Month: June 2014

Vertex Pharmaceuticals: European Recommendation For Kalydeco Additional Mutations

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Orphan Druganaut Blog

On June 27th, Vertex Pharmaceuticals gets European CHMP’s (Committee for Medicinal Products for Human Use) positive opinion recommending the approval of orphan drug Kalydeco (Ivacaftor) for Cystic Fibrosis (CF) patients, ages 6 and older, who have 1 of the following 8 non-G551D gating mutations, in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene:

•G178R   •S549N    •S549R   •G551S   •G1244E    •S1251N   •S1255P   •G1349D.

These 8 additional mutations affects approximately 250 patients in Europe. The next step, is for the European Commission (EC), that has the authority to approve drugs for the European Union, to review the CHMP’s positive opinion. The EC usually follows the recommendation of the CHMP and issues a marketing approval within 3 – 4 months. Kalydeco receives approval in Europe in July 2012 for patients with CF ages 6 and older, who have at least 1 copy of the G551D mutation, which is the most common gating…

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安心マグネシウムサプリメント

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美容と健康

安心マグネシウムサプリメント

カラダガヨロコブサプリメントシリーズ
ニューサイエンス マグネシウム

ニューサイエンス マグネシウムは吸収性や安全性を考慮した特製酵母ミネラルで、鉱物マグネシウムと違い、キレート状態の有機マグネシウムを無添加でGMP取得工場にて植物性カプセルに凝縮した高品質マグネシウムサプリメントです。

マグネシウムとは

マグネシウムはストレスで消費されやすいので不足しやすいミネラルです。体の中では300種以上の酵素の働きに必要でありカルシウムよりも重要な栄養素で、カルシウムやタンパク質の働きも助ける役目があります。骨や筋肉にも使われる、健康と美容にとても重要な栄養素と言えます。このようにマグネシウムなど必須ミネラルの栄養素はとても重要ですが、通常は吸収が良くありません。吸収が良くないとということは、せっかく摂取しても意味がないということです。そのためサプリメントとしてのマグネシウムは吸収に優れていることが重要になってきます。

ニューサイエンス マグネシウムの特徴

ニューサイエンス マグネシウムは一般的な合成由来のマグネシウムサプリや鉱物マグネシウムと違い安全や吸収に優れた特製酵母ミネラルの体にとって自然なキレート有機マグネシウムです。香料や着色料、保存料など合成添加物は無添加で製造も*GMP取得工場、高品質だから安心です。

*GMPとはGood Manufacturing Practiceの略で品質管理を行っている工場で製造されたことを表しています。

特製酵母ミネラルとは

シュラウザー博士(ドイツ)が発明した、ミネラルの製造方法で安全面・吸収面で優れたミネラルです。酵母を培養する過程で製造されるミネラルは人の体が必要とする有機ミネラルとなります。
ニューサイエンス マグネシウムについて
杏林予防医学研究所の開発・検定品

ニューサイエンス マグネシウム公式ページ

カラダがヨロコブシリーズ

ニューサイエンス マグネシウム正規販売店ページ

ニューサイエンス マグネシウム正規販売楽天店ページ
カラダガヨロコブ

杏林予防医学研究所公式サイト
杏林予防医学研究所について

ニューサイエンス サプリメント

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Surviving an audit, in simple terms

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Dycem CleanZone Technology

ARTICLE REFERENCE: How to survive an FDA audit by Paul Dupontaudit_image_cleanroomThe arrival of an audit inspection can instill feelings of fear and anxiety that can be duly diffused with the right preparation and mentality.

We’ve compiled a few concise pointers to help see you through the process.

Keep your employees in the loop

Identify several key members of personnel to liaise with the investigator during the audit process, and make them aware of their role. Prepare them as best as possible, so that they are in line with your organisation’s approach to the audit.


surviving_an_audit(1)

Do your research

Spend some time to familiarise yourself with the regulations, to make sure that your daily processes conform to the required standard.

Keep an open mind

Try not to be overly defensive in response to the investigator’s criticisms. Think clearly, and discuss the issue at hand openly. ‘You’re more likely to respond to…

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What GMP Changes can we still expect for 2014?

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New Drug Approvals

What GMP Changes can we still expect for 2014?

http://www.gmp-compliance.org/enews_4349_What%20GMP%20Changes%20can%20we%20still%20expect%20for%202014%3F_n.html

Heraclitus once said: “There is nothing permanent except change”. This statement is even true for the rather conservative GMP environment. What can we still expect for 2014? The answer to that question can be found in a work plan of EMA’s GMP/GDP Inspectors Working Group.

What are the coming plans?

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Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

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New Drug Approvals

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity
The applicant for an ANDA in the USA has to submit data of several stability tests. The FDA guidance on this topic coming into force last year left open some issues, however, that now are clarified with a questions and answers document published lately.

Read more.

http://www.gmp-compliance.org/enews_4352_Stability%20Data%20for%20ANDAs%20in%20the%20USA%3A%20a%20new%20Q%26A%20Document%20of%20the%20FDA%20provides%20further%20Clarity_8445,8489_n.html

Stability Data for ANDAs in the USA: a new Q&A Document of the FDA provides further Clarity

The FDA Guidance for Industry with the title “ANDAs: Stability Testing of Drug Substances and Drug Products” was published in the Federal Register on 20 June 2013 (also see our News dated 1 August 2013) and is addressed to applicants for ANDAs in the USA. This guidance describes the stability data the FDA expects in the documents submitted for an ANDA and is rather short having…

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The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China.

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New Drug Approvals

FDA issues Warning Letter for API Facility

http://www.gmp-compliance.org/enews_4367_FDA%20issues%20Warning%20Letter%20for%20API%20Facility_8509,S-WKS_n.html
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility. Read more about the FDA Warning Letter.


FDA issues Warning Letter for API Facility
The US FDA has issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co. Ltd. in Tianjin, China. The company produces APIs and failed to establish adequate GMP procedures at the facility.

For quite some time India was in the center of attention and very little was heard about GMP problems in China (see also RAPS article). This is a bit surprising because a number of non-compliant facilities have been detected in the past. Also the facilities which caused the Heparin Scandal were located in China. The last enforcement action from FDA which became public referred to Import…

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The Discovery of MK-4256, a Potent SSTR3 Antagonist as a Potential Treatment of Type 2 Diabetes

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New Drug Approvals

somatostatin receptor antagonist

C27 H23 F N8 O

494.5229

3(R)-[4-(4-Fluorophenyl)-1H-imidazol-2-yl]-1(R)-(5-methyl-1,2,4-oxadiazol-3-yl)-1-(1-methyl-1H-pyrazol-4-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole
3(R)-[4-(4-Fluorophenyl)-1H-imidazol-2-yl]-1(R)-(5-methyl-1,2,4-oxadiazol-3-yl)-1-(1-methyl-1H-pyrazol-4-yl)-2,3,4,9-tetrahydro-1H-beta-carboline

1H-Pyrido[3,4-b]indole, 3-[5-(4-fluorophenyl)-1H-imidazol-2-yl]-2,3,4,9-tetrahydro-1-(5-methyl-1,2,4-oxadiazol-3-yl)-1-(1-methyl-1H-pyrazol-4-yl)-, (1R,3R)-

3-((1R,3R)-3-(4-(4-fluorophenyl)-1H-imidazol-2-yl)-1-(1-methyl-1H-pyrazol-4-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indol-1-yl)-5-methyl-1,2,4-oxadiazole

Merck & Co. (Originator)

Somatostatin srif1C (sst3) Antagonists

The Discovery of MK-4256, a Potent SSTR3 Antagonist as a Potential Treatment of Type 2 Diabetes 
(ACS Medicinal Chemistry Letters) Thursday May 10th 2012
Author(s): Shuwen HeZhixiong YeQuang TruongShrenik ShahWu DuLiangqin GuoPeter H. DobbelaarZhong LaiJian Liu,Tianying JianHongbo QiRaman K. BakshiQingmei HongJames DellureficioAlexander PasternakZhe FengReynalda deJesusLihu YangMikhail ReibarkhScott A. BradleyMark A. HolmesRichard G. BallRebecca T. RuckMark A. Huffman,Frederick WongKoppara SamuelVijay B. ReddyStan…

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