It is currently Wed Nov 26, 2014 9:46 pm

News News of Campath (Lemtrada, Alemtuzumab)

Site map of Campath (Lemtrada, Alemtuzumab) » Forum : Campath (Lemtrada, Alemtuzumab)

A board to discuss the soon-to-be released drug Campath as a treatment for Multiple Sclerosis

MS drug Lemtrada to be resubmitted to FDA for approval

Nearly four months after the Food and Drug Administration rejected a multiple sclerosis drug developed by Genzyme, citing the clinical trial’s design and a risk of serious side effects, the Cambridge biotech said Monday that it will resubmit an application for approval to the agency..... Read More - http://www.ms-uk.org/lemtrada
Read more : MS drug Lemtrada to be resubmitted to FDA for approval | Views : 694 | Replies : 2


NICE says 'yes' to Genzyme's MS drug Lemtrada

In final draft guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi subsidiary Genzyme's multiple sclerosis drug Lemtrada (alemtuzumab).

NICE is appraising alemtuzumab as a treatment for adults with relapsing & remitting multiple sclerosis, a chronic and disabling neurological condition that, as it progresses, can have a substantial negative impact on a person’s quality of life........ Read More - http://www.ms-uk.org/lemtrada
Read more : NICE says 'yes' to Genzyme's MS drug Lemtrada | Views : 520 | Replies : 0


Lemtrada(R) approved in Mexico for treatment of MS

Genzyme, a Sanofi company, announced today that Mexico's national regulatory authority, COFEPRIS, has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing remitting forms of multiple sclerosis (MS) to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations..... Read More - http://www.ms-uk.org/lemtrada
Read more : Lemtrada(R) approved in Mexico for treatment of MS | Views : 711 | Replies : 0


MS drug Lemtrada investigators protest FDA decision

Several multiple sclerosis (MS) experts who were involved in the clinical development program for alemtuzumab (Lemtrada, Genzyme) have voiced their disappointment and frustration over the recent decision by the US Food and Drug Administration (FDA) not to approve the drug.

Stephen Krieger, MD, from Mount Sinai Medical Center, New York; Edward Fox, MD, from the Multiple Sclerosis Clinic of Central Texas, Round Rock; and Jeffrey Cohen, MD, from Cleveland Clinic, Ohio, all told Medscape Medical ...
Read more : MS drug Lemtrada investigators protest FDA decision | Views : 742 | Replies : 1


Sanofi faces U.S. class action over MS drug Lemtrada

A U.S. law firm is launching a class action against France's Sanofi over what it calls misleading statements on the safety and efficacy of its multiple sclerosis drug Lemtrada.

Sanofi acquired Lemtrada when it bought U.S. biotech firm Genzyme for $20.1 billion in 2011. The drug's prospects took center-stage in a drawn-out takeover battle and led to a deal in which Genzyme shareholders received listed contingent value rights (CVRs) linked to Lemtrada's future success...... Read ...
Read more : Sanofi faces U.S. class action over MS drug Lemtrada | Views : 777 | Replies : 0


MS drug Lemtrada approved in Australia

Genzyme, a Sanofi company, has announced that the Australian Therapeutic Goods Administration (TGA) has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.......... Read More - http://www.ms-uk.org/lemtrada
Read more : MS drug Lemtrada approved in Australia | Views : 857 | Replies : 1


Lemtrada approved in Canada for treatment of MS

Genzyme, a Sanofi company, announced today that Health Canada has approved Lemtrada (alemtuzumab) for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies........ Read More - http://www.ms-uk.org/lemtrada
Read more : Lemtrada approved in Canada for treatment of MS | Views : 788 | Replies : 1


MS drug Lemtrada does not benefit patients, FDA panel says

Lemtrada hasn’t proven to help against disability in the treatment of relapsing multiple sclerosis, said U.S. advisers who questioned whether the company’s studies were conducted well enough to assess the drug.

While the U.S. Food and Drug Administration advisory panel decided that potential safety risks don’t preclude approval of Lemtrada, its members voted 14-2 that the drug didn’t help improve a patient’s disability. The agency isn’t required to accept the recommendations of its advisers..... Read ...
Read more : MS drug Lemtrada does not benefit patients, FDA panel says | Views : 824 | Replies : 0


FDA staff says new oral MS drug Lemtrada may be too risky

Sanofi’s multiple sclerosis treatment Lemtrada may not offer enough benefit to patients to outweigh risks including cancer, U.S. regulators said. The French drugmaker’s shares fell.

Lemtrada’s “serious and potentially fatal safety issues,” which include the risk of autoimmune and thyroid diseases, may make the medicine too dangerous to approve unless there is substantial clinical benefit shown, Food and Drug Administration staff said in a report today. Agency reviewers also questioned whether Sanofi conducted adequate trials ...
Read more : FDA staff says new oral MS drug Lemtrada may be too risky | Views : 966 | Replies : 1


Alemtuzumab 3-year data show durable effect on MS disability

Latest data from the CARE-MS II extension study show that alemtuzumab (Lemtrada, Genzyme/Sanofi) has a durable effect on disability in multiple sclerosis (MS), with the mean Expanded Disability Status Scale (EDSS) score at 3 years still below that at baseline.<br><br>

These new data were presented in a poster at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) last week...... Read More - http://www.ms-uk.org/lemtrada
Read more : Alemtuzumab 3-year data show durable effect on MS disability | Views : 927 | Replies : 0


 

Login  •  Register


Statistics

Total posts 221777 • Total topics 23029 • Total members 14553


Contact us | Terms of Service