Monday, April 28, 2025

Teva Price Target Lowered to $20 from $24 at HSBC

(4/28, The Fly) ...HSBC lowered the firm's price target on Teva to $20 from $24 and keeps a Buy rating on the shares. The firm says the confluence of first-time U.S. tariffs risks combined with a large patent cliff and Part D/Inflation Reduction Act headwinds might create some pressure on biopharma earnings. HSBC's analysis suggests innovative pharma could face earnings headwinds of roughly 6%-14% if a 25% U.S. tariff were applied... Full

Attorney General Jackley, Emily's Hope, State Agencies Partner To Distribute 20,000 Naloxone Kits Throughout South Dakota

(4/25, Attorney General Marty Jackley) ...South Dakota Attorney General Marty Jackley and Emily's Hope, along with South Dakota Departments of Social Services and Health, announce a partnership that will result in the distribution of 20,000 naloxone kits, which equals 40,000 doses, throughout South Dakota...The distribution of these kits is funded by the South Dakota Attorney General's South Dakota Opioid Settlement and supplied by TEVA Pharmaceuticals... Full

AbbVie's Immunology Franchise Remains a Powerhouse, As Skyrizi, Rinvoq Combine for $5B

(4/25, Max Gelman, Endpoints News) ...AbbVie's overall revenues for the first quarter totaled $13.3 billion, coming in about $550 million ahead of its estimates and at an 8.4% increase over the same period last year. Immunology drugs contributed to almost half of that, totaling about $6.3 billion for the quarter... Sub. Req’d

Denosumab Race Heats Up In Europe With Eight More Nods

(4/28, Dave Wallace, Generics Bulletin) ...Four biosimilars sponsors – Biocon Biologics, Gedeon Richter, Mabxience and Zentiva – have each received dual positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use for pairs of denosumab rivals to Amgen's Prolia and Xgeva, at the CHMP's April meeting...The eight nods serve to double the number of denosumab biosimilars endorsed by the EMA so far, teeing up the biosimilars industry for a competitive market once the denosumab rivals begin to launch later this year... Global Sub. Full

European Regulators Recommend New Drugs from Vertex, Amgen and Jazz 

(4/28, Anna Brown, Endpoints News) ...The European Medicines Agency's human medicines committee (CHMP) said on Friday that it recommended the European Commission to give the go-ahead for six new medicines and 10 label expansions. Among the six new medicines was Vertex's cystic fibrosis oral therapy called Alyftrek, which was approved by the FDA last December for the same indication. Amgen similarly got a CHMP nod for Tepezza in moderate to severe Thyroid Eye Disease. Tepezza was approved by the FDA for that condition in January 2020. Jazz also secured a positive opinion for its bile duct cancer antibody Ziihera, which was approved by the FDA in November last year... Full

Aurobindo Arm's Biosimilar for Breast Cancer Gets EMA Panel Nod

(4/26, The Hindu) ...The positive opinion is based on demonstrating comprehensive analytical similarity and clinically no meaningful differences between Dazublys and the reference biologic product Herceptin in terms of pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity. Upon European Commission approval that is expected in July, Dazublys will be available for use across EU member states, Aurobindo Pharma Director and CEO Biologics, Vaccines and Peptides Satakarni Makkapati said... Full

Dr Reddys Eyes Global GLP-1 Market with Generic Drug Rollout On Patent Expiry

(4/26, Swati Bharadwaj, The Times Of India) ...Dr Reddy's Laboratories is positioning itself to enter the lucrative GLP-1 (glucagon-like peptide-1) drug market, with plans to launch generic versions of blockbuster diabetes and obesity drugs like Semaglutide as innovator patents expire from 2026 onwards...The Hyderabad-based pharma major is looking at a portfolio of around 15 GLP-1 drugs that are used to treat diabetes and obesity, which it plans to roll out at various points in time based on patent expiry in different markets globally... Full

Glenmark, Cipla Plan to Step Up US Manufacturing

(4/28, Anjali Singh, Sohini Das Mumbai, Business Standard) ...Cipla is "actively scaling operations in the US", a key global market for generics, particularly in respiratory and oncology segments, said a person familiar with the development. The company currently operates four manufacturing facilities in New York (3) and Massachusetts (1), focusing on inhalation products, oral therapy sachets, and the production of tablets and capsules. Cipla believes complex generics and peptide-based drugs are two areas where it can achieve long-term strategic growth... Sub. Req’d

With Industry's Onshoring Tide Rolling On, Amgen Blueprints $900M Expansion at Ohio Biomanufacturing Plant

(4/25, Fraiser Kansteiner, Fierce Pharma) ...Amgen is plugging $900 million into an expansion of its biomanufacturing facility in New Albany, Ohio, the company said Friday. The project is expected to bring the total number of Amgen jobs in the state to 750 and increase the company's overall investment in Ohio to more than $1.4 billion...Amgen's latest outlay isn't on the same scale as some other pharma investments that have followed Trump's tariff threat. It also comes after the California drugmaker announced a similar $1 billion project at its Holly Springs manufacturing site in North Carolina in December... Full

Samsung Biologics Signs $514 Million CDMO Deal with US Pharma Company

(4/28, Lee Han-soo, Korea Biomedical Review) ...The latest deal represents approximately 16.21 percent of its consolidated revenue of 4.55 trillion won in 2024. The contract value, originally set at $513.96 million, was calculated based on an exchange rate of 1,434.6 won per dollar. Under the terms of the agreement, Samsung Biologics will manufacture pharmaceutical products for the undisclosed client until Dec. 31, 2031... Full

Germany's Merck KGaA in $3.9 Billion Deal to Buy US Biotech Firm SpringWorks

(4/28, Ludwig Burger, Reuters) ...Merck KGaA has struck a deal to buy U.S. biotech company SpringWorks Therapeutics for an equity value of $3.9 billion, as the German company seeks to acquire treatments for rare tumours to boost its cancer drugs business...The transaction will likely close during the second half of 2025, subject to approval of SpringWorks' shareholders and regulatory clearance, Merck added... Full

Zydus Gets 6 Observations from USFDA for API Unit

(4/28, Press Trust Of India) ...Zydus Lifesciences on Saturday said the US health regulator has issued six observations after inspecting its Gujarat-based API manufacturing unit. "We wish to inform that the US Food and Drug Administration (USFDA) conducted a surveillance inspection at the group's API (active pharmaceutical ingredient) unit located at Dabhasa in Gujarat," the drug firm said in a regulatory filing... Full

Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market

(4/25, Cameron Santoro, The Center for Biosimilars) ...Streamlining regulatory processes, addressing patent abuse, and evolving reimbursement models to ensure sustainability can help overcome barriers and expand biosimilars into new therapeutic areas, according to Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz... Full

Exclusive: US Pharma Tariffs Would Raise US Drug Costs by $51 Billion Annually, Report Finds

(4/25, Maggie Fick, Reuters) ...A 25% U.S. tariff on pharmaceutical imports would increase U.S. drug costs by nearly $51 billion annually, boosting U.S. prices by as much as 12.9% if passed on, a report commissioned by the industry's U.S. trade group and reviewed by Reuters shows. The analysis, conducted by Ernst & Young, found the United States imported $203 billion in pharmaceutical products in 2023, with 73% coming from Europe -- primarily Ireland, Germany and Switzerland. Total U.S. sales of finished pharmaceuticals that year were $393 billion... Full

Another Drugmaker Says Tax Reform, Not Tariffs, Would Drive U.S. Manufacturing

(4/25, James Rogers, MarketWatch) ...AbbVie Inc. took a little shot at the Trump administration's trade policy, as the drugmaker said Friday that rather than tariffs, tax reform is the key to boosting U.S. manufacturing..."As we continue to invest and grow our U.S. operational footprint, we believe a more competitive tax policy building on what was accomplished through 2017 tax reform will encourage a sustainable shift towards U.S. manufacturing over the long term," said AbbVie Chief Financial Officer Scott Reents, according to a FactSet transcript... Full

Following Pharma's Tariff Trend, AbbVie Unveils $10B US Investment in 10 Years

(4/25, Fraiser Kansteiner, Fierce Pharma) ...AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker's CEO, Rob Michael, said on a call with analysts Friday...Should those pharmaceutical-specific tariffs come down, AbbVie expects the impact on its operations to be "in line with our peers," Michael said on the call...Nevertheless, AbbVie is bracing for potential near-term headwinds if pharmaceutical tariffs touch down, said CFO Reents. "We are actively preparing for a number of potential scenarios and would expect to put into place mitigation strategies as we have more information relevant to these dynamics," he explained... Full

Rage Against The Machine: Generics CEOs Slam Systemic Problems In The US

(4/25, Dave Wallace, Generics Bulletin) ...During the "CEOs Unplugged" panel at the AAM's annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars... Global Sub. Full

Community Pharmacists: DOGE Should Focus On PBM Waste & Fraud

(4/25, Gabrielle Wanneh, Inside Health Policy) ...The National Community Pharmacists Association (NCPA) specifically wants DOGE to audit PBMs that administer the drug benefits for Medicare Part D, Medicaid, Tricare and Federal Employee Health Benefit Programs. The group wants DOGE to investigate the use of certain business practices, reimbursement models and contracting terms the group says contribute to payers and patients paying more than they should for prescription drugs, saying in a Friday (April 25) letter to HHS Senior Advisor Rachel Riley these PBM practices are draining the government of resources for federal health programs... Sub. Req’d

Pharma Funding Of Patient Orgs, Doctors In Spotlight Through Anti-PDAB Advocacy

(4/25, Luke Zarzecki, Inside Health Policy) ...Sen. Chuck Grassley (R-IA) plans to reintroduce a bill he introduced last December with Sen. Maggie Hassan (D-NH), called the "Open Payments Expansion Act." The bill seeks to force medical product companies to publicly reveal any payments made to tax-exempt patient advocacy groups -- tightening transparency around the financial ties influencing patient advocates... Sub. Req’d

340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

(4/25, Cathy Kelly, Pink Sheet) ...An Senate HELP Committee report on the 340B program offers insights into the program's operation from hospitals, federally-qualified health centers, pharmacy chains and pharma manufacturers. The report states that a significant and growing share of 340B revenue is being collected by pharmacies and third party administrators from hospitals and other participating entities. The committee recommends legislation to establish a clear purpose for the program and ensure it operates in accordance with congressional intent, which likely will renew reform efforts... Global Sub. Full

FDA Chief Makary Talks Expediting Drug Approvals, RIFs and the Abortion Pill

(4/25, Max Bayer, Endpoints News) ...In an interview with PBS' "NewsHour" co-anchor and co-managing editor Amna Nawaz on Thursday, Makary expanded on his efforts to expedite drug approvals, especially for rare diseases, and addressed reports that HHS Secretary Robert F. Kennedy Jr. is considering the removal of Covid-19 vaccines from the childhood vaccine schedule. The interview was part of the World Economy Summit hosted by the outlet Semafor. Here are four key takeaways from the interview... Sub. Req’d

Europe's Pharma Industry Braces for Pain as Trump Tariff Threat Looms

(4/27, Jeanna Smialek, Liz Alderman, Melissa Eddy, The New York Times) ...Pharmaceutical products and chemicals are the bloc's No. 1 export to America. Among them are the weight-loss blockbuster Ozempic, cancer treatments, cardiovascular drugs and flu vaccines. Most are name-brand drugs that yield a large profit in the American market, with its high prices and vast numbers of consumers. "These are critical things that keep people alive," said Léa Auffret, who heads international affairs for BEUC, the European Consumer Organization. "Putting them in the middle of a trade war is highly concerning."... Sub. Req’d

Industry-Backed Study Highlights Value of Antibiotic R&D Incentive

(4/25, The Pharma Letter) ...A new analysis by Charles River Associates, commissioned by European industry group EFPIA, suggests that a proposed reward system for antibiotic developers could be significantly cheaper for EU governments than previously estimated by the European Commission... Sub. Req’d

French Body Welcomes Call For Greater Uptake

(4/25, Dave Wallace, Generics Bulletin) ...French off-patent industry association Gemme has welcomed a call for greater uptake of generics and biosimilars made by the country's Cour des Comptes, or audit court, which regulates public spending..."Increasing the volume of generic, hybrid, and biosimilar medicines without lowering their value would allow additional savings to be generated," Gemme underlined. "These resources could then be reinvested in the healthcare system."... Global Sub. Full

Canada's Complicated Drug-Approval System Needs Overhaul, Former Regulator Says

(4/28, Chris Hannay, The Globe and Mail) ...Canada has some of the highest drug prices in the world and among the longest waits for new drugs to come to market. Mr. Clark has pointed words for the drug lobby, who say the wait times are owing to Canada trying to contain costs. "The price thing is a red herring," he said. But he thinks drug makers have a valid point on something else: too much red tape... Full

Goyal Criticises Attempts to Secure Pharma Patents Through Minor Innovations

(4/27, Press Trust Of India) ...Commerce and Industry Minister Piyush Goyal on Sunday criticised attempts of certain firms to secure pharmaceutical patents through minor incremental innovations, stating that such practices could deprive millions from access to affordable medicines... Full

India Tightens Grip On Pharma Quality Amidst OTC Regulatory Push

(4/28, The Pharma Letter) ...Seeking to ensure the quality and safety of pharmaceutical products, India's regulatory bodies have intensified their crackdown on substandard and spurious drugs. The move comes at a crucial juncture as the country inches closer to establishing a comprehensive regulatory framework for over-the-counter (OTC) medications, reports The Pharma Letter's India correspondent... Sub. Req’d

Roche Made Over 100 Times the Cost of a Medicine that it Sold in India, Calculations Show; Company Defends Itself

(4/28, The Economic Times) ...A recent report in The Times of India reveals that Roche may have profited immensely from risdiplam, a drug for spinal muscular atrophy (SMA), potentially earning 115 times its clinical trial expenses. Knowledge Ecology International estimates trial costs at $50 million, while Roche's risdiplam revenue reached $5.8 billion. Roche defends its pricing, citing unsuccessful projects and ongoing research... Full

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