New Infrastructure Is Needed to Create Value

February 18, 2013, 8:10 am

≫ Next: Plan to Cut Drug Costs Will Hurt Pharma Industry’s Bottom-Line

Précis:

Developing and commercializing personalized medicine requires that top executives at life sciences companies become value managers and support a value management infrastructure, Jeff Elton examines and explains...

Those life sciences companies which are advancing personalized and targeted therapeutics are realizing the vast amounts of increasingly diverse data they must access, combine and analyze if they are to interpret and communicate the value of their innovative therapeutics.Data from patient-specific electronic medical records (EMRs), genomic and genetic data, electronic patient-reported data, and financial data offers practical insight into how to optimize patient care and determine those therapies that can provide the highest overall value to patients and health care systems.

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eyeforpharma Barcelona

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Plan to Cut Drug Costs Will Hurt Pharma Industry’s Bottom-Line

February 18, 2013, 8:45 am

≫ Next: Merck Settles Vytorin Clinical Trials Data Lawsuit For US$688 Million

≪ Previous: New Infrastructure Is Needed to Create Value

Précis:

President Barack Obama is targeting drug rebates in efforts to reduce ever rising Medicare costs. This could potentially result in billions of dollars in lost profits for the drug industry.

In his State of the Union address presented last week President Obama confirmed a focus on reducing the government payments for pharmaceuticals used by low-income Medicare beneficiaries. He said he would “reduce taxpayer subsidies to prescription drug companies”.

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Merck Settles Vytorin Clinical Trials Data Lawsuit For US$688 Million

February 19, 2013, 3:27 am

≫ Next: Real World Data: A Fundamental Tool

≪ Previous: Plan to Cut Drug Costs Will Hurt Pharma Industry’s Bottom-Line

Précis:

In what is claimed to be one of the top 25 securities class action settlements of all time, Merck & CO has settled investor claims that the company withheld negative data from clinical trials on Vytorin.

Investors believed that Merck & Co had failed to disclose important details about the clinical trials it was undertaking on Vytorin, a combination of the generic cholesterol drug Zocor and the newer medicine Zetia.

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Real World Data: A Fundamental Tool

February 21, 2013, 7:08 am

≫ Next: Awarding Science Prodigies - Life Sciences Breakthrough Prize

≪ Previous: Merck Settles Vytorin Clinical Trials Data Lawsuit For US$688 Million

Précis:

Louise Kelly speaks to Dr. John Parkinson, Director of the Clinical Practice Research Datalink about Real World Data, it's true value in improving the clinical development process and its ability to drive costs down.

Using the right type of data in the correct manner within the pharma industry fosters the healthcare of patients and assists pharmaceutical companies to demonstrate the value of their products to the necessary regulatory bodies. But it is the effective and efficient gathering of this real world data (RWD) at the right time – and in the right place – that will really help bridge the gap between the development of medicines and what happens in real life clinical practice.

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Real World Data Europe

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Awarding Science Prodigies - Life Sciences Breakthrough Prize

February 21, 2013, 9:51 am

≫ Next: An Increase in Drug Approvals – But at What Cost?

≪ Previous: Real World Data: A Fundamental Tool

Précis:

A group of Silicon Valley moguls have launched an awards program that eclipses the Swedish Nobel Prize in terms of winnings. Over the next two years alone, $50m has been pledged to reward medical science innovation but will this scheme inspire new research or simply foster ‘old boy’ syndrome?

Some of the world's richest internet entrepreneurs have awarded eleven disease researchers $3m (£1.9m) each – more than twice as much as the award money for a Nobel Prize – in the inaugural Breakthrough Prize in Life Sciences. The first winners, mostly hailing from the US were announced on Wednesday (20^thFebruary 2013). The impressive prize fund is intended to go towards the research of the scientists in the fields of cancer, genetics, and stem cells.

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Real World Evidence USA

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An Increase in Drug Approvals – But at What Cost?

February 22, 2013, 4:28 am

≫ Next: The Challenging Pathway Ahead For Biosimilar Pharmaceuticals

≪ Previous: Awarding Science Prodigies - Life Sciences Breakthrough Prize

Précis:

The BMJ Open journal has reports that the number of new drugs introduced into the UK over the last thirty years has been rising, not falling. The bigger picture however, shows the rising costs of drug development and the steady decline of the R&D talent pool are still proving problematic.

Report author Dr. Derek Ward states that“this is obviously a good thing for patients, if more new medicines are becoming available.” However, as eyeforpharma explores in this article, this is only half of the story, as pharma deals with rising costs and a lack of efficiency in developing new drugs.

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eyeforpharma Barcelona

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The Challenging Pathway Ahead For Biosimilar Pharmaceuticals

February 25, 2013, 8:43 am

≫ Next: eyeforpharma Turkey

≪ Previous: An Increase in Drug Approvals – But at What Cost?

Précis:

Over the past couple of years there has been much debate about the development of biosimilars and the potential threat that these present for current innovator products.

More recently however the considerable challenges associated with biosimilar development mean that it is likely it is still some time before biosimilar products can truly become a major player in the healthcare sector.

The challenge of molecular complexity

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Oncology Marketing & Market Access USA

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eyeforpharma Turkey

February 26, 2013, 3:58 am

≫ Next: NICE backs All Trials Campaign

≪ Previous: The Challenging Pathway Ahead For Biosimilar Pharmaceuticals

Event Duration

Event Date:

Wed, 2013-10-09 - Thu, 2013-10-10

Entire Month Duration:

All Month

Event URL:

http://www.eyeforpharma.com/turkey

Event Location:

Istanbul

History:

2nd Annual

Number of attendees:

250

Event Organiser:

Thushani Kumarasinghe

Event Organiser E-mail:

thushani@eyeforpharma.com

Précis:

The most prestigious event in Turkey, with international experts

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NICE backs All Trials Campaign

February 26, 2013, 4:22 am

≫ Next: Oncology Japan

≪ Previous: eyeforpharma Turkey

Précis:

The UK National Institute for Health and Clinical Excellence (NICE) joined the supporters of the All Trials campaign, which calls on responsible bodies to ensure that all trials, past and present, for all treatments, are registered and that the full methods and full results are published.

NICE's chairman, Michael Rawlins, said in a statement, “We strongly believe that all clinical trial data should be made available so that that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.”

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Patient Summit Europe

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Oncology Japan

February 26, 2013, 4:58 am

≫ Next: Patient-Centric Services Europe

≪ Previous: NICE backs All Trials Campaign

Event Duration

Event Date:

Wed, 2013-11-06 - Thu, 2013-11-07

Event URL:

http://www.eyeforpharma.com/oncologyjapan/

Event Location:

Tokyo

History:

4th Annual

Number of attendees:

200

Event Organiser:

Stephanie Coombes

Event Organiser E-mail:

scoombes@eyeforpharma.com

Précis:

Deliver the most appropriate cancer treatments for patients and maximize your sales revenue.

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Patient-Centric Services Europe

February 26, 2013, 5:26 am

≫ Next: Window dressing: Roche Launches New Process for Accessing Clinical Trial Data

≪ Previous: Oncology Japan

Event Duration

Event Date:

Wed, 2013-09-18 - Thu, 2013-09-19

Entire Month Duration:

All Month

Event URL:

http://www.eyeforpharma.com/patient/

Event Location:

London

History:

1st Annual

Number of attendees:

120

Event Organiser:

Lanre Ibitoye

Event Organiser E-mail:

lanre@eyeforpharma.com

Précis:

Become a health provider and add value beyond the pill

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Window dressing: Roche Launches New Process for Accessing Clinical Trial Data

February 27, 2013, 4:23 am

≫ Next: India Considers Ending Compulsory Licensing Tactics

≪ Previous: Patient-Centric Services Europe

Précis:

Roche announced they will set up an 'independent body of recognized experts' to evaluate and approve requests to access patient-level clinical trial data by third party researchers.

Roche will support the release of case study reports for all its licensed medicines. The Swiss manufacturer follows a similar commitment made by the English GlaxoSmithKline who backed the All Trials campaign earlier this month.

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Real World Evidence USA

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India Considers Ending Compulsory Licensing Tactics

February 28, 2013, 6:06 am

≫ Next: Compulsory Licence Upheld but Pricing Guidelines Waiting in the Wings

≪ Previous: Window dressing: Roche Launches New Process for Accessing Clinical Trial Data

Précis:

Following a cold war between the Indian government and Big Pharma which has lasted for months, if not years, there are now indications that India may be looking to revise its compulsory licensing tactics.

The industry is still reeling from the news that India plans to grant three more compulsory licenses, which will give generics firms the right to manufacture vastly cheaper versions of two of Roche’s drugs and one of Bristol Myers-Squibb’s. Now it has emerged that India is considering an end to the practice of issuing compulsory licenses, replacing them instead with price controls.

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Compulsory Licence Upheld but Pricing Guidelines Waiting in the Wings

March 6, 2013, 4:22 am

≫ Next: Lawsuits against Generic Competition after Patent Increase for Pfizer’s Celebrex

≪ Previous: India Considers Ending Compulsory Licensing Tactics

Précis:

India’s Intellectual Property Appellate Board (IPAB) yesterday upheld the country’s first compulsory licence to a generic manufacturer for Bayer’s cancer drug Nexavar. The ruling sets a legal precedent for further patent challenges but new pricing guidelines may act as something of a safeguard.

India's patent appeals office has rejected international drug maker Bayer's plea to stop local drug manufacturer, Natco Pharma from manufacturing a cheaper generic version of the firm’s patented kidney and liver cancer treatment. The German company had filed an appeal against the IPAB's decision in March 2012 to issue a compulsory license to Natco, arguing that their high prices would not have a detrimental effect on public interest as another company was selling the drug at a lower price.

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Lawsuits against Generic Competition after Patent Increase for Pfizer’s Celebrex

March 6, 2013, 7:46 am

≫ Next: New EU Safety Symbol Identifies Pharmaceuticals Subject To Additional Monitoring

≪ Previous: Compulsory Licence Upheld but Pricing Guidelines Waiting in the Wings

Précis:

Pfizer filed lawsuits against several US generic drug manufacturers after a patent for its drug Celebrex was reissued, thus extending its exclusivity to 18 months.

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New EU Safety Symbol Identifies Pharmaceuticals Subject To Additional Monitoring

March 11, 2013, 4:06 am

≫ Next: Emerging Markets: Realizing the Potential for Growth

≪ Previous: Lawsuits against Generic Competition after Patent Increase for Pfizer’s Celebrex

Précis:

The European Commission has confirmed that the labels of medicinal products which are undergoing extra monitoring will be required to carry a new symbol to identify them.

This decision to make the new symbol, an inverted black triangle, a legal requirement was part of an act adopted by the European Commission late last week. The purpose of the inverted black triangle is to ensure that health professionals and patients are able to easily recognize pharmaceuticals that are still being monitored. Its intention is that people will be encouraged to report any unexpected adverse reactions to certain drugs through the national reporting processes.

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eyeforpharma Barcelona

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Emerging Markets: Realizing the Potential for Growth

March 13, 2013, 6:35 am

≫ Next: Poorest Countries Seek More Time for Intellectual Property Transition

≪ Previous: New EU Safety Symbol Identifies Pharmaceuticals Subject To Additional Monitoring

Précis:

Ben Steele speaks with David Stern, Head of the Global Fertility Franchise at Merck Serono, about how pharma companies can utilize a ‘beyond the pill’ approach in order to realize potential growth opportunities in emerging markets.

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eyeforpharma Philadelphia

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Poorest Countries Seek More Time for Intellectual Property Transition

March 14, 2013, 5:32 am

≫ Next: Pfizer Seeks Capitol Hill Support Against ‘Protectionist’ India

≪ Previous: Emerging Markets: Realizing the Potential for Growth

Précis:

The World Trade Organization has postponed a decision on whether they will extend the July 2013 deadline for the implementation of the TRIPS agreement in developing countries, putting into doubt whether life-saving medicines will continue to be widely available to the poorest nations.

The property rights committee, responsible for the implementation of Trade-Related Aspects of Intellectual Property Rights (TRIPS), met on March 5th to discuss the proposal of the Least Developed Countries (LDCs) to allow more time to develop the financial and technological capacity, i.e. to graduate to a 'more' developed category under the UN classification, before enforcing intellectual property. The motion met with support of the developing countries and restrained enthusiasm from the developed nations, although the final decision has been postponed.

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Pfizer Seeks Capitol Hill Support Against ‘Protectionist’ India

March 15, 2013, 7:56 am

≫ Next: New EU Legislation Needed To Investigate Long-Term Safety Of Chronic Treatment

≪ Previous: Poorest Countries Seek More Time for Intellectual Property Transition

Précis:

Pfizer has become the first pharma company to call on the U.S government to “review all available policy tools” in the battle against what it has termed the “protectionist” regime in India, ahead of a renewal of Indian trade benefits in July.

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New EU Legislation Needed To Investigate Long-Term Safety Of Chronic Treatment

March 20, 2013, 8:55 am

≫ Next: GW Pharma Fall Foul Of German Reimbursement System

≪ Previous: Pfizer Seeks Capitol Hill Support Against ‘Protectionist’ India

Précis:

Current legislation is insufficient to evaluate the long-term safety and efficacy of chronic drugs for patients before regulatory approval.

Recently, European researchers led by Robert Duijnhoven from Utrecht University gathered information from the European Commission relating to 200 medicines that were approved between 2000 and 2010. The authors of this study, as published in PLOS Medicine, used this information to investigate whether the amount of patients included before approval met the International Conference on Harmonisation E1 guidelines.

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Real World Data Europe

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