Pharma News
10 Aug 2025 to 16 Aug 2025
Aug 16, 2025
Roche Holding AG: Managing Patent Expirations and Fostering Innovation in a Competitive Pharmaceutical Landscape
Roche Holding AG faces significant challenges as key drugs Ocrevus and Tocilizumab approach patent expirations, risking substantial revenue losses. With Ocrevus generating CHF 6.38 billion in 2023 and Tocilizumab embroiled in a patent dispute with Biogen, Roche is focusing on innovation, including its promising inavolisib pipeline for breast cancer, to maintain market leadership amid rising biosimilar competition.
Aug 16, 2025
Merck's Strategic Adaptability: Managing Patent Expirations While Fostering Future Growth
Merck (MRK) faces significant challenges with the impending patent expirations of its blockbuster drug Keytruda, projected to lose $21 billion in revenue by 2028. In response, the company is implementing a $3 billion cost-optimization initiative while investing in a robust pipeline of 20 potential blockbuster drugs, including Winrevair and Ohtuvayre, to ensure long-term growth and innovation.
Aug 16, 2025
ICH initiates public consultation regarding the Q3E guideline on drug impurities related to leachables.
The International Council for Harmonisation (ICH) has initiated a public consultation regarding its draft guideline on drug impurities related to leachables. This move aims to enhance the understanding and management of extractables and leachables in pharmaceuticals.
Aug 15, 2025
AstraZeneca Capitalizes on Oncology Success with Major Drug Launches - Yahoo Finance
AstraZeneca's oncology sales surged 18% in Q2 2025, reaching $6.3 billion, driven by drugs like Tagrisso, Lynparza, and Truqap, which generated $302 million. The company anticipates continued growth, with a projected 11.1% CAGR over the next three years. Competitors include Pfizer, Merck, and Bristol-Myers, with Pfizer also reporting a 9% revenue increase in oncology.
Aug 15, 2025
Eli Lilly announces plans to increase the list prices of its medications in international markets. What are the implications? - STAT News
The Trump administration is considering invoking "march-in rights" under the Bayh-Dole Act to potentially seize and relicense Harvard University patents linked to federally funded research. Commerce Secretary Howard Lutnick's letter indicates a review of the university's compliance with disclosure and licensing rules, raising concerns about political motivations behind this unprecedented action.
Aug 15, 2025
Veru Unveils New Modified-Release Oral Formulation for Enobosarm - TradingView
Veru Inc. has selected a novel modified-release oral formulation of enobosarm for chronic weight loss management, developed in collaboration with Laxxon Medical. This formulation aims to enhance fat loss while preserving lean mass. Following successful pharmacokinetic studies, Veru plans to advance enobosarm to Phase 3 clinical trials. The global anti-obesity drug market is projected to grow significantly, highlighting the industry's potential.
Aug 15, 2025
Precigen receives approval for its immunotherapy, while Pfizer's sickle cell treatment does not succeed in trials - BioPharma Dive
The FDA has granted full approval to Precigen's Papzimeos, an immunotherapy for recurrent respiratory papillomatosis, showing promising results in reducing surgery needs. Meanwhile, Pfizer's inclacumab for sickle cell disease failed in Phase 3 trials. Eli Lilly is partnering with Superluminal Medicines for cardiometabolic drug development, while Autolus Therapeutics delays its leukemia therapy Aucatzyl launch in Europe. Generation Bio is undergoing a strategic review amid workforce cuts.
Aug 15, 2025
Eli Lilly's Leadership in Endocrinology and International Market Presence: A Rapidly Expanding Pharmaceutical Company...
Eli Lilly has solidified its leadership in the GLP-1 market, capturing a 57% share in Q2 2025, driven by Mounjaro and Zepbound, which generated $8.58 billion in revenue. The company is expanding globally, launching Mounjaro in India and partnering with EVA Pharma in Egypt. With a projected revenue increase to $58–61 billion in 2025, Lilly is well-positioned for long-term growth in chronic disease treatments.
Aug 15, 2025
Optimistic Projections from AI and Pharmaceutical Leaders: What PLTR and LLY Indicate About Strength Ahead...
Palantir Technologies (PLTR) and Eli Lilly (LLY) showcased impressive Q2 2025 earnings, with Palantir reporting a 48% revenue increase and Eli Lilly a 38% rise, driven by strong demand for AI solutions and blockbuster drugs Zepbound and Mounjaro. Both companies upgraded their financial guidance, highlighting their strategic positioning in the AI and pharmaceutical sectors.
Aug 15, 2025
Authorities in Sri Ganganagar have confiscated 50,000 capsules of Pregabalin and taken two individuals into custody.
Sri Ganganagar Police seized 50,000 Pregabalin capsules during 'Operation Seema Sankalp,' leading to the arrest of two individuals. This operation, aimed at combating drug trafficking, was conducted under the leadership of Superintendent of Police Dr. Amrita Duhan.
Aug 15, 2025
Large quantity of pharmaceuticals confiscated, no purchase invoices located, according to DrugsControl Media Services.
A significant stock of medicines was seized by police and the drug department from a shop in Rath Nagar, Alwar, due to illegal purchases without bills, violating the Drugs and Cosmetics Act of 1940. The operation was conducted by the Vijay Nagar police under the NDPS Act.
Aug 15, 2025
FTC and DOJ Conduct Final Listening Session Regarding Drug Pricing and Patents in the U.S.
The FTC and DOJ held a final session on President Trump's Executive Order aimed at lowering drug prices. Panelists discussed barriers to drug affordability, including PBM practices and patent manipulation. They advocated for bipartisan reforms like the PBM Reform Act and the Biosimilar Red Tape Elimination Act to enhance market access for generics and biosimilars, while emphasizing the need for fairer pricing policies.
Aug 15, 2025
PM Modi Calls on Researchers and Entrepreneurs to Foster Self-Reliance in Healthcare and Pharmaceutical Innovation
Prime Minister Narendra Modi urged researchers and entrepreneurs to establish India as a hub of medical self-reliance, focusing on developing new drugs and technologies. He emphasized the importance of domestic pharmaceutical innovation and called for increased investment in research. Modi also issued a public health advisory against obesity, advocating for healthier lifestyle choices and reduced cooking oil consumption.
Aug 15, 2025
Prime Minister urges for research initiatives to attain independence in pharmaceuticals - The Week
Prime Minister Narendra Modi, during Independence Day celebrations, called for India to achieve self-reliance in medicines and innovation, emphasizing the need for research to develop affordable, indigenous drugs. He highlighted India's success in vaccines and urged researchers to secure patents, aiming to position India as a global hub for medical self-reliance and innovation.
Aug 15, 2025
The Russian Supreme Court has permitted the manufacturing of versions of Ozempic without the ... - GxP News
The Russian Supreme Court has upheld the government's authority to issue compulsory licenses for essential medications, including generic versions of Ozempic (semaglutide), allowing local firms to produce it by 2025. Novo Nordisk's patents were challenged, citing a health emergency due to halted supplies. Meanwhile, Innovent Biologics' Mazdutide has gained approval in China, posing competition to Novo Nordisk and Eli Lilly.
Aug 14, 2025
Eli Lilly increases the price of its popular weight loss medication Mounjaro in the UK by as much as 170%.
Eli Lilly announced a price increase of up to 170% for its weight loss drug Mounjaro in the UK, raising the monthly cost from £122 to £330 effective September 1. The increase aims to align UK prices with those in other European countries, while access through the NHS remains unaffected. Rival drugs include Novo Nordisk's Ozempic and Wegovy.
Aug 14, 2025
Is Novo Nordisk experiencing its own "Nokia moment"? Shares drop to $50 from a peak of $139 last year...
Novo Nordisk faces significant challenges as competition from Eli Lilly's Zepbound and Mounjaro, along with compounded drugs, erodes its market share. The company has lowered its sales guidance, prompting investor concerns about its future. Despite these headwinds, Novo Nordisk's promising pipeline and global expansion efforts may offer long-term growth opportunities.
Aug 14, 2025
Tariffs Expected to Impact Ireland, as U.S. Pharmaceutical Companies Engage in Tax Strategies - The New York Times
President Trump's proposed 15% tariff on European medicines highlights Ireland's significant role in supplying the U.S. with cancer medications and pharmaceutical products. American drug companies benefit from tax advantages by manufacturing in Ireland, but the tariffs could force a reevaluation of production strategies, as moving to the U.S. may incur higher costs.
Aug 14, 2025
Eli Lilly increases the price of its popular weight loss medication Mounjaro in the UK by as much as 170% | Euronews
Eli Lilly announced a price increase of up to 170% for its weight loss drug Mounjaro in the UK, raising the monthly cost from £122 to £330 effective September 1. The price hike will not affect NHS patients, but private providers may raise their fees. The adjustment aims to align UK prices with those in other European countries.
Aug 14, 2025
The Cost of Pharmaceuticals: Understanding Why Prescription Drug Prices Are Higher in the U.S. - IPWatchdog.com
A panel discussion highlights the reasons behind the high cost of prescription drugs in the U.S., including the role of pharmacy benefit managers (PBMs) and the burden of R&D costs on American consumers. The conversation will also address policy proposals like the most favored nation (MFN) Executive Order, aiming to balance affordability, innovation, and patient access.
Aug 14, 2025
2025 Evaluation Report on Drug Discovery Services Firms | - GlobeNewswire
A new report titled "Drug Discovery Services - Company Evaluation Report, 2025" has been released by ResearchAndMarkets.com, analyzing the global drug discovery services market. It highlights key players like LabCorp, Evotec, and Selvita, and discusses market drivers such as increased R&D investments and the demand for specialized testing services. The report categorizes top companies and evaluates their strategies and market presence.
Aug 14, 2025
Lexaria's GLP-1 Innovation: A Transformative Change in Oral Medication Delivery and Industry Dynamics...
Lexaria Bioscience Corp. (NASDAQ: LEXX) is poised to disrupt the $156 billion GLP-1 receptor agonist market with its DehydraTECH drug delivery platform, enabling oral administration of GLP-1 drugs like liraglutide and semaglutide. Clinical trials show significant reductions in adverse events and nausea, enhancing patient compliance. Lexaria's technology could redefine treatment standards and attract strategic partnerships as it advances toward commercialization.
Aug 14, 2025
Pfizer Aims to Increase Revenue through Inclusion in China's Private Insurance List - AInvest
Pfizer, Eli Lilly, and Novo Nordisk are vying for their treatments to be included in China's new commercial health insurance catalog, which has cleared 121 drugs for initial screening. This initiative aims to enhance access to innovative medicines in China's pharmaceutical market, potentially boosting sales for these companies while navigating ongoing legal challenges related to drug pricing in the U.S.
Aug 14, 2025
ANTF launches operation and confiscates drugs being abused as narcotics.
The Anti Narcotic Task Force (ANTF) in Solan has launched a campaign to combat drug misuse, seizing psychotropic drugs being used as intoxicants. The operation targets unscrupulous traders, with nearly 147 firms involved in the manufacturing of these drugs.
Aug 14, 2025
Piyush Goyal expresses concern over the potential for evergreening in intellectual property rights to drive up medicine costs.
Commerce and Industry Minister Piyush Goyal emphasized the need for data exclusivity in India's Intellectual Property Rights (IPR) regime without allowing evergreening, which could inflate medicine costs. He assured that India's stance protects its generic pharmaceutical sector, particularly against UK and Swiss firms like AstraZeneca and GSK. India aims to foster investment and job creation while maintaining affordable drug access.
Aug 14, 2025
Bonum Therapeutics Secures Important Mechanism of Action Patent from USPTO for its Conditional...
Bonum Therapeutics has received a key patent from the U.S. Patent and Trademark Office for its Dual-Binding Antibody (DBA) technology, enhancing its intellectual property for conditionally regulated therapeutics. The patent covers various marker-specific binding pairs, including LRRC15-IFNa, PD-L1-IFNa, and PD1-IL2, supporting Bonum's innovative approach to safer, more selective biologics.
Aug 14, 2025
Resolution of Drug Patent Linkage Disputes When the Original Drug's Technical Approach...
The Supreme People's Court dismissed Corporation A's lawsuits regarding the "Tocilizumab Injection" biosimilar, ruling that the technical solution did not fall within the protection scope of its patents. The court emphasized that litigation under Article 76 of the Patent Law requires the originator drug's technical solution to align with patent claims, which was not the case here.
Aug 14, 2025
Immuneering Releases Financial Results for Q2 2025 and Shares Business Developments
Immuneering Corporation announced exceptional 94% overall survival at 6 months in its Phase 2a trial of atebimetinib combined with modified Gemcitabine/nab-paclitaxel (mGnP) for first-line pancreatic cancer. The company plans to share updated data in Q3 2025 and has submitted a request for an End of Phase 2 meeting with the FDA, aiming to initiate a pivotal trial in 2026.
Aug 14, 2025
Steering Through Challenges: Novo Nordisk's Strategic Strength in the Obesity Medication Sector
Novo Nordisk faces significant challenges in the obesity drug market, primarily due to over 2,190 lawsuits related to its GLP-1 drugs, Ozempic and Wegovy, and competition from Eli Lilly's Zepbound. Despite a recent stock plunge and legal liabilities, Novo's robust pipeline, patent protections, and innovative strategies position it for long-term success in a projected $470 billion market by 2030.
Aug 14, 2025
Pharmaceutical companies need to partner with academic institutions to succeed in the post-LDC landscape | The Daily Star
Bangladesh's pharmaceutical sector, which now meets 98% of domestic medicine needs and exports to over 150 countries, faces challenges as it prepares to graduate from LDC status by November 2026. The end of TRIPS waivers may raise drug prices and limit local production. A national strategy focusing on innovation, collaboration, and workforce readiness is essential for future success.
Aug 14, 2025
Summary of Conference Call Discussing the Patenting and Pricing of Eliquis, Ozempic, and Additional Medications...
I-MAK co-founder Tahir Amin discussed the report "Overpatented, Overpriced" during a Capitol Forum conference call, highlighting how pharmaceutical companies, like AbbVie and Novo Nordisk, exploit the patent system to delay generic competition and maintain high drug prices. The report reveals that drugs such as Eliquis, Ozempic, Wegovy, and Rybelsus are subject to extensive patent thickets, costing consumers billions.
Aug 14, 2025
Gujarat FDCA is allocated ₹32 crore by the state government to enhance the Surat drug testing facility.
The Gujarat Food and Drug Control Administration (FDCA) has been allocated Rs. 32 crore by the state government to expand its drug testing laboratory in Surat. This funding is part of a broader initiative aimed at enhancing pharmaceutical quality control infrastructure in the region.
Aug 13, 2025
Boehringer vs. HHS – The Second Circuit Reiterates the Principle of "Voluntary Participation
The Second Circuit upheld the legality of the Inflation Reduction Act’s Medicare Drug Price Negotiation Program in Boehringer Ingelheim Pharmaceuticals, Inc. v. Department of Health & Human Services. The court ruled that participation is voluntary, rejecting claims of unconstitutional conditions and affirming Congress's authority to bypass APA notice-and-comment requirements. This decision solidifies legal precedents affecting pharmaceutical pricing and negotiations.
Aug 13, 2025
Daewoong's microneedle patch for semaglutide achieves 80% absorption, posing a challenge to traditional injection methods.
Daewoong Pharmaceutical and Daewoong Therapeutics announced that their semaglutide microneedle patch achieved over 80% relative bioavailability compared to injections in a pilot study, a significant advancement in obesity drug delivery. The patch, developed on the CLOPAM platform, offers stable drug levels for a week and eliminates cold-chain storage needs. Final clinical results are expected this month.
Aug 13, 2025
Pfizer Shares Jump Following Updated Earnings Forecast with Trading Volume Reaching $850 Million, Placing 117th
Pfizer (PFE) stock rose 0.28% on August 12, 2025, following an upward revision of its 2025 EPS guidance. Analysts project a forward P/E of 8.06x for 2025, with a consensus price target of $33.58. Despite challenges from patent expirations and reduced U.S. sales, Pfizer's oncology segment, including drugs like Padcev and Lorbrena, shows growth potential.
Aug 13, 2025
Syndax Pharmaceuticals' Journey Towards Major Success: Utilizing FDA Priority Review and ...
Syndax Pharmaceuticals' Revuforj (revumenib) is under FDA Priority Review for R/R mutant NPM1 AML, with a decision expected by October 25, 2025. The drug shows promise with a 26% remission rate and could significantly expand its market. Syndax's strategic partnerships and financial growth position it well for future success, potentially transforming it into a blockbuster in oncology.
Aug 13, 2025
ANDA Litigation Settlement Updates for Q2 2025 | Robins Kaplan LLP - JDSupra
Numerous pharmaceutical lawsuits have been dismissed with prejudice or without prejudice across various cases involving companies like Astellas Pharma, Pacira Pharmaceuticals, AbbVie, and Pfizer. Key drugs mentioned include Xtandi® (enzalutamide), Exparel® (bupivacaine), and Xeljanz® (tofacitinib). Parties involved will bear their own costs, and some cases allow for future claims under specific conditions.
Aug 13, 2025
Reevaluating the Standards in Patent Infringement Cases Involving Biosimilars - Mondaq
The Delhi High Court has issued an interim injunction preventing Zydus Lifesciences from manufacturing its biosimilar of Nivolumab, a cancer treatment, until the patent expires in 2026. E.R. Squibb and BMS, the patent holders, claimed imminent infringement, leading to the court's decision. Zydus plans to appeal, with a final hearing scheduled for August 2025.
Aug 13, 2025
Inauguration of the Biotech and Biomanufacturing Center - Patent - Mondaq
The European Commission has launched a Biotech and Biomanufacturing Hub to support start-ups and SMEs in the biotech sector. The Hub offers resources on EU funding, research infrastructures, scaling up, intellectual property, and marketing authorisation procedures. Additionally, a new European Biotech Act is expected in 2026 to streamline product development in the EU.
Aug 13, 2025
New Lawsuit Claims Widely Used Medication Led to Patient's Breast Cancer - CounterPunch.org
Bridgett Brown has filed a lawsuit against Johnson & Johnson, Eli Lilly, and their subsidiaries, claiming that the antipsychotics Risperdal (risperidone) and Zyprexa (olanzapine) caused her breast cancer. The suit alleges that the manufacturers obscured risks while promoting the drugs, leading to her suffering disfigurement and emotional distress. Brown seeks a jury trial to address these claims.
Aug 13, 2025
Diabetes patients in India face heightened optic nerve risks from weight-loss medications Mounjaro and Wegovy.
A new study published in JAMA highlights potential eye risks associated with weight-loss drugs Mounjaro (tirzepatide) and Wegovy (semaglutide). Researchers found an increased incidence of optic nerve disorders, including non-arteritic anterior ischaemic optic neuropathy (NAION), among diabetes patients using these medications. While the overall risk remains low, regular eye screenings are recommended for those on GLP-1 drugs.
Aug 13, 2025
Eli Lilly's Stock Increases by 0.66% Following Lawsuit Allegations in Texas, Supported by $4.42 Billion in Trading Volume...
Eli Lilly's shares rose 0.66% on August 12, 2025, amid a lawsuit filed by Texas Attorney General Ken Paxton, alleging illegal kickbacks related to its GLP-1 drugs, Mounjaro and Zepbound. The company dismissed the claims as baseless and plans to challenge the lawsuit, which could increase regulatory scrutiny on its weight-loss and diabetes treatments.
Aug 13, 2025
Pfizer aims to secure a place in China's private insurance list, according to a report by Bloomberg - TipRanks.com.
Eli Lilly (LLY), Pfizer (PFE), and Novo Nordisk (NVO) are aiming to increase sales of their innovative medicines in China by seeking inclusion in Beijing's new commercial health insurance catalog. A report indicates that 121 drugs, including blockbuster and rare disease treatments, have passed the initial screening for this catalog.
Aug 13, 2025
Texas Files Lawsuit Against Lilly, Alleging 'Bribery' of Prescribers to Promote Mounjaro and Zepbound
Texas has sued Eli Lilly, alleging the company offered illegal incentives to healthcare providers to prescribe its GLP-1 drugs, Zepbound and Mounjaro. Attorney General Ken Paxton claims Lilly engaged in a kickback scheme compromising medical decision-making. The lawsuit seeks civil recoveries and an injunction against further unlawful acts. Eli Lilly has denied the allegations and plans to defend itself vigorously.
Aug 13, 2025
Eli Lilly introduces Mounjaro pen in India amid intensifying competition in the obesity medication market - Mint
Eli Lilly has launched the Mounjaro KwikPen, a prefilled pen version of its weight-loss drug Mounjaro, in India, competing with Novo Nordisk's Wegovy. The KwikPen offers six dosage strengths and is priced similarly to injectable vials. Both drugs are GLP-1 receptor agonists targeting obesity and type 2 diabetes, as the market is projected to grow significantly before generics enter.
Aug 13, 2025
Insmed receives FDA clearance for potential blockbuster Brinsupri - Pharmaceutical Technology
Insmed's Brinsupri (brensocatib) has received FDA approval as the first DPP1 inhibitor and therapy for non-cystic fibrosis bronchiectasis (NCFB). This oral medication, available in 10mg and 25mg tablets, shows promise in reducing exacerbations. Insmed anticipates significant sales growth, with forecasts of $1.7 billion by 2033. Brinsupri is also under review by the EMA and MHRA.
Aug 13, 2025
KPB Biosciences of Singapore unsuccessful in attempt to lift asset freeze related to US$830 million case with Novo Nordisk.
KPB Biosciences has failed to overturn a court order freezing its assets, as the Singapore International Commercial Court dismissed its application. Danish drugmaker Novo Nordisk claims KPB misled it about a hypertension drug, seeking S$830 million in damages. The freeze affects KPB's assets, including US$218 million in a DBS account and property owned by founder Huang Zhenhua.
Aug 13, 2025
Alteogen plans to start building its facility this year to manufacture its medication SC (subc..
Alteogen plans to construct a domestic pharmaceutical plant by the end of 2023, aiming for completion in 2028. The facility will produce raw materials for its SC formulation platform, ALT-B4, which includes drugs like Keytruda and Enhertu. This move is expected to enhance production efficiency and management autonomy, with global exports anticipated to start in 2029.
Aug 13, 2025
Lilly introduces Mounjaro pen in India priced at Rs. 14,000 for the initial dose, intensifying competition with Novo.
Eli Lilly has launched its weight-loss drug Mounjaro Kwikpen in India, priced at 14,000 rupees for the 2.5 mg dose. This move intensifies competition with Novo Nordisk's Wegovy, which was recently introduced. Mounjaro is available in six strengths, and both drugs are GLP-1 receptor agonists aimed at controlling blood sugar and promoting satiety.
Aug 13, 2025
Analysis: The Rise of China's Biotechnology Sector is Transforming the Global Pharmaceutical Landscape
The global prescription drug industry is projected to grow from $1.23 trillion in 2024 to $2.45 trillion by 2032, driven by chronic diseases and aging populations. China's biotech sector is emerging as a leader, producing over 1,250 new drugs in 2024, including cancer treatments like Ivonescimab from Akeso Inc. and Summit Therapeutics, challenging U.S. pharmaceutical dominance.
Aug 12, 2025
Insmed's Medication Receives Initial Approval in the US for Severe Lung Condition - Bloomberg Law News
Insmed Inc. shares surged following the US approval of Brinsupri, the first treatment for bronchiectasis, a chronic lung condition. The once-daily pill, brensocatib, helps patients manage mucus clearance and reduces hospitalizations, marking a significant advancement after two centuries of waiting for effective therapy.
Aug 12, 2025
Insmed's Brinsupri: A Major Success in an Overlooked Market - AInvest
Insmed Inc. has received FDA approval for Brinsupri™ (brensocatib), the first therapy for non-cystic fibrosis bronchiectasis (NCFB). Launching in Q3 2025, Brinsupri aims to address significant unmet needs in a market of over 1.25 million patients. With a projected peak U.S. sales of $500–700 million, Insmed is positioned for substantial growth amid minimal competition.
Aug 12, 2025
Biogen Identifies Opportunities in Merging Alzheimer's and Obesity Medications - Bloomberg Law News
Biogen Inc. CEO Chris Viehbacher views the potential success of Novo Nordisk A/S's weight-loss drug in Alzheimer’s trials as an opportunity for collaboration rather than competition. He suggests that combining therapies could lead to more effective treatments for complex diseases, emphasizing the need for diverse mechanisms of action in future Alzheimer’s therapies.
Aug 12, 2025
Insmed receives US authorization for lung disease medication expected to be a major success - Yahoo Finance
Insmed has received FDA approval for Brinsupri, its second lung disease medication, targeting bronchiectasis not caused by cystic fibrosis. This DPP-1 inhibitor, expected to generate $6 billion in annual sales, is priced at $88,000 per year. The drug shows promise in reducing cough and respiratory issues, with broad adoption anticipated due to minimal prescribing restrictions.
Aug 12, 2025
Insmed receives US authorization for lung disease medication expected to be a major success | BioPharma Dive
Insmed has received FDA approval for Brinsupri, its second lung disease medication, aimed at treating bronchiectasis not caused by cystic fibrosis. As the first DPP-1 inhibitor, Brinsupri is projected to generate $6 billion annually. Insmed's market valuation has surged to over $25 billion, bolstered by its existing drug Arikayce and promising pipeline candidates.
Aug 12, 2025
Texas Claims Eli Lilly Encouraged Healthcare Providers to Prescribe Medications - Bloomberg Law News
Texas Attorney General Ken Paxton has filed a lawsuit against Eli Lilly & Co., alleging the company unlawfully pressured providers to prescribe its obesity drugs, including Mounjaro and Zepbound, to secure Medicaid payments. The complaint claims Lilly's practices violated the Texas Health Care Program Fraud Prevention Act, resulting in millions in fraudulent claims. Lilly plans to vigorously defend against these allegations.
Aug 12, 2025
PureTech establishes Celea to advance a potential treatment for lung disease - Fierce Biotech
PureTech is launching Celea Therapeutics to develop deupirfenidone (LYT-100) for idiopathic pulmonary fibrosis (IPF) and other lung conditions. Former Teva North America CEO Sven Dethlefs will lead the company. Phase 2b data suggests deupirfenidone may offer best-in-class efficacy and safety. PureTech plans to meet with the FDA to discuss trial results and future plans.
Aug 12, 2025
Do popular weight loss medications have an impact on your vision? Recent research reveals the findings.
Recent studies published in JAMA Network Open have linked diabetes medications semaglutide and tirzepatide to an increased risk of eye conditions, including diabetic retinopathy and NAION. Despite this, the drugs are deemed transformative for diabetes and obesity management. Researchers recommend close monitoring for patients with existing eye conditions and suggest incorporating eye safety parameters in future trials.
Aug 12, 2025
Second Circuit Reinstates Antitrust Lawsuit Against Pharmaceutical Companies | Practical Law
Mosaic Health, Inc. and Central Virginia Health Services, Inc. have filed a lawsuit against drug manufacturers Sanofi-Aventis U.S., Eli Lilly and Company, Novo Nordisk Inc., and AstraZeneca Pharmaceuticals LP. The case involves Section 340B, a government program mandating discounts on drug prices for Medicaid and Medicare eligibility, impacting the pricing of blockbuster diabetes drugs.
Aug 12, 2025
Could China's domestically developed obesity medications transform the worldwide weight loss industry?
Innovent Biologics has launched mazdutide, China's first domestically developed weight loss drug, approved in June. The drug, licensed from Eli Lilly, aims to combat rising obesity rates in China. With 98 GLP-1 drugs in late-stage trials, competition is set to intensify against Western brands like Ozempic and Wegovy as patents expire. The global obesity drug market is projected to reach $150 billion by 2035.
Aug 12, 2025
Reevaluating the standards in patent infringement cases involving biosimilars - Lexology
The Delhi High Court granted an interim injunction against Zydus Lifesciences, preventing the manufacture of its biosimilar Nivolumab until 2026, citing patent infringement concerns. E.R. Squibb and BMS hold the patent for Nivolumab, and Zydus has appealed the decision. The case highlights the complexities of biosimilar regulations and patent law in India.
Aug 12, 2025
Bayer invests in KRAS cancer treatment; Novartis achieves success with immune therapy | BioPharma Dive
Bayer has licensed an experimental cancer therapy targeting the KRAS G12D mutation from Kumquat Biosciences for over $1 billion. Meanwhile, Novartis reported positive Phase 3 results for ianalumab in primary immune thrombocytopenia. Biohaven's drug, troriluzole, failed in OCD trials, while Stoke Therapeutics' zorevunersen for Dravet syndrome has entered Phase 3. The FDA has restricted Bluebird bio's Skysona use due to cancer risks.
Aug 12, 2025
Government Initiatives to Curb the Sale of Contaminated Medications Nationwide, DrugsControl ...
The Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have implemented measures to combat the sale of adulterated drugs in India. These include regulatory actions, quality monitoring, and the use of QR codes for tracking drug authenticity. The initiative aims to ensure compliance with the Drugs & Cosmetics Act and enhance public safety.
Aug 12, 2025
The Saffron Book: An Indian Orange Book - Express Pharma
India is urged to develop a "Saffron Book," akin to the U.S. FDA's Orange Book, to enhance its pharmaceutical regulatory system. This comprehensive database would provide transparent drug approval information, therapeutic equivalence, and patent details, promoting patient safety, competition, and innovation. The initiative aims to position India as a global leader in pharmaceuticals while ensuring public trust and access to accurate drug information.
Aug 12, 2025
Reply to 'The enigma of patents for biologics manufacturing platforms' - Nature
Amgen defends its position as a leader in biologics and biosimilars, countering claims by Jefferson et al. that biosimilar competition is slow due to manufacturing patents. Amgen highlights the FDA's approval of nearly 70 biosimilars since 2015, including its own Amjevita, launched in January 2023. The company asserts that the biosimilars market is robust and growing, contrary to the authors' assertions.
Aug 12, 2025
Announcement of a new patent for a medication aimed at treating traumatic brain injuries - Drug Target Review
TauGen has filed a US patent application for a new series of drug candidates targeting endoplasmic reticulum (ER) stress, a key factor in secondary brain injury following traumatic brain injury (TBI). CEO Dr. Henry Chilton emphasized the potential of these compounds to provide acute and chronic management solutions for TBI, addressing a significant gap in treatment options.
Aug 12, 2025
Second Medical Use Claims at the UPC: What Are the Requirements for Infringement? - Mondaq
The Düsseldorf Local Division has issued a landmark decision regarding second medical use claims, outlining the requirements for proving infringement. Claimants must demonstrate both the expected use of the product and the infringer's knowledge of such use. This ruling, significant for the UPC system, emphasizes a case-by-case assessment of relevant factors influencing infringement.
Aug 12, 2025
Xspray Pharma enters into licensing deal with Handa Therapeutics, potentially earning up to twice...
Xspray Pharma has signed a license agreement with Handa Therapeutics, allowing Handa to commercialize a dasatinib product in the US and select Asian markets. Xspray will receive royalties on Handa's net proceeds. This marks Xspray's first out-licensing from its patent portfolio, supporting its strategy to develop improved PKI-drugs, including its lead candidate, Dasynoc, awaiting FDA approval.
Aug 12, 2025
Trends in the Specialty Generics Market in the United States - openPR.com
The U.S. specialty generics market is projected to grow from USD 26.28 billion in 2024 to USD 65.73 billion by 2034, driven by patent expirations, rising chronic diseases, and increased FDA approvals. Key players include Akorn, Amneal Pharmaceuticals, and USA Pharmaceuticals & Sports Science, focusing on oncology and complex formulations. The market is expanding due to demand for affordable specialty therapies.
Aug 11, 2025
Clearmind Medicine announces the filing of an international patent application for its innovative ...
Clearmind Medicine Inc. announced the publication of an international patent application for a combination therapy using its proprietary 5-methoxy-2-aminoindane (MEAI) and SciSparc Ltd.'s Palmitoylethanolamide (PEA) to treat metabolic syndrome and obesity. This collaboration has resulted in 13 patent families aimed at addressing various health disorders, including mental health and metabolic conditions.
Aug 11, 2025
Carpmaels and A&O Shearman initiate the inaugural SPC lawsuit at the UPC on behalf of Merz against Viatris.
Merz Therapeutics has revoked its opt-out from the UPC system for its SPC EP 2 377 536, which covers the multiple sclerosis drug Fampyra. The company is seeking a preliminary injunction against Viatris, which plans to launch a generic version, Fampidrin Viatris LP, in France. This marks a significant UPC action in the pharmaceutical sector.
Aug 11, 2025
Emerging Trends in Patent Litigation within the Chinese Pharmaceutical Industry - Mondaq
China's evolving pharmaceutical patent landscape significantly impacts global strategies, with a focus on its patent linkage system and recent litigation trends. Key cases involve drugs like Apremilast and Edoxaban Mesylate. In 2024, over 60% of patent disputes were withdrawn, highlighting the effectiveness of generic companies in demonstrating non-infringement. The CNIPA's administrative enforcement is also gaining traction for resolving disputes efficiently.
Aug 11, 2025
Veru Reveals Choice of Innovative Modified Release Oral Formulation - GlobeNewswire
Veru Inc. has announced the selection of a novel modified release oral formulation of enobosarm, a selective androgen receptor modulator, for chronic weight loss management. The formulation, developed in collaboration with Laxxon Medical, showed promising pharmacokinetic results in a clinical study. Veru plans to advance this formulation into Phase 3 clinical studies, with patent protection extending through 2046.
Aug 11, 2025
Pharmalittle: We're exploring Prasad's comeback at the FDA, a journal's conflict with RFK Jr., and additional updates.
The Annals of Internal Medicine has rejected U.S. Health Secretary Robert F. Kennedy Jr.'s call to retract a Danish study showing aluminum in vaccines poses no health risks to children. Meanwhile, Vinay Prasad is returning to the FDA to oversee vaccine and gene therapy regulation after a brief departure amid controversy over Sarepta Therapeutics' gene therapy for Duchenne’s muscular dystrophy.
Aug 11, 2025
The increase in US pharmaceutical prices is primarily driven by competition from generic drugs and pricing strategies.
The past year has seen significant developments in pharmaceutical antitrust law, particularly following the US Supreme Court's FTC v Actavis ruling. Key issues include reverse-payment settlements, product hopping, and challenges to improper Orange Book patent listings. Notable cases involve Bystolic and Regeneron, with courts increasingly scrutinizing pricing practices and the role of pharmacy benefit managers amid ongoing legislative efforts to regulate drug prices.
Aug 11, 2025
Regulators focus on Mexico's pharmaceutical and healthcare industries amid increasing scrutiny.
The Mexican pharmaceutical sector is undergoing significant antitrust reforms, with a new bill enhancing regulatory frameworks and penalties for anticompetitive practices. The Mexican Competition Commission is actively investigating cartels in drug distribution and public procurement, with recent cases involving companies like AstraZeneca and Marzam. A class action lawsuit has also been filed against pharmaceutical firms for damages related to anticompetitive conduct.
Aug 11, 2025
Astellas Pharma Inc. vs. Zydus, Inc. I | Robins Kaplan LLP - JDSupra
Astellas Pharma Inc. successfully defended its patent for Myrbetriq® (mirabegron) against Zydus and Lupin in a Delaware court. The court upheld U.S. Patent No. 10,842,780, affirming its enablement, written description, and definiteness, allowing Astellas to maintain exclusivity over the hydrogel-based sustained-release formulation used to treat overactive bladder.
Aug 11, 2025
Semaglutide, a blockbuster drug, is nearing the end of its patent protection, presenting a multi-billion-dollar opportunity for Indian pharmaceutical companies.
The patent expiry of semaglutide, a leading diabetes and anti-obesity drug from Novo Nordisk, will enable generic versions to enter the market, potentially reducing costs by 50-70% starting next year. Indian companies like Biocon and Dr Reddy’s are preparing to launch generics, aiming to capture a share of the growing $11 billion anti-obesity market.
Aug 11, 2025
Ozempic, a weight-loss medication, has dropped from the list of Europe's ten most valuable companies.
Novo Nordisk's diabetes drug Ozempic, which has gained popularity for weight loss and heart attack risk reduction, faces challenges as its share price has dropped over 50% this year. Despite $24 billion in sales, competition from Eli Lilly's Mounjaro and concerns over Ozempic's side effects have impacted growth. Analysts question the weight-loss market's potential amid rising pressures on drug pricing.
Aug 11, 2025
Analyzing the Q2 Earnings of Branded Pharmaceutical Stocks: A Look at Royalty Pharma (NASDAQ:RPRX)
In Q2, branded pharmaceuticals showed strong performance, with revenues surpassing estimates by 3.1%. Royalty Pharma (RPRX) reported $578.7 million, while Supernus Pharmaceuticals (SUPN) excelled with a 9.9% stock increase. Corcept Therapeutics (CORT) and Zoetis (ZTS) faced challenges despite revenue growth. Bristol-Myers Squibb (BMY) also beat expectations, maintaining stable stock prices. Overall, the sector remains optimistic amid regulatory pressures and patent cliffs.
Aug 11, 2025
Could China's domestically developed obesity medications transform the international weight-loss industry?
China's first home-grown weight loss drug, mazdutide, developed by Innovent Biologics, has received regulatory approval, marking a significant step in combating obesity. The drug, licensed from Eli Lilly, aims to challenge Western competitors like Ozempic and Wegovy. With a growing number of GLP-1 drugs in development, China's pharmaceutical sector is poised for rapid expansion in the global weight loss market.
Aug 11, 2025
Is Pfizer Stock a Good Addition to Your Portfolio Following Strong Q2 Performance? - The Globe and Mail
Pfizer (PFE) reported strong Q2 2025 results, with adjusted EPS of 78 cents and revenues of $14.7 billion, surpassing estimates. Key products like Vyndaqel, Padcev, and Paxlovid contributed to growth, despite challenges from Medicare Part D and COVID product sales. The company remains optimistic about its oncology pipeline and expects significant revenue growth from its Seagen acquisition.
Aug 11, 2025
Key Figure Behind Online Distribution of Narcotic Pills Captured in Mumbai, Reports DrugsControl Media Services
Manish Kumawat, accused of facilitating the online sale of 7,200 prohibited Alprazolam tablets to Ankit Singh Rajput, has been arrested by Durg Police in Mumbai. The operation highlights ongoing efforts to combat the illegal narcotics trade.
Aug 10, 2025
Mounjaro Achieves ₹100 Crore in Sales Within 4 Months: A New Era in Weight Loss for India
Eli Lilly's weight loss drug Mounjaro has achieved over ₹100 crore in sales within four months of its March 2025 launch in India, addressing the country's obesity and Type 2 diabetes crisis. With an average weight loss of 20.2%, Mounjaro is rapidly gaining market share, reflecting a growing demand for effective treatment solutions in India's healthcare landscape.
Aug 10, 2025
Eli Lilly Stock Update: Company Achieves 27.1% ROIC and Rapid Expansion Driven by New Blockbuster Medications
Eli Lilly (LLY) has achieved a remarkable 27.1% Return on Invested Capital, driven by its innovative treatments for diabetes, cancer, and obesity, including drugs like Mounjaro and Zepbound. The company's stock has surged over 50% year-to-date, attracting institutional investment. Eli Lilly's growth also influences cryptocurrency markets, particularly AI-driven healthcare tokens, highlighting interconnected trading opportunities.
Aug 10, 2025
Researchers at IIT-Roorkee create a potential drug candidate to combat antibiotic resistance.
IIT-Roorkee researchers have developed a promising drug candidate, Compound 3b, aimed at combating antibiotic resistance. This new compound has the potential to restore the effectiveness of a potent antibiotic against deadly drug-resistant bacteria, marking a significant advancement in the global fight against antibiotic resistance.
Aug 10, 2025
Himachal requests a distinct e-way bill for monitoring narcotic materials.
The Himachal Pradesh Government has requested the GST Council to implement a separate e-way bill system to enhance tracking of narcotic substances. This initiative aims to combat drug abuse and prevent the diversion of narcotics from pharmaceutical companies.
Aug 10, 2025
Ascendis Pharma Reports Q2 2025 Earnings: A Strategic Move Towards Achieving Blockbuster Success - AInvest
Ascendis Pharma A/S reported a remarkable Q2 2025, with revenues soaring 339% to €158 million, driven by its flagship products YORVIPATH and SKYTROFA. The company is positioned for long-term growth, bolstered by regulatory advancements and a strong pipeline, including the upcoming FDA review for TransCon CNP. Despite a net loss, Ascendis maintains a robust financial outlook, making it a compelling investment opportunity.
