Latest News in the pharma Industry

Policy & Regulation

Eisai Receives Canadian Approval of Banzel as Adjunctive Treatment for Severe Epilepsy Disorder

Eisai Receives Canadian Approval of Banzel as Adjunctive Treatment for Severe Epilepsy Disorder

26 Sep 2011

Canadian regulators have given approval of Banzel for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Read more 
Tokai Secures Financing to Advance Cancer Drug Study

Tokai Secures Financing to Advance Cancer Drug Study

26 Sep 2011

Tokai Pharmaceuticals has received $23m funding in a Series D3 financing to support its ongoing clinical development of galeterone.

Read more 
Remicade Approved to Treat Ulcerative Colitis in Children Older Than 6 Years

Remicade Approved to Treat Ulcerative Colitis in Children Older Than 6 Years

26 Sep 2011

Janssen's Remicade has been approved by FDA to treat moderately to severely active ulcerative colitis in children older than 6 years who have had inadequate response to conventional therapy.

Read more 
FDA Approves Soliris for Rare Pediatric Blood Disorder

FDA Approves Soliris for Rare Pediatric Blood Disorder

26 Sep 2011

The FDA has approved Soliris to treat patients with atypical Hemolytic Uremic Syndrome that can lead to kidney failure and is also associated with increased risk of death and stroke.

Read more 
EMA Recommends Restricting Use of Multaq

EMA Recommends Restricting Use of Multaq

23 Sep 2011

Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered.

Read more 
EMA Starts Review of Orlistat-containing Medicines

EMA Starts Review of Orlistat-containing Medicines

23 Sep 2011

The EMA is reviewing relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations should be revoked, suspended or changed.

Read more 
EMA Recommends Discontinuation of Vimpat Syrup

EMA Recommends Discontinuation of Vimpat Syrup

23 Sep 2011

The recommendation follows the voluntary recall of Vimpat 15mg/ml syrup on 15 September 2011. The recall was initiated because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup.

Read more 
NIH to Facilitate License Agreements of Medical Technologies

NIH to Facilitate License Agreements of Medical Technologies

21 Sep 2011

NIH is reducing both the cost and paperwork requirements for start-up companies to obtain an exclusive option agreement to license the extensive patents and patent applications from research laboratories.

Read more 
FDA Probes into GlaxoSmithKline's Zofran

FDA Probes into GlaxoSmithKline's Zofran

21 Sep 2011

The investigation is focused around active ingredient ondansetron. It is feared that the ingredient could cause QT interval prolongation, potentially leading to abnormal heart rhythms.

Read more 
FDA Grants Orphan Drug Designation to Avedro's VibeX

FDA Grants Orphan Drug Designation to Avedro's VibeX

19 Sep 2011

The FDA has granted orphan drug designation to Avedro's VibeX solution for use with its KXL System for corneal cross-linking to treat keratoconus.

Read more 
EU Approves Marketing Authorisation for Zytiga

EU Approves Marketing Authorisation for Zytiga

8 Sep 2011

The approval comes after an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive CHMP opinion.

Read more 
India's Pharmacy Council to Regulate Sale of Un-prescribed Drugs by Pharmacists

India's Pharmacy Council to Regulate Sale of Un-prescribed Drugs by Pharmacists

8 Sep 2011

With this move, the number of drugs sold over the counter (OTC) in pharmacies may come down in the near future.

Read more