Industry Watch

2004 ◽  
Vol 08 (21) ◽  
pp. 1150-1152
Keyword(s):  
Ovarian Tumor ◽  
Drug Application ◽  
Tumor Detection ◽  
Dna Chip ◽  
International Agreement ◽  
Strategic Investment ◽  
Fda Approval ◽  
Milestone Payment ◽  
New Drug Application ◽  
Investment In China

Proteome Systems Develops Ovarian Tumor Detection Kit. Pharmaxis Closer to Market Aridol. Acrux Receives Milestone Payment from VIVUS. Biota Raises Funds from Share Purchase Plan. GSK's Strategic Investment in China. Aurobindo Pharma Obtains FDA Approval for Mirtazapine Tablets. IPA Urges for Prudent Patent Legislation. Zonegran Shown to Reduce Seizures in Infants. Takeda Pushes for New Drug Application for Ramelteon. Takeda Collaborates with Sucampo on Constipation Drug. Eisai Gains Access to MultiCell's Hepatocyte Technology. SiMEMS Signs International Agreement to Further Develop Revolutionary DNA Chip.

Lithane: The Story of Lithium Carbonate

1970 ◽  
Vol 18 (5) ◽  
pp. 25-27
Keyword(s):  
Drug Application ◽  
Lithium Carbonate ◽  
Manic Depressive ◽  
Clinical Investigations ◽  
Fda Approval ◽  
Service Role ◽  
The Subject ◽  
New Drug Application ◽  
Experimental Use ◽  
The U.S

“Lithium, the 20-year-old Cinderella of psychopharmacology, is at last receiving her sovereign due.” So stated one of the nation's leading research psychiatrists on the subject of lithium carbonate, newly-approved by the U.S. Food and Drug Administration for treating the manic phase of manic depressive psychosis. The recent FDA approval marked the culmination of a long and sometimes controversial journey for this relatively well-known chemical entity. A part of the controversy has been conjecture in press reports that because lithium cannot be patented and because of the significant investment contrasted with a modest return, “no company has wanted to market it.” Even as these reports were being circulated, Pfizer's J. B. Roerig Division had completed an extensive laboratory toxicology program supported by clinical investigations, had produced over one million tablets for experimental use by 18 clinical investigators, had organized and collected existing experimental data from sources throughout the world, and had submitted these voluminous data to the FDA in compilation of a New Drug Application. The approval of Lithane as an addition to the U.S. physician's stock of weapons against mental illness is eloquent testimony to the important public service role played by research-oriented pharmaceutical companies.

Analyzing United States Prescribing Information to gain insight into FDA-sponsor discussions

1969 ◽  
Vol 17 (3) ◽  
Author(s):  
Iraj Daizadeh
Keyword(s):  
United States ◽  
Drug Development ◽  
Drug Application ◽  
The United States ◽  
Data Repository ◽  
Fda Approval ◽  
New Drug Application ◽  
Development Paradigm ◽  
Prescribing Information ◽  
Insight Into

The United States Prescribing Information (USPI) is a key vehicle for communicating the benefit-risk information of a Food and Drug Administration (FDA) approved prescription drug. The USPI is typically the last step of the drug development process and requires discourse between the FDA and the sponsor for a new drug application. The USPI may also be updated after obtaining FDA approval. As a social artifact of industry and FDA discussions, it is hypothesized that an analysis of a library of USPI records may yield insight into this dialog. Here, an analysis of DailyMed – a USPI data repository – reveals that structural language similarities (linguistic typologies) exist across USPI. Interestingly, these typologies describe labeling language that may not be explicitly described in FDA regulatory documentation. It is proposed that the methodology herein proposed may be leveraged to potentially facilitate USPI development and FDA dialogue (and therefore expedite the drug development paradigm). Several examples are used to showcase the approach. A discussion on limitations of the methodology and opportunities for development is also presented.

Drug Trials, Doctors, and Developing Countries: Toward a Legal Definition of Informed Consent

1996 ◽  
Vol 5 (3) ◽  
pp. 387-399 ◽  
Author(s):  
Adina M. Newman
Keyword(s):  
Clinical Stage ◽  
Drug Application ◽  
Research Process ◽  
New Drug ◽  
Third Phase ◽  
Drug Companies ◽  
Fda Approval ◽  
Definition Of ◽  
New Drug Application ◽  
To Receive

Assume this hypothetical situation: an American pharmaceutical company, Maxwell Fisch Pharmaceuticals, Inc. (Maxwell), wishes to perform clinical trials involving a new antipsychotic medication, Klezac. Klezac is in its third phase of the clinical stage of the drug research process. Once the testing is complete, Maxwell plans to submit a New Drug Application, the official request to begin marketing Klezac, to the Food and Drug Administration (FDA). The new drug is expected to receive FDA approval in 2 or more years. The company decides to shift its research and development activities to Z, a small, developing country. In doing so, Maxwell is following the course taken by numerous other drug companies who wish to take advantage of faster governmental approval in foreign sites and ensuing cheaper research costs.

Industry Watch

2005 ◽  
Vol 09 (09) ◽  
pp. 353-363
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Drug Application ◽  
Biotechnology Industry ◽  
Biotechnology Firm ◽  
Fda Approval ◽  
New Treatment ◽  
New Drug Application ◽  
Investigational New Drug Application

CyGenics Files Investigational New Drug Application. Biocon Limited is India's Largest Biotechnology Firm. INS Enterprise Making Waves in Biotechnology. Dow AgroSciences and MerLion Pharma Collaborate on Discovery of Novel Agrochemical Agents. Taiwan's Thriving Biotechnology Industry. Malaysian Firm to Explore Thai Padi Technology. New Treatment for Chronic Hepatitis B Obtain FDA Approval.

Utility of Bayesian Single-Arm Design in New Drug Application for Rare Cancers in Japan: A Case Study of Phase 2 Trial for Sarcoma

2018 ◽  
Vol 52 (3) ◽  
pp. 334-338 ◽  
Author(s):  
Akihiro Hirakawa ◽  
Tadaaki Nishikawa ◽  
Kan Yonemori ◽  
Taro Shibata ◽  
Kenichi Nakamura ◽  
...  
Keyword(s):  
Drug Application ◽  
Phase 2 ◽  
Rare Cancers ◽  
New Drug ◽  
Phase 2 Trial ◽  
New Drug Application

scholarly journals Performance of ceftazidime/avibactam susceptibility testing methods against clinically relevant Gram-negative organisms

2018 ◽  
Vol 74 (3) ◽  
pp. 633-638 ◽  
Author(s):  
E Wenzler ◽  
M Lee ◽  
T J Wu ◽  
K A Meyer ◽  
R K Shields ◽  
...  
Keyword(s):  
Susceptibility Testing ◽  
Drug Application ◽  
Error Rates ◽  
Testing Methods ◽  
Suitable Alternative ◽  
Gram Negative ◽  
Treatment Regimens ◽  
Carbapenem Resistant ◽  
Gram Negative Organisms ◽  
New Drug Application

Abstract Objectives To ensure the accuracy of susceptibility testing methods for ceftazidime/avibactam. Methods The performances of the Etest (bioMérieux), 30/20 μg disc (Hardy diagnostics) and 10/4 μg disc (Mast Group) were evaluated against the reference broth microdilution (BMD) method for 102 clinically relevant Gram-negative organisms: 69 ceftazidime- and meropenem-resistant Klebsiella pneumoniae and 33 MDR non-K. pneumoniae. Essential and categorical agreement along with major and very major error rates were determined according to CLSI guidelines. Results A total of 78% of isolates were susceptible to ceftazidime/avibactam. None of the three methods met the defined equivalency threshold against all 102 organisms. The Etest performed the best, with categorical agreement of 95% and major errors of 6.3%. Against the 69 ceftazidime- and meropenem-resistant K. pneumoniae, only the Etest and the 10/4 μg disc met the equivalency threshold. None of the three methods met equivalency for the 33 MDR isolates. There were no very major errors observed in any analysis. These results were pooled with those from a previous study of 74 carbapenem-resistant Enterobacteriaceae and data from the ceftazidime/avibactam new drug application to define optimal 30/20 μg disc thresholds using the error-rate bound model-based approaches of the diffusion breakpoint estimation testing software. This analysis identified a susceptibility threshold of ≤19 mm as optimal. Conclusions Our data indicate that the Etest is a suitable alternative to BMD for testing ceftazidime/avibactam against ceftazidime- and meropenem-resistant K. pneumoniae. The 30/20 μg discs overestimate resistance and may lead to the use of treatment regimens that are more toxic and less effective.

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