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【EXPERT Q&A】What are the dilemmas facing the pharmaceutical industry?

Drugdu.com expert’s response: The pharmaceutical industry faces numerous challenges, including: Ⅰ.High R&D Costs: Drug development is a lengthy and expensive process, often requiring billions of dollars and many years. The risk of failure is high, with many drugs not passing clinical trials. Ⅱ.Regulatory Pressure: Drug regulatory agencies (e.g., FDA, EMA) have increasingly stringent approval requirements for new drugs, necessitating more resources for clinical trials and data collection, thus increasing the difficulty and cost of bringing new drugs to market. Ⅲ.Short Patent Protection Period: The patent protection period for new drugs is relatively short. Once the patent expires, generic drugs quickly enter the market, significantly reducing the market share and profits of the original drug. Ⅳ.Intense Market Competition: The pharmaceutical market is highly competitive, not only from other innovative drugs but also from generic drugs and biosimilars. Ⅴ.Price Pressure: Governments and the public are increasingly concerned about drug prices, especially high-priced ...
- Source: drugdu
- 96
- July 24, 2024
Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. By Frank VinluanAn Ionis Pharmaceuticals drug in development for Angelman syndrome has mid-stage clinical trial results showing improvement across a range of measures of this rare neurodevelopmental disorder, and the company now plans to advance therapy to Phase 3 testing. Angelman is an inherited disorder that presents in infancy and leads to learning disability, muscle impairment, balance problems, and seizures. Patients typically develop little to no verbal ability. While Angelman patients can be treated with drugs that manage some of these symptoms, there are no FDA-approved therapies for the disease itself. The results announced Monday for the drug, ION582, come from the multiple-ascending dose portion of ...
- Source: drugdu
- 75
- July 24, 2024
Artiva’s IPO Reels In $167M to Bring NK Cell Therapy to Autoimmune Diseases

Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
- Source: drugdu
- 71
- July 23, 2024
Meitheal gains rights to CONTEPO from Nabriva in North America

Meitheal Pharmaceuticals has expanded its biopharmaceutical portfolio through the acquisition of rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region. Meitheal gains access to the rights to CONTEPO, including development and regulatory works, intellectual property rights, technology and related know-how. Nabriva will receive payment upon the agreement closing in addition to royalties on net sales of the injection in the US. An intravenous broad-spectrum antibiotic, CONTEPO has shown activity against multi-drug resistant strains causing complicated urinary tract infections (cUTI). Fosfomycin for intravenous administration is already marketed outside the US and has been approved for nine indications, including cUTI and other serious bacterial infections. CONTEPO’s new dosing approach aims to optimise the compound’s pharmacokinetics and pharmacodynamics. It met the primary endpoint in the ZEUS trial enrolling patients with cUTI. Nabriva filed a new drug application with the US Food and Drug Administration (FDA) seeking approval for ...
- Source: drugdu
- 60
- July 22, 2024
Novel Molecular Test to Help Prevent and Control Multi Drug-Resistant Fungal Pathogen in Healthcare Settings

Candida auris (C. auris) is a rapidly emerging multi drug-resistant fungal pathogen that is commonly found in healthcare environments, where it presents a challenge due to its ability to asymptomatically colonize patients, facilitating its spread within these settings. Known to be a significant risk factor for invasive infections, C. auris is associated with high mortality rates and is resistant to many antifungal medications typically used for treatment. It has been responsible for outbreaks in over 35 countries in the past decade, marking it as a critical antimicrobial resistance threat. Given this, it is crucial to screen for C. auris to enable the timely implementation of contact precautions and infection control measures that can curb its spread within healthcare facilities and prevent potential outbreaks. Traditional testing methods can take days to yield results and often require sending samples to a reference laboratory. Now, a real-time polymerase chain reaction (RT-PCR) assay for ...
- Source: drugdu
- 80
- July 20, 2024
Automated Benchtop System to Bring Blood Testing To Anyone, Anywhere

Almost all medical decisions are dependent upon laboratory test results, which are essential for disease prevention and the management of chronic illnesses. However, routine blood testing remains limited worldwide. Many adults avoid routine blood tests due to their complexity and the long wait times for results, which can lead to delayed interventions or missed diagnoses, resulting in substantial avoidable costs. Now, a groundbreaking diagnostic platform is set to transform the existing global infrastructure by providing lab-accurate, actionable test results that aid in the early detection and prevention of chronic conditions. Truvian Health (San Diego, CA, USA) has developed an automated benchtop system that allows simple, accurate, and comprehensive routine blood tests to be conducted directly in clinics, doctor’s offices, and pharmacies. Utilizing patented technologies and intelligent integration, Truvian’s compact device offers a convenient and economical alternative to traditional off-site labs, delivering quick, lab-accurate results from just a small blood sample, ...
- Source: drugdu
- 82
- July 20, 2024
Ardelyx sues CMS over revamped kidney disease drug payment bundle

Ardelyx has declared that it is filing a lawsuit against the US Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) to keep essential phosphate-lowering therapies separate from the CMS’s renal disease payment bundle, claiming that the action could “limit patient choice”. Ardelyx has teamed up with the American Association of Kidney Patients (AAKP) and the National Minority Quality Forum (NMQF) to sue the government organisations regarding the CMS’s renal disease payment bundle. The End Stage Renal Disease (ESRD) Prospective Payment System (PPS) is a bundled payment scheme for renal dialysis services available for Medicare beneficiaries. The ESRD PPS adjusts treatment costs at the patient and facility level for renal dialysis treatment at an ESRD facility or the patient’s home. This payment includes costs for laboratory services, drugs, supplies, and more, as per CMS’s description. The litigation states that the CMS has “violated ...
- Source: drugdu
- 85
- July 20, 2024
Bayer eyes Nubeqa’s label expansion in prostate cancer following Phase III win

Bayer is set to pursue a label expansion for Nubeqa (darolutamide) in a distinct subgroup of prostate cancer patients—those with metastatic hormone-sensitive prostate cancer (mHSPC)—after announcing that a Phase III trial with the therapy met its primary endpoint. The company did not disclose detailed trial data, only stating that the combination of Nubeqa and androgen deprivation therapy (ADT) demonstrated “a statistically significant and clinically meaningful increase”, compared to the placebo and ADT combination, in the radiological progression-free survival (rPFS), the study’s primary endpoint. Bayer plans to share the detailed results from the trial at an upcoming scientific conference. Nubeqa has been approved by the US Food and Drug Administration (FDA) to treat patients with mHSPC, but only in combination with docetaxel chemotherapy. The company now plans to seek approval for the drug’s use mHSPC indication sans additional chemotherapy. To that end, Bayer plans to submit the Phase III ARANOTE trial ...
- Source: drugdu
- 65
- July 20, 2024
Novartis reports 43% increase in net income in Q2 2024

Novartis has reported a significant 43% increase in net income from continuing operations, reaching $3.24bn in the second quarter (Q2) of 2024, up from $2.27bn in the same period of 2023. This notable growth in net income was attributed primarily to an increase in core operating income. Operating income for Q2 2024 soared to $4.01bn – a substantial year-on-year increase from $2.80bn. The rise in operating income has been chiefly attributed to higher net sales and reduced impairments, although this was partly offset by a rise in research and development investments. Net sales from continuing operations for the company stood at a robust $12.51bn in Q2 2024, an increase on the $11.43bn recorded in Q2 2023. Alongside the growth in net sales, Novartis also experienced a 40% rise in free cash flow from continuing operations, which amounted to $4.61bn compared to $3.29bn in the corresponding period of 2023. For the ...
- Source: drugdu
- 85
- July 20, 2024
Revolution sets sights on Phase III trial for pan-RAS inhibitor

Revolution Medicine plans to kickstart a Phase III trial following positive data from a first-in-human study of its investigational KRAS inhibitor RMC-6236 in pancreatic cancer patients. In an investor deck released yesterday [15 July], the company outlined updated data from the Phase I trial (NCT05379985) that outlined responses from 127 patients with pancreatic ductal carcinoma (PDAC) who received between a dose of RMC-6236 ranging from 160mg to 300mg. Median progression-free survival was 8.1 months in patients with the KRAS G12X mutation, and 7.6 months in those who broadly have RAS-mutant tumours. Among participants who had at least three prior treatment regimens, the median progression-free survival was 4.2 months. Out of the 127 participants, 96% suffered from side effects. The most common were rashes, diarrhoea, nausea, and mouth sores. Those adverse events were deemed severe or medically significant in 28% of patients. The company had previously presented early Phase I data, ...
- Source: drugdu
- 71
- July 19, 2024

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