Okay. This is
, as I would have guessed Mr. Read was
than this — or at least
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. . . .
Phase III clinical trials of arterolane, in combination with piperaquine, began in India in 2009. When clinical trial results were disappointing, the MMV withdrew support and Ranbaxy continued developing the drug combination on its own.
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.
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.
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.
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
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
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
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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