LeadDiscovery Editorials
15 years of drug development experience distilled into 5 minute editorials
LeadDiscovery has been providing information to the drug development sector for over 10 years. DailyUpdates keeps readers up to date with what is happening in the world of research...now our editorial service draws on our experience and ability to identify what is hot and deliver our insights on recent events.
Latest Editorials
GSK's Avandia survives FDA panel vote but damage may have been done
The majority of a 33-member FDA advisory panel has voted against the complete market withdrawal of GlaxoSmithKline's Avandia. However, considering the safety concerns surrounding the drug, and with 12 of the panelists voting for withdrawal, Avandia's sales are likely to decline further even if it remains on the market.
Continue Reading...New data analysis reduces some of the concerns over upcoming Systemic Lupus Erythematosus (SLE) treatment, Benlysta (belimumab)
A gradual improvement in the treatment of Systemic Lupus Erythematosus (SLE) through the use of non-biologics has been seen over recent decades. Data emerging on Human Genome Science and GSK’s Benlysta (belimumab) is increasingly revealing the potential of biologics, as part of the next era of lupus treatment. We featured a detailed analysis of the lupus pipeline and market in March 2010 looking at the relative clinical and commercial potential of emmerging lupus treatments (click here to access). Two recent meetings, EULAR in Rome and LUPUS2010 in Vancouver have provided further understanding of new treatments and in particular data from the two pivotal Benlysta (belimumab) studies, BLISS-52 and BLISS-76 have highlighted these meetings.
Continue Reading...APS 2010: fibromyalgia newcomer seeks differentiation while prospective player draws nearer
Established drugs such as Cymbalta and Lyrica will serve to restrict uptake of the most recent entrant to the fibromyalgia market, Savella. Accordingly, data presented at this year's American Pain Society Annual Meeting indicate that Savella's marketing companies are endeavoring to differentiate the product from its key competitors in order to maintain uptake and drive sales.
Related research
- Forecast Insight: Fibromyalgia - Regulatory caution threatens EU market expansion priced $15,200
- The Pain Management Market Outlook To 2014: Competitive landscape, pipeline analysis and growth opportunities priced $3,835
- Stakeholder Opinions: Targeting Nerve Growth Factor for Pain Therapy - Groundbreaking class to breathe new life into saturated market priced $3,800
- Pain Therapeutics - Drugs, Markets and Companies $3500
- Neuropathic Pain: Emerging Drugs and Current Treatment Practices £2999
NicOx: FDA panel negative opinion casts future of osteoarthritis drug into doubt
An FDA advisory meeting has voted 16 to one against recommending the potential osteoarthritis drug naproxcinod. The decision comes after the panel found insufficient safety data to support the drug's target indication. While naproxcinod's commercial potential is now uncertain, the announcement further highlights the FDA's enhanced scrutiny of safety in the post-Vioxx era.
Related research
- Stakeholder Insight: Osteoarthritis - Drug development lags behind rising osteoarthritis population priced $15,200 [further details]
- The osteoarthritis market - COX-2 inhibibitors, NSAIDs and corticosteroids $15,200 [further details]
- Nitric Oxide - Therapeutics, Markets and Companies $2,800 [further details]
Dendreon: landmark cancer vaccine approval but high costs may hinder uptake
Having been approved by the FDA in castration-resistant prostate cancer, Dendreon's Provenge represents the first therapeutic cancer vaccine to reach the market. This is a significant step forward: the current standard of care is Taxotere-based chemotherapy, which is associated with significant toxicity. However, it remains to be seen how frequently Provenge is used.
Related Reports
- Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
- Emerging Cancer Vaccines: Market Forecasts, New Developments and Pipeline Analysis
Could generic lansoprazole become the next major advance for hepatocellular cancer
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world.
For further informaion on HCC see Hepatocellular Carcinoma - Opportune indication for novel therapies
Continue Reading...AAN 2010: new treatments address unmet needs in Alzheimer's and epilepsy
A number of leading drug makers used this year's meeting of the American Academy of Neurology to present new data for promising pipeline candidates. Despite promising results, however, epilepsy drugs will likely struggle to find their place in the market. Moreover, the positive Phase II data for Baxter’s potential Alzheimer’s therapy Gammagard do not guarantee later success.
Related reports:
- Pipeline Insight: Alzheimer's Disease - The ultimate high-risk, high-reward therapy market
- The CNS Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities
- Diagnostics in Neurology - Predictive biomarkers expand drug revenues
Clavis and Clovis collaboration to tackle problem of Gemzar (gemcitabine) resistance - New hope for pancreatic and non-small cell lung cancers
Gemcitabine was initially launched in the 1990’s as a treatment for non-small cell lung cancer (NSCLC) and pancreatic cancer and it is now part of first line treatment for both. Gemcitabine is also indicated for other cancers such as metastatic breast cancer, ovarian cancer and bladder cancer. The efficacy of gemcitabine, like most other cytotoxic agents diminishes with time as resistance develops impeding cancer cell entry. Today we look at CP-4126 (also known as CO-101) which is being codeveloped by Clovis Oncology and Clavis Pharma. This exciting clinical stage agent is a fatty acid derivative of gemcitabine that passively enters cancer cells and is therefore less susceptible than gemcitabine to resistance
Related Reports
- Commercial Insight: Cytotoxic Therapies
- Pipeline Insight: Non-Small Cell Lung Cancer - Emerging Therapies
- Pancreatic Cancer - Gemzar Dominance Will Continue Among High Levels of Persistent Unmet Needs
- Companion Diagnostics in Personalized Medicine and Cancer Therapy
Hope for an Alzheimers breakthrough remains despite Dimebon's failure
On March 3rd we highlighted a press release issued by Medivation/Pfizer announcing that a Phase 3 study of Dimebon in Alzheimer's disease had failed to meet any of its clinical endpoints, despite high hopes of the drug after promising Phase 2 results. This is a significant setback for Dimebon's developers, particularly Medivation, however as recently discussed in our recent feature, Pipeline Insight: Alzheimer's Disease, there remains significant hope for the millions of Alzheimer's sufferers and their caregivers in the pipeline.
Continue Reading...Agendia's MammaPrint prognostic technology: Improving medical management of breast cancer patients with small tumours
Today's issue of DailyUpdates features a new study evaluating MammaPrint, Agendia's breakthrough breast cancer prognostic tool. While the scientific and pharmaceutical communities continue to make advances in the development of treatments of metastatic breast cancer, so too are strides being taken towards the diagnosis and prognosis of the disease. Hopefully these two avenues will meet with increasing effect. MammaPrint is one good example. As breast cancer screening programs have increased the number of women diagnosed with small tumours has increased. However, the problem of how to manage these patients remains thorny. The prognosis for small tumours is quite good however a minority of patients will develop distant metastases and die from their disease. MammaPrint has been shown to accurately identify women at high risk and who should be treated with more aggressive therapies now and hopefully with new agents targeting metastatic breast cancer as they reach the market. On the other hand, those at low risk can be treated with endocrine therapies safe in the knowledge that they are unlikely to be undertreated.
Continue Reading...Advaxis lights up the future for cervical cancer and maybe some head and neck cancers
Today's issue of DailyUpdates features exciting data emmerging from Advaxis on their therapeutic vaccine, ADXS11-001 (formerly Lovaxin C). This candidate is in development for cervical cancer and potentially rare forms of head and neck cancer. Despite the launch of HPV vaccines, cervical cancer will remain a significant clinical problem in the developing world as well as in the developed world for the near future. Data from the phase 1 study highlighted today suggests that some advanced cancer patients innoculated with ADX11-001 have survived an astonishing 3 years. In today's editorial we discuss these data and the cervical cancer/therapeutic vaccine field in general.
Note: We have just uploaded the following report relating to this editorial:
Continue Reading...Javelin Pharmaceuticals continues to show promise in the pain arena
With today's upload of the brand new stakeholder insight report into cancer pain and recent news from Javelin Pharmaceuticals regarding both their intranasal ketamine formulation, Ereska and the company's injectable diclofenac, Dyloject, pain is definately in the air at LeadDiscovery. In today's editorial we focus on the recent news coming out of Javelin.
Continue Reading...Promising data reads out from ADVANCE as first generation oral HCV therapies march on
Two protease inhibitors are running neck and neck to become the first oral antivirals to reach the clinic for the treatment of hepatitis C: telaprevir (Vertex/Tibotec/Mitsubishi Tanabe) and boceprevir (Merck). Teleprevir won the race to deliver Phase 3 data first but how do these data look
Continue Reading...
Previous Editorials
- GSK's Avandia survives FDA panel vote but damage may have been done
- New data analysis reduces some of the concerns over upcoming Systemic Lupus Erythematosus (SLE) treatment, Benlysta (belimumab)
- APS 2010: fibromyalgia newcomer seeks differentiation while prospective player draws nearer
- NicOx: FDA panel negative opinion casts future of osteoarthritis drug into doubt
- Dendreon: landmark cancer vaccine approval but high costs may hinder uptake
- Could generic lansoprazole become the next major advance for hepatocellular cancer
- AAN 2010: new treatments address unmet needs in Alzheimer's and epilepsy
- Clavis and Clovis collaboration to tackle problem of Gemzar (gemcitabine) resistance - New hope for pancreatic and non-small cell lung cancers
- Hope for an Alzheimers breakthrough remains despite Dimebon's failure
- Agendia's MammaPrint prognostic technology: Improving medical management of breast cancer patients with small tumours
- Advaxis lights up the future for cervical cancer and maybe some head and neck cancers
- Javelin Pharmaceuticals continues to show promise in the pain arena
- Promising data reads out from ADVANCE as first generation oral HCV therapies march on