intended to strengthen the Transparency in Coverage rule are significant, but whether they will force costs lower is unclear, an Avalere expert said. Health plans will be required to publish machine-readable files with data on drug pricing and discounts at a level not previously seen. Insurers may be the group most aggrieved about publishing granular drug pricing data... Global Sub. Full

They Said It! Consumer Advocates and Experts Shine a Light On Big Pharma's Egregious Anti-Competitive Tactics that Extend Monopolies and Keep Drug Prices High

(7/1, The Campaign for Sustainable Rx Pricing) ...Consumer advocates at Monday's session called for reining in forms of patent abuse like "patent thicketing" – where a Big Pharma company files dozens or even hundreds of patents on a single medication to extend exclusivity – that block competition from more affordable generic or biosimilar alternatives. Such tactics significantly drive up costs for patients, with patent thickets on just five drugs amounting to more than $16 billion in lost savings over a single year... Full

Experts Question Whether FDA, CMS Collaborating On Approvals

(7/1, Luke Zarzecki, Inside Health Policy) ...FDA Commissioner Marty Makary and biologics center director Vinay Prasad laid out their priorities for the agency in a Journal of the American Medical Association article earlier this month. In their JAMA article, the two said they will establish a new pilot program to speed up drug approvals and use artificial intelligence for drug investigations and postmarket surveillance... Sub. Req’d

AbbVie Denied Freeze On Tennessee Pharmacy Contract Law

(7/1, Bernie Pazanowski, Bloomberg Law) ...AbbVie and the other plaintiffs aren't entitled to a preliminary injunction based on claims that the regulation is preempted by federal law, said Judge Aleta A. Trauger of the US District Court for the Middle District of Tennessee. And the drugmakers' claims that the state law is vague or unconstitutional similarly don't hold up, Trauger said Monday... Full

Gov. Pritzker Signs Health Care Bills Lowering Prescription Drug Costs, Expanding Health Care Access

(7/1, Amber Ruch, KFVS) ...Governor JB Pritzker signed two health care bills into law on Tuesday, July 1. According to the governor's office, the Prescription Drug Affordability Act (HB 1697) and the Healthcare Protection Expansion Act (HB 3019) will lower prescription drug costs and expand health care access... Full

PCMA Statement On Illinois H.B. 1697

(7/1, PCMA) ..."We are disappointed with the misguided legislation that Governor Pritzker has signed that will hurt the ability of employers in Illinois to provide affordable health benefits to employees and their families. This legislation imposes a new tax on patients and health plan sponsors and will increase health care costs for everyone. It further removes choices for employers providing health benefits by dictating how they can contract with their pharmacy benefit manager (PBM) and restricts tools that lower prescription drug costs..."... Full

Digital Inhaler May Predict Acute COPD Exacerbations

(7/1, Lori Solomon, HealthDay News) ...Digital inhalers may help predict the occurrence of acute exacerbations of chronic obstructive pulmonary disease (COPD) for patients in an ambulatory setting, according to a study published online in the May issue of Chronic Obstructive Pulmonary Diseases. M. Bradley Drummond, M.D., from the University of North Carolina at Chapel Hill, and colleagues examined variation in digital inhaler (ProAir Digihaler; Teva)-measured physiologic and inhaler use metrics in ambulatory patients with COPD in advance of acute exacerbations of COPD... Full

Fresenius Expands Biosimilars Portfolio with Denosumab Biosimilars in the U.S.

(7/1, Rachel Klemovitch, Contract Pharma) ...Fresenius announced that its operating company, Fresenius Kabi, has introduced two new biosimilars – Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht) – in the United States. These denosumab biosimilars are approved by the FDA for all indications of the reference products: Prolia (denosumab) and Xgeva (denosumab), respectively... Full

Samsung Bioepis Partners with Boryung to Sell Xbryk, Xgeva Biosimilar in Korea

(7/2, Yeom Hyun-a, ChosunBiz) ...Accordingly, Samsung Bioepis will be responsible for the production and supply of Xbryk as the developer, while Boryung will handle exclusive sales and marketing activities in Korea...Through this contract, Samsung Bioepis and Boryung have expanded their domestic partnership product line to include the biosimilars 'Onbevzi' for the anticancer drug Avastin, 'Samfenet' for Herceptin, and now the Xgeva biosimilar Xbryk... Full

Richter Receives European Commission Approval for Junod and Yaxwer, Its Biosimilar Denosumab Products for Bone Disease and Osteoporosis

(7/1, Gedeon Richter) ...Junod® and Yaxwer® are approved for all indications of the reference medicines Prolia® and Xgeva® (Amgen), including the treatment of osteoporosis in postmenopausal women, prevention of skeletal-related events in patients with bone metastases from solid tumors, and treatment of unresectable giant cell tumor of bone. The EC approval is based on a comprehensive development program demonstrating biosimilarity to the reference products in terms of quality, safety, and efficacy... Full

India's Biocon Aims to Lead Copycat Wegovy Sales in Canada From Next Year

(7/1, Satviki Sanjay, Bloomberg) ...The Bengaluru-based company is seeking approval of generic Ozempic by September from Canadian authorities, and also in some emerging markets, its managing director, Siddharth Mittal, told Bloomberg News. "I would say that we have the best chance in Canada" to start launching off-patent semaglutide, he said. "If everything goes seamlessly," then Biocon can receive an approval to sell sometime in 2026, Mittal added...Other firms, including sector giant Teva Pharmaceutical Industries Ltd. and China's Gan & Lee Pharmaceutical Ltd., are gearing up likewise for a slice of the fast-growing global market for generic obesity medicines... Full

Celltrion Intensifies US Sales Efforts for Drug Jimpenetra, Plans Product Expansion

(7/2, Heo Ji-yoon, ChosunBiz) ...Celltrion is intensifying efforts to expand sales of its autoimmune disease treatment, Jimpenetra (Korean name: Remsima SC), in the United States. The company plans to continuously launch new autoimmune disease treatments in the U.S. market following Jimpenetra, aiming to enhance its growth momentum...According to the company, prescription reimbursement for Jimpenetra will fully begin in the U.S. this year... Full

Lupin Gets USFDA Nod for Loteprednol Etabonate Ophthalmic Gel

(7/2, Business Standard) ...The product is a generic equivalent of Lotemax SM Ophthalmic Gel, 0.38%, marketed by Bausch & Lomb Inc. Lupin is the exclusive first-to-file applicant for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins Pithampur facility in India... Full

Sandoz Breaks Ground On Slovenian Biosimilar Manufacturing Facility

(7/1, Josh Abbott, BioProcess International) ...The site will bolster the firm's standing as a leading producer of biosimilars, with investments complementing the company's work in building a biosimilar drug substance production facility in Lendava, also in Slovenia...The Brnik facility will produce injectable products for both existing and upcoming biosimilars, including preparation, filling, assembly, and packaging... Full

Biocon Withheld Key Info, Amgen Says in Bone-Drug Patent Suit

(7/1, Christopher Yasiejko, Bloomberg Law) ...Biocon's Bmab 1000, the working name for biosimilars of both treatments, infringes 34 patents covering the drugs' active ingredient denosumab and their formulation and manufacturing processes, according to a complaint filed Monday in the US District Court for the District of Massachusetts. Amgen's suit said Biocon didn't provide it with key details about how the biosimilars are made as required under federal law, which hampered its ability to assess infringement... Sub. Req’d

Novartis Cites Trial Evidence in Bid to Block MSN Entresto Copy

(7/1, Christopher Yasiejko, Bloomberg Law) ...Novartis AG already provided evidence that proves MSN Laboratories Ltd.'s proposed copies of Entresto infringe a key patent for the heart-disease drug, it said in a redacted filing...Unless Judge Richard G. Andrews rules before July 16, at which point Novartis expects MSN's launch, Novartis said, it would suffer irreparable harm—including lost sales, market share, and its statutory right to delay US Food and Drug Administration approval of MSN's generics... Sub. Req’d

Teva Recalls Acid Reflux Drug After Wrong Pills Found in Bottles

(7/1, Alexandra Murphy, Becker's Hospital Review) ...Teva pharmaceuticals has issued a voluntary recall of one lot of its reflux medication after discovering that bottles contained tablets of a drug used to treat fluid retention. The recall affects lot No. 5420094 of 10 mg metoclopramide tablets in 100-count bottles after three sealed bottles were found to each contain a 20 mg torsemide tablet, a diuretic used to treat edema caused by heart, liver or kidney conditions, according to an FDA enforcement report issued June 20... Full

Dr Reddy's Preparing for Challenges in the US Market in Q4

(7/2, G Naga Sridhar, The Hindu BusinessLine) ..."One of our key products in the US will face increased competition beginning February 2026 with an anticipated decline in sales and profits,'‘ K Satish Reddy, Chairman, Dr Reddy's Laboratories, and GV Prasad, its Co-Chairman and Managing Director, said in this message to investors in the annual report for 2024-25 released on Wednesday. However, the Hyderabad-based company was preparing to face it through a combination of organic and inorganic strategies, they said... Full

AstraZeneca CEO Wants to Move Listing to the US

(7/1, Alex Ralph, The Times) ...Sir Pascal Soriot has spoken privately of his preference to move the FTSE 100 company's listing on a number of occasions and has even discussed moving AstraZeneca's domicile, according to a source familiar with his thinking. They added that Soriot, 66, was likely to face resistance from parts of the board should he push for such a move, as well as the British government. The government is not believed to have been informed... Sub. Req’d

Hikma Receives FDA Approval for TYZAVANTM (Vancomycin Injection, USP) in the US

(7/2, Hikma) ...TYZAVANTM is a glycopeptide antibacterial indicated for the treatment of the following infections in adult and pediatric patients (1 month and older) for whom appropriate dosing with this formulation can be achieved: (i) septicemia; (ii) infective endocarditis; (iii) skin and skin structure infections; (iv) bone infections; and (v) lower respiratory tract infections...TYZAVANTM is the only FDA-approved vancomycin product commercially available for all patients that is available at room temperature and requires no compounding, thawing, activation or dilution—reducing preparation steps and supporting faster treatment... Full

Torrent Pharma Shells Out $1.4B to Take Over Controlling Stake in India's JB Pharma from KKR

(7/1, Zoey Becker, Fierce Pharma) ...The deal merges J.B. Pharma into Torrent's fold, bolstering the latter company's vision of creating a "future-ready, diversified healthcare platform," Torrent explained in a June 29 release.The combination of the India-based pharma companies "offers immense potential to scale both revenue and profitability," Torrent's executive chairman, Samir Mehta, noted in the release. J.B. Pharma's CDMO platform, specifically, provides a "new long-term avenue of growth" for Torrent, Mehta added... Full

Cipla in Talks to Add New Customers for its China Factory, Executive Says

(7/2, Andrew Silver, Reuters) ..."Sometimes we face capacity restrictions ... so they (customers) do approach us whether we can handle the supplies," Deepak Hegde, Cipla's general manager for China, told Reuters. He said the company was in talks with "at least two or three different countries", for product shipments from China and those discussions began around six or eight months ago... Full

Life Sciences Plan Delayed Over Pricing Battle with Pharma Industry

(7/1, Anna Gross and Hannah Kuchler, Financial Times) ...A battle between ministers and the pharmaceutical industry over drug prices has forced the UK government to delay publication of its long-awaited plan for the life sciences. The release of the "life sciences review", initially scheduled for the start of this week, was delayed in large part because both sides had been unable to reach an agreement over a contentious review of drug pricing, according to three people familiar with the matter... Sub. Req’d

EU's Pharma Package Falls Short of Europe's Goal of Global Competitiveness

(7/1, Frankie Fattorini, Pharmaceutical Technology) ...In a bid to chase competitiveness, the EU is advancing its most drastic revision of pharmaceutical law in 20 years. Experts praise the reforms to rare disease and antimicrobial research, but they worry that some provisions in the EU Pharma Package may harm innovation on the continent, contrary to its stated objectives. The package would amend a number of regulations to better meet patients' needs by addressing the security of supply and boosting innovation, according to an explainer by the European Council (EC), one of the three EU bodies that are now in discussions on this package... Full

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