Wednesday, April 2, 2025

EMA Validates Henlius' Pertuzumab Biosimilar Application

(4/1, Adam Zamecnik, Generics Bulletin) ...News of the validation serve as another milestone for the firms' Perjeta biosimilar in another major market. Most recently, the US Food and Drug Administration accepted Organon's filing for the biosimilar earlier this year. Organon previously noted that it expects to launch the biosimilar in 2026 or 2027... Global Sub. Full

Organon Expands Biosimilar Portfolio With Tofidence Acquisition

(4/1, Briana Contreras, Managed Healthcare Executive) ...When asked why Biogen decided to sell the rights to the drug, a spokesperson shared with Managed Healthcare Executive that, "This divestment reflects our previously announced decision to optimize our biosimilars business and focus on innovative medicines and key growth drivers in the U.S., including the ongoing launches of Leqembi, Skyclarys, and Zurzuvae. We believe Organon's expertise in biosimilars commercialization will help Tofidence reach its full potential."... Full

Amneal and Shilpa Introduce Boruzu in US for Cancer Treatment

(4/2, Pharmaceutical Technology) ...Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma, and lowers the compounding preparation process needed for administration. A proteasome inhibitor, Boruzu references branded Velcade, a lyophilised powder that needs reconstitution before usage. Shilpa has created the molecule, while Amneal will handle the manufacturing and commercialisation of the product... Full

Bayer Eyes Launch of Menopause Relief, Heart Drugs This Year

(4/1, Ludwig Burger and Patricia Weiss, Reuters) ...Bayer said on Tuesday it was preparing market launches this year of two new drugs that could each have annual peak sales of at least $1 billion, as it seeks to strengthen its pharmaceuticals business amid a high debt burden... Full

Glenmark Launches Vancomycin Hydrochloride for Injection

(4/1, Sandra Levy, Drug Store News) ...Glenmark is introducing vancomycin hydrochloride for injection, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-dose vial), which is the generic of Mylan's Vancomycin Hydrochloride for Injection. Vancomycin Hydrochloride for Injection had a market value of approximately $39.3 million for the 12 month period ending January 2025, per IQVIA... Full

Boehringer Ingelheim 2024 Sales Up Forex-Adj 6.1%

(4/2, Patricia Weiss, Reuters) ...Germany's largest pharmaceutical company Boehringer Ingelheim on Wednesday reported a currency-adjusted 6.1% gain in 2024 revenues, buoyed by diabetes drug Jardiance and lung drug Ofev...Boehringer is in a collaboration with Denmark's Zealand Pharma to develop a weight loss drug that the partners hope can be launched over the next few years, to compete with Lilly's recently launched obesity drug Mounjaro. For 2025, Boehringer said it expects a slight increase in group revenues, adjusted for currency swings and one-off effects... Full

Novo Holdings Nearly Doubles Earnings as Wegovy Swells Coffers

(4/2, Maggie Fick, Stine Jacobsen, Reuters) ...Novo Holdings, the controlling shareholder of obesity drugmaker Novo Nordisk, nearly doubled annual income and investment returns to a record 8 billion euros ($8.66 billion) in 2024, it said on Wednesday. Fuelled by dividends from the company behind blockbuster weight-loss drug Wegovy and diabetes treatment Ozempic, Novo Holdings is a life sciences investment powerhouse that manages assets for the Novo Nordisk Foundation, one of the world's biggest philanthropic bodies... Full

Gubra's AbbVie-Partnered Amylin Looks Competitive with Zealand's in Early Trial

(4/1, Elizabeth Cairns, Endpoints News) ...The Danish company said Tuesday that the high dose tested in the Phase 1 study — 2 mg once weekly — allowed subjects to lose 7.8% of their weight after around six weeks of treatment. Those given placebo had weight gain of nearly 2% by the cutoff on day 43...While GUBamy didn't give as strong a showing as some other obesity drugs, it still had impressive data given the trial was not conducted in obese patients and instead enrolled lean and overweight subjects... Full

Eli Lilly Sues Large Compounding Pharmacies Empower, Strive Over Tirzepatide Products

(4/1, Shelby Livingston, Endpoints News) ...The drugmaker sued Houston-based Empower Pharmacy and Arizona-based Strive Pharmacy for allegedly violating state and federal laws by making false claims about their tirzepatide products, including that they are safe, effective and personalized for each patient...In an emailed statement to Endpoints News, Empower CEO Shaun Noorian said that compounding plays a role in expanding options for patients. "In the case of GLP-1s, Empower has stepped in to provide quality, affordable formulations for patients underserved by mass-market pharmaceutical companies," he said. "Restricting access to personalized alternatives to commercial drugs is not in the best interest of patients, which is why we remain committed to offering these life-changing formulations."... Full

Hims & Hers to Sell Lilly's Weight-Loss Drug On its Telehealth Platform

(4/1, Sneha K, Puyaan Singh, Reuters) ..."The increased level of product availability broadens HIMS' weight loss offerings, which is a positive, although we do note that the Zepbound is being sold at a fairly expensive price point of $1,899 per month," said Jefferies analyst Michael Cherny. The addition of Lilly's drugs on Hims & Hers' platform should help widen the company's customer funnel while it contends with the end of the shortage of Novo's drugs, Cherny said... Full

Who Should Pay for Ozempic Is the Next Big Workplace Fight

(4/1, Callum Borchers, The Wall Street Journal) ...Still, some businesses that resist paying for weight-loss drugs may only give in when the bottom line changes, says Rena Conti, a health economist at Boston University. The FDA in December approved the first generic GLP-1, a version of Victoza. Generic versions of Trulicity and Saxenda could arrive in 2027... Sub. Req’d

Use of Long-Acting Injectable Antipsychotic Medications in Schizophrenia Treatment

(4/1, Angie Oster, PharmD and Cara Colodonato, PharmD, Pharmacy Times) ...Maintenance treatment of schizophrenia may include first- or second-generation antipsychotic agents in oral, sublingual (SL), transdermal (TD), or long-acting injectable (LAI) formulations...First-generation/typical oral antipsychotics (these are dopamine blockers and have more extrapyramidal symptoms [EPS] than second-generation agents)...Perphenazine (Trilafon; Teva Pharmaceuticals, Inc, Etrafon/Triavil/Triptafen; Mylan Pharmaceuticals, Inc)... Full

The Health Industry is Starting to Express Alarm About RFK Jr.

(4/1, David Lim, Politico) ...The Pharmaceutical Research and Manufacturers of America, the powerful lobbying arm of the brand-name drug industry, also questioned the wisdom of the large cuts at the agency. "We recognize the need to find efficiencies, but it's critical the FDA has the expertise and capacity it needs to maintain its gold standard regulatory review," PhRMA spokesperson Alex Schriver said. "The rapid and substantial changes at FDA this week raise questions about the agency's ability to fulfill its mission to bring new innovative medicines to patients."... Full

AAM Comments On Staff Layoffs at FDA

(4/1, AAM) ..."AAM is deeply concerned by reports that key officials within the FDA's generic drug and biosimilar programs and officials responsible for administering the industry user fee programs were let go from the Agency," said John Murphy III, President and CEO of AAM. "While we support improving FDA efficiency to deliver more affordable generic and biosimilar medicines to patients faster, many of the reported cuts appear to do the opposite."... Full

‘It'll Be a Challenge': BIO Chief Crowley Addresses Seismic FDA Overhaul

(4/1, Max Bayer, Endpoints News) ...Sitting in a corner office closer to the power brokers that crafted the restructuring, BIO CEO John Crowley tried not to catastrophize. "It'll be a challenge," he said in an exclusive interview with Endpoints News. "We take the FDA as we find it and this is the FDA we have today."...Crowley said FDA leaders now needed to "provide certainty," pointing to the markets that rely on it to invest in an already-risky biotech industry. "We need to bring certainty, and I think the sooner that leadership can provide that vision for what the agency is going to look like, areas where they're going to focus, I think that will be greatly helpful," he said... Full

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

(4/1, Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery, Pink Sheet) ...Medical product reviewers were spared during the April 1, layoffs at FDA, but cuts to support and policy staff likely will slow drug development and approval, experts said. The result could be that the US loses its status as the first region companies turn to for product approval. The nature of the 3,500-person reduction-in-force also is expected to increase voluntary departures in application review-related positions... Global Sub. Full

Will They Or Won't They? Tariff Questions Loom For Drugmakers

(4/2, Jessica Merrill, Pink Sheet) ...Industry is waiting to find out if pharmaceutical imports will be included in a new wave of tariffs that the Trump Administration will announce on April 2. Tariffs could be yet another hit to industry under the Trump Administration as it grapples with big changes at the US Food and Drug Administration. Analysts said transfer pricing used by some drug manufacturers on imported goods could have particularly negative consequences when it comes to tariffs... Global Sub. Full

Pharma Tariffs Could Also Hit Medicare, Medicaid, Insurers, Experts Warn

(4/1, Maaisha Osman, Inside Health Policy) ...Tariffs may not only drive up the cost of producing medications but could lead to a rippling effect that impacts Medicare, Medicaid and insurance costs, said Michael Grosberg, vice president of product management at Model N, a software company for high tech and life science industry. "Tariffs will not just impact the cost to produce medications, but it will have downstream and interdependent impact," Grosberg told Inside Health Policy. He warned that higher medication prices -- especially for generic drugs -- could strain the federal Medicaid budget, which is already facing potential cuts in Congress... Sub. Req’d

Regeneron CEO Leonard Schleifer On Tariffs: Let's Make Sure the Europeans Pay Their Fair Share

(4/1, CNBC) ...Regeneron founder, chair and CEO Leonard Schleifer joins ‘Squawk Box' to discuss the impact of President Trump's tariff policies on biotech and pharmaceuticals, his thoughts on HHS Secretary RFK Jr., fixing the health care industry, and more... Full

New Administration Doubles Down On Tariffs: What It Means for Pharmaceuticals and Beyond

(4/1, Deyaa Shaheen, Lachman Consultants) ...The pharmaceutical industry has voiced serious concerns about the potential ramifications of these tariffs. Industry leaders warn that such measures could disrupt global supply chains, making it more difficult and costly to procure essential medications. This, in turn, could limit patient access to vital treatments and drive up healthcare costs in the United States. Economists have also raised red flags, suggesting that the tariffs could lead to unintended economic consequences... Full

How Trump's Tariffs Could Upend Pharma's Overseas Tax Strategy

(4/2, David Wainer, The Wall Street Journal) ...Pharmaceuticals have historically been exempt from tariffs to protect patient access to essential medicines. That means the industry is now scrambling to prepare, said Chris Desmond, a leader in the U.S. Global Trade Services team at PwC. To reduce their tariff burden, companies are dissecting a drug's price to separate the physical components—like ingredients and packaging—from intangible ones, such as patents and royalties. Those may not always be tariffed, Desmond says. At the same time, they are stockpiling inventory in the U.S. In the long term, major pharmaceutical companies are looking to shift more production to the U.S... Sub. Req’d

Analyzing the Expansion of the Medicare Drug Price Negotiation Program to Part B

(4/1, Rachel Sachs and Richard G. Frank, Brookings) ...As CMS develops guidance for the 2028 cycle of the program, we examine three key sets of issues CMS is likely to face in implementing and operationalizing this expansion, offering policy suggestions for agency officials... Full

FTC Halts In-House Court Case Against Pharmacy Benefit Managers

(4/1, Katie Arcieri, Bloomberg Law) ...The Federal Trade Commission has paused an enforcement action alleging pharmacy benefit managers used illegal rebate programs that spiked the price of insulin. In a Tuesday order, the agency's general counsel, Lucas Croslow, cited a lack of sitting commissioners able to participate in the matter, which is before an administrative court. Chairman Andrew Ferguson and Commissioner Melissa Holyoak are both recused... Sub. Req’d

Europe's Pharma Industry Braces for Tariffs as Carve-Out Hopes Fade

(4/2, Karen Gilchrist, CNBC) ...Gradual implementation of tariffs on the sector could reduce the immediate financial hit and allow companies time to relocate their manufacturing stateside. Nevertheless, some firms have warned that the lack of clarity is already having negative secondary effects... Full

European Drug Regulator Seeks to ‘Streamline' Biosimilar Approval Process

(4/1, Anna Brown, Endpoints News) ...Comparative efficacy studies compare the quality of the active substances between the biosimilar candidate and the reference medicine already approved to confirm they give the same clinical output. These trials are very expensive for biosimilar companies and act as a "blocker" to enter the market, Tracey Roberts, a partner at UK-based law firm Pinsent Masons, said in an interview with Endpoints News. This proposal is important as there's a current "biosimilar void" in the industry, where there are hardly any biosimilars in clinical trials for marketed products that are soon to have their patent expire, Roberts said. That means prices will continue to be high for healthcare providers and patients, she added... Full

England's NICE Wants Industry Involvement In HTA Sandbox Projects

(4/1, Eliza Slawther, Pink Sheet) ...Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating "innovative and disruptive" therapies... Global Sub. Full

Spain's Rise to European Pharma Hotspot Faces China Challenge

(4/2, Ashleigh Furlong, Clara Hernanz Lizarraga, Rodrigo Orihuela and Julia Janicki, Bloomberg) ...Spain has risen to the top of European rankings for clinical trials, using some of the region's most generous tax breaks and a relatively speedy regulatory process to reduce the lag from the start of a drug trial to approval. Investors also point to comparable science quality at a cheaper price than rivals. It's a package that's helped persuade AstraZeneca Plc, Novartis AG, Roche Holding AG and others to expand their Spanish footprint in the last few years. Prime Minister Pedro Sanchez is keen to attract more, and earlier this year gathered the likes of Johnson & Johnson, Daiichi Sankyo Co., Eli Lilly & Co. and Sanofi to Madrid's Palacio de La Moncloa for talks... Sub. Req’d

Trump's Reciprocal Tariff Announcement Soon: What Are India's Options

(4/2, Sumana Sarkar, Financial Express) ...With almost 30 % of total global spending and about $ 5 trillion stock of foreign direct investment (FDI) (the largest globally), the USA remains the pivot of the global economy. According to economists at Emkay, " India has some leverage over the US in certain areas of the trading relationship. While the aim should be to reduce disruption as much as possible by offering concessions in areas which will not hurt domestic production/capacity, there is one sector with enough influence/importance to be used as a bargaining chip. Pharma."... Full

Japan Pushes Generic Industry Reforms Via New Govt Fund

(4/2, Lisa Takagi, Pink Sheet) ...The Japanese government will enhance its financial support to reform the troubled domestic generic industry in the next five years through a national fund to support the stable supply of such drugs...Recently, one of Japan's largest wholesaling and healthcare business groups, Medipal Holdings, has invested in several generics firms in Japan including Nichi-Iko and Kyowa Yakuhin. In December, it announced a strategic investment in Takeda Teva through a 20% stake in an investment firm set up by domestic private equity fund J-Will Partners, which in turn that month announced it would acquire Takeda Teva... Global Sub. Full

Brazil Catches Up With International Standards on Viral Safety Evaluations For Biotech Products

(4/1, Francesca Bruce, Pink Sheet) ...Companies can soon expect that Brazilian requirements on standards for viral safety evaluations of biotechnology products will be brought into line with standards published by the International Conference On Harmonisation (ICH) in 2023. Separately, the country's drug regulator, ANVISA, is also planning to remedy the current "lack of clear guidelines" and uncertainty for companies with respect to requirements for radiopharmaceuticals that are exempt from registration... Global Sub. Full

Albanese Refuses To Budge On Key Trade Issues Ahead Of US Tariff Announcement

(4/1, Vidhya CK, International Business Times) ...Australian Prime Minister Anthony Albanese has made it clear that the country will not back down on several key issues, such as biosecurity regulations and media-related laws, despite upcoming tariffs from the United States... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.