United States Patent and Trademark Office ….. published and made electronically available a new edition of the Manual of Patent Examining Procedure (MPE

New Drug Approvals

United States Patent and Trademark Office

Today we published and made electronically available a new edition of the Manual of Patent Examining Procedure (MPEP).

Manual of Patent Examining Procedure

uspto.gov

http://www.uspto.gov/web/offices/pac/mpep/index.html

Manual of Patent Examining Procedure (MPEP)Ninth Edition, March 2014

The USPTO continues to offer an online discussion tool for commenting on selected chapters of the Manual. To participate in the discussion and to contribute your ideas go to: http://uspto-mpep.ideascale.com.

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Aldoxorubicin…….Treatment of cancer …HIV-derived Kaposi’s Sarcoma, pancreatic cancer and for the treatment of soft tissue sarcoma.

New Drug Approvals

Aldoxorubicin

Click to access aldoxorubicin.pdf

 in phase 3

(E)-N’-(1-((2S,4S)-4-(((2R,4S,5S,6S)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-2-yl)-2-hydroxyethylidene)-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)hexanehydrazide hydrochloride

1H-Pyrrole-1-hexanoic acid, 2,5-dihydro-2,5-dioxo-, (2E)-2-[1-[(2S,4S)-4-[(3-amino-
2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-1,2,3,4,6,11-hexahydro-2,5,12-trihydroxy-
7-methoxy-6,11-dioxo-2-naphthacenyl]-2-hydroxyethylidene]hydrazide

N’-[(1E)-1-{(2S,4S)-4-[(3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-2,5,12-
trihydroxy-7-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-2-yl}-2-
hydroxyethylidene]-6-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)hexanohydrazide
MOLECULAR FORMULA C37H42N4O13

MOLECULAR WEIGHT 750.7

SPONSOR CytRx Corp.

CODE DESIGNATION INNO-206

CAS REGISTRY NUMBER 1361644-26-9

CAS:  151038-96-9 (INNO-206); 480998-12-7 (INNO-206 HCl salt),  1361644-26-9

hydrochloride

CAS:  151038-96-9

Chemical Formula: C37H42N4O13

Exact Mass: 750.27484

Molecular Weight: 750.75

Certificate of Analysis:	View current batch of CoA
QC data:	View NMR, View HPLC, View MS
Safety Data Sheet (MSDS):	View Material Safety Data Sheet (MSDS)

In vitro protocol:	Clin Cancer Res. 2012 Jul 15;18(14):3856-67
In vivo protocol:	Clin Cancer Res. 2012 Jul 15;18(14):3856-67. Invest New Drugs. 2010 Feb;28(1):14-9. Invest New Drugs. 2012 Aug;30(4):1743-9. Int J Cancer. 2007 Feb 15;120(4):927-34.
Clinical study:	Expert Opin Investig Drugs. 2007 Jun;16(6):855-66.

Aldoxorubicin (INNO-206): Aldoxorubicin, also known as INNO-206,  is the 6-maleimidocaproyl hydrazone derivative prodrug of the anthracycline antibiotic doxorubicin (DOXO-EMCH) with antineoplastic activity. Following intravenous administration…

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Delamanid……….an experimental drug for the treatment of multi-drug-resistant tuberculosis.

New Drug Approvals

Delamanid

http://www.ama-assn.org/resources/doc/usan/delamanid.pdf

(2R)-2-Methyl-6-nitro-2-[(4-{4-[4-(trifluoromethoxy)phenoxy]-1-piperidinyl}phenoxy)methyl]-2,3-dihydroimidazo[2,1-b][1,3]oxazole

2(R)-Methyl-6-nitro-2-[4-[4-[4-(trifluoromethoxy)phenoxy]piperidin-1-yl]phenoxymethyl]-2,3-dihydroimidazo[2,1-b]oxazole

(R) -2-methyl-6-nitro-2- { 4- [4- (4- trifluoromethoxyphenoxy) piperidin-l-yl] phenoxymethyl } -2 , 3- dihydroimidazo [2 , 1-b] oxazole

Imidazo[2,1-b]oxazole, 2,3-dihydro-2-methyl-6-nitro-2-[[4-[4-[4-(trifluoromethoxy)phenoxy]-1-piperidinyl]phenoxy]methyl]-, (2R)-

(R)-2-methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole

681492-22-8 cas no

Delamanid, 681492-22-8, Delamanid (JAN/USAN), Delamanid [USAN:INN],UNII-8OOT6M1PC7,

• OPC 67683
• OPC-67683
• UNII-8OOT6M1PC7

Molecular Formula: C₂₅H₂₅F₃N₄O₆

Molecular Weight: 534.48441

Clinical trials……….http://clinicaltrials.gov/search/intervention=OPC+67683+OR+Delamanid

CLINICAL TRIALS

Trial Name: A Placebo-Controlled, Phase 2 Trial to Evaluate OPC 67683 in Patients With Pulmonary Sputum Culture-Positive, Multidrug-Resistant Tuberculosis (TB)
Primary Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Trial ID / Reg # / URL: http://clinicaltrials.gov/ct2/show/NCT00685360

Delamanid (USAN, codenamed OPC-67683) is an experimental drug for the treatment of multi-drug-resistant tuberculosis. It works by blocking the synthesis of mycolic acids in Mycobacterium tuberculosis, the organism which causes tuberculosis, thus destabilising its cell wall.^[1][2][3]

In phase II clinical trials, the…

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Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 4 Mn. as research fee payment from Forest Laboratories Inc.

New Drug Approvals

Total Payment received for the mpges-1 program from Forest Laboratories is USD 15 million

March 25, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received

USD 4 million as research fee payment from Forest Laboratories Inc. on a collaboration for the development of novel mPGES-1 inhibitors to treatchronic inflammatory conditions, including pain.

Under the terms of the agreement signed in FY 2012-13, Forest made USD 6 million upfront payment and also provided an additional USD 3 million

to support the next phase of work. In September 2013, Glenmark received an additional amount of USD 2 million as research fee payment from Forest Laboratories Inc.

Hence, the total amount received by Glenmark from Forest Laboratories Inc towards its novel mPEGS-1 inhibitors program is USD15 million.

MEDIA

• Click here for pdf

read at

http://www.thehindubusinessline.com/companies/announcements/others/glenmark-pharmaceuticals-ltd-through-its-swiss-subsidiary-receives-usd-4-mn-as-research-fee-payment-from-forest-laboratories-inc-total-payment-received-for-the-mpges1-program-from-forest-laboratories-is-usd-15-million/article5829435.ece

pdf

Click to access Click_here_for_pdf_1808928a.pdf

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Cabazitaxel

New Drug Approvals

Cabazitaxel

For treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

4-acetoxy-2α-benzoyloxy-5β,20-epoxy-1-hydroxy-7β,10β-dimethoxy-9-oxotax-11-en-13α-yl(2R,3S)-3-tert-butoxycarbonylamino-2-hydroxy-3-phenyl-propionate

(1S,2S,3R,4S,7R,9S,10S,12R,15S)-4-(Acetyloxy)-15-{[(2R,3S)-3-{[(tert-butoxy)carbonyl]amino}-2-hydroxy-3-phenylpropanoyl]oxy}-1-hydroxy-9,12-dimethoxy-10,14,17,17-tetramethyl-11-oxo-6-oxatetracyclo[11.3.1.0^3,10.0^4,7]heptadec-13-ene-2-yl benzoate

183133-96-2

Jevtana, Taxoid XRP6258, Cabazitaxelum, 183133-96-2, Xrp6258, CHEBI:63584, XRP-6258, TXD 258, XRP 6258

Molecular Formula: C₄₅H₅₇NO₁₄   Molecular Weight: 835.93238

EMA:Link, US FDA:link

Cabazitaxel is prepared by semi-synthesis from 10-deacetylbaccatin III (10-DAB) which is extracted from yew tree needles. The chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tert-butoxycarbonyl)amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxy-tax-11-en-2-yl benzoate and is marketed as a 1:1 acetone solvate (propan-2-one),

Cabazitaxel is an anti-neoplastic used with the steroid medicine prednisone. Cabazitaxel is used to treat people with prostate cancer that has progressed despite treatment with docetaxel. Cabazitaxel is prepared by semi-synthesis with a precursor extracted from yew needles (10-deacetylbaccatin III). It was approved…

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Mexico and S. Korea: pharma cooperation agreement

Regulatory Affairs in Latin America

On Tuesday 11th March 2014, the COFEPRIS, Mexico’s regulatory authority, and the South Korean Ministry of Health and Wellbeing, through their representatives, signed a collaboration agreement on matters of regulatory affairs for drug products, cosmetic products and medical devices.

The Memorandum of Understanding was signed at the COFEPRIS headquarters in Mexico by the head of the COFEPRIS, Commissioner Mikel Arriola, and the Deputy Minister of Health Policy of South Korea, Choi Younghyun. Also present in the meeting were the South-Korean Vice-Minister of Food and Drug Safety, Jang Byungwon, representatives of the Ministry of Foreign Relations and of the pharmaceutical industry of South Korea, and officers of the Mexican Ministry of Health.

The goal of the agreement is to reinforce the technical and scientific cooperation for the benefit of the health of both countries’ populations. The authorities also agreed to work on international cooperation and pharmaceutical innovation to boost their respective…

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FDA Asked To Improve Approval Processes For Orphan Drugs

Lawmakers appealed to FDA Commissioner Margaret Hamburg to improve consistency of approval processes for orphan drugs, in a letter spearheaded by Senator Edward Markey.

“We write in recognition of the Food and Drug Administration (FDA’s) efforts to ensure public access to safe, innovative and novel therapeutics, particularly for rare diseases and where there are unmet medical needs, and to ask that you continue to commit to ensuring that potential new medicines are guided and reviewed consistently across the agency,” the letter stated, which was signed by 38 members of Congress. The lawmakers said that many families continue to struggle with limited options for rare diseases and development of new, more effective medical treatments often comes too slow. “Innovation of new and safe drugs is especially urgent for rare diseases, for which either no approved therapeutics or no cures currently exist,” the letter stated.

read

http://www.outsourcedpharma.com/doc/fda-asked-to-improve-approval-processes-for-orphan-drugs-0001?sectionCode=dept5&templateCode=Departments&user=2901684&source=nl:39595&utm_source=et_6214173&utm_medium=email&utm_campaign=OUTPH_2014-03-12&utm_term=2F94FA2C-DD1C-4D5F-B9A5-89863456FF33&utm_content=FDA+Asked+To+Improve+Approval+Processes+For+Orphan+Drugs

EMA publishes New Process Validation Guideline

New Drug Approvals

EMA publishes New Process Validation Guideline

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. What’s new?  click here

After the publication of the Annex 15 draft at the beginning of February 2014, the EMA made a move towards the revision of its process validation guideline. The final document was published on 27 February 2014. For a long time now, the EMA had already announced this revision in a concept paper. The objective of the revision was to integrate modern GMP aspects:

• Integration of the ICH Q8, Q9 and Q10 Guidelines
• Incorporation of Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing…

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FDA Implementation of eCTD Module 1 Update Scheduled for Q4 2014

The biggest change in the history of eCTD is one step closer to implementation.

According to a notice posted this week on its website, the US FDA will be able to receive submissions using the new Module 1 specifications in the 4th Quarter of 2014. Industry will be given 30 days’ advance notice.

The long-awaited update to the eCTD’s administrative section is designed to:

• Reflect regulatory changes
• Provide clarification of business rules for submission processing and review
• Refine the characterization of promotional marketing materials and advertising material
• Facilitate automated processing of submissions

In conjunction with the announcement of a revised timeline for Module 1, the FDA published final versions of relevant support documents and specifications.

 

http://theectdsummit.com/2014/02/fda-implementation-of-ectd-module-1-update-scheduled-for-q4-2014/

Clinical Trial Applications in Mexico: decentralization and acceleration of protocol approval

Regulatory Affairs in Latin America

With the goals of accelerating the development of new molecules that improve the healthcare and quality of life of Mexicans, and of stimulating clinical investigation, pharmaceutical innovation and foreign investment in the country, on the 5th of March 2014, the COFEPRIS has authorized the eight National Institutes of Health and the High-Specialty Hospitals Coordinating Commission to pre-approve clinical investigation protocols.

Once the Institutes pre-revise the clinical protocol, it would take the COFEPRIS about 20 working days to grant the final approval. This decentralizing action is expected to reduce the total approval timelines to just a month: a third of what it takes today.

During the official designation of the entities, Mikel Arriola, head of the COFEPRIS said: “This is a great window of opportunity. We want more investigation in Mexico, in Mexican patients, we want more and better treatments to be developed and we wantbig pharma companies to invest more in…

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RUXOLITINIB…FOR THE TREATMENT OF INT OR HIGH-RISK MYELOFIBROSIS

New Drug Approvals

Ruxolitinib

(3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile, cas no 941678-49-5

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile

• 1H-Pyrazole-1-propanenitrile, beta-cyclopentyl-4-(7H-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betaR)-

Formula: C₁₇H₁₈N₆Molecular Weight: 306.37

Phosphate salt

(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate

INCB 018424

• INCB 018424
• INCB018424
• Ruxolitinib
• UNII-82S8X8XX8H

CAS No.: 1092939-17-7
M.Wt: 404.36
Formula: C17H21N6O4P
Ruxolitinib phosphate

LAUNCHED 2011, INCYTE FOR MYELOFIBROSIS, NDA202192, 2011-11-16

CLINICAL TRIALS.http://clinicaltrials.gov/search/intervention=INCB018424+OR+ruxolitinib

EMA:Link,

US FDA:link

HPLC, MS, NMR…http://www.medkoo.com/Product-Data/Ruxolitinib/Ruxolitinib-QC-LC20130225.pdf

http://file.selleckchem.com/downloads/nmr/S137803-INCB018424-HNMR-Selleck.pdf

http://file.selleckchem.com/downloads/hplc/S137803-INCB018424-HPLC-Selleck.pdf

Ruxolitinib phosphate is a kinase inhibitor with the chemical name (R)-3-(4-(7H-pyrrolo[2,3d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate and a molecular weight of 404.36.

Ruxolitinib is a janus-associated kinase inhibitor indicated to treat bone marrow cancer, specifically intermediate or high-risk myelofibrosis. FDA approved on November 16, 2011.

INCB018424 is the first potent, selective, JAK1/2 inhibitor to enter the clinic with IC50 of 3.3 nM/2.8 nM, >130-fold selectivity for JAK1/2 versus JAK3

Ruxolitinib phosphate has the following structural formula:

Ruxolitinib phosphate is a white to off-white to light pink powder…

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Indian Regulators promote two levels of GMP

New Drug Approvals

GMP deviations and even data falsification have been identified in a number of companies in India. How is it possible that interpretation of FDA and EU authorities on one side and the Indian authority on the other side come to a completely different picture? Read more in our GMP News

GMP deviations and even data falsification have been identified in a number of companies in India. The FDA has issued numerous Warning Letters, the EU has published GMP Non Compliance Reports in its EudraGMDP database and EDQM has withdrawn various CEPs because of GMP inspection findings.

In an article published by Regulatory Focus on 28 January 2014 the question has been raised whether Indian companies have a chronic data falsification problem. The article lists 7 companies in India which have received a Warning Letter in the past months – all of them because of GMP deviations and because of “actually…

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