11. October 2011 12:11
Roche has appointed Dr Harsukh Parmar as Head of Translational and Experimental Medicine (TM) of its Inflammation Discovery and Translational Area (DTA).
Dr Parmar will be responsible for the strategy and implementation of early clinical progress in Inflammation as well as collaborating with Discovery and Clinical Development to ensure high quality of compounds used throughout drug production.
Dr Jacques Banchereau, Head of the Inflammation and Virology Discovery and Translational Areas, said that Harsukh is recognised as “an expert in respiratory, inflammation, immunology and oncology, and possesses the right combination of experience for this pivotal position”.
Dr Parmar joins Roche from AstraZeneca in the UK, where he worked as Early Development Director, Vice President and Global Head of Early Clinical Development in the Respiratory and Inflammation Therapeutic Area. He also previously served at Roche as Global Clinical Science Leader and Director in Oncology, Immunology, Virology and Transplantation.
“Having previously worked for Roche and recognising the rich heritage of innovation that has come from the pharma business in small molecules and biologics, I was excited to rejoin a company that has been a leader in many of its respective fields,” said Dr Parmar.
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.
16. September 2011 13:10
The FDA has changed the way it reviews new cancer drugs in the hope to make faster and better informed decisions.
The Agency’s Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganised and renamed the Office of Hemotology and Oncology Products (OHOP).
Janet Woodcock, CDER Director, said: “Under the new office structure, the Agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market.”
The new department includes four separate drug review units, aimed at increasing the level of expertise. The Division of Oncology Products 1 (DOP1), and Division of Oncology Products 2 (DOP2) units will each focus on a short list of solid tumours. The Division of Hematology Products (DHP) unit will assess haematological tumours, while the new Division of Hematology Oncology Toxicology (DHOT) will handle non-clinical pharmacology and toxicology regarding cancer therapies.
Dr Richard Pazdur, Head of the department, said: “As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognised the need and importance of taking a more disease-specific review approach to these therapies.”
He also added that the reorganisation aligns the FDA with the structure of leading cancer treatment centres, academic programmes and the National Cancer Institute.
The department’s previous system assessed drugs separately from biologics under three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP) and Division of Biologic Oncology Products (DBOP).