Drug Product

Type: Keyphrase
Name: Drug Product
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

USPTO Grants a New Inhaler Patent to Hovione

Lisbon, April 7 th 2014. Hovione announced today that the United States Patent and Trademark Office (USPTO) has granted a patent for a capsule-based, low-cost dry powder inhaler (DPI) to Hovione. This happened less than three years after the patent was ... [Published American Pharmaceutical Outsourcing - Apr 16 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

System and method for managing pedigree information

Methods and systems are provided for managing and transmitting pedigree information. The methods and systems allow a user to access a pedigree information portal to submit and transmit pedigree data to a recipient of the physical drug product. The method ... [Published Free Patents Online - Apr 16 2014]
First reported Apr 14 2014 - Updated Apr 14 2014 - 1 reports

EL Seminar organized by Intertek held in Mumbai

An initiative to expedite thorough extractable/leachables evaluations for patient & product safetyIntertek, a leading quality solutions provider to industries worldwide organised and presented a seminar “Manage your Extractable & Leachables Risk” on Wednesday, ... [Published EHealth Magazine - Apr 14 2014]
First reported Apr 12 2014 - Updated Apr 12 2014 - 1 reports

Principal Scientist - Biologics (Protein Formulation)

A Principal Scientist in this role plans, directs, and executes formulation and drug product process development activities related to biologic molecules in support of pre-clinical/phase 1 candidates through new commercial product launches. In addition, ... [Published PharmaDiversity - Apr 12 2014]
First reported Apr 08 2014 - Updated Apr 09 2014 - 3 reports

USPTO Grants Patent To Hovione Inhaler

By Estel Grace MasangkayHovione announced that the United States Patent and Trademark Office (USPTO) has granted its patent application for a capsule-based, low-cost dry powder inhaler (DPI) for pulmonary diseases. The decision came after three years ... [Published Pharmaceutical Online - Apr 09 2014]
First reported Mar 28 2014 - Updated Mar 28 2014 - 1 reports

Associate Director, Clinical Drug Product Outsourcing

This position reports to the Director, Formulations Product DevelopmentEssential Duties and Job Functions:-Manages outsourced clinical drug product manufacturing activities at contract manufacturing organizations (CMO's)-Works with legal group to establish ... [Published PharmaDiversity - Mar 28 2014]
First reported Mar 27 2014 - Updated Mar 28 2014 - 2 reports

Cytovance Precision extend cGMP manufacturing agreement for NEO-102 drug product

US-based full-service contract manufacturer (CMO) of mammalian and microbial biologics, Cytovance Biologics is extending its manufacturing agreement with a clinical stage biopharmaceutical firm ... ... [Published Big News Network - Mar 28 2014]
First reported Mar 26 2014 - Updated Mar 26 2014 - 1 reports

An Interview Terry Pilkey: Marketing a Drug in Canada

Health Canada Therapeutic Products Directorate, Health Products Food Branch is the governing regulatory body over the marketing of drug products in Canada.The actual marketing of a drug in Canada is becoming increasingly complicated and subject to close ... [Published American Pharmaceutical Outsourcing - Mar 26 2014]
Entities: Drug Product, Canada, Drugs
First reported Mar 26 2014 - Updated Mar 26 2014 - 1 reports

Quality-by-Design Approach to Stability Indicating Method Development for Linagliptin Drug Product

In this work, method development process is performed using QbD tools, in order to minimize variationin execution and method transfer. Multiple column chemistries are evaluated, with the help of QbD software and theAgilent 1200 Infinity Method Development ... [Published PharmTech.com - Mar 26 2014]
First reported Mar 26 2014 - Updated Mar 26 2014 - 1 reports

Global Drug Product Strategy Sourcing Manager

Job descriptionPosition: India, location : MumbaiLead Zoetis' India Drug Product Sourcing activities in support of the India External Supply Operations Leader. Responsible for supporting the development of the External Supply Drug Product category, contract ... [Published PharmaDiversity - Mar 26 2014]
First reported Mar 25 2014 - Updated Mar 25 2014 - 4 reports

Cytovance Biologics, Inc. and Precision Biologics, Inc. Announce Extension of cGMP Manufacturing Agreement for NEO-102 Drug Product

OKLAHOMA CITY, OK -- (Marketwired) -- 03/25/14 -- , a leading full-service contract manufacturer ("CMO") of mammalian and microbial biologics, is extending its manufacturing agreement with Precision Biologics, Inc., a Texas-based clinical stage biopharmaceutical ... [Published Freshnews.com - Mar 25 2014]
First reported Mar 24 2014 - Updated Mar 24 2014 - 2 reports

Perrigo sues FDA over failure to grant therapeutic equivalence rating for testosterone gel

By Kurt R. Karst –In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA ... [Published MedCity News - Mar 24 2014]

Quotes

"We are pleased to add this next generation inhaler to OPKO’s growing product portfolio," stated Phillip Frost, M D , OPKO’s CEO and Chairman. "We expect this innovative device to play a valuable role in the improvement of therapy for asthma, chronic obstructive pulmonary disease, cystic fibrosis and other respiratory diseases. We plan to use the Inspiromatic™ device to test the inhaled form of OPKO’s new sulfated disaccharide drug against these disorders. This drug product is still undergoing pre-clinical testing prior to submission of an IND, but animal data indicates safety and efficacy for both inhaled and orally delivered forms. Of course, we believe that Inspiromatic™ can improve outcomes of treatment with other drugs, those presently available in more 'standard' type inhalers, as well as new inhalation drugs being developed. This acquisition fits our strategy of developing new products that address large markets in need of more effective therapeutic solutions."
The following quote was obtained by the news editors from the background information supplied by the inventors: "The invention relates to crystalline forms of a compound which inhibits tyrosine kinase enzymes, compositions which contain the tyrosine kinase inhibiting compound and methods of using the crystalline form of inhibitors of tyrosine kinase enzymes to treat diseases which are characterized by an overexpression or upregulation of tyrosine kinase activity such as cancer, diabetes, restenosis, arteriosclerosis, psoriasis, Alzheimer's disease, angiogenic diseases and immunologic disorders."
The theme of this year's PDA Annual Meeting is "Biopharmaceutical and Sterile Pharmaceutical Manufacturing - Embracing Innovation to Meet Global Challenges."

More Content

All (406) | News (352) | Reports (0) | Blogs (41) | Audio/Video (0) | Fact Sheets (0) | Press Releases (4)
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OPKO Health Acquires Inspiro Medical Ltd. [Published Citybizlist - 11 hours ago]
OPKO Acquires Next Generation Dry Powder Inhale... [Published Business Wire - 14 hours ago]
Patent Issued for Crystalline Forms of (S)-1-(4... [Published 4 Traders - Apr 17 2014]
USPTO Grants a New Inhaler Patent to Hovione [Published American Pharmaceutical Outsourcing - Apr 16 2014]
Patheon to Highlight Sterile and Biologic Capab... [Published American Pharmaceutical Outsourcing - Apr 16 2014]
Multisorb at Interpack 2014 to Focus on QbD and... [Published PharmaAsia - Apr 16 2014]
Why Johnson & Johnson Can Be Prescribed For Mos... [Published Seeking Alpha - Apr 16 2014]
System and method for managing pedigree informa... [Published Free Patents Online - Apr 16 2014]
Manager- Inventory Control [Published PharmaDiversity - Apr 15 2014]
BDP Week 2014: Biosimilars [Published Future of BioPharma - Apr 15 2014]
Multisorb's In-Booth Symposium At Interpack 201... [Published Pharmaceutical Online - Apr 15 2014]
Sobeys to challenge to ban on pharmacy reward p... [Published Chain Drug Review - Apr 15 2014]
Sr Scientist, Analytical Chemisry [Published PharmaDiversity - Apr 15 2014]
FDA Seeks Information for Implementation of Dru... [Published JD Supra - Apr 14 2014]
WuXi Single-Use Biotech Facility Gets ISPE FOY Nod [Published Pharmaceutical Manufacturing Magazine - Apr 14 2014]
EL Seminar organized by Intertek held in Mumbai [Published EHealth Magazine - Apr 14 2014]
Reevaluating Gilead Sciences After The Sell-Off [Published Seeking Alpha - Apr 14 2014]
Novo Nordisk speaking at Lyophilisation 2014 sh... [Published PRWeb UK - Apr 12 2014]
Principal Scientist - Biologics (Protein Formul... [Published PharmaDiversity - Apr 12 2014]
Specialty Pharmacy Presents Opportunities for H... [Published ASHP - Apr 12 2014]
Intertek organises EL seminar in Mumbai [Published Express Pharma - Apr 11 2014]
Recent Acquisitions, Trial Opinions, Upcoming E... [Published Finwin - Apr 11 2014]
PSE & Pfizer form the Systems-based Pharmaceuti... [Published NewsRX - Apr 11 2014]
Nanosimilars and follow-on nanomedicines [Published PharmTech.com - Apr 10 2014]
Acura Pharmaceuticals Inc. ends licensing agree... [Published GantDaily.com - Apr 10 2014]
Researchers Submit Patent Application, "Method ... [Published Pharmacy Choice - Apr 10 2014]
PFIZER : PSE & Pfizer form the Systems-based Ph... [Published 4 Traders - Apr 10 2014]
Associate Director , Biologics Outsourced Manuf... [Published PharmaDiversity - Apr 10 2014]
CUBIST PHARMACEUTICALS : Patent Application Tit... [Published 4 Traders - Apr 10 2014]
USPTO Grants Patent To Hovione Inhaler [Published Pharmaceutical Online - Apr 09 2014]
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Blogs

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BDP Week 2014: Biosimilars [Published Future of BioPharma - Apr 15 2014]
Biosimilars had a brief spotlight at BDP Week in two track sessions, Analytical Technologies for Biotherapeutic Development (ATBD) and as a featured presentation in Antibody Development and Production (ADP). The focus of the presentations in the ATBD ...
FDA is Asked to Reconsider Denial of NCE Exclus... [Published FDA Law Blog - Apr 09 2014]
By Kurt R. Karst –When FDA announced on February 21, 2014 that the Agency would, upon finalization of a draft guidance document, reinterpret the New Chemical Entity (“NCE”) exclusivity provisions of the FDC Act to award NCE exclusivity for a newly approved ...
Zogenix Update on Legal Action [Published PR Newswire: Policy & Public Interest - Apr 09 2014]
SAN DIEGO, April 8, 2014 /PRNewswire/ -- Today Zogenix presented its case in U.S. District Court in Boston requesting an immediate order staying the ban on the U.S. Food and Drug Administration (FDA)-approved prescription drug product, Zohydro™ ER (hydrocodone ...
Another REMS Antitrust Lawsuit: Mylan Sues Celg... [Published FDA Law Blog - Apr 04 2014]
By Kurt R. Karst –In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust ...
This week: Petards Fit for Growth, Galasys off ... [Published Proactiveinvestors United Kingdom website - Apr 03 2014]
BILL debt reduction,CCE award,CHRR trading update,ECK payment contracts,Galasys Intention to float on AIM,Haydale Graphene Industries Intention to float on AIM,PPT Pay in Your Currency,PEG final results,RAME Energy Intention to float on AIM,RENE UK regulatory ...
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Press Releases

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Gateway Analytical to Exhibit Pharmaceutical Fo... [Published PR Newswire - Nov 08 2013]
Peer-Reviewed Study Proves Effectiveness of Cry... [Published PR Newswire - Oct 29 2013]
Pharmalink Receives US Orphan Drug Designation ... [Published PR Newswire - Oct 29 2013]
Omeros Hires Michael K. Inouye to Lead Commerci... [Published PR Newswire - Oct 08 2013]
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