Drug Product

Type: Keyphrase
Name: Drug Product
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions

By Kurt R. Karst –In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371) concerning their testosterone gel 1% drug products ... [Published FDA Law Blog - Jul 28 2014]
First reported Jul 28 2014 - Updated Jul 28 2014 - 1 reports

BioSyent Pharma Inks Exclusive Licensing and Distribution Pact with European Partner for New Urgent Care Drug Product

BioSyent reported that its subsidiary BioSyent Pharma has signed an exclusive Licensing and Distribution Agreement with an existing European partner for a new product that will be marketed by its' Hospital Products Division.In its release, BioSyent said ... [Published Individual.com - Jul 28 2014]
First reported Jul 25 2014 - Updated Jul 25 2014 - 1 reports

Associate Scientist - Drug Product Clinical Manufacturing

Org Marketing StatementAll over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of ... [Published PharmaDiversity - Jul 25 2014]
First reported Jul 23 2014 - Updated Jul 24 2014 - 2 reports

FDA Announces Voluntary Recall of All Non-Expired Sterile Drugs from Unique Pharmaceuticals

The Food and Drug Administration (FDA) is alerting healthcare professionals and consumers of a voluntary recall of all non-expired drug products produced for sterile use by Unique Pharmaceuticals Ltd., of Temple, Texas.The recalled products include lot ... [Published Infection Control Today - Jul 23 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

BioSyent signs licensing deal for new urgent care drug product

BioSyent Pharma has signed an exclusive licensing and distribution agreement with an existing European partner for a new product that will be marketed by its Hospital Products Division. ... [Published PBR - News - Jul 24 2014]
First reported Jul 23 2014 - Updated Jul 24 2014 - 1 reports

Camargo Strengthens Research Team and Therapeutic Expertise

CINCINNATI--( BUSINESS WIRE )-- Camargo Pharmaceutical Services , a leading drug development organization specializing in the 505(b)(2) approval pathway, expands its research team and therapeutic expertise with the addition of Dr. ... [Published BioMedReports - Jul 23 2014]
First reported Jul 24 2014 - Updated Jul 24 2014 - 1 reports

FDA Alerts Not to Use Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): AttorneyOne Monitor and Keep Consumers Informed

On July 19, healthcare professionals and consumers were notified not to use drugs marketed as sterile produced by Downing Labs LLC, aka NuVision Pharmacy, as they may be contaminated. In light of this news, AttorneyOne, a recognized authority on law, ... [Published PRWeb - Jul 24 2014]
First reported Jul 23 2014 - Updated Jul 23 2014 - 2 reports

BioSyent Pharma Signs Exclusive Licensing and Distribution Agreement For New Urgent Care Drug Product

TORONTO, ONTARIO -- (Marketwired) -- 07/23/14 -- BioSyent Inc. ("BioSyent") ( TSX VENTURE: RX ) is pleased to announce that its subsidiary BioSyent Pharma Inc. has signed an exclusive Licensing and Distribution Agreement with an existing European partner ... [Published Ask.com - Jul 23 2014]
First reported Jul 23 2014 - Updated Jul 23 2014 - 1 reports

Mgr Manufacturing

Reporting to the Sr. Manager Manufacturing, AWM Manufacturing, this position is primarily responsible for the supervision and development of manufacturing floor staff. In addition, the manager is responsible for manufacturing operations related to upstream ... [Published PharmaDiversity - Jul 23 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

AMRI to Announce Second Quarter Results

/PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced it will issue second quarter financial results before the opening of the market on Tuesday, August 5 , 2014.  Following the release of its results, the company will host a conference call and simultaneous ... [Published OSIX News - Jul 22 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

Specialist Quality Operations

Org Marketing StatementAll over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of ... [Published PharmaDiversity - Jul 22 2014]
First reported Jul 15 2014 - Updated Jul 16 2014 - 4 reports

Aptuit to upgrade cytotoxic drug product manufacturing facility in Glasgow

, a US-headquartered supplier of early to mid-phase drug development services, is to invest US$1m at its facility in Glasgow, Scotland.The investment will finance an upgrade in the site's sterile cytotoxic liquid and lyophilised drug product manufacturing ... [Published Manufacturing Chemist - Jul 16 2014]

Quotes

SAN DIEGO, CA -- (Marketwired) -- 07/29/14 -- Dr. Dennis Carlo, President and CEO of Adamis, stated, "This is a major milestone in that the PFS will be the company's first product to generate revenues. With the FDA's acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for the PFS in the U S in the first half of 2015."
...Practice for Pharmacists and Pharmacy Technicians, and Standards for the Operation of Licensed Pharmacies approved by the ACP council on April 10, "A regulated member must not offer or provide or be party to the offering or provision of an inducement to a patient where the inducement is offered or provided on the condition that the patient obtains a drug product or a professional service"
"We rate AMGEN INC (AMGN) a BUY. This is based on the convergence of positive investment measures, which should help this stock outperform the majority of stocks that we rate. The company's strengths can be seen in multiple areas, such as its revenue growth, reasonable valuation levels, good cash flowflow from operations, increase in stockstock price during the past year and expanding profit margins. We feel these strengths outweigh the fact that the company has had sub par growth in net income."
...as this will be our first clinical study evaluating AVP-786 in patients," said Joao Siffert, MD, chief medical officer at Avanir Pharmaceuticals. "There are millions of patients with MDD who do not respond adequately to existing therapies. With a mechanism of action addressing multiple neurotransmitter systems involved in depression, AVP-786, if approved, could offer a potential new treatment option for these patients. We look forward to initiating our clinical research program in the coming months."

More Content

All (340) | News (252) | Reports (0) | Blogs (78) | Audio/Video (0) | Fact Sheets (0) | Press Releases (4)
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FDA Accepts for Review Adamis' New Drug Applica... [Published Wall Street Select - 27 mins ago]
FDA Accepts for Review Adamis' New Drug Applica... [Published Individual.com - 31 mins ago]
Sobeys earns victory in legal challenge on phar... [Published Chain Drug Review - 6 hours ago]
J&J done with Boehringer plant after building a... [Published FiercePharmaManufacturing - 10 hours ago]
Braintree Labs., Inc. v. Novel Labs., Inc. (Fed... [Published JD Supra - 17 hours ago]
Amgen Shares Have the Right Prescription for Lo... [Published AdvisorSource.com - 21 hours ago]
Amgen Shares Have the Right Prescription for Lo... [Published TheStreet.com - 21 hours ago]
Amgen Shares Have the Right Prescription for Lo... [Published The Street Latest - 21 hours ago]
Avanir Pharmaceuticals Announces FDA Acceptance... [Published Drugs.com - Jul 28 2014]
FDA Rejects Requests to Initiate Rulemaking for... [Published FDA Law Blog - Jul 28 2014]
BioSyent Pharma Inks Exclusive Licensing and Di... [Published Individual.com - Jul 28 2014]
Associate Scientist - Formulation and Process D... [Published PharmaDiversity - Jul 25 2014]
Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed... [Published JD Supra - Jul 25 2014]
Associate Scientist - Drug Product Clinical Man... [Published PharmaDiversity - Jul 25 2014]
Rockwell Medical Schedules 2nd Quarter 2014 Inv... [Published InvestorPoint.com - Jul 25 2014]
Simultaneous Determination of Amlodipine and It... [Published Chromatography Today - Jul 25 2014]
Pharmacy Manager [Published PharmaDiversity - Jul 25 2014]
Asterias Biotherapeutics Announces Live Investo... [Published Bio-Medicine - Jul 24 2014]
‘Sterile’ Drug Products Recalled [Published P&T Community - Jul 24 2014]
Asterias Biotherapeutics Announces Live Investo... [Published Wall Street Business Network - Jul 24 2014]
Celgene posts strong sales and earnings for 2nd... [Published Pharma Letter - Jul 24 2014]
Allergan, Inc. v. Apotex, Inc. (Fed. Cir.) [Published JD Supra - Jul 24 2014]
PDA Training and Research Institute Adds 31 Cou... [Published Finwin - Jul 24 2014]
BioSyent signs licensing deal for new urgent ca... [Published PBR - News - Jul 24 2014]
Protalix BioTherapeutics Names Shlomo Yanai as ... [Published Stock Nod - Jul 24 2014]
FDA Alerts Not to Use Sterile Drug Products by ... [Published PRWeb - Jul 24 2014]
Unique Pharmaceuticals Recalls All Sterile Drug... [Published Diabetes Care - Jul 23 2014]
FDA Announces Voluntary Recall of All Non-Expir... [Published Infection Control Today - Jul 23 2014]
Vaccine Development Advancing Due to New Techno... [Published Future of BioPharma - Jul 23 2014]
Doctors Warned Not To Use Compounded Drugs From... [Published KWTX - Jul 23 2014]
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Blogs

sort by: Date | Relevance
FDA Rejects Requests to Initiate Rulemaking for... [Published FDA Law Blog - Jul 28 2014]
By Kurt R. Karst –In a rather lengthy (33-page) response to two citizen petitions submitted to FDA by AbbVie Inc. (Docket No. FDA-2011-P-0610) and Auxilium Pharmaceuticals, Inc. (Docket No. FDA-2013-P-0371) concerning their testosterone gel 1% drug products ...
BioSyent signs licensing deal for new urgent ca... [Published PBR - News - Jul 24 2014]
BioSyent Pharma has signed an exclusive licensing and distribution agreement with an existing European partner for a new product that will be marketed by its Hospital Products Division. ...
Vaccine Development Advancing Due to New Techno... [Published Future of BioPharma - Jul 23 2014]
Vaccine development may significantly improve as technology on the fields of antigens, genomics and immunological monitoring advances. The report published in Nature Immunology stated that a focus on the human immune system will overcome the challenges ...
BioSyent Pharma Signs Exclusive Licensing and D... [Published Marketwire - Breaking News Releases - Jul 23 2014]
TORONTO, ONTARIO--(Marketwired - July 23, 2014) - BioSyent Inc. ("BioSyent") (TSX VENTURE:RX) is pleased to announce that its subsidiary BioSyent Pharma Inc. has signed an exclusive Licensing and Distribution Agreement with an existing European partner ...
FDA’s Intervening NDA Approval Policy Strikes A... [Published FDA Law Blog - Jul 17 2014]
By Kurt R. Karst —Beginning in 1999, around the time FDA issued a (still) draft guidance document on 505(b)(2) applications, and lasting until about 2009, this blogger taught an introduction to drug law course at FDA to FDAers.  The focus of my talk was ...
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Press Releases

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Ohr Pharmaceutical Announces Agreement to Acqui... [Published GlobeNewswire: Acquisitions News - May 15 2014]
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]
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