Florida Joins Growing Number of States Passing Biosimilar Substitution Bills

May 7, 2013, 6:03 am

≫ Next: India Tightens Clinical Trial Monitoring

≪ Previous: High Price of Cancer Treatments Coming Under Fire

Précis:

Last week, the state of Florida passed legislation allowing for the substitution of biologics with biosimilars alternatives, joining a growing list of states in America to do so.

The legislation in Florida sets out the requirements for pharmacists to substitute biologics when they are determined to be biosimilar and interchangeable with the brand name product. It also outlines the requirements for the state board of pharmacy to maintain a current list of interchangeable products.

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India Tightens Clinical Trial Monitoring

May 7, 2013, 7:45 am

≫ Next: False World Vs. Real World: A Strong Argument for RWD

≪ Previous: Florida Joins Growing Number of States Passing Biosimilar Substitution Bills

Précis:

India’s Drug Controller General is to increase monitoring of clinical trials following health activists’ pushing for tougher regulations in the Supreme Court, as concerns continue to arise about the safety and integrity of trials across the country.

Additionally, the Expert Committees will now be required to visit all clinical trials sites annually to verify the sites’ compliance with India’s Schedule Y regulations on clinical trials, Good Clinical Practice Guidelines and “other applicable regulatory requirements”.

The sites will also be required to keep records detailing the names, qualifications, and other relevant details of study investigators and clinical-trial sites falling under their jurisdiction, the Drugs Controller General says.

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False World Vs. Real World: A Strong Argument for RWD

May 16, 2013, 5:48 am

≫ Next: Reaching the Smart Patient Requires ‘360-Degree Marketing’

≪ Previous: India Tightens Clinical Trial Monitoring

Précis:

Lucy Brake speaks to Mike Rea, CEO of IDEA Pharma, about how he believes real world evidence impacts current development and trials processes, and the ways in which pharma can take best take advantage of all this offers.

Find the pathway

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Real World Evidence USA

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Reaching the Smart Patient Requires ‘360-Degree Marketing’

May 20, 2013, 3:38 am

≫ Next: Russia, Ukraine and Kazakhstan Expanding Access to Medicine

≪ Previous: False World Vs. Real World: A Strong Argument for RWD

Précis:

Ben Steele talks with Eduardo Tchouhadjian, CEO of E. Tchouhadjian & Associates, about how companies in Latin America are responding to the rise of the ‘smart patient’ and how to use “360-degree marketing” to combat the issue of prescription switching in these fast-growing markets.

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Sales & Marketing Excellence Latam

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Russia, Ukraine and Kazakhstan Expanding Access to Medicine

May 22, 2013, 4:04 am

≫ Next: New Pharma Standards in China Paves the Way for Higher Standards and Increased Competition

≪ Previous: Reaching the Smart Patient Requires ‘360-Degree Marketing’

Précis:

New findings suggest that if recent steps taken by the CIS countries are seen through to completion, it will revolutionize the pharma landscape, and open up access to medicines in these countries.

A new strategy for medication provisions, which extends until 2025, was approved by Russia’s Minister of Health in February 2012, aiming to increase availability of medicines, supporting the use of domestically-made products and increasing the scope of preventive health interventions. The new policy, scheduled to take effect in 2016, also extends the reimbursement scheme, which is currently limited to veterans, invalids and children up to the age of three.

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Real World Data Europe

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New Pharma Standards in China Paves the Way for Higher Standards and Increased Competition

May 23, 2013, 6:19 am

≫ Next: Pharma Must “Change Dialogue” around BRIC Markets

≪ Previous: Russia, Ukraine and Kazakhstan Expanding Access to Medicine

Précis:

Revision of China’s Good Supply Practice for Pharmaceutical Products took almost three years to finalise, the final product establishing higher standards for quality controls in drug distribution and supply chain management across the region. But is there another ultimate goal?

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Sales & Marketing Australia

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Pharma Must “Change Dialogue” around BRIC Markets

May 24, 2013, 6:04 am

≫ Next: Market Access Canada

≪ Previous: New Pharma Standards in China Paves the Way for Higher Standards and Increased Competition

Précis:

Pharma companies looking to expand into emerging markets such as Brazil, Russia, India and China (BRIC) must avoid cutting corners and concentrate more on establishing value according to a new report.

The study from Frost & Sullivan advises companies that they must change their approach in emerging markets, focussing more on catering to local needs and building regional alliances in order to achieve sustainability in these markets.

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Market Access Canada

May 24, 2013, 8:30 am

≫ Next: Global Ethics Codes and the Latin American Pharma Market

≪ Previous: Pharma Must “Change Dialogue” around BRIC Markets

Event Duration

Event Date:

Mon, 2013-10-07 - Tue, 2013-10-08

Entire Month Duration:

All Month

Event URL:

http://www.eyeforpharma.com/macanada/

Event Location:

Toronto

Number of attendees:

150

Event Organiser:

Brynn Smith-Raska

Event Organiser E-mail:

Brynn@eyeforpharma.com

Précis:

Meet the key stakeholders and understand their needs.

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Global Ethics Codes and the Latin American Pharma Market

June 6, 2013, 3:42 am

≫ Next: New Initiative to Turn Big Data into Insight

≪ Previous: Market Access Canada

Précis:

Ben Steele talks with the Vice President of Ferring Pharmaceuticals in Latin America, about the impact of global ethics codes on business the Latin American (LatAm) pharma market.

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New Initiative to Turn Big Data into Insight

June 7, 2013, 7:36 am

≫ Next: Payers' Forum Europe

≪ Previous: Global Ethics Codes and the Latin American Pharma Market

Précis:

A new international initiative has been launched with the aim of improving the approach to, and overcoming the challenges of genetic and clinical ‘big data.’

The alliance of over 60 healthcare, research and disease advocacy organizations from 41 countries wants to standardize the way these data are gathered, interpreted and shared, in order to start reaping the benefits of the rise in genome sequencing.

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Real World Evidence USA

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Payers' Forum Europe

June 10, 2013, 2:27 am

≫ Next: Major Cuts Imminent For India’s Key Drugs

≪ Previous: New Initiative to Turn Big Data into Insight

Event Duration

Event Date:

Mon, 2013-10-21 - Tue, 2013-10-22

Event URL:

http://www.eyeforpharma.com/payers-forum-europe/

Event Location:

Berlin, Germany

Number of attendees:

100

Event Organiser:

Ben Swanson

Event Organiser E-mail:

bswanson@eyeforpharma.com

Précis:

Engage with NHS, HAS, G-BA, AIFA, Spain and more to understand what Payers and HTAs want to enable you to create Value Adding Propositions

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Major Cuts Imminent For India’s Key Drugs

June 18, 2013, 4:25 am

≫ Next: US Pay-For-Delay Deals Can be Challenged but are Not Illegal

≪ Previous: Payers' Forum Europe

Précis:

India’s National Pharmaceutical Pricing Authority (NPPA) has announced that some key cancer drugs, antibiotics and medicines which are used to treat cardiovascular diseases and tuberculosis will become cheaper to buy by up to 50 per cent within the next 45 days.

According to reports in India’s leading business daily newspaper, the Business Standard, the decision to reduce the pricing of essential medicines is based on the NPPA’s new pharma pricing policy.

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US Pay-For-Delay Deals Can be Challenged but are Not Illegal

June 18, 2013, 5:41 am

≫ Next: Pfizer's Customer Approach: Change and Deliver

≪ Previous: Major Cuts Imminent For India’s Key Drugs

Précis:

Deals by pharmaceutical companies to delay generic competition can be challenged by US regulators but are not in themselves illegal, according to a recent ruling by the Supreme Court.

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Pfizer's Customer Approach: Change and Deliver

June 19, 2013, 3:49 am

≫ Next: FDA/EC Agreement Allows a More Efficient, Safer US-EU Drug Supply

≪ Previous: US Pay-For-Delay Deals Can be Challenged but are Not Illegal

Précis:

“Our primary focus is the on-going evolution of the delivery of our customer-facing operating model, increasing our relevance with our customers in the most effective and efficient manner possible,” says Matt Portch, VP Commercial Model Innovation at Pfizer.

The traditional model of monolithic delivery practices employed by the pharmaceutical industry is being rapidly replaced by tailored delivery models designed to improve quality and decrease cost. As a result of this shift, the skills, knowledge, and behaviors that previously served commercial professionals in the market will not necessarily ensure the future success of their respective firms. Because the healthcare market is changing so dramatically, the key component is to stay on top of those changes with regular monitoring and analysis, says Portch.

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FDA/EC Agreement Allows a More Efficient, Safer US-EU Drug Supply

June 24, 2013, 5:44 am

≫ Next: FDA Reject Merck’s New Insomnia Drug and Suggest More Studies

≪ Previous: Pfizer's Customer Approach: Change and Deliver

Précis:

US pharmaceutical companies can now export certain pharmaceutical products to the EU without additional documentation, as the U.S. is granted status as a ‘listed’ country by the European Commission.

Earlier this year, the FDA filed a formal ‘listing request’ with the EC so that their Good Manufacturing Practices could be seen as equal. The EC has now approved this request after having a detailed audit of the FDA’s regulatory and inspectional practices related to importing active pharmaceutical ingredients (APIs).

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FDA Reject Merck’s New Insomnia Drug and Suggest More Studies

July 2, 2013, 2:44 am

≫ Next: Proposal for EMA Pharmacovigilance Fees Adopted

≪ Previous: FDA/EC Agreement Allows a More Efficient, Safer US-EU Drug Supply

Précis:

The US Food and Drug Administration (FDA) have declined an application by Merck & Co for a New Drug Application for suvorexant, Merck’s investigational medicine for the treatment of insomnia, but at the same time suggested more studies of lower dosages.

Reuters reported that Merck had received a complete response letter from the FDA saying that the agency could “consider a 10 milligram starting dose of suvorexant for most patients, but that the company would have to have that dosage ready before it could be approved”.

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Proposal for EMA Pharmacovigilance Fees Adopted

July 2, 2013, 3:37 am

≫ Next: Pfizer Joins Feds in Attack on India’s ‘Discriminatory Trade Practices’

≪ Previous: FDA Reject Merck’s New Insomnia Drug and Suggest More Studies

Précis:

The European Commission has adopted a legal proposal outlining the specific fees that pharmaceutical companies are required to pay to support European Union-wide pharmacovigilance activities.

The fee proposal resulted from recent legislation that was developed around pharmacovigilance activities in the EU and has been in law since July 2012. The legislation broadened the role to the European Medicines Agency (EMA). The increased functions of the decentralised EU agency reinforced the role it plays in coordinating scientific resources that are made available from EU Member States.

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Pfizer Joins Feds in Attack on India’s ‘Discriminatory Trade Practices’

July 2, 2013, 5:46 am

≫ Next: Doctors in India Unlikely to Follow Guidelines on Generic Drugs

≪ Previous: Proposal for EMA Pharmacovigilance Fees Adopted

Précis:

Members of a key US Congressional committee have said that the Indo-US trade partnership is being threatened by India's adoption of discriminatory trade practices – a view re-iterated by a Pfizer spokesperson, who called for "an equally bold response" from the US government.

At the hearing held last week (27^thJune), entitled, “A Tangle of Trade Barriers: How India's Industrial Policy is Hurting US Companies”, the Subcommittee on Commerce, Manufacturing, and Trade discussed how India's industrial policies are hurting US companies, including forced localisation requirements that do not comport with internationally accepted intellectual property (IP) standards.

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Doctors in India Unlikely to Follow Guidelines on Generic Drugs

July 2, 2013, 6:18 am

≫ Next: Prognosis for “Patchwork” Canadian Drug System

≪ Previous: Pfizer Joins Feds in Attack on India’s ‘Discriminatory Trade Practices’

Précis:

Doctors in India are unlikely to prescribe unbranded generics despite two advisories from the Medical Council issued in 2012 and 2013 urging them to do so, some private and government doctors have said.

Krishan Kumar Aggarwal, a senior cardiologist in New Delhi who is also head of the ethics committee of the Delhi Medical Council, told the BMJ: “Doctors in India are already prescribing generic drugs, but through their brand names. If the authorities want us to prescribe drugs through chemical names, why do they allow so many brand names and why are there such wide price variations?”

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Prognosis for “Patchwork” Canadian Drug System

July 4, 2013, 5:51 am

≫ Next: Oncology Europe

≪ Previous: Doctors in India Unlikely to Follow Guidelines on Generic Drugs

Précis:

The Canadian Life and Health Insurance Association is calling for both tactical and fundamental reforms to the nation’s prescription drug system so that Canadian citizens can reap the benefits long term.

More than 23 million Canadians depend on private insurance to pay for their prescription drugs as only a minority of citizens (those over 65, on social assistance or with catastrophic drug costs) are covered by public insurance. Cost pressures for these citizens are set to get worse due to steadily increasing number of extremely expensive drugs prescribed to treat rare diseases, rates which the Canadian Life and Health Insurance Association (CLHIA) forecasts will grow from 15 per cent of total expenses to over 25 per cent in just three years.

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