Friday, May 9, 2025

Teva Price Target Raised to $22 from $20 at BofA

(5/8, The Fly) ...BofA analyst Jason Gerberry raised the firm's price target on Teva to $22 from $20 and keeps a Buy rating on the shares following what the firm views as "a solid 1Q update," mainly driven by cost saving initiatives. Factoring in cost savings, the firm is more confident in Teva's ability to grow its bottom-line in 2026 despite major product headwind and approach its 2027 profitability targets, the analyst tells investors... Full

Teva Plots Thousands of Job Cuts as Restructuring Drive Enters 'Acceleration' Phase

(5/8, Fraiser Kansteiner, Fierce Pharma) ...The move comes as Teva enters the "Acceleration Phase" of its"Pivot to Growth" restructuring strategy the company unveiled in early 2023, CEO Richard Francis said in a statement. The overall restructuring project is designed to both streamline operations at the Israeli-American company and solidify Teva's position as both a generic drug maker and developer of new, branded medicines. "We're accelerating innovative growth and strengthening our generics business, while streamlining our operations, sharpening our business and optimizing processes," Francis said... Full

Takeda Looks Toward 'Inflection Point' as it Eyes New Launches to Shake Off Vyvanse Generic Impacts

(5/8, Zoey Becker, Fierce Pharma) ...While six new launches are expected to help weather the storm ahead of biosimilar competition to lead sales driver Entyvio at the end of the decade, three "potentially life-transforming" new treatment options are on track for phase 3 readouts this year, the company said in its 2024 full-year earnings release. Takeda's fiscal year just wrapped up in March 2025 and began in April 2024. 2025's fiscal year, meanwhile, will be "pivotal" as it invests in launch readiness, which is key for the company's long-term growth potential despite a flat 2025 outlook, CEO Christophe Weber commented... Full

Takeda Announces Handful of Pipeline Cuts in Effort to ‘Pivot Resources'

(5/8, Nicole DeFeudis, Endpoints News) ...When asked for clarity on why the cuts were made, a Takeda spokesperson told Endpoints News that "we continue to make data-driven decisions to maintain focus on our most promising pipeline programs."...The spokesperson said Thursday the recent cuts will "allow us to pivot resources and rapidly advance development of our six late-stage programs." Takeda has been sharply focused on six experimental programs, two of which have Phase 3 readouts coming this year: oveporexton in narcolepsy and zasocitinib in psoriasis... Full

Amneal Bolsters US Manufacturing Capacity with Apiject Collaboration Deal

(5/8, Joseph Keenan, Fierce Pharma) ...Amneal Pharmaceuticals inked a collaboration deal with syringe maker Apiject that will see the New Jersey-based biopharma boost its production capacity in the U.S. as well as support its efforts to reshore drug manufacturing in the country..."We continue to invest in advanced pharmaceutical manufacturing in the United States, which reflects our commitment to producing essential and affordable medicines," Chirag Patel and Chintu Patel, co-CEOs of Amneal, said in the release. "We believe the country has an opportunity to build a more resilient U.S. pharmaceutical supply chain and to onshore critical drug production."... Full

Merck Boosts U.S. Investments with $895M Expansion in Kansas Site

(5/8, Seeking Alpha) ...Merck (NYSE:MRK) on Thursday announced plans to invest $895M to expand a manufacturing facility in Kansas, becoming the latest pharma major to boost capital expenditure in the U.S. amid the Trump administration's tariff threats... Full

Celltrion Q1 Net Soars On Strong Sales of Biosimilars

(5/9, Choi Kyong-ae, Yonhap) ...Net profit for the three months ended March soared to 108.3 billion won (US$77.4 million) from 20.7 billion won in the same period last year, the company said in a regulatory filing. Higher demand for the company's flagship biosimilars -- including Remsima SC, Yuflyma and Vegzelma -- in global markets buoyed the quarterly result, a company spokesperson said... Full

India's Dr Reddy's Beats Quarterly Profit View On New Drug Launches

(5/9, Rishika Sadam and Kashish Tandon, Reuters) ...Indian generic drugs maker Dr Reddy's Laboratories, reported a fourth-quarter profit that beat analysts' expectations on Friday, helped by new drug launches in oncology and other chronic therapy areas. The company's consolidated net profit increased to 15.93 billion rupees (nearly $187 million) in the quarter ended March 31, beating analysts' estimate of 14.91 billion rupees, as per data compiled by LSEG... Full

Biocon Targets High-Teens Generics Growth in FY26

(5/9, Ekta Batra, CNBC TV-18) ...Biocon is preparing for a year of strong momentum in 2025-26 (FY26), led by major upcoming launches across its generics and biosimilars portfolio. Siddharth Mittal, MD & CEO, said the company is targeting ‘high teens' growth in the generics business with key products such as Liraglutide and Epaxol expected to enter new markets... Full

Viagra-Maker Viatris Beats Quarterly Estimates On Demand for Branded Drugs in China

(5/8, Puyaan Singh, Reuters) ...Sales of its generic drugs were hurt after the U.S. Food and Drug Administration restricted imports of 11 products from its facility in Indore, India due to violations found during an inspection. Revenue in its bigger branded drugs unit, under which the company sells anti-anxiety medication Xanax and Yupelri for lung disease, rose 3% to $2.12 billion, reflecting expansion in emerging markets, and strong growth in Greater China and developed markets... Full

GSK Awaits Nucala Decision After FDA Target Date Passes

(5/8, Nicole DeFeudis, Endpoints News) ..."The FDA continues to review our submission for Nucala in COPD and we are working closely with them to ensure we can bring this important treatment option to patients as quickly as possible," a GSK spokesperson said. The spokesperson said that "based on our latest discussions with the FDA, we continue to expect approval." When asked for further detail on the FDA's communications, they said the agency is "actively reviewing our submission," and "we do not comment on ongoing discussions with regulatory authorities."... Full

Zydus Life Gets US FDA Nod for MS Treatment Drug Glatiramer Acetate

(5/9, Business Standard) ...Zydus Lifesciences said that it has has received final approval from the United States Food and Drug Administration for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. The Glatiramer Acetate Injection is an AP-rated substitutable generics of Copaxone, 20 mg/ml, 40 mg/ml... Full

Hikma Pharma to Pay $50 Million to Settle Narcolepsy Drug Antitrust Case

(5/8, Mike Scarcella, Reuters) ...Hikma Pharmaceuticals has agreed to pay $50 million to settle a class action accusing the drugmaker of scheming to delay a generic version of Jazz's blockbuster narcolepsy drug Xyrem, causing health plans to pay higher prices. The proposed settlement filed on Wednesday in the San Francisco federal court resolved claims from drug buyers including the city of Providence, Rhode Island, and the New York State Teamsters Council Health and Hospital Fund... Full

We Are Well-Aligned to Capitalise On the CDMO Opportunity

(5/9, Viveka Roychowdhury, Express Pharma) ...Dr Abdelaziz Toumi, CEO, Lupin Manufacturing Solutions (LMS), explains to Viveka Roychowdhury how LMS is aligning long-term strategies, repositioning key assets, lining up investments in new modalities and leveraging India's API ecosystem to capitalise on this opportunity... Full

GOP Eyes Pharma Tax Hike, Nixing Drug Price Deal for Trump Bill

(5/8, Rachel Cohrs Zhang, Bloomberg) ...House Republicans are considering nixing a Medicaid drug pricing plan floated by President Donald Trump and fiercely opposed by the pharmaceutical industry as the party pushes to strike a massive tax and spending deal in the coming days. But drugmakers may not be totally off the hook... Sub. Req’d

Trump's Drug Price Plan Expected to Push Drugmakers to Charge Same as Other Countries

(5/8, Berkeley Lovelace Jr., NBC News) ...In a statement, Alex Schriver, a spokesperson for Pharmaceutical Research and Manufacturers of America, the drug industry trade group that filed the lawsuit against Trump's original drug pricing rule, said the Trump administration should instead focus on so-called pharmacy benefit managers to address high drug costs... Full

Trump Works Towards US Tariffs On Drug Imports

(5/10, Susan Jaffe, The Lancet) ...Imposing tariffs on drugs could instigate retaliatory tariffs from other countries where drug makers rely on US patents and other intellectual property assets, said Jessica Samuels, who has written about the impact of pharmaceutical tariffs for the Harvard Law School Petrie Flom Center. A trade war over life-saving medicine that increases costs for patients "would be devastating to the health care system", she said... Full

1 Big Thing: Pharma's Perfect Storm

(5/9, Maya Goldman, Axios) ..."Every dollar collected in tariffs would be a dollar less that innovative biopharmaceutical companies are able to invest in U.S. R&D, manufacturing facilities and infrastructure," PhRMA wrote to the Commerce Department. The American Cancer Society Cancer Action Network said that imposing tariffs on generic sterile injectables without addressing the underlying economic factors that make their domestic production difficult would only worsen cancer drug shortages... Full

NCPA: Any Pharma Tariffs Should Be Tailored to Avoid Increasing Shortages and Costs

(5/8, NCPA) ...While supportive of the overarching goal of bringing pharmaceutical manufacturing back to the United States, the National Community Pharmacists Association is urging the Trump administration to ensure any tariffs on the pharmaceutical sector are carefully tailored to avoid further strain on patients and independently owned community and long-term care pharmacies. In comments to the Department of Commerce this week, NCPA expressed specific concern that these tariffs could trigger shortages in the near term and, just as dangerous, force independent pharmacies to absorb higher costs... Full

Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

(5/8, Cathy Kelly, Pink Sheet) ...President Trump appears poised to reintroduce the Most Favored Nation drug pricing policy in government insurance programs. He recently floated the idea of applying the policy in Medicaid for the first time, prompting manufacturer concerns that 340B discount obligations would balloon as a result. Trump could not initiate an MFN demonstration project to lower Medicare drug prices during his first term, but reportedly wants try again... Global Sub. Full

More Medicare Plans Cover Humira Biosimilars, But Do Little to Encourage Patient Use

(5/8, Ed Silverman, STAT+) ...The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies. And some did not cover the brand-name version. This was a big jump in coverage from 2024, when only 64% of the Part D plans and 52% of the Medicare Advantage drug plans covered at least one biosimilar version of Humira... Sub. Req’d

US Court Shuts Down AstraZeneca's Challenge to Medicare Drug Price Plan

(5/8, Diana Jones, Reuters) ...The 3rd U.S. Circuit Court of Appeals upheld a lower court's ruling dismissing the British drugmaker's challenge to the program, which was part of former President Joe Biden's signature Inflation Reduction Act. The court said AstraZeneca hadn't shown how it had suffered a specific injury related to the program or that the company's due process rights were violated... Full

Costs Of Extending The Small Molecule Exemption Period In Medicare Drug Price Negotiation

(5/8, Christopher Cai Aaron S. Kesselheim Benjamin N. Rome, Health Affairs) ...If policymakers desire to treat biologic and small-molecule drugs equally, shortening the waiting period for biologics—ending the biologics bonus—rather than lengthening the period for small molecule drugs is a far more sensible approach. This would limit excess Medicare spending on prescription drugs, and Congress could use these additional savings to lower costs for Medicare beneficiaries similar to how existing savings were used to cap out-of-pocket costs at $2000 per year... Full

FDA Says 27 Drugs Were Not Withdrawn from Sale for Safety or Efficacy Reasons

(5/8, Bob Pollock, Lachman Consultants) ...As a refresher, a reference listed drug (RLD) product for which sale has been discontinued or for which the firm has withdrawn its approval for commercial reasons and that was relied upon as the basis for submission of an ANDA creates a regulatory problem for firms that have approved ANDA versions or drug products with ANDAs pending at the Agency. The FDA must make a determination that the RLD, the one relied upon for ANDA submission, was not discontinued from sale or, when the NDA was withdrawn, removed from marketing for safety or efficacy (S&E) reasons... Full

Knock Knock. Who's There? (or Quién es? or Qui est-ce? or Wer ist es?) Surprise, it's FDA!

(5/9, Anne K. Walsh & Esther Petrikovsky & John W.M. Claud, FDA Law Blog) ...The stated goals are to ensure that "foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies," and "every product entering the U.S. is safe, legitimate, and honestly made." This change builds on the pilot program conducted by FDA's Office of Inspection and Investigations Foreign Unannounced Inspection, which focused on drug manufacturing facilities in India and China. FDA's plan now expands the use of foreign surprise inspections to other countries as well as to other types of FDA-regulated facilities (foods and medical devices)... Full

US FDA Expands Surprise Foreign Inspections

(5/9, Sue Sutter, Generics Bulletin) ...The FDA is expanding its unannounced inspections at foreign drug manufacturing facilities, building on a pilot program for surprise inspections in India and China. FDA Commissioner Martin Makary said the initiative will level the playing field for domestic manufacturers because foreign facilities traditionally received advance notice, but experts disputed the characterization. The program will move ahead without the FDA's top inspections official, Michael Rogers, who is retiring after 34 years with the agency... Global Sub. Full

CVS Health Overcharged Medicaid Programs, States Complain in Lawsuit

(5/9, Noah Tong, Fierce Healthcare) ...Four state attorneys general sued CVS Health and its pharmacies for allegedly submitting "false and fraudulent" claims to state Medicaid programs. Connecticut, Indiana, Oklahoma and Massachusetts claim CVS has not submitted usual and customary prices available to other payers on prescription drug claims to Medicaid since 2016. This resulted in state Medicaid programs overpaying CVS compared to other health plans... Full

Top Nevada Lawmaker Seeks to Cap Insulin Prices at $35 a Month Under Private Insurance

(5/9, Tabitha Mueller, The Nevada Independent) ...Assembly Speaker Steve Yeager (D-Las Vegas) introduced a bill Thursday to cap the price of insulin drug copays to $35 a month for Nevadans on private insurance — a measure that could have major implications for the more than 1 in 10 Nevada adults with diabetes... Full

Tariffs Won't Trigger EU Pharma Exodus, Says Dutch Minister

(5/8, Christoph Schwaiger, Euractiv) ...Tariffs won't lead to an exodus of the EU's pharmaceutical industry, in the short term, Dutch Health Minister Fleur Agema told Euractiv...In Parliament, the Health Ministry said that while incentives make the EU market more attractive for offering a drug, they determine to a lesser extent where the drug is developed or manufactured... Sub. Req’d

EU Wants Industry To Define ‘Trade Secrets' Under Health Data Sharing Regulation

(5/8, Eliza Slawther, Pink Sheet) ...The European Commission is intentionally vague about protecting trade secrets in the European Health Data Space Regulation because it wants industry to shape guidance and recommendations on this topic. This will primarily be achieved through a consortium that is in the process of being set up under the Innovative Health Initiative, a public-private partnership between the EU and the European life science industries. Industry is still concerned that there is room for interpretation regarding the implementation of the EHDS when it comes to keeping trade secrets safe from competition... Global Sub. Full

Brazil's Drug Pricing Shake Up Calls For More Robust Evidence From Companies

(5/8, Francesca Bruce, Pink Sheet) ...A drug pricing shakeup in Brazil would ensure that companies submit more "robust" information for drug pricing decisions. A draft resolution updating the pricing framework would create new drug categories, including for biosimilars. The draft resolution would also clarify when the drug pricing authority can set prices without a submission from the company... Global Sub. Full

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