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Research & Development
EVENTS
04 April 2016
Stockholm, Sweden
06 April 2016
Hamburg, Germany
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Akashi Therapeutics Inc. said it was investigating whether there was a link between its experimental Duchenne muscular dystrophy (DMD) therapy HT-100 and the death of a patient who had been participating in the firm's HALO trial when he experienced serious life-threatening health issues. The privately held company revealed the death on Feb. 5, posting a notice on the firm's website. The Cambridge, Mass., biotech said it was beginning its "comprehensive" investigation with detailed data reviews ...
 
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), told lawmakers on Feb. 4 she was concerned the agency's biosimilars program "is going to explode" because it lacks funding and resources, with the anticipation the agency could be facing a multitude of ...
Roche Holding AG is behind Merck & Co. Inc. and Bristol-Myers Squibb Co. in the commercial PD-1/PD-L1 immunotherapy race, but the Swiss company says its answer in the drug class, atezolizumab, has now started out on the regulatory road to approval amid high hopes for its therapeutic ...
 
Pfizer Inc. 's pending $160bn merger with Allergan PLC may be its best shot at significant revenue growth this year, since the company's 2015 revenue and earnings fell below 2014 totals due to foreign currency impacts and the loss of patent exclusivity for multiple products – factors that again ...
As understanding increases about the complex reasons for brain injury in new-borns, the paucity of the drug R&D pipeline is thrown into fresh light. Historically, the primary cause of neonatal brain injury (NBI) was attributed to acquired insults sustained at birth, such as asphyxia. More recently, ...
 
The 180-day notice of commercial marketing for biosimilars is a "standalone" measure in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and there's nothing in the law or in a ruling last summer from an appeals court that "conditions" the provision on any other part of the ...
A positive review by FDA scientists may have just put Celltrion Inc.'s CTP13, a version of Janssen Biotech Inc.'s tumor necrosis factor (TNF) blocker Remicade (infliximab), in line to be the next biosimilar to enter the US market, although the product must first get past a panel of experts at a ...
 
An interim report by French government inspectors has identified three "major failings" in the conduct of the Phase I trial run by the CRO Biotrial that led to the death of one volunteer and the hospitalization of five others with suspected neurological damage. The report, by the General ...
US regulators on Jan. 22 said they are conducting a safety probe of fatty acid amide hydrolase (FAAH) inhibitors being developed and studied in the US after one healthy volunteer in a French Phase I trial testing a product in that class died and five other participants experienced severe adverse ...
 
The 180-day notice of commercial marketing for biosimilars is a "standalone" measure in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and there's nothing in the law or in a ruling last summer from an appeals court that "conditions" the provision on any other part of the ...
An interim report by French government inspectors has identified three "major failings" in the conduct of the Phase I trial run by the CRO Biotrial that led to the death of one volunteer and the hospitalization of five others with suspected neurological damage. The report, by the General ...
 

Editorial: Put Robots In The C-Suite!
13 January 2016
Eleanor Malone

GW high on pipeline of cannabis extracts
23 August 2010
Katie McQue

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