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

21st July 2010 18:39

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.

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New data analysis reduces some of the concerns over upcoming Systemic Lupus Erythematosus (SLE) treatment, Benlysta (belimumab)

28th June 2010 22:07

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.

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APS 2010: fibromyalgia newcomer seeks differentiation while prospective player draws nearer

21st May 2010 20:32

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

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NicOx: FDA panel negative opinion casts future of osteoarthritis drug into doubt

17th May 2010 12:35

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]

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Dendreon: landmark cancer vaccine approval but high costs may hinder uptake

7th May 2010 19:30

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

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Could generic lansoprazole become the next major advance for hepatocellular cancer

27th April 2010 23:52

Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world.  HCC patients are poorly served by existing treatment options, with only a small proportion amenable to curative therapy such as surgical resection and liver transplantation . Prognosis is poor for unresectable patients and so R&D interest in HCC is relatively high.  This has lead to recent advances, notably for example with the launch of sorafenib (Nexavar) in 2007.  Yesterday the FDA approved a Phase 2 study evaluating PrevOnco (lansoprazole) as a candidate treatment of HCC.

For further informaion on HCC see Hepatocellular Carcinoma - Opportune indication for novel therapies

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AAN 2010: new treatments address unmet needs in Alzheimer's and epilepsy

23rd April 2010 19:07

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:

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Clavis and Clovis collaboration to tackle problem of Gemzar (gemcitabine) resistance - New hope for pancreatic and non-small cell lung cancers

11th March 2010 16:47

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

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Hope for an Alzheimers breakthrough remains despite Dimebon's failure

5th March 2010 16:14

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.

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Agendia's MammaPrint prognostic technology: Improving medical management of breast cancer patients with small tumours

4th March 2010 12:06

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.

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Advaxis lights up the future for cervical cancer and maybe some head and neck cancers

24th February 2010 17:44

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:

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Javelin Pharmaceuticals continues to show promise in the pain arena

22nd February 2010 21:43

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.

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Promising data reads out from ADVANCE as first generation oral HCV therapies march on

17th February 2010 09:15

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

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