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
UpdatesPlus-Rheumatoid Arthritis (April 2013)
UpdatesPlus-Rheumatoid Arthritis is a monthly service that combines monitoring and analysis.In this month's 70 slide issue we provide Q1 sales figures for each of the biologics used in the treatment of rheumatoid arthritis. We lso offer fully up to date pipeline and clinical timelines as well as listings of key journal article, some of which are analyzed in this issue
Continue Reading...Galapagos has announced filing to initiate Phase 2b rheumatoid arthritis program for GLPG0634
In its research update call which has just completed, Galapagos has laid out its global Phase 2b RA program for GLPG0634, at the end of which Abbvie has a licensing option
Continue Reading...Was the FDA correct in updating its warning of increased CV events with Chantix/Champix?
Continue Reading...
Pfizer just can't seem to win with Champix/Chantix as another label change approaches
Pretty much since its launch it seems that Pfizer has been having problems with Chantix (also known as Champix outside of the US). Firstly fears of neuropsychiatric adverse events now risk of heart attack
Continue Reading...Tacrolimus as a new approach to pulmonary artery hypertension?
Stanford researchers have taken a large panel of approved medicines from a broad range of conditions and ran them through an assay of BMPII activity. One molecule lit the assay up - tacrolimus - also known as Prograf or FK506. Continue Reading...As the HCV field continues to move forward all looks rosy for telaprevir but we are not so sure about boceprevir
Lots of headlines are coming through the newswires now about last week's unanimous decisions by the FDA's advisory panel to approve two new HCV candidates, telaprevir (Vertex/Janssen) and boceprevir (Merck). On the surface things look pretty good for both compounds, however look below the surface a bit and you will see that telaprevir has come out of last week better off.
Continue Reading...Telaprevir takes a leap towards the HCV market while boceprevir appears to be crawling over the line
HCV news hot off the press from Maryland: We now have positive opinions on two HCV candidates in two days.
Continue Reading...The patent cliff is set to drive global generic uptake despite tougher market conditions
According to a new Datamonitor report, branded pharmaceutical companies are set to lose $82bn in sales by the end of 2014 due to the imminent patent cliff. However, this presents a significant opportunity for generics players at a time when the generics market is not only becoming increasingly competitive, but also facing tougher regulations as well as pricing pressures.
Dual advances in the treatment of Clostridium difficile
Two recent decisions set to redefine the fight against Clostridium difficile. On April 5th Optimer announced that the FDA's advisory panel had recommended the approval of DIFICID; this followed, the previous day, the FDA's decision to clear Cepheid's diagnostic, Xpert C. difficile/Epi test.
Continue Reading...FDA to decide of everolimus (Afinitor) and Sunitinib (Sutent) for the treatment of advanced pancreatic neuroendocrine tumors (PNET)
PNET are normally non-functional and have usually already metastasised (to the liver) by the time they are diagnosed explaining why most PNET patients are advanced stage at the time of diagnosis. PNET have a 5-year survival that can range from 97% in benign insulinomas to as low as 30% in non-functional metastatic PNET. Surgery with curative intent is the mainstay of treatment for localized or loco-regional disease. Surgery as well as other forms of local treatment like transarterial chemoembolization or radiofrequency ablation can also improve prognosis in patients with liver metastases. Unfortunately however patients with pNET have few therapeutic options, and up untill recently no new drug has been approved for the disease for over 25 years. Sutent became the first new treatment of PNET in December 2010 when it was approved by the EMA. For further information on PNET see our recently featured report: Pipeline Insight: Cancer Overview Malignant Melanoma, Neuroendocrine Tumors and Thyroid Cancer
Vandetanib is approved in the US for medullary thyroid cancer
Multi-targeted tyrosine kinase inhibitors dominate the thyroid cancer pipeline (see: Pipeline Insight: Cancer Overview Malignant Melanoma, Neuroendocrine Tumors and Thyroid Cancer). There are four late-stage drugs which are forecast to achieve sales of $97m by 2019. It has long been thought likely that at least one of the late-stage drugs will be the first agent approved specifically for medullary thyroid cancer.
Likelihood has now become reality as the FDA has approved orphan drug vandetanib for the treatment of thyroid cancer.
Clopidogrel variability - GIFT data puts the brakes on PON-1 as a major factor modifying the response to clopidogrel.
A presentation of the GIFT sub-study of GRAVITAS, delivered by Matt Price today at ACC in New Orelans has put a dampner on the PON-1 story building around clopidogrel responsiveness.
Continue Reading...UK recommendation for Merck's Simponi but it may struggle to make an impact in the rheumatoid arthritis market
The National Institute for Health and Clinical Excellence has recommended Simponi for psoriatic arthritis. Based on this, Datamonitor believes that the drug will gain further positive recommendations in other rheumatology indications. However, while Simponi does have dosing advantages over other approved biologics, it is unlikely to make a huge impact on the UK market.
Continue Reading...HPV vaccine fight against cervical cancer continues to be hampered in some parts of Europe
According to "Epidemiology: Cervical Cancer", during 2010, it was estimated that 35,898 women will develop cervical cancer in the seven major markets. Of this number 13,170 cases will have been in the US and approximately 18,000 in the EU5. France is one of the countries to be less affected but this may not remain the case as uptake of HPV vaccines continues to be poor.
Continue Reading...Ipilimumab continues to push forward expectations for the treatment of melanoma
Exciting news has emerged from BMS on its anti-CTLA-4 mAb, ipilimumab. The antibody has met its primary endpoint, overall survival, in a study looking at first line treatment of metastatic melanoma. Ipilimumab is already under regulatory review for later stage treatment of melanoma. Approval for this indication could draw sales worth $1.1 billion/year. Approval for first line treatment could double this figure.
Continue Reading...Further evidence points to nicotinic receptors modifying amyloid as well as improving cognition
Researchers have identified a further link between nicotinic receptors and the etiology of Alzheimer's disease
Continue Reading...Repligen reports Phase 3 RG1068 data: Improved MRI imaging of pancreatic and biliary disease expected to reduced ERCP procedures
According to a recent report, Medical Imaging Markets: MRI and Ultrasound the market for MRI continues to grow despite the recession. This is due to improvements in MRI cameras and also imaging agents. One advance which likely to further drive the use of MRI, specifically in the area of pancreobiliary imaging is Repligen's RG1068. Yesterday, the company announced Phase 3 data supporting the use of RG1068 in combination with MRI for the diagnosis of pancreatic and biliary disease.
Continue Reading...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
- UpdatesPlus-Rheumatoid Arthritis (April 2013)
- Galapagos has announced filing to initiate Phase 2b rheumatoid arthritis program for GLPG0634
- Was the FDA correct in updating its warning of increased CV events with Chantix/Champix?
- Pfizer just can't seem to win with Champix/Chantix as another label change approaches
- Tacrolimus as a new approach to pulmonary artery hypertension?
- As the HCV field continues to move forward all looks rosy for telaprevir but we are not so sure about boceprevir
- Telaprevir takes a leap towards the HCV market while boceprevir appears to be crawling over the line
- The patent cliff is set to drive global generic uptake despite tougher market conditions
- Dual advances in the treatment of Clostridium difficile
- FDA to decide of everolimus (Afinitor) and Sunitinib (Sutent) for the treatment of advanced pancreatic neuroendocrine tumors (PNET)
- Vandetanib is approved in the US for medullary thyroid cancer
- Clopidogrel variability - GIFT data puts the brakes on PON-1 as a major factor modifying the response to clopidogrel.
- UK recommendation for Merck's Simponi but it may struggle to make an impact in the rheumatoid arthritis market
- HPV vaccine fight against cervical cancer continues to be hampered in some parts of Europe
- Ipilimumab continues to push forward expectations for the treatment of melanoma
- Further evidence points to nicotinic receptors modifying amyloid as well as improving cognition
- Repligen reports Phase 3 RG1068 data: Improved MRI imaging of pancreatic and biliary disease expected to reduced ERCP procedures
- 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