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Τρίτη 3 Φεβρουαρίου 2015

Greece's Anti-Austerity Government Sets Out Pharma Plans



PharmExec | Julian Upton 

Pharma and healthcare are among the many areas being viewed with increasing attention inside and outside Greece, following the victory in the country’s elections of the radical left-wing, anti-austerity Syriza party (a victory it secured by forming a coalition with the right-wing Independent Greeks party).
Healthcare is very much on Syriza’s agenda: the party has described Greece’s compromised access-to-healthcare situation as a "humanitarian crisis”. The country’s new prime minister, Alexis Tsipras, was barely through the doors of the Presidential Mansion when he filed a decree to restructure the Greek Ministry of Health.
To improve access for the country’s poorest citizens, Tsipras wants to make significant reductions to co-payments paid by Greek patients for prescription medicines; he has tasked the Ministry of Health to once again issue social insurance funds. A restructuring of primary care is also on the cards.
Greece owes its creditors — the European Financial Stability Facility, the International Monetary Fund, and the European Central Bank — around €315 bn ($355 bn); Syriza’s promise to overhaul the country’s repayment plan is of course a major factor in propelling the party to victory. Syriza says its plans to boost public health spending can be achieved by clearing tax arrears, backlogs in social insurance contributions and combating tax fraud.
However, Greece has already been pushing its luck with non-payment of its pharma debts. As in-Pharma Technologist’s Gareth MacDonald points out, as of November last year, for example, the country owed Merck & Co. $71m for drugs supplied on credit, and accounts for part of the $907m Pfizer is still owed from crisis-hit Europe. Syriza’s rejection of the strictest austerity measures is not likely to see these pharma debts settled any time soon.
Syriza wants to bolster Greece's indigenous pharma industry with increased production of "high-quality generics". But IHS.com writes that "Greek producers have also been adversely affected by pricing regulation changes introduced last year, which resulted in drastic reductions in the prices of generics". And of Syriza's bid to increase the current level of pharmaceutical reimbursement (€2 bn) by €350m, IHS adds that while this increase is not particularly high, "considering the lengths to which the previous government was going to in order to keep reimbursement spending down, it is a massive change”. As such, "many questions remain" about how Syriza will deliver on its pharma and healthcare promises

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Κυριακή 1 Φεβρουαρίου 2015

Pharma Predictions for 2015



Πηγή: PharmExec Staff   


An expert CPhI Worldwide panel has identified "the good, the bad, and the ugly" in its forecast for the pharmaceutical industry for 2015.
Among the "good" developments are the shift in FDA’s role from “investigator” of products to “enabler” of better quality processes and cultures within pharma manufacturing; breakthrough treatments for infectious diseases; and growth across NCEs and biopharmaceuticals.

The bad will continue to be defined by shortages of popular drugs in western markets due to marginal pressures and reduced stockpiling; fears for pharma not ‘walking the talk'; and the challenging year ahead for virtual drug developers as pharma exercises closer inspection of the robustness of CMC regulatory packages.
The "ugly truths" pointed out by the panel include predictions that outsourcing and related quality issues are unlikely to be reduced in the near future (big Pharma may even, in some cases, repatriate key elements of the drug development chain), and that the battle between IP protection and patient access is set to further heat up.
Details of the panelists and some of their individual predictions are further outlined below.

Πέμπτη 29 Ιανουαρίου 2015

Novartis-GSK mega deal



European regulators have given conditional blessing to a proposed three-part deal between GlaxoSmithKline and Novartis, under which the firms will exchange assets and form a new consumer healthcare joint venture.

GSK intends to sell its portfolio of cancer drugs to Novartis for up to $16 billion and is buying the Swiss drug giant's vaccines unit for up to $7.1 billion (excluding flu jabs), and both plan to create "a world-leading consumer healthcare business" JV between Novartis OTC and GSK Consumer Healthcare. 

In relation to the vaccines acquisition, the European Commission has requested that GSK sell its meningitis vaccines, Nimenrix and Mencevax, on a global basis, and divest two small Novartis bivalent vaccines for protection against diphtheria and tetanus in Italy and Germany.

With regard to the consumer JV, GSK has agreed to sell its NiQuitin smoking cessation products and Coldrex cold & flu products in the European Economic Area, its local Panodil pain management and Nezeril/Nasin cold and flu products in Sweden, and Novartis’s topical cold sore business in the EEA.  

The deals remain subject to other closing conditions but bagging regulatory backing is a major advance, and the transaction is on track to complete during the first half of 2015, the firms noted.

Φαρμακευτικό Μάρκετινγκ: Θεωρία, Πρακτική, Δεοντολογία
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Τρίτη 27 Ιανουαρίου 2015

Novartis expects 10 NME filings by end 2016



Novartis told investors today that it is entering a particularly fruitful period of product development, with 10 new molecular entities (NMEs) due to be submitted for approval in 2015 and 2016.

The hike in R&D output for the company's pharmaceuticals division comes after a transitional year for the company which saw it divest animal health and vaccines operations and set up a joint venture for over-the-counter drugs, allowing it to focus on its prescription medicine and eyecare businesses.

The new crop of filings - which includes potential blockbusters for cancer and heart failure - is coming through while Novartis is still enjoying buoyant growth for recently launched products, including oral multiple sclerosis therapy Gilenya (fingolimod), Jakavi (ruxolitinib) for myelofibrosis and its stable of therapies for chronic obstructive pulmonary disease (COPD).

Κυριακή 18 Ιανουαρίου 2015

How do doctors want to engage with pharma on new products?



With more than 80 per cent of European doctors saying they want to stay abreast of new developments about pharmaceutical products, it is important to understand how they wish to receive this information.

A survey by M3 Global Research of over 1,800 doctors from the top five EU countries and beyond has consolidated their thinking and finds that they value pharma's contribution. In fact, 72 per cent say the industry's delivery of new medicines will be the main factor helping to improve the outlook for their patients over the next three years.

Download the White Paper now to discover how doctors are accessing the latest developments about medicines and their preferred ways of receiving promotional material.


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Drug Launch Watch List 2015 by Frost & Sullivan



Oncology, cardiovascular, autoimmune/anti-inflammatories, and infectious diseases will be the top areas of investments in 2015, according to Frost & Sullivan. Pharma companies will also be keen to invest in in-vitro diagnostics such as biomarkers; molecular, tissue, companion diagnostics; predisposition disease; and predictive testing, added the company's Life Sciences Global Program Director, Jennifer Lazar.

Frost & Sullivan has released its "Drug Launch and Phase 3 Trial Watch List for Top Therapy Areas for 2015". It includes: 
  • Puma Biotechnology’s tyrosine kinase inhibitor, neratinib, for breast cancer adjuvant therapy.
  • Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, for previously treated advanced melanoma patients. 
  • Novartis’ selective IL-17A inhibitor, secukinumab, for the treatment of plaque psoriasis. 
  • Novartis’ angiotensin receptor neprilysin inhibitor (ARNi), LCZ696, for the treatment of heart failure.
  • AbbVie’s ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavirin for the treatment of hepatitis C.
  • GlaxoSmithKline’s RTS,S vaccine is expected to be the first malaria vaccine in the market.
  • Sanofi Pasteur's Dengue Vaccine. 
In addition to new molecular entity product launches, Frost & Sullivan reports that there are "abundant opportunities for generic and biosimilar drugs due to the patent expiry of several blockbuster drugs in 2014 and 2015". Some of those include: 
  • Otsuka Pharmaceutical’s Abilify (anti-psychotic) 
  • Teva Pharmaceutical’s Copaxone (relapse-remitting multiple sclerosis) 
  • Novartis’ Gleevec (chronic myeloid leukemia) 
  • Forest Laboratories’ Namenda (Alzheimer’s disease) 
  • Pfizer’s Zyvox (anti-viral) and, 
  • GlaxoSmithKline’s Avodart (benign prostatic hyperplasia) 
 

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