Monday, December 22, 2025

Teva Price Target Raised to $40 from $30 at Piper Sandler

(12/22 The Fly) ...Piper Sandler raised the firm's price target on Teva to $40 from $30 and keeps an Overweight rating on the shares. The firm is also making an argument for further multiple expansion. Teva's peer group is evolving as the mix continues to shift towards novel brand assets. In other words, the larger cap biopharma group is becoming a more appropriate peer group for Teva, Piper argues... Sub. Req’d

Partners Alvotech, Teva Eye 2026 Eylea Biosimilar Launch in US with Regeneron Settlement

(12/19, Eric Sagonowsky, Fierce Pharma) ...Regeneron has inked another settlement related to Eylea biosimilars, this one with Alvotech and Teva, enabling the partners to launch their product "in the fourth quarter of 2026, or earlier under certain circumstances," according to a Dec. 19 press release from Alvotech. Alvotech and Teva's Eylea biosim, AVT06, has been under review at the FDA since February. In a Feb. 18 press release, the partners said the review was expected to be complete by the end of this year. Teva's online pipeline lists the program as "under regulatory review." The partners didn't disclose the "certain circumstances" that could enable a launch earlier in 2026... Full

Celltrion Launches Bone Disease Biosimilars in Major European Markets

(12/22, Park Su-Hyeon, Chosun Biz) ...Celltrion said on the 22nd that it has launched the bone disease treatments "Stoboclo–Osenbelt (denosumab)" in major European countries including Germany, Spain and France. Stoboclo and Osenbelt are biosimilars of Prolia and Xgeva, developed by U.S.-based Amgen... Full

Samsung Biologics to buy US drug production facility from GSK for $280 million

(12/21, Reuters) ...South Korea's Samsung Biologic said on Monday it is acquiring its first U.S. drug production facility from GSK for $280 million to respond to long-term U.S. market demand. The company's U.S. unit, Samsung Biologics America, is acquiring a 100% stake in Human Genome Sciences Inc of Rockville, Maryland, the South Korean contract drug manufacturer said in a statement. Samsung Biologics plans additional investments to expand the site's capacity, currently a combined 60,000 liters of drug substance capacity, and to upgrade technology, it said... Full

2026 Forecast: Pharma Clicks with Patients as Direct Sales Model Shifts Marketing Strategies

(12/19, Nick Paul Taylor, Fierce Pharma) ...Pharma marketers enter 2026 asking where DTC fits in the DTP era. That question, which few foresaw 12 months ago, reflects the fast rise of direct-to-patient (DTP) programs. In the last few months alone, Amgen, Bristol Myers Squibb, AstraZeneca, Genentech, Novartis and Boehringer Ingelheim have all launched DTP services with discounts for self-pay patients on certain popular medications, joining earlier adopters Eli Lilly, Pfizer and Novo Nordisk. The programs are changing how patients access medicines—and how patients hear about medicines could therefore evolve to reflect the emerging sales channel... Full

Miyares Sues Pharmacy Benefit Managers, Drug Firms Over Soaring Insulin Prices

(12/22, Dave Ress, Richmond Times-Dispatch) ...The three biggest pharmacy benefit managers and two pharmaceutical giants colluded to send insulin prices soaring, Attorney General Jason Miyares says. He is suing pharmacy benefit managers Express Scripts, CVS' Caremark unit and UnitedHealth Group's Optum business as well as the drug-makers Novo Nordisk and Sanofi, asserting they violated the Virginia Consumer Protection Act. The lawsuit said the firms worked together for more than a decade to send insulin prices ever higher, at a cost to patients of billions of dollars... Full

Europe Leads Charge As Private Equity Roars Back Into Off-Patent Pharma

(12/22, Dean Rudge, Generics Bulletin) ...A pair of private equity mega-deals dominated the mergers and acquisitions landscape in 2025, but there was still a clear appetite for smaller, strategic takeovers and tuck-ins across the generics, biosimilars, and off-patent medicines field. The year's defining moments came from Europe, where private equity reaffirmed its conviction in the resilience and scalability of off-patent companies... Global Sub. Full

Lupin Joines Forces With PolyPeptide For Peptide APIs

(12/19, Dave Wallace, Generics Bulletin) ...Lupin has announced details of a strategic alliance with contract development and manufacturing organization PolyPeptide that the Indian firm says will bolster its supply chain for peptide-based active pharmaceutical ingredients. Organized through the firm's Lupin Manufacturing Solutions subsidiary, the alliance "aims to enhance supply chain resilience, improve operational efficiency, and accelerate readiness for the rapidly expanding global peptides market," Lupin set out... Global Sub. Full

AstraZeneca Unit Gets Partial Win in Soliris Drug Monopoly Case

(12/19, Katie Arcieri, Bloomberg Law) ...A subsidiary of AstraZeneca Plc partly won its motion to dismiss a case accusing the pharmaceutical company of cornering the market for a blood disorder drug, after a federal judge tossed federal monopolization claims Friday but allowed allegations of sham litigation to proceed. Judge Brian E. Murphy of the US District Court for the District of Massachusetts dismissed health insurer plaintiff EmblemHealth Inc.'s claims under Section 2 of the Sherman Act, which prohibits attempts to monopolize, and analogous state law claims... Sub. Req’d

UK Bodies Warn Market ‘Not Sustainable' As Prices Hit ‘Rock Bottom'

(12/19, Dave Wallace, Generics Bulletin) ...A joint letter sent to the House of Lords Public Services Committee – signed by Medicines UK chief executive Mark Samuels, as well as leaders from the Company Chemists' Association, Community Pharmacy England and the Healthcare Distribution Association – highlights the "urgent need for investment in the generics medicines market," emphasizing that "following the recent UK–US agreement and the commitment to increase prices for new branded medicines, it is essential that these changes are not funded by further pressure on the generic medicines market."... Global Sub. Full

This Week: FDA Staff Raise Alarm Over CNVP, no COVID-19 Vaccine Boxed Warning, and More

(12/19, Ferdous Al-Faruque, Regulatory Focus) ...FDA staffers have told STAT News that the Commissioner's National Voucher Program (CNVP) is being used as a political tool by the Trump administration. While agency product reviews have historically been left to career scientists to avoid the appearance of political interference, agency staff members have anonymously raised concerns that political appointees steered vouchers to companies that are party to the administration's drug-pricing agreements... Full

This Is How Exposed European Big Pharma Is to the U.S.

(12/19, Elsa Ohlen, CNBC) ...Among the 10 largest biopharmaceutical companies in the Stoxx 600 health index, five have a majority of their total sales from the U.S.: Roche, Novo Nordisk, GSK, Argenx, and UCB. Argenx is the most exposed, with 85% of total sales originating in the U.S. in its last reported period. The least exposed are Germany's Merck KGaA and Bayer, with about 30% of sales coming from the U.S. Both Merck and Bayer have diversified businesses that go beyond pharmaceuticals while Roche also has a sizeable diagnostics division... Full

9 Pharma Giants Reach US Drug Price Deals with Trump Administration

(12/19, Angus Liu, Fierce Pharma) ...Nine large pharma companies have reached agreements with the Trump administration to lower certain drug prices in the U.S. Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, GSK, Merck & Co., Novartis, Roche's Genentech and Sanofi have agreed with the White House to reduce the prices of certain prescription medicines in exchange for pharmaceutical tariff relief, President Donald Trump announced at an event Friday together with top U.S. health officials and senior executives from the companies... Full

Trump Announces Agreements With Nine Drugmakers to Lower Prices

(12/20, Margot Sanger-Katz, Rebecca Robbins, The New York Times) ...In a White House briefing announcing the deals, Mr. Trump and top health officials framed the agreements as part of a focus on affordability at a time when the administration is facing intense scrutiny for not doing more to stem rising prices. The announcements were made as health insurance subsidies in the Obamacare marketplace were set to expire at the end of the year, which will likely to drive up premiums for millions of Americans. Standing at the podium, the president also took the opportunity to threaten the health insurance industry. Mr. Trump said he would call insurance executives to Florida or the White House soon to discuss lowering premiums... Full

CMS Proposes GUARD, GLOBE Models To Punish Manufacturers If Part D And B Prices Exceed MFN Rates

(12/19, Sigi Ris, Maaisha Osman, Inside Health Policy) ...CMS is proposing rules to require manufacturers pay rebates if their Medicare Part D and Part B prices exceed most favored nation rates, the agency announced Friday (Dec. 19), just hours after the White House announced nine additional drugmakers will participate in the Trump Administration's most favored nation drug pricing deals... Global Sub. Full

Roche CEO Says US Deal May Mean Higher Swiss Drug Prices

(12/22, Fergal O'Brien, Bloomberg) ...Roche Holding AG Chief Executive Thomas Schinecker said the new US drug deal signed last week could raise prices for some medicines in Switzerland. The agreement, with nine pharmaceutical companies, is intended to lower lower drug costs for some Americans, while the firms will get a reprieve from threatened tariffs. In comments published in Swiss newspapers Tribune de Geneve and Tages-Anzeiger, Schinecker said that prices for new products will be affected, because the US wants other nations to contribute more to medical innovation... Sub. Req’d

Trump To Ask Insurers To Slash Prices, Lobbies Welcome Meeting

(12/19, Amy Lotven, Inside Health Policy) ...President Donald Trump Friday (Dec. 19) said during a press conference on drug pricing that he wants to meet with health insurers as soon as next week and thinks the talks will to lead to prices going down by up to 70%. Insurers say they welcome talks with the White House, but also note insurers' margins are well below those of drug manufacturers and the Affordable Care Act requires plans spend at least 80% of premiums on claims or provide rebates to consumers... Global Sub. Full

Reshoring, Tariffs Dominate 2025's Pharma Manufacturing News

(12/19, Greg Slabodkin, Pharma Manufacturing) ...2025 has been a year of unprecedented pledges by Big Pharma to reshore pharmaceutical manufacturing to the United States, fueled by President Donald Trump's ongoing threats to impose industry-specific tariffs and push for Most-Favored-Nation drug pricing deals. "A wave of transformative U.S. drug-pricing agreements and record manufacturing investments from leading biopharmaceutical companies is poised to reshape the global landscape for pharmaceutical access, production, and industrial policy," data and analytics firm GlobalData declared in a report this week... Full

Carter: House Leadership Committed to PBM Reform

(12/19, David Lim, Lauren Gardner, Politico Prescription Pulse) ...Congress is leaving town for the holidays — and another year has gone by, with bipartisan pharmacy benefit manager legislation still on the flight deck. House Republicans included a handful of provisions in their health care bill this week that aim to increase transparency in how PBMs, which negotiate drug prices between health plans and drug companies, operate in the commercial market. But the bill, narrowly passed in a 216-211 vote, does not address expiring Affordable Care Act tax credits and is expected to be dead on arrival in the Senate... Full

Indian Pharma Cos Applaud US FDA's Strong Stance on Safety Reporting in BA/BE

(12/22, Pharmabiz) ...With a growing number of Indian companies conducting BA/BE studies to support the approval of generic drugs in global markets, the updated safety reporting framework is expected to streamline processes and improve compliance with international regulatory standards. The move is being hailed as a win-win for both patient safety and the global competitiveness of Indian pharma. Industry noted that BA/BE evaluation is crucial for demonstrating a drug's consistency, safety, and clinical efficacy, especially for generics and modified formulations... Full

What Is Data Exclusivity, and How Government Push May Hit Availability of Cheap, Generic Drugs

(12/22, Anonna Dutt, Indian Express) ...The Indian government appears to be considering implementing "data exclusivity" in the pharmaceutical drugs sector after rejecting demands for the provision during trade deal negotiations with the UK and the European Free Trade Association (EFTA). The lack of a data exclusivity provision is what has given India's pharmaceutical industry, which thrives on marketing cheaper generics, its edge in the global market. In recent weeks, government officials have held a flurry of meetings with pharmaceutical industry stakeholders in recent weeks to discuss ways in which data exclusivity may be implemented... Full

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