9. November 2011 10:27
Novartis has appointed Dr Timothy Wright as its new Global Head of Development.
Dr Wright joined the pharmaceutical company in 2004 and most recently served as Senior Vice President and Global Head of Translational Sciences at Novartis Institutes for BioMedical Research (NIBR).
His previous positions include exploratory therapy area leader for Inflammation at Pfizer and chief of the Division of Rheumatology and Clinical Immunology at the University of Pittsburgh.
8. November 2011 16:26
Medtronic has launched its T2 Altitude expandable corpectomy device for spinal stabilisation and correction worldwide.
The expandable vertebral body replacement cage features a self-locking mechanism that removes the need for placing a set screw during surgery, using bone graft to create contact to encourage fusion with the device.
Doug King, Senior Vice President and President of Medtronic Spinal, said that the new product demonstrates the company’s “long-term commitment to therapies for complex spine disorders for spinal tumour, trauma and deformity patients”.
Cancer patients can also benefit from the product. If the cancer has spread to the spine, the surgeon may replace the affected vertebrae with the T2 Altitude device.
More than 150,000 spinal fractures occur in North America every year, of which approximately 11,000 are spinal cord injuries.
Based in Memphis, Medtronic Spinal provides advanced treatment through the collaboration with surgeons and researchers to offer affordable, minimally-invasive products and medical technologies for neurological, orthopaedic and spinal conditions.
4. November 2011 11:42
Bristol-Myers Squibb has entered into a strategic partnership with Singapore-based ASLAN Pharmaceuticals for the licensing and development of one of its investigational oncology compounds.
Under the agreement, ASLAN has the rights to develop and commercialise BMS-777607, a small molecule inhibitor of the MET receptor tyrosine kinase for treatment of solid tumours, in China, Australia, Korea, Taiwan and other selected Asian countries. BMS will retain rights for the rest of the world.
ASLAN will also complete and fund the development of the compound under a pre-agreed programme that will initially target gastric and lung cancers.
Francis Cuss, Senior Vice President, Research, BMS, says the agreement is part of the company’s “Oyster strategy” which aims to produce “high-quality data that may be used to further develop and commercialise the medicine worldwide”.
“As part of our biopharma strategy, Bristol-Myers Squibb seeks to seed companies in key markets with promising investigational medicines of continued interest to Bristol-Myers Squibb,” he said.
2. November 2011 14:43
The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.
The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.
The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.
Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”
He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.
Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.
Xience Prime received CE Mark Approval in 2009.
Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.
31. October 2011 12:09
The FDA has approved Spinal USA’s two spinal treatment products, the VAULT Stand Alone ALIF System and the S-Lok PC Posterior Cervical System (pictured, right).
Rich Dickerson, Senior Vice President of Operations for Spinal USA, said that the two medical devices “provide our customers with a wider array of surgical options”.
The VAULT System (pictured, below) is designed for use with autogenous bone graft for intervertebral body fusion of the spine in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis, aiming to “reduce surgical trauma and yield a net cost saving”, said Mr Dickerson.
He added that the S-Lok PC Posterior Cervical System offers “surgeons a comprehensive fixation system with enhanced ease of use and greater intraoperative flexibility”, indicated to promote fusion of the cervical and thoracic spine in mature patients in the treatment of DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and revision of previous cervical spine surgery and tumours.
DDD is characterised by back pain caused by the degeneration of the disc. Spondylolithesis is a condition in which a bone in the lower part of the spine slips out of place.
Cervical spine surgery is intended to restore nerve function, stop or prevent abnormal motion in the spine, and relieve pain, numbness, tingling and weakness.
Mississippi-based Spinal USA provides spine products for the treatment of serious medical conditions, aiming to reduce medical costs.
26. October 2011 11:27
Eli Lilly has withdrawn Xigris (drotrecogin alfa) from all markets due to it showing no gain in 28-day survival of septic shock patients in the PROWESS-SHOCK study.
New results showed that the drug failed to meet its primary endpoint and question the overall benefit-risk balance of Xigris for patients with severe sepsis.
Timothy Garnett, Senior Vice President and Chief Medical Officer of Lilly, said that the results were unexpected to the company. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”
Xigris was approved in the US by the FDA in November 2001, and in the EU in 2002 under exceptional circumstances for septic shock patients with multiple organ failure, in addition to best standard care.
As a condition for continued market authorisation in Europe, Eli Lilly established the placebo-controlled PROWESS-SHOCK study in March 2008, to assess the benefit-risk profile of the product.
Aside from failing its primary aim, the study also failed its secondary endpoint of reducing mortality in patients with severe protein C deficiency. The small difference in the 28-day mortality of the overall population (26.4% in the Xigris arm versus 24.2% in the placebo arm) was not statistically significant.
Xigris is administered as a continuous intravenous infusion, in one dose for a total duration of 96 hours.
The CHMP will assess the issue during its plenary meeting in November 2011.
21. October 2011 12:31
Amgen has appointed Tony Hooper as its new Executive Vice President of Global Commercial Operations.
The 56-year-old joins from Bristol-Myers Squibb and will take on the responsibility for the companies commercial operations around the globe.
Robert Bradway, President and Chief Operating Officer, says Mr Hooper’s “passion for serving patients across the globe make him an outstanding addition”.
He joins after 16 years at BMS where he led the commercial business in the US, Asia, Middle East, Africa, South America and Europe. Most recently he served as the Senior Vice President, Commercial Operations and President, United States, Japan and Intercontinental.
“It's a privilege to join Amgen, a Company well-known for scientific innovation and developing life-changing therapies for people with serious illnesses,” said Mr Hooper. “I am looking forward to bringing my global commercial experience to Amgen as it moves to implement its strategic vision for growth and international expansion.”
On the same day at Hooper’s appointment, Amgen decided to cut 380 R&D jobs.
20. October 2011 15:14
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.
19. October 2011 14:45
Hologic, a manufacturer of diagnostics, surgical products and medical imaging technology for women, has received FDA clearance for its Trident specimen radiography system.
The device uses the company’s proprietary direct digital detector technology to produce high quality images of tissue samples, aiming to reduce procedure steps, streamline workflow and increase accuracy.
Peter Soltani, Senior Vice President and General Manager for Breast Health, said: “Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their healthcare providers.”
The Trident is designed for use in the operating room where breast tissue is surgically excised, and in biopsy suites where minimally-invasive breast biopsies are performed.
Based in Massachusetts, USA, Hologic is a developer, manufacturer and supplier of diagnostics, medical imaging systems and surgical products dedicated to the healthcare needs of women with a focus on breast health, diagnostics, GYN surgical, and skeletal health.
18. October 2011 15:06
Cubist Pharmaceuticals has appointed Dr Jennifer Jackson as its new Senior Vice President of Regulatory Affairs.
Dr Jackson will oversee all aspects of Cubist’s Regulatory Affairs, providing oversight for all regulatory matters, reporting to Dr Steve Gilman, the company’s Executive Vice President of R&D and CSO.
Dr Gilman said: “Jennifer’s extensive international experience, collaborative nature, and focus on disciplined execution will help us as we advance our exciting pipeline in the years ahead.”
Dr Jackson joins Cubist from Biogen Idec Hemophilia, where she worked as vice president of Regulatory Affairs and Clinical Compliance. She has also worked at Vertex Pharmaceuticals and Bristol-Myers Squibb.
Cubist Pharmaceuticals is a biopharmaceutical company focused on the research, development and commercialisation of pharmaceutical products that address the unmet medical needs in acute care.