Tuesday, February 18, 2025

Teva Pharm CEO Calls On Trump for Faster US Drug Approvals

(2/17, Steven Scheer, Reuters) ...U.S. President Donald Trump's administration needs to speed up generic drug approvals and exempt some drugs from funding freezes, the CEO of Israel's Teva Pharmaceutical Industries said on Monday. "In the FDA (Food and Drug Administration), there is no speed. I would like them to do things on a regular time because the more generics we bring, the more savings we bring to the United States healthcare system, so just approve them," Richard Francis told Reuters on the sidelines of a news conference... Full

Teva's CEO On the Stock Decline, Expectations, and the Company's Vast Potential

(2/17, Bizportal) ...Richard Francis, Teva's CEO, remains optimistic despite high investor expectations. He discusses the company's growth drivers, the importance of R&D investment, and why these efforts will pay off in the long run...Francis emphasizes that Teva's strategy is set for 2030 and beyond... Full

Teva CEO Responds to 25% Share Price Fall

(2/17, Shiri Habib-Valdhorn, Globes) ...Teva CEO Richard Francis said that he had not expected such a harsh reaction from the market but he sees a positive side to it..."Today's Teva is seen as a company that can do more, and there is a change in expectations from it, whereas in the past the question was whether Teva could even survive and pay its debts, to the question today of whether it can grow more." Francis added, "We are investing in the business. Our strategy is to grow Teva in the long term, and you can't achieve that without investing in the right areas."... Full

Lupin Eyes Sustained Growth In US Market With New Launches, Strong Product Pipeline

(2/16, NDTV Profit) ...Commenting on the company's Q3 performance, Ramesh Swaminathan, global chief financial officer at Lupin, expressed confidence in sustained growth across key markets, driven by upcoming launches and a strong product pipeline...Addressing the underperformance of the respiratory segment, Swaminathan dismissed any long-term concerns. "There's no reason why it shouldn't bounce back. There are a lot of patients with respiratory problems, and we are focusing on bringing differentiated products, including our triple combination therapy in India," he added... Full

No Revision, Glenmark Pharma Sticking to Full-Year Guidance: VS Mani

(2/17, The Economic Times) ...VS Mani, ED & Global CFO, Glenmark Pharma, says in FY25, the pharma company expected to achieve around Rs 1,100 crore each quarter. The first half performed very well. Even with the third quarter included, we still experienced about 6.5% growth. By the end of the year, he anticipates averaging around Rs 1,100 crore per quarter, and they will assess Q4 later. Currently, the acute respiratory business is facing some challenges. Glenmark will monitor the situation, but are sticking to their full-year guidance... Full

Formycon Suffers at Hands of Higher Biosimilar Discounts in US

(2/17, Matthew Dennis, FirstWord Pharma) ...Formycon will halt the late-stage Lotus study of FYB206 in non–small-cell lung cancer ahead of schedule, which it added will not only shorten the development time, but also result in savings in the high double-digit millions over the next few years. The decision represents "a pioneering role" among pembrolizumab biosimilar developers, according to the pharma...CEO Stefan Glombitza explained "for biosimilars in the so-called Pharma Benefit market segment in the US, it is becoming apparent that the market opening for biosimilars is still progressing slower and requires greater price discounts than previously anticipated."... Full

Formycon Signs APAC Eylea Biosimilar Deal With Taiwan's Lotus

(2/14, Adam Zamecnik, Generics Bulletin) ...Formycon and its licensing partner Klinge have signed a deal with Taiwan-headquartered player Lotus Pharmaceutical for commercialization rights to Formycon's Eylea (aflibercept) biosimilar FYB203 in multiple countries in the Asia-Pacific region. Signed for an undisclosed sum, the deal will hand over commercialization rights to Lotus in countries such as Indonesia, Malaysia and the Philippines... Global Sub. Full

Samsung Bioepis Joins Denosumab Battle with FDA, EU Nod As Amgen's $5.5-Bil. Stronghold Nears Patent Cliff

(2/17, Kim Ji-hye, Korea Biomedical Review) ...The approvals, announced Sunday, position Samsung Bioepis to compete directly with Amgen's osteoporosis and cancer-related bone disease drugs, which pulled in approximately 8 trillion won ($5.5 billion) in global sales in 2024. With the patent cliff set to trigger a wave of biosimilar launches, Samsung Bioepis, Sandoz, and Celltrion are racing to capture market share...Meanwhile, Fresenius Kabi, Teva, and Organon have all filed for FDA approval, but Amgen has aggressively pursued patent litigation, prolonging uncertainty over their market entry... Full

Celltrion Gains European Approval for Osteoporosis Biosimilars Stoboclo, Ocensbelt

(2/18, Heo Ji-yoon, Chosun Biz) ...Celltrion announced on the 18th that it has simultaneously obtained European marketing authorization for its osteoporosis treatment biosimilars, STOBOCLO and OSENVELT. STOBOCLO and OSENVELT are biosimilars of the original drugs Prolia and Xgeva (active ingredient denosumab)... Full

Biocon's Ustekinumab Biosimilar Gets Marketing Authorisation for EU Region

(2/18, Business Standard) ...Biocon said that the European Commission has granted marketing authorisation in the European Union (EU) for Biocon Biologics' Ustekinumab biosimilar 'YESINTEK'. YESINTEK is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohns disease... Full

Sanofi Leapfrogs Biocon To Land First US Rapid-Acting Insulin Biosimilar

(2/17, Dean Rudge, Generics Bulletin) ...Sanofi has capitalized on regulatory issues hamstringing Biocon to scoop the first US Food and Drug Administration approval for a biosimilar to Novo Nordisk's NovoLog (insulin aspart), marking the third insulin biosimilar approved by the agency, and the first rapid-acting insulin biosimilar product...Biocon has been waiting in the wings to launch its own US biosimilar to Novolog, but has found its progress scuppered by FDA strikes against its insulins manufacturing facility in Johor, Malaysia, as well as its Biocon Park facilities in Bengaluru, India... Global Sub. Full

Glenmark, FDC Recall Products in US Due to Manufacturing Issues: USFDA

(2/17, Press Trust Of India) ...Glenmark Pharmaceuticals and FDC Ltd are recalling some products in the US market. Glenmark is recalling certain strengths of Carvedilol tablets due to impurity issues. FDC Ltd is recalling bottles of glaucoma medication Timolol Maleate due to defective containers. Both recalls were initiated in January 2025 to ensure safety... Full

Aurobindo Pharma Expands to Europe with New China Facility

(2/17, Dr. R. Shruthi, The Daily Guardian) ...The pharmaceutical industry has been navigating a complex global market, with fluctuating demand and regulatory challenges. However, Aurobindo Pharma's efforts to expand its global presence and diversify its product portfolio are indicative of the company's long-term strategy to weather these challenges and achieve sustained growth... Full

8 Drugs in Shortage

(2/14, Alexandra Murphy, Becker's Hospital Review) ...Here are eight new drug shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists... Full

Gen Z's Expensive Drug Habit: More Want Brand-Name Meds that are 79% More Expensive

(2/14, Lindsey Leake, Fortune Well) ...The Food and Drug Administration vouches for the generic versions of brand-name medications, and an overwhelming majority of survey respondents (84%) said they believe these cheaper options are equally effective. Gen X (86%) was the most likely to agree, and Gen Z (77%) the least. Gen Z's doubts didn't stop there, with 24% considering generics to be lower quality and 17% thinking they're less effective than brand-name drugs...Among all respondents, top reasons for brand-name drug preference included trust (62%), perception of quality (57%), and brand familiarity (54%)... Full

Exclusive: Drugmakers Plan Trump Meeting Next Week Amid Washington Health Shakeups

(2/14, Drew Armstrong, Endpoints News) ...The details of the meeting are still being confirmed, but it would be led by pharma CEOs that include Pfizer's Albert Bourla, Merck's Rob Davis and Gilead's Dan O'Day, as well as the industry's lobbying group PhRMA...The meeting is expected to be high-level, however, and largely focused on how the industry and White House can work together and where they have common areas of interest, according to several sources... Full

Last-Minute Biden Prescribing Policies Paused by Trump Agencies

(2/14, Ganny Belloni, Bloomberg Law) ...The Drug Enforcement Administration and the Department of Health and Human Services on Friday issued a notice in the Federal Register that the agencies would pause the effective date of two Biden-era telemedicine prescribing policies until March 21. They agencies also said they would seek public comment regarding that effective date... Full

Trump Casts Psychiatric and Weight-Loss Drugs As Threats to Children

(2/17, Fenit Nirappil, Ariana Eunjung Cha and Caitlin Gilbert, The Washington Post) ...The order said the commission should prepare a "Make Our Children Healthy Again" assessment within 100 days that examines "the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs."...Kush Desai, a White House spokesman, said the order follows concerns about doctors overprescribing the drugs and harming Americans of all ages. The president called for a review of prescription practices and use of the drugs to determine whether the government should offer new guidance on the medication... Sub. Req’d

Congress Can, But Likely Will Not, End Part D Stabilization Demo

(2/17, Leslie Small, Pink Sheet) ...Any changes to the controversial Part D Premium Stabilization demo likely will come from CMS, rather than Congress, a health policy expert said... Global Sub. Full

Q&A: Mysterious Drug Pricing Needs a Dose of Sunshine With U.S. Sen. Chuck Grassley

(2/14, United States Senator Chuck Grassley) ...Q: What are you doing in this Congress to hold PBMs accountable? A: Returning as Chairman of the Senate Judiciary Committee in January, lowering drug prices is among my top legislative and oversight priorities. That includes building on my efforts to shine a bright light on PBMs. To that end, I'm pushing the FTC to finish its work... Full

What to Expect When you are Expecting…a Government Shutdown

(2/18, Richard A. Lewis, Principal Regulatory Device and Biologics Expert, FDA Law Blog) ...If you are preparing a submission to FDA in the next few weeks, you may want to consider the ramifications of the March 1st FDA funding deadline and plan accordingly... Full

Firing of FDA Probationary Staff Creates Widespread Uncertainty

(2/17, Ferdous Al-Faruque, Regulatory Focus) ...An unknown number of probationary staff at the US Food and Drug Administration (FDA) were fired this weekend as part of the Trump Administration's effort to shrink the size of the federal government. While the administration has not provided any specifics on the scope of the reductions, the round of firings, which affected staff across several federal health agencies, targeted workers with fewer employment protections... Full

Drugmakers Fighting Hard in Virginia to Keep Control of Medicine Prices

(2/18, Eric Kolenich, Richmond Times-Dispatch) ...Sent by drug manufacturers and their advocates, the lobbyists spoke against a bill designed to cap the cost of certain drugs. If House Bill 1724 passes, the state would create a board of experts with the power to limit the price of certain prescription drugs. Supporters of the measure say it would help fix a broken system... Full

Will US Tariffs Hit Indian Pharma? Sun Pharmaceutical MD Dilip Shanghvi Weighs In | GBS 2025

(2/16, Samannay Biswas, ETNOW) ...Dilip Shanghvi, Founder and Managing Director of Sun Pharmaceutical Industries, has indicated potential plans to segment the company's operations into distinct verticals. This strategic consideration emerges as the US proposes a 25 per cent tariff on pharmaceutical imports, prompting Sun Pharma to evaluate its business structure and market strategies... Full

India Should Seek Key Concessions from US to Boost Pharma Exports: Pharma Industry

(2/17, G Naga Sridhar, The Hindu BusinessLine) ...As part of the recommendations for country-specific targeted interventions in a road map for making India a global pharma exports hub, the apex industry bodies and the Council, an arm of the Ministry of Commerce, said in a joint report that India could seek an exception in the US on the over 55 per cent domestic component rule for federal imports though exceptions exist for WTO GPA members, of which India is not currently a part... Full

Irish Exports Hit Record High with Pharmaceuticals Showing Major Boost

(2/17, Eleanor Butler, Euronews) ...Irish exports were valued at a record €223.8 billion last year, with medical and pharmaceutical products contributing heavily to the total. Compared to 2023, the value of exports was up 14%, Ireland's Central Statistics Office (CSO) said on Monday... Full

Stephan Eder – President, Medicines for Europe

(2/17, Pharma Boardroom) ...As the new president of Medicines for Europe, STADA's Stephan Eder is now at the forefront of driving the change that Europe needs. In this new role as head of the leading EU-level lobby group for the generics, biosimilars, and value-added medicines industries, Eder argues that long-term sustainability requires moving beyond price-driven policies to recognize the sector's broader role in innovation, resilience, and patient access... Full

NHS England Proposes Boosting Biosimilar Use

(2/18, Dave Wallace, Generics Bulletin) ...An enhanced requirement for the National Health Service in England to use "best-value biological medicines" whenever possible has been included in a new draft NHS standard contract published by the NHS for 2025/2026. The NHS said that the measure had been introduced "in recognition of the increasing importance of biosimilars in the provision of biological medicines."... Global Sub. Full

Biosimilars Fuel Price Cuts in European Insulin Glargine Markets

(2/14, Skylar Jeremias, The Center For Biosimilars) ...Although originator insulin glargine (Lantus) continues to be the leading insulin glargine product prescribed globally, its price has significantly been impacted by biosimilar competition, according to a review of 28 European countries. Authors of the review, published in BMJ Open, sought to quantify insulin glargine prices following market introduction of biosimilars, assessing access and pricing differences across European Union member states... Full

Manufacturers Asked to Revise MRP for Drugs with Nil, Reduced Customs Duty

(2/17, Sanket Koul, Business Standard) ...In an office memorandum released on Monday, the National Pharmaceutical Pricing Authority (NPPA) asked manufacturers to revise MRPs for 36 drugs that received an exemption from customs duty and six drugs that now attract a concessional duty of 5 per cent. In her budget speech, Finance Minister Nirmala Sitharaman announced the exemption of 36 drugs used to treat cancer, rare diseases, and other severe chronic diseases from the basic customs duty (BCD). This includes Mepolizumab, used to treat severe asthma, and anticancer drugs such as Asciminib and Daratumumab, among others... Full

Dutch Cancer Patients Forced to Wait for Drug Pricing Dispute Resolution

(2/18, Christoph Schwaiger, Euractiv) ...Dutch cancer patients have been denied access to two drugs after the Dutch Healthcare Institute claimed the drug manufacturers did not provide the information necessary to determine whether the drugs were worth their asking price. One of the pharmaceutical companies involved is disputing this claim...A spokesperson for Gilead directed Euractiv to a study showing that patients receiving their treatment had a median overall survival of 25.4 months, compared to 6.2 months if they were only to receive the standard treatment... Full

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