Pharma News
27 Apr 2025 to 03 May 2025
May 3, 2025
Insights on the Penalty for Pill Pricing in the Inflation Reduction Act
The Inflation Reduction Act's Medicare drug price negotiation creates a "pill penalty," disadvantaging small molecule drugs compared to biologics. Negotiations for small molecules begin nine years post-FDA approval, while biologics start at 13 years. Proposed fixes, including the Ensuring Pathways to Innovative Cures Act, aim to align timelines but may impact Medicare costs and the biosimilar market.
May 2, 2025
What is the Future Outlook for Viking Therapeutics in Three Years? - The Globe and Mail
Viking Therapeutics (NASDAQ: VKTX) is a clinical-stage biopharmaceutical company focusing on weight loss drug VK2735, a dual GLP-1 and GIP receptor agonist. With a market cap of $2.9 billion and over $851 million in cash, the company aims to enter a $150 billion market. However, its future hinges on successful phase 3 trials, with only a 25-30% approval rate.
May 2, 2025
U.S. FDA approves Novo Nordisk's request for oral Wegovy — TradingView News
The U.S. FDA has accepted Novo Nordisk's marketing application for an experimental once-daily oral version of its weight-loss drug Wegovy, the company announced on Friday.
May 2, 2025
Halozyme Files Lawsuit Against MSD Regarding Subcutaneous Version of Keytruda, Drawing Attention to Alteogen
Halozyme has filed a patent infringement lawsuit against MSD (Merck) over the subcutaneous formulation of Keytruda, claiming violations of 15 patents related to its ENHANZE technology. The lawsuit could impact the SC drug delivery market, as MSD partners with Alteogen for this development. The outcome may delay Keytruda SC's launch, expected by 2025, amid ongoing legal challenges.
May 2, 2025
Investor Attention Remains on Amgen's Weight-Loss Drug Candidate - TradingView
Amgen (AMGN) reported a 24% increase in first-quarter profit, driven by product sales. Analysts remain focused on the experimental weight-loss drug MariTide, with mixed outlooks on its potential. RBC Capital Markets emphasizes the need for clarity on Horizon-derived products like Tepezza and Krystexxa, while Piper Sandler supports Amgen's biosimilar strategy to mitigate revenue losses.
May 2, 2025
Summit Therapeutics Reports Smaller-Than-Expected Loss in Q1, No Sales Recorded - TradingView
Summit Therapeutics (SMMT) reported a narrower first-quarter 2025 loss per share of 9 cents, compared to the expected 10 cents. The company has no marketed products and recorded no revenue. Its pipeline drug, ivonescimab, showed positive results in the HARMONi-6 study against BeiGene’s Tevimbra. Summit is also collaborating with Pfizer to explore ivonescimab in various solid tumors.
May 2, 2025
Eli Lilly's CEO dismisses the CVS-Novo Nordisk agreement, stating, "It seems reminiscent of the previous decade.
Eli Lilly (LLY) faced a $90 billion market cap loss after Novo Nordisk (NVO) secured a CVS deal for its GLP-1 weight-loss drug, Wegovy. Despite this, Eli Lilly CEO David Ricks emphasized the company's focus on upcoming obesity drugs, including the oral GLP-1 orforglipron, and dismissed exclusive deals as outdated. He remains confident in Zepbound's market performance.
May 2, 2025
Reasons Behind the Surge in Stocks of Eli Lilly, Viking Therapeutics, and Novo Nordisk on Friday
Positive job growth in the U.S. and potential trade negotiations with China are boosting stock markets. In pharmaceuticals, shares of Eli Lilly, Novo Nordisk, and Viking Therapeutics are rising, with Novo Nordisk's Wegovy being made available at lower prices by CVS Health. JPMorgan believes the sell-off of Lilly stock is overdone, while a price war in the GLP-1 market looms.
May 2, 2025
Lilly's weight-loss medication Zepbound encounters competition from CVS Health - WTHR
CVS Health has announced that Novo Nordisk's drugs Wegovy and Saxenda will be preferred options on its standard formulary, effective July 1, excluding Eli Lilly's Zepbound. This decision may complicate access to Zepbound, which has seen significant sales growth. CVS will also offer Wegovy at a discounted price of $500 monthly for uninsured patients.
May 2, 2025
FDA Delays Decision on Cytokinetics Heart Medication to Evaluate Suggested Safety Protocols
Cytokinetics announced a delay in the FDA's decision on its heart drug aficamten, now set for December 26, due to a request for a safety plan. Aficamten, aimed at treating obstructive hypertrophic cardiomyopathy, may offer a safety advantage over Bristol Myers Squibb's Camzyos, which has a black box warning. The FDA's request for a Risk Evaluation and Mitigation Strategy (REMS) raises questions about the approval process.
May 2, 2025
Amgen's Stronger-Than-Projected Q1 Profits Take a Backseat as Focus Shifts to MariTide Obesity Results
Amgen Inc. reported first-quarter sales of $8.15 billion, a 9% increase year-over-year, surpassing expectations. The launch of Imdelltra generated $81 million in sales. Adjusted EPS rose 24% to $4.90. Amgen reaffirmed its 2025 revenue guidance of $34.3-$35.7 billion. Analysts remain focused on upcoming MariTide results, with stock down 2.27% to $277.34.
May 1, 2025
J&J receives FDA approval for immune therapy expected to be a major success | PharmaVoice
The FDA has approved Johnson & Johnson's antibody drug, Imaavy, for treating generalized myasthenia gravis in adults and children aged 12 and older. Priced at $12,480 per vial, Imaavy aims to reduce harmful autoantibodies affecting muscle communication. J&J anticipates peak sales could exceed $5 billion, positioning Imaavy as a key player in their immune medicine portfolio.
May 1, 2025
Goodwin Advises Apnimed on Securing Worldwide Patent Rights for Sulthiame, a ...
Apnimed has acquired the global rights to develop and commercialize sulthiame, a carbonic anhydrase inhibitor, from Desitin Arzneimittel GmbH for sleep apnea and related diseases. The drug, already approved for other conditions, will be developed with Shionogi & Co. Ltd. through their joint venture, SASS, which will also explore its use in Obesity Hypoventilation Syndrome.
May 1, 2025
CVS will enhance availability of Novo Nordisk's weight loss medication Wegovy for individuals enrolled in its prescription plans.
CVS Health will expand access to Novo Nordisk's weight loss drug Wegovy through its pharmacy benefit manager, Caremark, starting July 1. Wegovy will be prioritized on standard formularies, while Eli Lilly's Zepbound will be removed. Caremark aims to offer Wegovy at a lower net price, enhancing affordability for patients.
May 1, 2025
Lilly's weight-loss medication Zepbound encounters competition from CVS Health in terms of coverage.
Eli Lilly's stock fell nearly 11% after CVS Health announced that its weight-loss drug Zepbound will be excluded from its standard formulary, favoring competitors Wegovy and Saxenda from Novo Nordisk instead. Zepbound's sales surged to $2.3 billion in Q1, but access issues may force Lilly to adjust pricing to regain coverage.
May 1, 2025
CVS Health Presents Coverage Obstacles for Lilly's Weight-Loss Medication Zepbound
Eli Lilly's stock fell nearly 11% after CVS Health announced that its weight-loss drug Zepbound will be excluded from its standard formulary, favoring Novo Nordisk's Wegovy and Saxenda instead. Zepbound's access may be complicated for patients, although they can switch to Wegovy. Zepbound's sales surged to $2.3 billion in Q1, highlighting its market impact.
May 1, 2025
Navigating the Fine Line: Drug Patents, Health Concerns, and the Pursuit of New Developments
India has solidified its position as a leader in generic drug production, significantly impacting global healthcare affordability. The country’s patent framework, particularly Section 3(d) of the Patents Act, prevents evergreening by requiring substantial therapeutic efficacy for new drug forms. Landmark cases, including Novartis AG v. Union of India, emphasize this balance between innovation and public health access.
May 1, 2025
An Overview of Patent Revocation in Indian Patent Law: The Case of Macleods...
In the case of MacLeods Pharmaceuticals Ltd v. Boehringer Ingelheim Pharma, the Delhi High Court ruled that a revocation petition under Section 64 of the Patents Act can proceed even after a patent's expiration. The court clarified the distinction between revocation petitions and invalidity defenses, allowing MacLeods to challenge Boehringer's patent for Linagliptin despite ongoing infringement claims.
May 1, 2025
Upcoming Patent Expirations Expected to Transform the Global Biologics Market with Surge in Biosimilars
The impending expiration of patents for major biologics, including Perjeta® (pertuzumab) and Keytruda® (pembrolizumab), is set to reshape the global biologics market, potentially unlocking over $200 billion in revenue for biosimilar developers. This shift presents opportunities for affordable therapies, but navigating regulatory and manufacturing complexities will be crucial for success.
May 1, 2025
FDA Approval Granted for J&J's Autoimmune Treatment Marks the First of Several Anticipated for the Promising Drug
Johnson & Johnson's autoimmune disease treatment, Imaavy (nipocalimab), has received FDA approval for generalized myasthenia gravis (gMG), targeting a broader patient population than competitors Argenx's Vyvgart and UCB's Rystiggo. The drug, projected to reach $5 billion in peak sales, shows significant autoantibody reduction and is suitable for patients aged 12 and older. J&J plans to explore additional indications for Imaavy.
May 1, 2025
Scinai Immunotherapeutics and Pincell to Present Webinar on a Block - GuruFocus
Scinai Immunotherapeutics (NASDAQ: SCNI) will host a webinar on May 7, 2025, to discuss PC111, a novel monoclonal antibody targeting Pemphigus Vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN). The company’s Polish subsidiary has applied for a €12 million grant to support its initiatives, with results expected in Q3 2025.
Apr 30, 2025
Should Investors Consider Buying Eli Lilly Stock (LLY) Before Earnings Despite an Uncommon Downgrade?
Eli Lilly (LLY) is set to report Q1 earnings on May 1, with expected revenue of $12.67 billion and EPS of $4.17. The focus will be on its GLP-1 drugs, Mounjaro and Zepbound, which generated $3.53 billion and $1.9 billion, respectively. Analysts remain mostly bullish, despite a recent downgrade from HSBC, with price targets ranging from $700 to $1,150.
Apr 30, 2025
The Impact of GLP-1 Drug Patents on Healthcare Inequities - TechTarget
Novo Nordisk and Eli Lilly have leveraged GLP-1 receptor agonists, like semaglutide and tirzepatide, into multibillion-dollar markets through strategic patent extensions, creating barriers to generic competition. Despite high sales, their focus on shareholder returns over public health exacerbates access issues, particularly for underserved populations, including Black Americans, who face significant disparities in treatment access and obesity rates.
Apr 30, 2025
J&J receives FDA approval for immune therapy expected to be a major success - Yahoo
The FDA has approved Johnson & Johnson's antibody drug, Imaavy, for treating generalized myasthenia gravis in adults and children aged 12 and older. Priced at $12,480 per vial, Imaavy aims to reduce harmful autoantibodies affecting muscle communication. J&J anticipates peak sales could exceed $5 billion, marking a significant addition to its portfolio of immune medicines.
Apr 30, 2025
Hims & Hers shares rise following collaboration with Novo Nordisk on GLP-1.
Hims & Hers (HIMS) shares surged over 20% after Novo Nordisk (NVO) partnered with telehealth platforms to provide access to its weight loss drug Wegovy. Patients can obtain the drug through NovoCare for $599 monthly. This collaboration aims to counter competition from Eli Lilly (LLY) in the obesity market, as both companies navigate challenges in the GLP-1 sector.
Apr 30, 2025
J&J receives FDA approval for immune therapy expected to be a major success - BioPharma Dive
The FDA has approved Johnson & Johnson's antibody drug, Imaavy, for treating generalized myasthenia gravis in adults and children aged 12 and older. Imaavy aims to reduce harmful autoantibodies affecting muscle communication. Priced at $12,480 per vial, J&J anticipates peak sales could exceed $5 billion, marking a significant step in their immune medicine strategy.
Apr 30, 2025
Regeneron reports disappointing first-quarter results due to decreased demand for Eylea - Yahoo Finance
Regeneron reported first-quarter earnings of $8.22 per share, missing Wall Street estimates due to competition for its drug Eylea, which saw U.S. sales drop 26% to $1.04 billion. The FDA denied approval for a pre-filled syringe version of Eylea HD, while sales of Dupixent rose 19% to $3.67 billion. Shares fell nearly 8%.
Apr 30, 2025
Positive Developments: These pharmaceutical companies are making new investments in the U.S. as Trump's tariffs on drugs approach.
Pharmaceutical companies are ramping up U.S. manufacturing investments amid tariff threats from the Trump administration, aiming to strengthen the domestic drug supply chain. Pfizer's CEO Albert Bourla expressed concerns that tariff uncertainty is hindering further investments. Meanwhile, Abbott Laboratories announced integration of its Libre continuous glucose monitoring data with Epic Systems' EHR, enhancing diabetes management for patients.
Apr 30, 2025
Merck & Co. (MRK) is focusing on a new cholesterol medication as the expiration of Keytruda approaches.
Merck & Co. (MRK) saw an 8% stock boost following disappointing data from competitor Summit Therapeutics' ivonescimab, which has not yet shown overall survival benefits in cancer trials. Keytruda, Merck's leading drug, faces challenges with its 2028 loss of exclusivity. Analysts remain optimistic about Merck's future, particularly with its new cholesterol drug candidate, enlicitide.
Apr 29, 2025
AbbVie Receives FDA Authorization for Rinvoq, Its Successful Arthritis Treatment
The FDA has approved AbbVie Inc.'s Rinvoq (upadacitinib) for treating giant cell arteritis (GCA), following its earlier approval in the EU. The approval is based on positive Phase 3 trial results showing significant remission rates. AbbVie also reported strong Q1 2025 earnings, with Rinvoq sales reaching $1.72 billion, a 57.2% increase.
Apr 29, 2025
Explore the Keytruda Market, a 'miraculous cancer treatment' valued at 43 trillion won!" The competition...
The competition for Keytruda biosimilars intensifies as Merck's blockbuster drug, which generated $29.5 billion in sales last year, faces patent expiration in 2028. Celltrion's CT-P51 and Samsung Bioepis' SB27 are in phase 3 trials, while Merck plans to launch a subcutaneous formulation, "Kytruda SC," to protect its market share.
Apr 29, 2025
Regeneron reports first-quarter results fall short due to decreased demand for Eylea - TradingView
Regeneron reported first-quarter earnings of $8.22 per share, missing estimates due to competition for its drug Eylea, which saw U.S. sales drop 26% to $1.04 billion. The FDA denied approval for a pre-filled syringe version of Eylea HD, while sales of Dupixent rose 19% to $3.67 billion. Shares fell nearly 8% following the news.
Apr 29, 2025
Merck's U.S. investment and the postponement of FDA approval - STAT News
Merck is set to invest $1 billion in a new manufacturing plant in Delaware, marking its first U.S. site for producing Keytruda, its leading cancer drug. This move aims to bolster domestic supply amid looming tariffs. Meanwhile, Stealth BioTherapeutics faces delays in FDA approval for its rare disease drug, elamipretide, developed for Barth syndrome.
Apr 29, 2025
Northstrive Submits Four Patents for GLP-1 Combination Treatment and Veterinary Health | ELAB Stock Update
Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB), has filed four new patent applications for its obesity treatment candidates EL-22 and EL-32. These patents cover therapies for muscle loss in obese patients and animal health applications, including combination therapies with GLP-1 receptor agonists. The company aims to enhance its IP portfolio and advance obesity care.
Apr 29, 2025
Eli Lilly's Stock (LLY) Receives Two-Level Downgrade Before Earnings Report - The Globe and Mail
Eli Lilly (LLY) has been double downgraded to a "reduce" rating by HSBC analyst Rajesh Kumar ahead of its May 1 earnings report. The downgrade reflects concerns over competition from Novo Nordisk (NVO) and potential tariffs from the U.S. government. Despite a 13% stock increase this year, Kumar warns of risks impacting LLY's outlook.
Apr 29, 2025
Hims & Hers Health (HIMS) Sees 23.03% Surge in Stock Price Following Breakthrough Weight Loss Medication
Hims & Hers Health (HIMS) saw a 23.03% stock surge after announcing a partnership with Novo Nordisk to offer the weight loss drug Wegovy through its platform. This collaboration enhances patient access to weight management solutions, combining Wegovy with Hims & Hers' membership services. The move positions Hims & Hers as a leader in telehealth and weight management, attracting significant investor interest.
Apr 29, 2025
Dupixent Becomes the First Biologic Medication Approved by the FDA for Managing Uncontrolled COPD
Dupixent (dupilumab), developed by Regeneron and Sanofi, is the first biologic approved for chronic obstructive pulmonary disease (COPD). It targets eosinophils to reduce inflammation, offering hope for adults with uncontrolled moderate-to-severe COPD. Clinical trials showed a 30%-34% reduction in exacerbations. Priced at $3,993 monthly, Dupixent may shift COPD treatment paradigms and inspire further drug development.
Apr 29, 2025
Merck plans to allocate $1 billion for a new manufacturing facility in the United States to produce its leading cancer medication, Keytruda.
Merck announced a $1 billion investment in a new Delaware plant to enhance domestic production, particularly for biologic drugs and its blockbuster cancer treatment, Keytruda. This facility will be Merck's first in-house US site for Keytruda, creating 500 full-time jobs and 4,000 construction positions. The plant is expected to be operational by 2028, with experimental drug production by 2030.
Apr 29, 2025
Hims & Hers partners with Novo Nordisk to offer Wegovy, leading to a 28% surge in stock prices.
Hims & Hers announced it will start selling Novo Nordisk's weight loss drug Wegovy, priced from $599, beginning later this week. This partnership aims to enhance access to the drug as the FDA ends the semaglutide shortage. Hims & Hers shares surged 36% in premarket trading, while Novo Nordisk's stock rose 3%.
Apr 29, 2025
Merck plans to invest $1 billion in a new manufacturing facility to produce supplies of its popular medication in the United States - Mint
Merck & Co. is investing $1 billion in a new manufacturing plant in Delaware, aimed at producing biologic drugs and a more user-friendly version of its cancer drug Keytruda. This facility will be Merck's first U.S. site for Keytruda, ensuring domestic supply amid looming tariffs. The plant is expected to create 500 jobs and begin operations by 2030.
Apr 29, 2025
Explore the Keytruda Market, a 'miracle cancer treatment' valued at W43 trillion globally!
Celltrion has received approval for a phase 3 clinical trial of its Keytruda biosimilar, CT-P51, targeting metastatic non-small cell lung cancer. The trial will compare CT-P51's efficacy and safety against Merck's Keytruda, which generated $29.5 billion in sales last year. Samsung Bioepis is also developing a Keytruda biosimilar, SB27, while Merck plans to introduce a subcutaneous formulation to protect its market.
Apr 28, 2025
Piyush Goyal Condemns Efforts to Extend Patent Durations, Critiques Profit-Oriented Pharmaceutical Companies
India's Patents Act faces scrutiny as the US, UK, and EU push for amendments to allow 'evergreening' of patents, particularly in the pharmaceutical sector. The US recently criticized Section 3(d) of the act, which prevents the granting of patents for drugs lacking therapeutic benefits, arguing it extends patent monopolies without innovation.
Apr 28, 2025
From Certifications to Legal Proceedings: Legal Disputes Over Second Medical Use Patents - Mondaq
The Court of Justice of the European Union ruled that second medical use patents cannot obtain supplementary protection certificates (SPCs) if there were prior marketing authorizations for different therapeutic applications. This decision affected Merck Serono's SPC application for cladribine, reinforcing the UK’s alignment with EU rulings post-Brexit. The upcoming Unified Patent Court may further influence these patent disputes.
Apr 27, 2025
Goyal condemns efforts to obtain pharmaceutical patents via slight modifications - Mint
Commerce and Industry Minister Piyush Goyal criticized pharmaceutical companies for seeking patents through minor innovations, which he claims hinders access to affordable medicines. He opposed calls to amend India's patent laws, emphasizing that such practices, known as "evergreening," prioritize profits for a few over public health. Section 3(d) of the Indian Patents Act restricts such patenting unless significant efficacy improvements are demonstrated.
Apr 27, 2025
Goyal condemns efforts to obtain pharmaceutical patents via slight modifications.
Commerce and Industry Minister Piyush Goyal criticized pharmaceutical companies for seeking patents through minor innovations, which he claims limits access to affordable medicines. He opposed calls to amend India's patent laws, emphasizing that such practices, known as "evergreening," prioritize profits for a few over public health. Goyal highlighted the importance of equitable healthcare access for sustainable development.
