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

Hitting pharma costs where it hurts

20th November 2014 13:55

The pharmaceutical industry is going through a period of almost unprecedented transformation. Drug patent lives are shortening, but the expense of developing new products continues to rise. What have traditionally been seen as predictably stable and profitable lines of business are rapidly becoming anything but.
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Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes

14th July 2014 22:22

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Takeda launches Entyvio (vedolizumab) in the US for IBD; Roche opens new Phase 3 etrolizumab study

17th June 2014 07:34

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Ahead of tomorrow's oral presentation at EULAR, BMS has announced data from AVERT, its Phase 3b study of Orencia

11th June 2014 15:38

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The FDA has approved Entyvio (vedolizumab) for the treatment of UC and CD

21st May 2014 20:57

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Boehringer-Ingelheim takes adalimumab biosimilar into Phase 3 development for RA

19th May 2014 16:16

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Abbvie announces new Phase 3 Humira studies for IBD - pediatric UC study and a test of high dose Humira for UC and CD

20th February 2014 16:35

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UpdatesPlus-Rheumatoid Arthritis (April 2013)

15th May 2013 23:41

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

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Galapagos has announced filing to initiate Phase 2b rheumatoid arthritis program for GLPG0634

27th March 2013 14:18

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

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Was the FDA correct in updating its warning of increased CV events with Chantix/Champix?

12th December 2012 23:53

Reports of neuropsychiatric AEs prompted Pfizer to focus Champix/Chantix on smokers at high risk if they do not quit.  This cohort includes those with CV disease.
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Pfizer just can't seem to win with Champix/Chantix as another label change approaches

17th June 2011 21:12

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

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Tacrolimus as a new approach to pulmonary artery hypertension?

19th May 2011 19:55

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

4th May 2011 23:45

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.

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Telaprevir takes a leap towards the HCV market while boceprevir appears to be crawling over the line

28th April 2011 23:32

HCV news hot off the press from Maryland: We now have positive opinions on two HCV candidates in two days.

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The patent cliff is set to drive global generic uptake despite tougher market conditions

26th April 2011 23:35

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.

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Dual advances in the treatment of Clostridium difficile

12th April 2011 22:02

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.

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FDA to decide of everolimus (Afinitor) and Sunitinib (Sutent) for the treatment of advanced pancreatic neuroendocrine tumors (PNET)

11th April 2011 22:28

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

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Vandetanib is approved in the US for medullary thyroid cancer

8th April 2011 00:50

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.

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Clopidogrel variability - GIFT data puts the brakes on PON-1 as a major factor modifying the response to clopidogrel.

5th April 2011 20:11

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.

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UK recommendation for Merck's Simponi but it may struggle to make an impact in the rheumatoid arthritis market

25th March 2011 19:51

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.

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HPV vaccine fight against cervical cancer continues to be hampered in some parts of Europe

23rd March 2011 23:21

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.

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Ipilimumab continues to push forward expectations for the treatment of melanoma

22nd March 2011 22:27

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.

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Further evidence points to nicotinic receptors modifying amyloid as well as improving cognition

18th March 2011 22:13

Researchers have identified a further link between nicotinic receptors and the etiology of Alzheimer's disease

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Repligen reports Phase 3 RG1068 data: Improved MRI imaging of pancreatic and biliary disease expected to reduced ERCP procedures

15th March 2011 09:08

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.

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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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