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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Handling of OOS Results in Europe
FDA’s Guidance on Out-of-Specification Results has been seen as the state of the art regarding the handling of OOS results. In the meantime, Europe – through the British MHRA and the German ZLG – has also developed requirements on that topic. Read more here about the most important regulations of the respective guidance documents.
GMP News: Handling of OOS Results in Europe
http://www.gmp-compliance.org/enews_4461_Handling-of-OOS-Results-in-Europe_8360,8430,Z-QCM_n.html
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Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain
Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain
August 25, 2014 — Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced today the United States Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain. This marks the second indication for Zorvolex, approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults1.
“Given the dose-related adverse events associated with NSAIDs as a class and the widespread use of NSAIDs for osteoarthritis, we are delighted to gain approval for our first SoluMatrix® NSAID for the management of osteoarthritis pain,” said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. “Iroko has already made great strides to help fill the need for low dose NSAID options in patients with acute pain and we are continuing to expand our portfolio to also address chronic pain indications.”
Zorvolex was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals2. Zorvolex is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology™ and is now available by prescription. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution.
“Expanding the use of Zorvolex beyond acute pain to osteoarthritis pain, a chronic condition, is a testament to Iroko’s continued commitment to developing a low dose NSAID portfolio to address a broad range of unmet patient needs,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “This second approval for Zorvolex continues to lay the groundwork for our future portfolio, which utilizes a new approach to pain management.”
The approval of Zorvolex for the management of osteoarthritis pain was supported by data from a 12-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled trial that enrolled 305 patients, aged 41-90 years, with osteoarthritis of the hip or knee. Half of the patients were between the ages of 61-90. Participants were randomized to Zorvolex 35mg three times daily or 35mg twice daily, or placebo3. The Supplemental New Drug Application (sNDA) also included data from a 12-month open-label safety study that enrolled 602 patients1.
“NSAIDs continue to be an integral part of the management for osteoarthritis, the most common type of arthritis4, and their use is likely to increase as the U.S. population continues to age and the incidence of osteoarthritis rises5,” said Dr. Roy Altman, Professor of Medicine in Rheumatology at UCLA. “The approval of Zorvolex is a welcome and meaningful advance and is the first SoluMatrix® NSAID option approved by the FDA for osteoarthritis pain.”
About Iroko Pharmaceuticals, LLC
Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products.
Iroko is at the forefront of the development of SoluMatrix® NSAIDs – new low dose drug products based on existing NSAIDs – using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™ exclusively licensed to Iroko for NSAIDs. Zorvolex is the first SoluMatrix® NSAID and is available in pharmacies; a second was approved by FDA in February 2014. For more information, visit http://www.iroko.com.
A CASE OF H.I.V. POSITIVE WITH TUBERCULER INFECTION ; एच० आई०वी० के साथ टी०बी० से इन्फेक्टेड मरीज का केस
कुछ दिन पहले एच०आई०वी० से infected एक मरीज का ई०टी०जी० आयुर्वेदास्कैन और इसके तत्सम्बन्धित परीक्षण किये गये /
मरीज की उम्र देखकर मुझे बहुत आश्चर्य हुआ क्योन्कि उसकी उमर के वल २१ साल की है / रोगी के रोग इतिहास को जानने की इछ्छा हुयी और मैने उत्सुकतावश उससे सारी तकलीफ बताने के लिये कहा / रोगी के साथ उसके गार्जियन भी थे /
मुझे यह मालूम करना था कि इतनी छोटी अवस्था मे इस नवयुवक को क्यो H.I.V. जैसा सन्क्रमण हुआ है /
जैसा मुझे बताया गया कि इस रोगी का ROAD accident हुआ था / इस दुर्घटना के बाद उसे अस्पताल मे भरती कराया गया था जहां इस रोगी को कुछ लोगो का रक्त चढाया गया था / इन्ही रक्त दाताओ मे कोई भी व्यक्ति एच०आई०वी० से इन्फेक्टेड होगा इसीलिये जब इस रोगी को रक्त चढाया गया तो इसके भी HIV Infection पैदा हो गया /
कुछ दिनो…
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Indian Sterile Manufacturer receives FDA Warning Letter and changes company name from Marck Biosience to Amanta Healthcare
Marck Biosciences Ltd. to “Amanta Healthcare Ltd.”, effective from June 24, 2014. Click here to visit website at
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| Marck Biosciences Limited is a producer of sterile products which has been producing sterile products for the US market. The FDA Warning Letter dated July 8, 2014 contains shocking details about the GMP situation at this facility. Read more here about the FDA Warning Letter to Marck Biosciences and about the name change to Amanta Healthcare. |
Which SOPs are required by GMP?
ECA is receiving a lot of questions on SOPs (Standard Operating Procedures) needed in a GMP environment. The most interesting is the one on which SOPs are required by law. Here is an Overview.
GMP News: Which SOPs are required by GMP?
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Drug from Mediterranean weed kills tumor cells in mice – Thapsia garganica
Just a three-day course reduced the size of human prostate tumors grown in mice by an average of 50 percent within 30 days
‘Molecular grenade’ now in clinical trials for advanced cancer
12 JUL 2012
Scientists at the Johns Hopkins Kimmel Cancer Center, working with Danish researchers, have developed a novel anticancer drug designed to travel — undetected by normal cells — through the bloodstream until activated by specific cancer proteins. The drug, made from a weedlike plant, has been shown to destroy cancers and their direct blood supplies, acting like a “molecular grenade,” and sparing healthy blood vessels and tissues.
In laboratory studies, researchers said they found that a three-day course of the drug, called G202, reduced the size of human prostate tumors grown in mice by an average of 50 percent within 30 days. In a direct comparison, G202 outperformed the chemotherapy drug docetaxel, reducing seven of nine human prostate…
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Wednesday, 20 August 2014 Glenmark enters Oncology with the Discovery and the Initiation of IND enabling Studies of an innovative bispecific Antibody
August 20, 2014: Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announces the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecific antibody. GBR 1302 was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. GBR 1302 is based on Glenmark’s innovative BEAT antibody technology platform which facilitates the efficient development and manufacture of antibodies with dual specificities, so-called bispecific antibodies. GBR 1302 is the first clinical development candidate based on the BEAT technology. Glenmark expects to obtain approval for the initiation of clinical studies during this financial year.
·GBR 1302 is the first bispecific antibody based on Glenmark’s proprietary BEAT platform
- GBR 1302 is Glenmark’s first clinical candidate targeting oncology indications
Glenmark Pharmaceuticals announced the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 1302, a HER2xCD3 bispecific antibody. GBR 1302 was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. GBR 1302 is based on Glenmark’s innovative BEAT antibody technology platform which facilitates the efficiend development and manufacture of antibodies with dual specificities, so-called bispecific antibodies. GBR 1302 is the first clinical development candidate based on the BEAT technology.Glenmark expect to obtain approval for the initiation of clinical studies during this financial year.
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Antimicrobial resistance
Antimicrobials are medicines that kill or inactivate microbes, small disease-causing organisms. They include antibiotics, which are used against bacteria. After being exposed to an antimicrobial repeatedly, microbes can undergo changes that stop them being killed or inactivated by the treatments. This is known as antimicrobial resistance.
The European Medicines Agency is concerned about the development of antimicrobial resistance, particularly resistance to antibiotics. A well-known example of a bacterium that is resistant to a number of antibiotics is meticillin-resistant Staphylococcus aureus(MRSA), which has caused infections that are difficult to treat across the European Union (EU).
This problem is being made worse by the fact that few new antimicrobials have been authorised over the past few years. This may lead to infections becoming more difficult to treat in the future.
Antimicrobial resistance is a growing problem in humans and in animals. Resistance can also spread from animals to humans through the food chain or direct contact.
The role of the Agency
The Agency works in collaboration with its EU and international partners in a number of initiatives aiming to limit the development of resistance. It is also monitoring and evaluating the risks to human and animal health.
A major such initiative is the Transatlantic Task Force on Antimicrobial Resistance
(TATFAR), which was established following the EU-United States summit in November 2009. The Task Force aims to increase levels of communication, coordination and co-operation between the EU and the United States on human and veterinary antimicrobials.
Human health
In human medicine, the availability of medicines to treat infections with resistant organisms has become a major problem in recent years.
In September 2009, the Agency published a joint report together with the European Centre for Disease Prevention and Control (ECDC) and the international network ReAct – Action on Antibiotic Resistance. This report highlights the gap between infections due to resistant bacteria and the development of new antibiotics.
The report states that at least 25,000 patients in the EU die each year from infections due to bacteria that are resistant to many medicines, and that infections due to these bacteria in the EU result in extra healthcare costs and productivity losses of at least €1.5 billion each year. Although it identified 15 antibiotics under development, most of these were early in development and were targeted against bacteria for which treatment options were already available.
Authorisation of new antibiotics
The Agency plays a key role in the authorisation of new antibiotics, because medicines with a significant therapeutic innovation or that are in the interest of public or animal health are authorised centrally in the EU, on the recommendation of the Agency.
In January 2012, the Agency updated its guidance to companies developing antibiotics, covering how they should carry out studies to test these medicines’ benefits and risks:
This is accompanied by an addendum giving information on how to study medicines for specific indications. The final addendum was published in November 2013 following a public consultation:
Animal health
The Agency is focused on promoting the prudent use of antimicrobials in animals, to limit the development of resistance. This goal is addressed in this document:
In line with this strategy, the Agency published a revised version of its guideline onefficacy for public consultation in May 2013. This draft guideline provides detailed recommendations for the design and conduct of pre-clinical and clinical studies to support clinical efficacy for antimicrobial veterinary products:
Since early 2010, the Agency has been leading a project collecting information on the sale of veterinary antimicrobials across the EU:
The CVMP has also published a large number of documents on microbial resistance in animals and its risks for humans.
Reports published by the Agency together with other European bodies, including ECDC, EFSA and the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) have emphasised the need for the prudent use of antibiotics in animals and the role of basic hygiene, and called for strengthened surveillance of resistance, the development of new antimicrobials and new strategies to combat the spread of resistance:
- Joint scientific report of ECDC, EFSA and the European Medicines Agency on MRSA in livestock, companion animals and food
- Joint opinion on antimicrobial resistance focused on zoonotic infections
In 2013 and 2014, the Agency carried out a large body of work to provide advice to the European Commission on the use of antibiotics in animals and the impact on public health and animal health.
Turkish man pleads guilty to importing illegal cancer drugs
August 15, 2014
Release
Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court for the Eastern District of Missouri, in St. Louis, Missouri, where he initially shipped his illegal drugs. The drugs did not meet the FDA’s standards and had not been approved for distribution in the United States.
The FDA’s Office of Criminal Investigations coordinated a complex, multi-layered international investigation that led to Akman’s arrest in Puerto Rico in January 2014. The investigation identified Akman and his company as a source of Altuzan, the Turkish version of the cancer treatment drug Avastin.
“These criminals exploited our most vulnerable patients when they arranged for their illicit drugs to be brought into the United States and used to treat cancer patients. We will continue to…
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Road map to 2015, The European Medicines Agency’s contribution to science, medicines and health
One of the European Medicines Agency’s long-term strategic goals is to foster researchand the uptake of innovative methods in the development of medicines.
READ………….Road map to 2015
The European Medicines Agency’s
contribution to science, medicines and health……………..http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf
This helps the Agency to meet its objective of making safe and effective medicines available to patients in a timely manner, following evaluation using state-of-the-art methods.
The Agency also supports the development of new therapies and technologies by working with interested parties in the European Union (EU).
Activities at the Agency
In 2004, the Agency set up the European Medicines Agency/Committee for Medicinal Products for Human Use (CHMP) Think-Tank Group on Innovative Drug Development.
This group included Agency staff and members of the CHMP and its working parties. Its work focused on identifying scientific bottlenecks and emerging science in the development of medicines, both in industry research and development…
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New Drug Approvals 