Drug Product

Type: Keyphrase
Name: Drug Product
First reported Oct 24 2014 - Updated Oct 24 2014 - 1 reports

AMRI to Announce Third Quarter Results on November 5, 2014

ALBANY, New York, Oct. 24, 2014 /PRNewswire/ -- AMRI (NASDAQ: AMRI) today announced it will issue third quarter financial results before the opening of the U.S. financial markets on Wednesday, November 5, 2014. Following the release of its results, the ... [Published FinanzNachrichten.de - Oct 24 2014]
First reported Oct 24 2014 - Updated Oct 24 2014 - 1 reports

Over-the-counter pain reliever recalled because packages contain wrong drug

Syracuse, N.Y. -- Boxes of naproxen sodium tablets sold under the brand name "Assured" are being recalled because some of the cartons contain ibuprofen, a different pain reliever.The drugs got switched because of a packaging error, according to the Food ... [Published Syracuse Online - Oct 24 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

Mayne Pharma Names U.S. Ops VP

Q. Dwight Lewis has been appointed vice president of quality for Mayne Pharma’s operations in the U.S. Mr. Lewis is responsible for managing all quality-related functions to ensure U.S. pharmaceutical operations, from labs to manufacturing lines, continue ... [Published Contract Pharma - Oct 22 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

Health Canada Seizes Unsafe Drug Product

Health Canada is warning Canadians of the serious risks to health associated with use of the unauthorized drug product Miracle Mineral Solution (MMS), which was sold as a treatment for serious diseases such as cancer through the website www.buymms.bi ... [Published Fountain Pen - Oct 22 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

FDA to survey pharmacists on their experiences with changes in generic drug pill appearance

SILVER SPRING, Md. — The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.The agency expressed a concern that generic drugs that differ ... [Published Drug Store News - Oct 22 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

Chef at Budd Lake restaurant who spit into patron's food was fired, report says

MOUNT OLIVE – A chef at Kennedy's Pub who allegedly spit into a meal that a man sent back for additional cooking was fired immediately after the incident occurred, according to a report. after an employee contacted authorities to report that 32-year-old ... [Published New Jersey Online - Oct 22 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

Restaurant Employee Reports Chef To The Police For Spitting In Customer’s Food

( agoailam ) It’s not always staff versus the customers when it comes to food disputes, which is good to know when someone’s spitting in your food: The chef at a New Jersey restaurant was arrested after another worker called police to report “multiple ... [Published The Consumerist - Oct 22 2014]
First reported Oct 22 2014 - Updated Oct 22 2014 - 1 reports

Gateway Analytical to Present on Formulation Development and Establishing Bioequivalence in Drug Products

PITTSBURGH, Oct. 22, 2014 /PRNewswire-iReach/ -- Gateway Analytical announced today that they will be presenting on chemically-specific particle analysis in addition to exhibiting at the upcoming Bioequivalence: Intersection between Science & Regulatory ... [Published TickerTech.com - Oct 22 2014]
First reported Oct 20 2014 - Updated Oct 21 2014 - 2 reports

Would You Like Phlegm With That? Pub Chef Spit in Food, Cops Say

Cook at Kennedy's Pub in Budd Lake arrested for tampering with customer's meal.The chef at one of Mt. Olive’s more popular restaurants wasarrested over the weekend for allegedly spitting into a customer’s food, policesaid.At 9:57 p.m. on Sunday, an employee ... [Published Long Valley Patch - Oct 21 2014]
Entities: Phlegm, Police, Drug Product
First reported Oct 21 2014 - Updated Oct 21 2014 - 1 reports

Vietnam, Switzerland work on low-cost medicines

The Vietnam Ministry of Health and Switzerland’s Novartis Group have signed a memorandum of understanding on low-cost with the aim of increasing Vietnamese people’s access to essential generic drugs that they can afford.The MoU covers the invention cooperation ... [Published VietnamPlus - Oct 21 2014]
First reported Oct 20 2014 - Updated Oct 20 2014 - 2 reports

BioReliance Adds Advanced In-Vitro ADME and Toxicology Services

BioReliance , Sigma-Aldrich Corporation’s biologics and early-development services business, announced that it has introduced select in vitro ADME (absorption, distribution, metabolism and excretion) and toxicology testing services its service offering. ... [Published PharmTech.com - Oct 20 2014]
First reported Oct 20 2014 - Updated Oct 20 2014 - 1 reports

Senior Director, Analytical Development Job

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion ... [Published PharmaDiversity - Oct 20 2014]

Quotes

...understanding of the relationship between changes in pill appearance and nonadherence to prescribed therapeutic regimens," the agency continued. "The surveys may enable us to investigate factors that may explain the association between changes in pill appearance and nonadherence, including which factors could be modified to improve the safe and effective use of generic drugs."
...of agglomeration meets the requirements of the brand drug via bioequivalence" said David Exline, Senior Vice President at Gateway Analytical. "Only by utilizing our patented Raman chemical imaging method can you obtain spectral information on every pixel in the data, which provides identification and characterization of the agglomerate. This allows us to see what the agglomerate is composed of, such as two active pharmaceutical ingredients (API), or an API and an excipient. This chemical specificity helps put Gateway and the forefront for helping formulators better understand their drug product, and ready it for FDA submission."
" This office will provide internal customers with a single drug quality assessment that captures the overall OPQ recommendation on approvability, and OPQ will provide feedback on quality deficiencies earlier in the review cycle ,” she added."
...the data from the nonclinical animal studies of OMS824," stated Gregory A Demopulos , M D , chairman and chief executive officer of Omeros. "Based on currently available data, we do not believe that the observation in the rats is caused by OMS824. We will work with the FDA and look forward to continuing the Phase 2 Huntington's trial."

More Content

All (392) | News (319) | Reports (0) | Blogs (68) | Audio/Video (0) | Fact Sheets (0) | Press Releases (3)
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Intravia Containers by Baxter: Recall - Particu... [Published Ein News - 8 hours ago]
CMC Documentation Specialist, Pharmaceutical De... [Published PharmaDiversity - 19 hours ago]
Ebola: Diagnosis, Prevention, and Treatment [Published American Journal of Managed Care - Oct 24 2014]
Depomed, Inc. v. Actavis Elizabeth LLC [Published JD Supra - Oct 24 2014]
Over-the-counter pain reliever recalled because... [Published Syracuse Online - Oct 24 2014]
AMRI to Announce Third Quarter Results on Novem... [Published FinanzNachrichten.de - Oct 24 2014]
Helix BioPharma Corp. Announces Fiscal 2014 Res... [Published Nasdaq - Oct 24 2014]
Helix BioPharma Corp. Announces Fiscal 2014 -2- [Published Scottrade - Oct 24 2014]
(CNCN) Helix BioPharma Corp. Announces Fiscal -2- [Published Scottrade - Oct 24 2014]
Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd. [Published JD Supra - Oct 23 2014]
Igenica Biotherapeutics to Present New Data on ... [Published Business Wire - Oct 23 2014]
Associate Scientist II - Commercial Analytical ... [Published PharmaDiversity - Oct 23 2014]
Mayne Pharma Names U.S. Ops VP [Published Contract Pharma - Oct 22 2014]
Health Canada Seizes Unsafe Drug Product [Published Fountain Pen - Oct 22 2014]
Mayne Pharma Appoints New VP of Quality for U.S... [Published PharmaceuticalProcessing - Oct 22 2014]
FDA to survey pharmacists on their experiences ... [Published Drug Store News - Oct 22 2014]
Chef at Budd Lake restaurant who spit into patr... [Published New Jersey Online - Oct 22 2014]
FDA News for Health Professionals - 10-22-2014 [Published Food Consumer - Oct 22 2014]
United Therapeutics Corp. v. Sandoz, Inc. [Published JD Supra - Oct 22 2014]
Restaurant Employee Reports Chef To The Police ... [Published The Consumerist - Oct 22 2014]
Sodium Pain Relief Pills Recalled Because They ... [Published The Consumerist - Oct 22 2014]
Gateway Analytical to Present on Formulation De... [Published TickerTech.com - Oct 22 2014]
Assured Brand Naproxen Sodium Tablets Recall [Published Kansas City Infozine - Oct 22 2014]
EH&S Mgr - Safety and Risk Management [Published PharmaDiversity - Oct 22 2014]
Social News 22/10 [Published VietNamNet Bridge - Oct 22 2014]
Contract Packaging Resources, Inc. Issues a Vol... [Published U.S. Food and Drug Administration - Oct 21 2014]
Poll: Are you reluctant to send food back at a ... [Published New Jersey Online - Oct 21 2014]
Novartis Pharms. Corp. v. Par Pharm., Inc. [Published JD Supra - Oct 21 2014]
Would You Like Phlegm With That? Pub Chef Spit ... [Published Long Valley Patch - Oct 21 2014]
FDA to combine all of its quality ops under a n... [Published In-Pharmatechnologist - Oct 21 2014]
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Blogs

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Restaurant Employee Reports Chef To The Police ... [Published The Consumerist - Oct 22 2014]
( agoailam ) It’s not always staff versus the customers when it comes to food disputes, which is good to know when someone’s spitting in your food: The chef at a New Jersey restaurant was arrested after another worker called police to report “multiple ...
Sodium Pain Relief Pills Recalled Because They ... [Published The Consumerist - Oct 22 2014]
Nearly 12,000 boxes of Assured Sodium Pain Relief Tablets actually contain bottles of ibuprofen. There are a number of reasons why a consumer would choose to purchase sodium pain relievers, for one, they might be allergic to ibuprofen. In that case, ...
No Good Precedent Goes Overlooked: FDA is Asked... [Published FDA Law Blog - Oct 21 2014]
By Kurt R. Karst –We were wondering how long it might be until a company went running to FDA to request that the Agency reset the date of approval of its NDA, as well as any unexpired marketing exclusivity, as the result of a proprietary name review issue ...
BlueOcean and Neptune Sign Licensing Agreement [Published Marketwire - Breaking News Releases - Oct 20 2014]
TORONTO, ONTARIO--(Marketwired - Oct. 20, 2014) - BlueOcean NutraSciences Inc. ("BlueOcean") (TSX VENTURE:BOC) announces the signing of an exclusive world-wide, royalty-bearing, non-transferable, License Agreement ("License") under Neptune's composition ...
Advisory - Health Canada seizes dangerous healt... [Published PR Newswire: Health - Oct 18 2014]
OTTAWA, Oct. 18, 2014 /CNW/ -The issue:Health Canada is warning Canadians of the serious risks to health associated with use of the unauthorized drug product Miracle Mineral Solution (MMS), which was sold as a treatment for serious diseases such as cancer ...
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Press Releases

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Revance Therapeutics Provides Update on RT001 C... [Published GlobeNewswire: Advertising News - Oct 01 2014]
Biostar Pharmaceuticals, Inc. Files a PRC Paten... [Published Financial Services - Sep 18 2014]
Ohr Pharmaceutical Announces Agreement to Acqui... [Published GlobeNewswire: Acquisitions News - May 15 2014]
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