Month: April 2014

Ian C. Read’s Pfizer Offer, For AstraZeneca: Now Clearly HOSTILE. Sheesh.

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New Merck, Reviewed

Okay. This is wild , as I would have guessed Mr. Read was smarter than this — or at least less stubborn . Pig-headed , actually.

He just went hostile. Open, notorious and hostile — on AZ’s board — at north of $100 billion. Wow. His April 28 letters are plainly a suggestion that he will consider going directly to AZ shareholders — i.e., a proxy fight. This, my friends, is hostile takeover talk:

. . . .We made our intentions public to communicate what we believe are the benefits of a potential combination to shareholders of both companies, and to make clear to all our stakeholders the many advantages such combination of Pfizer and AstraZeneca would present. And we believe pursuing a potential transaction would support our recent reorganization into three new commercial businesses. . . .

Next steps really depend on the response we get…

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Antimalarials………….Arterolane from Ranbaxy

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New Drug Approvals

Arterolane.png 664338-39-0   Arterolane
664338-39-0, UNII-3N1TN351VB, OZ277, RBX-11160, NCGC00274173-01
Molecular Formula: C22H36N2O4
 Molecular Weight: 392.53224
 cis-adamantane-2-spiro-3’-8’-[[[(2’-amino-2’ methylpropyl) amino] carbonyl] methyl] 1’,2’,4’-trioxaspiro [4.5] decane
cis-adamantane-2-spiro-3′-8′-[[[(2′- amino-2′-methylpropyl)amino]carbonyl]-methyl]- 1 ‘,2′,4’-trioxaspiro[4.5]decane

Arterolane, also known as OZ277 or RBx 11160,is a substance being tested for antimalarial activity[1] by Ranbaxy Laboratories.[2] It was discovered by US and European scientists who were coordinated by the Medicines for Malaria Venture (MMV).[3] Its molecular structure is uncommon for pharmacological compounds in that it has both an ozonide group and an adamantane substituent.[4]

Phase III clinical trials of arterolane, in combination with piperaquine, began in India in 2009.[5] When clinical trial results were disappointing, the MMV withdrew support[2] and Ranbaxy continued developing the drug combination on its own.

Ranbaxy launched India’s first new drug, Synriam

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Integrity and Security of Medicinal Products Supply Chains – New Instructions in the US-American Pharmacopeia (USP)

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Integrity and Security of Medicinal Products Supply Chains – New Instructions in the US-American Pharmacopeia (USP)
The revision of the General Chapters on Good Distribution Practices (GDP) has highlighted in a new USP chapter the safety and integrity of the supply chains for starting materials and medicinal products. More information can be found in the News.

GMP News
16/04/2014

Integrity and Security of Medicinal Products Supply Chains – New Instructions in

the US-American Pharmacopeia (USP)

A new series of General Chapters on the different aspects of the pharmaceutical supply

chain (“Good Distribution Practices”) which should replace the current chapters on the topic

has been published in the Pharmacopoeial Forum 40(1). A review of the current chapters

(<1079>, <1083> and <1197>) has shown that the contents partly overlap each other.

That’s why these GDP chapters should be reorganised from a higher perspective.

The chapters address material flow beginning with initial procurement and continuing

throughout the supply chain to delivery to the end user.

They apply to APIs, excipients, as well as to medicinal products and medical devices.

The 4 main GDP topics are now organised as follows:

  • 1083.1 Quality Management System
  • 1083.2 Environmental Conditions Management
  • 1083.3 Good Importation and Exportation Practices
  • 1083.4 Suppy Chain Integrity and Security

Supply Chain Integrity and Security (SCIS) is defined as a series of policies,

procedures, and technologies which are used to ensure visibility and traceability of products.

The ultimate objective is to identify falsified or manipulated products and prevent them

from entering the supply chain – and, as a matter of fact – the market.

You can find all information on the USP website of the Pharmacopeial Forum (PF).

Source: USP – http://www.usp.org

 

http://www.gmp-compliance.org/enews_4233_Integrity%20and%20Security%20of%20Medicinal%20Products%20Supply%20Chains%20-%20New%20Instructions%20in%20the%20US-American%20Pharmacopeia%20%28USP%29_8447,S-RPV_n.html

EU Commission issues new EU GMP Guide Chapter 6

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EU Commission issues new EU GMP Guide Chapter 6
In early April 2014, the EU Commission has published a new Chapter 6 Quality Control. The new chapter will become effective on 1 October 2014. Read more in the GMP news to the new EU GMP chapter quality control.

http://www.gmp-compliance.org/enews_4262_EU%20Commission%20issues%20new%20EU%20GMP%20Guide%20

Chapter%206_8267,8301,8399,8430,Z-QCM_n.html

 

EU Commission issues new EU GMP Guide Chapter 6

In early April 2014, the EU Commission has published a new chapter 6 Quality Control. The new chapter will become effective on 1 October 2014. The main reasons for the changes (as e.g. the insertion of a new chapter on transfer of analytical methods) were already subject of our news Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 – Quality Control).

The now published document comprises different additions. For instance, the following was added in 6.5. Good Quality Control Laboratory Practices: “laboratory equipment should not be routinely moved between high risk areas to avoid accidental cross-contamination. In particular, the microbiological laboratory should be arranged so as to minimize risk of cross-contamination.”

According to 6.9 now all Out of Trend (OOT) and all Out of Specification (OOS) results have to be considered and need to undergo an investigation. Also, in 6.12. a new requirement asks for a sampling plan based on risk assessment. Further content supplements (in addition to others) deal with the subject of reference standards. The newly inserted text under 6.20 states “… their qualification and certification as such should be clearly stated and documented. Whenever compendial reference standards from an officially recognised source exist, these should preferably be used as primary reference standards unless fully justified (the use of secondary standards is permitted once their traceability to primary standards has been demonstrated and is documented). These compendial materials should be used”.

The regulations with regard to “Technical Transfer of Testing Methods” starting with point 6.37 up to 6.41 are completely new.

All attendees of ECA courses and conferences can download a document comparison between the current chapter 6 and the new version in the ECA website members’ area. In this comparison all changes and additions are marked. Otherwise please also see the new Chapter 6 Quality Control for more information.

 

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi

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New Drug Approvals

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi  

Total Payment received for GBR 500 monoclonal antibody programme from Sanofi is USD 55 Mn 

MUMBAI, April 15, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received USD 5 million as

milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta1) integrin monoclonal antibody. GBR 500 is a first-in-class therapeutic monoclonal antibody for chronicautoimmune disorders.

Glenmark has received from Sanofi already USD 50 Mn as an upfront payment in FY2011-12. Hence, the total amount received by Glenmark from Sanofi for its first in class VLA-2monoclonal antibody is USD 55 million

read at

Glenmark – Updates

http://www.moneycontrol.com/stocks/stock_market/corp_notices.php?autono=790416

(copy paste on browser)

MD and CEO Mr Glenn Saldanha

old updates

Glenmark GBR 500 enters into Phase II clinical development for ulcerative colitis

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LM11A-31-BHS….. (2S,3S)-2-amino-3-methyl-N-(2-morpholinoethyl)-pentanamide

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New Drug Approvals

LM11A-31-BHS

(2S,3S)-2-amino-3-methyl-N-(2-morpholinoethyl)-pentanamide

2-Amino-3-methyl-N-[2-(4-morpholinyl)ethyl]-pentanamide dihydrochloride

  • CAS Number 1214672-15-7
  • Empirical Formula C12H25N3O2 · 2HCl
  • Molecular Weight 316.27

LM11A-31 is a non-peptide ligand of the p75 neurotrophin receptor (p75NTR). LM11A-31 blocks pro-NGF induced cell death in neuronal cultures, and protects neuronal cells from the the cytotoxic effects of cisplatin or methotrexate. Oral administration of LM11A-31 promotes the survival of oligodendrocytes and myelinated axons in a mouse spinal cord injury model and improves function in both weight-bearing and non-weight bearing tests.Inhibits death of hippocampal neurons at 100–1,000 pM

http://amcrasto.wix.com/anthony-melvin-crasto/apps/blog/lm11a-31-new-drug-can-help-paralyzed

PharmatrophiX

LM11A-31, NEW DRUG CAN HELP PARALYZED PEOPLE WALK AGAIN

Figure 2.

LM11A-31, C12 H25 N3 O2, Pentanamide, 2-amino-3-methyl-N-[2-(4-morpholinyl)ethyl]- WO 2010102212 TO LONGO FRANK, PUB 10.09.2010 THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL

PATENT LINK

http://patentscope.wipo.int/search/en/WO2010102212

Scientists have developed a pill which they claim could help paralyzed people walk again.

The…

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Glenmark’s novel molecule ‘GRC 27864’ for chronic inflammatory diseases including pain entering human trials

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New Drug Approvals

Glenmark’s novel molecule ‘GRC 27864’ for chronic inflammatory diseases including pain entering human trials 

 

  • GRC 27864 is a potent, selective, orally bioavailable inhibitor of mPGES-1
  • The molecule has successfully completed pre-clinical and Phase 1 enabling studies. Regulatory submission has been filed for Phase 1 trial (first-in-human)with MHRA, UK
  • mPGES-1 inhibitors selectively block the production of PGE2 while sparing other prostanoids of physiological importance
  • With this announcement, Glenmark has reaffirmed its position globally in the development of novel pain therapies

Mumbai, India: April 3, 2014: Glenmark Pharmaceuticals today announced that its Novel Chemical Entity (NCE) ‘GRC 27864’ is entering human trials. This NCE program targets Microsomal Prostaglandin E synthase-1 (mPGES-1) as a novel therapeutic target in pain management. Selective mPGES-1 inhibitors are expected to inhibit increased prostaglandin E2 (PGE2) production in the disease state without affecting other prostanoid metabolites and, consequently, may be devoid of the GI(gastrointestinal) and cardiovascular…

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