09/30/09
Global AIDS Detection and Treatment Surge
There has been an increase in the number of people being tested for H.I.V. in developing countries, improving detection of AIDS and resulting in amajor surge in those being treated with antiretroviral drugs.
Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives European Commission Approval
GlaxoSmithKline (GSK) confirmed that the European Commission has granted marketing authorization of GSK’s pandemic (H1N1) adjuvanted vaccine Pandemrix™.
http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10094.htm
Biotech in the Middle East
Oil rich countries like the UAE and Qatar are pouring money into biotech initiative, trying to transform teh deser nations into true research centers.
http://www.dubiotech.ae/index.php?
http://www.the-scientist.com/toc/2009/10/
Biotech in the Middle East
Oil rich countries like the UAE and Qatar are pouring money into biotech initiative, trying to transform teh deser nations into true research centers.
http://www.dubiotech.ae/index.php?
http://www.the-scientist.com/toc/2009/10/
Americans willing to fund healthcare reform
Surveys show that most Americans would pay higher taxes to fund healthcare reforms that provide the best quality of care, but only a minority expects Washington to deliver it.
Surveys show that most Americans would pay higher taxes to fund healthcare reforms that provide the best quality of care, but only a minority expects Washington to deliver it.
Novartis MS Pill Works, May Launch As Soon As '10
Healthcare for poor strained by recession
The U.S. recession has ramped up demand for Medicaid and states that manage the healthcare program for the poor are worried they may not be able to cover future costs.
09/29/09
Senators Reject Pair of Public Option Proposals
U.S. Senate committee rejected two Democratic proposals to create a government insurance plan to compete with private insurers.
Abbott to acquire Solvay for $7.6 billion dollars
Abbott beat out Nycomed in its bid for Solvay. Seen as a good deal by investors, allows Abbott to gain full control over drugs TriCor (fenofibrate) and TriLipix, which were co-sold by the companies.
Abbott beat out Nycomed in its bid for Solvay. Seen as a good deal by investors, allows Abbott to gain full control over drugs TriCor (fenofibrate) and TriLipix, which were co-sold by the companies.
UK girl died soon after a Cervarix injection
Other girls at the school reported other mild symptoms. The cause of death is unknown, however.
http://www.google.com/hostednews/ap/article/ALeqM5h0LTAtQ3mNdBuKKhqkQgZ2hZk4oQD9B0VOH80
Other girls at the school reported other mild symptoms. The cause of death is unknown, however.
http://www.google.com/hostednews/ap/article/ALeqM5h0LTAtQ3mNdBuKKhqkQgZ2hZk4oQD9B0VOH80
J&J bought 18% stake in Crucell
Companies will co-develop monoclonal antibodies against infectious influenza.
Companies will co-develop monoclonal antibodies against infectious influenza.
GSK entered long-term contract with Brazil for a Pneumococcal Vaccine
Brazil has been very aggressive negotiating inexpensive drugs and this deal, says GSK, could be a model for deals with other developing countries.
Sanofi-Aventis to launch insulin research program; analyzing potential association between cancer and insulin use
http://www.marketwatch.com/story/sanofi-aventis-to-launch-insulin-research-program-2009-09-29
New research that diabetes contributes to decreased bone density
http://www.medicalnewstoday.com/articles/165525.php
Brazil has been very aggressive negotiating inexpensive drugs and this deal, says GSK, could be a model for deals with other developing countries.
Sanofi-Aventis to launch insulin research program; analyzing potential association between cancer and insulin use
http://www.marketwatch.com/story/sanofi-aventis-to-launch-insulin-research-program-2009-09-29
New research that diabetes contributes to decreased bone density
http://www.medicalnewstoday.com/articles/165525.php
09/28/09
EMEA recommends approval of GSKs and Novartis' H1N1 vaccines
More availability of H1N1 vaccines through accelerated approval processes.
Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients
http://www.drugs.com/nda/glycopyrrolate_090929.html
Sciele Pharma Submits New Drug Application to FDA for Glycopyrrolate Oral Solution, a Treatment for Chronic, Moderate-to-Severe Drooling in Pediatric Patients
http://www.drugs.com/nda/glycopyrrolate_090929.html
Health Care Overhaul and Mandatory Coverage Stir States’ Rights Claims
Some lawmakers in more than a dozen statehouses across the country are pressing for state constitutional amendments to outlaw a crucial element of the health care plans under discussion in Washington: the requirement that nearly everyone buy insurance or pay a penalty.
http://www.nytimes.com/2009/09/29/us/29states.html?ref=health
09/27/09
Microchip analyzes urine to test for prostate cancer
http://www.thestar.com/comment/article/701781
09/27/09
Microchip analyzes urine to test for prostate cancer
http://www.thestar.com/comment/article/701781
09/25/09
Vaccine lowers rate of HIV by 30%
Study carried out in Thailand and sponsored by the US Army. The treatment is the first to show any effectiveness in immunizing against HIV.
FDA issues statement that Januvia causes pancreatitis, Merck denies link
http://www.drugs.com/news/merck-statement-januvia-sitagliptin-janumet-sitagliptin-metformin-20068.html
http://www.rttnews.com/Content/BreakingNews.aspx?Id=1077362
Roche halts enrollment in Avastin breast cancer trial after reports of congestive heart failure
Roche announced that enrollment into a late-stage trial of Genentech Inc.'s Avastin (bevacizumab) was halted after six patients experienced congestive heart failure (CHF).
Merck HPV Vaccine Gardasil will be Donated
Merck will provide drug for developing countries, but is looking for help administering the doses. Difficulty lies in ensuring the completion of the three dose regiment.
Merck will provide drug for developing countries, but is looking for help administering the doses. Difficulty lies in ensuring the completion of the three dose regiment.
09/23/09
Genzyme Allston Factory Back in Production
Genzyme Allston Factory Back in Production
The plant has recovered from a shutdown due to contamination. Demand for Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta), produced at the plant, should be met.
09/22/09
Avastin Improves Metastatic Melanoma Survival Rate
Analysts believe if approved, the indication has a $1 Billion potential market
Is Inhaled insulin still a possibility?
Discusses benefits of inhaled insulin that are potentially underestimated, and that there are reasons it should not be abandonded.
http://www.medicalnewstoday.com/articles/165093.php (article)
http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2009.0088?cookieSet=1 (full report)
Analysts believe if approved, the indication has a $1 Billion potential market
Is Inhaled insulin still a possibility?
Discusses benefits of inhaled insulin that are potentially underestimated, and that there are reasons it should not be abandonded.
http://www.medicalnewstoday.com/articles/165093.php (article)
http://www.liebertonline.com/doi/pdfplus/10.1089/dia.2009.0088?cookieSet=1 (full report)
09/21/09
GSK could buy 5% stake in Dr. Reddy
The deal would be valued at $150 mill. Will take stake in company to solidyfy relationship selling Dr. Reddy outside of India.
GSK could buy 5% stake in Dr. Reddy
The deal would be valued at $150 mill. Will take stake in company to solidyfy relationship selling Dr. Reddy outside of India.
Arena Obesity Drug, Lorcaserin, Meets Phase III Study Goals
However, the drug is not as effective as some other investigational drugs in clinical trials
However, the drug is not as effective as some other investigational drugs in clinical trials
Earlier
Denmark-based Zealand pharma develops a new dual Glucagon-GLP-1 agonist that both controls the blood glucose levels and reduces weight in obese diabetic models.
http://www.pharmaceutical-business-review.com/news/zealand_pharma_develops_zp2929_for_type_2_diabetes_090901
Highlights from ECCO-ESMO Conference from 09/20/09-09/24/09
- Amgen's Vectibix was effective against colorectal cancer, using KRAS biomarker testing is recommended
- Merck's Erbitux had mixed results for metastatic colorectal cancer, need for personalized care due to different types of KRAS genes
- Roche and Plexxikon PLX4032 shrinks metastatic melanoma
- Bayer and Onyx's Nexavar has good results with breast cancer
- Pfizer's Aromasin in effective for breast cancer Roche's Avastic improves neurocognition in glioblastoma
- Amgen announced denosumab is non-inferior to Novartis' Zometa, treating solid cancers (non-breast, non-prostate) in a head to head study
This is an example of what a comment would look like.
ReplyDeleteDavid Weingeist on GSK
ReplyDeleteLots in the news about GlaxoSmithKline…
As discussed in class, drug sales are predicted to grow at ~15% in emerging markets through 2013 (IMS Health Reports), compared with low single-digit growth in mature markets. In addition, many blockbusters will come off patent during this time, making generics an increasingly lucrative enterprise.
GlaxoSmithKline is aggressively moving into both these markets through deals with generics producers in India (see “GSK could buy 5% stake in Dr. Reddy”) and their 16% buy in Africa’s biggest generics manufacturer, Aspen Pharmacare, last May. This is a brilliant strategy, as both deals will give GSK access to new markets while stocking their pipelines with hundreds of generics. Lastly, the company is partnering with the Brazilian government (See “GSK entered long-term contract with Brazil for a Pneumococcal Vaccine”). Although the price they will sell Synflorix is significantly discounted to the European price, the high volumes and long timescale (8 year deal) will provide secure revenues and enable future penetration into this growing market. I think GSK has a winning strategy against the big issues we have been covering in class (drugs coming off patent, decrease in new chemical entities, emerging markets). However, they have much to strive for in the biologics sector, especially with the troubling news of the Cervarix fatality (See “UK girl died soon after a Cervarix injection”). Hopefully this is an isolated incident, or at worst, a faulty batch.
With regard to Americans' willingness to spend more for healthcare:
ReplyDeleteI would argue that we don't necessarily need to spend more, but to be more cognizant of the way we spend now. There is a lot of waste that can be attributed to inefficiencies within the healthcare system. For example, the continuing lack of reliable electronic medical records is a key barrier to cost reduction by way of reducing duplicative tests and procedures. Ultimately, there is an imperative to move towards a prevention-based system emphasizing better lifestyle choices. Perhaps this, in turn, starts with taxing unhealthy food choices or subsidizing healthy food choices. Money talks, but more money is not necessary when more efficient spending would be just as good.
This in response to the posting on ‘Microchip analyzes urine to test for prostate cancer’ …
ReplyDeleteThis article serves as a good example of the promise of biomolecular detection assays to improve the screening mechanisms for cancer and to provide a better prognosis for patients. Such devices can not only enable earlier detection that can improve the survival rate of patients, but also allow physicians to monitor the progress of the administered therapy to their patients. This calls for a non-invasive, high sensitivity and high specificity assay that the authors have demonstrated.
However, as is well-known that it is very hard to find biomarkers that uniquely characterize a cancer cell and distinguish it from a background of normal cells in a given patient sample. Another issue is the variability of molecular expression from patient to patient for a given type of cancer. This calls for identification of a host of biomarkers that will not only increase the sensitivity of the assay but also make it applicable to a larger patient population. In the same vein, probing multiple markers in a given patient sample would require mechanisms of multiplexing to be enabled. Another issue that is often short-sighted is the complexity of the blood or urine samples acquired from patients, as a lot of these studies are demonstrated on laboratory cultured immortalized cell lines. Often before one can use the patient sample on the device a number of filtration and separation steps have to be performed to reduce non-specific interactions and to increase the concentration of the biomolecule of interest in the sample. Using microfluidics such steps can be integrated with the device yielding a one-chip solution for molecular diagnostics. Efforts are also being made to miniaturize such devices and enable remote access of patient data to clinics so as to encourage their use in global health applications where one may not have the luxury of going into a doctor’s office or a medical laboratory to process the results.
This is a follow-up to the news article reporting the death of a 14-year old British girl shortly after receiving the HPV vaccine Cervarix.
ReplyDeleteOn Oct 2, 2009 a post-mortem pathology report confirmed that the death of Natalie Morton was due to an underlying condition. The large tumor found in the heart and lungs was attributed as the cause her death and not the HPV vaccine shot that she had received shortly before her demise. GlaxoSmithKline, the manufacturers of the vaccine had temporally recalled all vaccines in the batch that Natalie had received her dose from. However, soon after the above announcement, the recall was cancelled and the Department of Health issued a notice to all GPs and school nurses to resume the HPV immunization program.
http://www.medicalnewstoday.com/articles/165961.php.
Judy Wang
ReplyDeleteIn response to the New York Times article, “Health Care Overhaul and Mandatory Coverage Stir States’ Rights Claims,” I couldn’t help but think that this is potentially the messiest and possibly largest roadblock that the Obama administration will encounter en route to an overhaul of the American health care system. Most of the debate surrounding the health care reform debate has been regarding the public option, but turning the debate into a battle between states rights and federal rights will deal President Obama a huge blow in securing universal health care in the United States.
The states’ right issue in the health care reform debate is especially dangerous to the health care reform movement, as it potentially paves the way for multiple and differing state laws across the country. One example of this in the United States is the issue of abortion rights—every state has different laws regarding when a woman is allowed to have an abortion, based on the timeline of the pregnancy and the woman’s age. There are multiple stories of women having to cross state lines just to have an abortion. If the states’ rights issue reaches the health care reform movement, getting medical treatment could be subjected to this hassle, making it even more difficult for Americans to receive adequate medical care. This would make the American health care system even more inefficient than it is, and practically kills any chance of any real health care reform in the United States.
This is to expand on the insulin-cancer link article: http://www.marketwatch.com/story/sanofi-aventis-to-launch-insulin-research-program-2009-09-29
ReplyDeleteA study was published earlier this year in June http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=19565214 where ~130,000 patients were followed for about 2 years on average, and found a correlation between cancer and the dosage of an insulin analog, marketed by Sanofi-Aventis as "Lantus". The interesting thing to note is that the patients taking Lantus actually had a lower incidence of cancer developing, but because they were taking lower doses of the insulin analog compared to regular human insulin, the correlation of cancer related to the dose of insulin ended up being higher.
http://www.emea.europa.eu/humandocs/PDFs/EPAR/Lantus/47063209en.pdf The European Medicines Agency did respond to the study but called it inconclusive because of the methodology of the study. They also called on Sanofi-Aventis to do further research into their product.
Background on the insulin analog: some diabetic patients take a drug that is chemically similar to natural human insulin, but because of slight differences, it acts over a longer period of time, requiring a smaller dosage. However, because of these same differences, there is a chance that it could potentially be active elsewhere in the body, leading to side effects such as the development of disease and cancer.
- Lu Chou
This is an addendum to the comment about molecular diagnostics:
ReplyDeleteMultiple biomarkers are necessary and ultimately, the success of any molecular diagnostic device will boil down to sensitivity and specificity relative to existing methods of cancer screening. Many technologies are 5 - 10 years away from being useful for widespread cancer screening.
Re Novartis’ FTY720 (the oral MS drug)
ReplyDeleteNovartis AG may be closing in on a substantial portion of the growing MS market with an estimated >$1 billion annual revenue (compared with the leading MS drug Avonex whose 2008 sales totaled $2.2 billion).
As the first oral MS drug, the market appeal of FTY720 is huge. Current drugs on the market (Avonex, Copaxone, Rebif, Betaseron, etc) are all injection formulations. The profit margin of FTY720, however, may be larger, considering the probable lower production cost of FTY720 (a small molecule) than current drugs on the market, all of which are proteins. It is important to note, though, that if other oral drugs in development are approved, notably Merck KGaA’s cladribine or Biogen Idec’s BG-12, FTY720 will occupy a smaller share of the market and will generate less revenue.
Also important is that this drug, like the current market drugs, primarily aimed at reducing relapses and slowing progression of disease. Although of benefit to patients, the ultimate vision for MS treatment is reversing dysfunction and demyelination in patients. This vision has not yet been successfully approached by any serious drug candidate.
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ReplyDelete