Survey finds life science worries

by emma 8. November 2011 14:02

Pharma NHS News

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

ViroPharma buys DuoCort

by emma 31. October 2011 11:32

Pharma Industry News

ViroPharma has signed a definitive agreement to acquire Swedish-based DuoCort Pharma AB for an initial $33.6 million – but only if Plenadren is approved by the European Commission (EC).

Under the terms of the agreement, the deal will be closed after the tablet’s approval, after the EC’s confirmation of Plenadren’s orphan drug designation, and an amended agreement with the product’s contract manufacturer.

Vincent Milano, ViroPharma's President and CEO, says the deal is in line with the company’s “objective of broadening our orphan drug portfolio”.

Further milestone patients of up to $131 million associated with manufacturing, sales thresholds and territory expansion have also been agreed as part of the acquisition.

Plenadren is a once daily dual-release oral glucocorticoid tablet with a release profile designed to closely mimic the body's natural secretion pattern of cortisol. ViroPharma now anticipates the commercial launch of the treatment – which it says will be the first “true innovation in over 50 years” – of adrenal insufficiency in the EU within a year. It estimates that peak annual sales for Plenadren could reach up to $50 million.

The Committee for Orphan Medicinal Products confirmed in September that Plenadren’s orphan designation would be maintained and protected for a decade of market exclusivity.

Senior Management changes at BMS

by emma 20. October 2011 15:14

Pf industry news

Bristol-Myers Squibb (BMS) has made alterations to its Senior Management Team.

Giovanni Caforio has been promoted to President of US Pharmaceuticals from senior vice president of Oncology and Immunology Global Commercialisation, replacing Anthony Hooper, who has decided to leave the company.

In addition, Charles Bancroft and Béatrice Cazala have both been appointed as Executive Vice Presidents of the company, reporting to Lamberto Andreotti, CEO of BMS.

Mr Andreotti said that he looked forward “to working with these three senior leaders and the rest of my management team to continue to successfully execute our BioPharma strategy”.

Bristol-Myers Squibb is a global biopharmaceutical company aiming to discover, develop and deliver medicines to patients with serious diseases.

New Head of Emerging Markets at Nycomed

by emma 17. October 2011 12:51

Pf industry news

Nycomed, a Takeda company, has appointed Jostein Davidsen as its new Head of Emerging Markets.

Mr Davidsen will take on the post in addition to his current role as Area Head of Russia/CIS, reporting to Frank Morich, EVP, International Operations at Takeda Pharmaceuticals International, and CEO of Nycomed.

“Jostein's strong track record of leading Russia/CIS over the past 17 years makes him an ideal candidate for this position,” said Mr Morich.

“His extensive knowledge of the industry, combined with vision and tenacity, has propelled Russia/CIS to become one of Nycomed's top revenue contributors.”

Takeda’s acquisition of Nycomed in September 2011 was driven by Nycomed’s presence in Emerging Markets in Russia/CIS, Latin America, Middle East-Turkey-Africa and South Asia.

Takeda is a research-based global company with a main focus on pharmaceuticals. The combined company has an active commercial presence in the therapeutic areas of metabolic diseases, gastroenterology, oncology, cardiovascular health, CNS diseases, inflammatory and immune disorders, respiratory diseases and pain management.

Lilly’s erectile dysfunction drug approved in US

by emma 7. October 2011 13:26

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

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