Scrip    Clinica    RAJ    Scrip Clinical Research    AnimalPharm   
Email ID
Password
Forgotten your password?
Sign me in automatically next time
Home
Therapy Sector
Generics
Business
Policy & Regulation
Research & Development
International
Product Approvals
|
Clinical Trials
|
Product Filings
|
Product Safety
|
Preclinical
|
Product Delays
|
Research & Development - Product Delays
EVENTS
01 January 1970
London, UK
01 January 1970
San Diego, US
01 January 1970
Providence, Rhode Island, and San Francisco, California
JOB OF THE WEEK Promote your vacancy here
More FDA warnings on GMP: Sun Pharma's NJ plant and Albany Molecular
01 September 2010
The US FDA has issued a warning letter to a wholly owned US unit of India's Sun Pharmaceutical Industries in Cranbury, New Jersey, over good manufacturing practice (GMP) deviations at the plant. FDA inspectors made a number of observations, which ...
US judge denies Sanofi-Aventis's bid to stop generic rival for Lovenox
31 August 2010
A federal judge has denied Sanofi-Aventis 's request for a preliminary injunction that would have directed the US FDA to suspend and withdraw its approval of a generic version of Lovenox (enoxaparin sodium) from Sandoz (Novartis) and partner Momenta ...
Extended review for Acetadote supplement hits Cumberland shares
25 August 2010
Shares in Cumberland Pharmaceuticals, which have languished since the company broke the deadlock in a recession-hit pharmaceutical sector by raising around $75 million net in an IPO last August, took a further battering yesterday after Cumberland ...
FDA partially grants petitions on bioequivalence guidance for generic Pentasa and Asacol
25 August 2010
The US FDA opposes the idea that applicants of generic or "follow-on" formulations of extended or delayed-release oral mesalamine drug products need to show bioequivalence to ulcerative colitis treatments Pentasa or Asacol through data from ...
FDA hands refusal to file letter to EpiCept for lead leukaemia product
25 August 2010
EpiCept has received a rare refusal to file letter from the US FDA for its NDA for its lead product, Ceplene (histamine dihydrochloride), which it was intending to be a maintenance treatment for patients with acute myeloid leukaemia (AML) in their ...
 
2010 Scrip 100 - Mixed fortunes on the R&D front
23 August 2010
Continued problems with anti-obesity drugs, more measures designed to improve R&D efficiency, and the approval of first-in-class therapeutics such as Amgen's Prolia and Dendreon's Provenge: the first ...
Scrip Asia 100 - Rich pickings from Indonesia?
29 June 2010
Indonesia is attracting increasing attention from the international pharmaceutical industry, helped by the emergence of a middle class estimated to number around 35 million and the prospect of a more ...
Scrip Asia 100 - Bloc building
29 June 2010
ASEAN nations know that they need to get their regulatory systems in line before they can compete on the global stage. Phil Greenfield explains how market harmonisation will pave the way for better ...
 
GE Healthcare aims to end unpredictability in early drug research
Better consistency of the cells used in early-stage drug research could save R&D departments millions of dollars and a lot of wasted time and effort. At GE Healthcare, the commercialisation of ...
Face-to-face: The FDA, Amgen, and its blockbuster biologic, denosumab
15 June 2009
In escaping the sweltering heat of America's south, Scrip's US reporter Christopher Spillane meets Amgen's chief medical officer, Dr Sean Harper , who coolly explains how the firm plans to negotiate ...
 
GLP-1 receptor agonists vie for diabetes market share
13 July 2010
After enjoying almost five years of exclusivity, Lilly/Amylin's first-in-class antidiabetic GLP-1 receptor analogue Byetta (exenatide) has started to feel competition nipping at its heels. Asher ...
AstraZeneca judgement changes the rules for dominant companies
07 July 2010
On 1 July 2010 the EU General Court handed down its judgement in the long-running saga of AstraZeneca's proton pump inhibitor anti-ulcer product Losec (omeprazole). Although dealing with events that ...
Pfizer's fine: a revisit of self-regulation
10 September 2009
The US is a great place to do business. Being an almost free market, the profits are good, but so also are the temptations. So if you can't be bothered to put the money into a clinical trial to find ...
 
COMPANY/ORGANISATION
CONDITION
GEOGRAPHY
DRUG
© 2010 Informa plc. All rights reserved.
This site is owned and operated by Informa plc ("Informa") whose registered office is Mortimer House, 37-41 Mortimer Street, London, W1T 3JH. Registered in England and Wales. Number 3099067. UK VAT Group: GB 365 4626 36
Home
Therapy Sector
Generics
Business
Policy & Regulation
Research & Development
International
Terms & Conditions
Privacy Policy
Sitemap
About Us
Advertise
Subscribe
Scrip
Clinica
RAJ
Scrip Clinical Research
Animal Pharm