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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
GVK Biosciences (GVK BIO), the discovery research and development organisation based in Hyderabad, India, has reached a definitive agreement to acquire Aragen Bioscience, a preclinical contract research organisation operating out of Morgan Hill, US and specialising in high-value biologics services.
No financial terms were disclosed for the deal, in which GVK BIO is acquiring the capital stock of Aragen Bioscience. It is the Indian company’s first international acquisition.
According to a report in India’s Business Standard, GVK is taking a 65% stake in Aragen Biosciences and will acquire the remaining 35% over a period of two years, leaving Aragen to function as a separate entity.
Read more at: http://www.pharmatimes.com/Article/14-01-30/India_s_GVK_BIO_goes_international_with_Aragen_deal.aspx#ixzz2s3enmHuZ
Follow us: @PharmaTimes on Twitter
| Compound* | Clinical phase | Indication | Therapeutic principle | Mode of action |
|---|---|---|---|---|
| Olodaterol | Submitted | Chronic obstructive pulmonary Disease (COPD) | Long-acting beta-agonist | Bronchodilation |
| Tiotropium | Submitted | Cystic fibrosis (CF) | Bronchodilatator | Long Acting Muscarinic Antagonist |
| Afatinib | Phase III | Breast cancer | Signal transduction inhibition | Novel irreversible ErbB Family blocker |
| Afatinib | Phase III | Head and neck cancer | Signal transduction inhibition | Novel irreversible ErbB Family blocker |
| Deleobuvir (BI 207127) |
Phase III | Hepatitis C | Direct acting antiviral small molecule | Oral NS5B RNA-dependent polymerase inhibitor |
| Empagliflozin | Phase III | Diabetes mellitus type II |
SGLT-2-inhibitor | Inhibition of glucose transporter-2 |
| Faldaprevir (BI 201335) |
Phase III | Hepatitis C | Direct acting antiviral small molecule | Oral HCV NS3/4A protease inhibitor |
| Nintedanib | Phase III | Non-small cell lung cancer (NSCLC) | Angiogenesis inhibition | Triple angiokinase inhibitor, simultaneously blocks VEGFR, FGFR, PDGFR |
| Nintedanib | Phase III | Ovarian cancer | Angiogenesis inhibition | Triple angiokinase inhibitor, simultaneously blocks VEGFR, FGFR, PDGFR |
| Nintedanib | Phase III | Idiopathic pulmonary fibrosis (IPF) | Anti-fibrotic kinase inhibition | Anti-fibrotic kinase inhibitor |
| Tiotropium | Phase III | Asthma | Bronchodilatator | Long Acting Muscarinic Antagonist |
| Volasertib | Phase III | Various cancer types | Cell-cycle kinase inhibition | PLK-1 antagonist |
* These are investigational agents; their safety and efficacy have not yet been established.
Status: April 2013
| Product name | First launch | Active ingredient | Indication |
|---|---|---|---|
| Gilotrif™ | 2013 | Afatinib | Non-small cell lung cancer (NSCLC) |
| Trajenta® | 2011 | Linagliptin | Diabetes mellitus type II |
| Pradaxa® | 2010 2008 |
Dabigatran etexilate | Stroke prevention in atrial fibrillationPrevention of venous thromboembolic events (VTE) in adults |
| Spiriva® Respimat Soft Mist™ InhalerSpiriva® |
2007 2002 |
Tiotropium | COPD |
| Micardis® | 1998 | Telmisartan | Essential hypertension |
| Sifrol® / Mirapex® /Mirapexin® | 20061997 | Pramipexole | Restless legs syndrome (RLS) Parkinson’s disease (PD) |
| Viramune® | 1996 | Nevirapine | HIV/AIDS |
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The SCRIP Awards 2013 celebrated achievements in the global biopharma industry last night at the Lancaster, London.
Hosted by Justin Webb, the evening was a fantastic mix of dining, entertainment and awards.
Among the winners were:
You can view the full roll of honour by clicking on the button below.
It was a great night and we would like to thank all those who entered and attended this year’s awards.
Finally congratulations to our winners and a huge thanks to our sponsors for helping us make it such a fantastic success.
Don’t forget to check our website in the next couple of days for all the pictures from the night.
2013 Winners
Best Company in an Emerging Market – Sponsored by Clinigen Group
Best Technological Development in Clinical Trials
Best Partnership Alliance
Financing Deal of the Year
Best Advance in an Emerging Market
Clinical Advance of the Year – Sponsored by Quintiles
Licensing Deal of the Year – Sponsored by Hume Brophy
Executive of the Year
Biotech Company of the Year
Best Contract Research Organization
Management Team of the Year
Best New Drug – Sponsored by INC Research
Pharma Company of the Year – Sponsored by ICON
Lifetime Achievement Award
…….read about bexero at
DR ANTHONY MELVIN CRASTO Ph.D
This is the first time Mr Dilip Shanghvi, founder of Sun Pharmaceutical has been named in the top three with a 66 percent surge in his wealth –
25 oct 2013
Singapore: For the first time, founder of leading Indian drugmaker Sun Pharmaceuticals, Mr Dilip Shanghvi has been named in the top three of India’s richest men. Mr Shanghvi has made an appearance in the list prepared by China based ‘Hurun India Rich List’ as the third richest Indian man with a 66 percent surge in his wealth. Energy tycoon and Reliance Industries chairman Mr Mukesh Ambani has topped the list as India’s richest man with personal assets of $18.9 billion, news reports mentioned. The report pointed out that Mr Ambani has retained the top position for the second year even after a wealth decrease of two percent. London-based steel baron Mr Lakshmi Narayan Mittal has been named the second richest, with assets of $15.9 billion. – See more at: http://www.biospectrumasia.com/biospectrum/news/199210/sun-pharma-s-founder-named-india-s-3rd-richest#.Umzu4fmnqls
Read more at: http://www.biospectrumasia.com/biospectrum/news/199210/sun-pharma-s-founder-named-india-s-3rd-richest#.Umzu4fmnql
s
Potential of US pipeline continues to be under appreciated
SUNP’s US pipeline is shaping up well, with an interesting mix of complex products, branded generics and me-too products. Motilal Oswal believe that SUNP’s strong pipeline in the US is well placed to deliver revenue CAGR of 25% to USD1.8b. While a meaningful contribution to this growth is being led by Doxil and recently acquired URL Pharma, we estimate that SUNP’s own pipeline is set to witness revenue CAGR of 40% to USD6 20m. They build flat sales growth for Taro as they expect incremental competition to impact the market share for key Taro products. If competition is delayed, their estimates may have room for positive surprise.
Even after a 50-plus per cent return in one year, Sun Pharma’s stock continues to hold promise. While domestic revenues are growing well, US sales growth has been phenomenal, driven by a strong product pipeline and the acquisitions of Taro, DUSA, URL generics and Caraco.
NCE & NDDS Development Pipeline / 2. Disclaimer. Except for the historical information contained herein, statements in this presentation and the subsequent …
Oct 1, 2013 – 1. For Immediate Release. Sun Pharma and Intrexon Form Joint Venture to Develop. New Class of Therapeutics for Ocular Diseases. Pipeline …
pipeline
Sun Pharma Advanced Research (SPARC, US$345
mn market cap), a proprietary product research
company, detailed its NDDS and NCE product pipelines
in its latest filing with the SEBI, pursuant to its proposed
rights issue. Overall, there has been modest
clinical/regulatory progression in the NDDS pipeline
since the last disclosure six-seven months back. See
Exhibits 1 and 4 inside.
Key highlights: Big picture – New Drug Delivery
System (NDDS) – Overall SPARC is developing a
diverse collection of seven technology platforms for oral,
injectable and topical delivery systems (including nano
particulate, bio-degradable depot, DPI, SMM, GFR).
SPARC has 19 NDDS products under development.
New Chemical Entity (NCE) – The company has a
pipeline of five compounds that are pro-drugs of existing
molecules (such as baclofen, gabapentin etc). The NCE
pipeline appears to be in its early stages, with market
launch a few years away.
Update on key products (NDDS) – Three lead drugs:
1) levetiracetam XR 1000/1500 mg (505(b)(2) filing with
USFDA is now targeted for F1Q13), 2) baclofen GRS
(Special Protocol Assessment, SPA, agreement has
been received from FDA and patient enrollment for
Phase 3 studies is targeted in F4Q12) and 3) BAK-free
latanoprost (Phase III patient enrollment over in US).
These timelines imply that the first product launch in the
US is likely in 2H13. SPARC continues to validate its
underlying technology platforms by launching drugs in
the domestic market (six proprietary launches, seven
generic launches so far).
Other milestones for CY12: IND filing with USFDA for
two drugs – Octreotide Depot Inj (1 month) and Dry
Powder Inhaler (Salmeterol and Fluticasone
combination); paclitaxel (with carboplatin) Phase I
results in US and clinical progress of second WRAP
based drug, cardiovascular agent (and its combination)
NDDS
LATANOPROST
LATANOPROST+TIMOLOLOL
BACLOFEN VENLAFAXINE
LEVETIRACETAM
PICN, PACLITAXEL
NCE
SUN597,
SUN L731
SUN K706
OTHERS
DRY POWDER INHALER
DOCETAXEL NANODISPERSION
OCTEOTIDE
MAY 2013
mn market cap), a proprietary product research
company, detailed its NDDS and NCE product pipelines
in its latest filing with the SEBI, pursuant to its proposed
rights issue. Overall, there has been modest
clinical/regulatory progression in the NDDS pipeline
since the last disclosure six-seven months back. See
Exhibits 1 and 4 inside.
Key highlights: Big picture – New Drug Delivery
System (NDDS) – Overall SPARC is developing a
diverse collection of seven technology platforms for oral,
injectable and topical delivery systems (including nano
particulate, bio-degradable depot, DPI, SMM, GFR).
SPARC has 19 NDDS products under development.
New Chemical Entity (NCE) – The company has a
pipeline of five compounds that are pro-drugs of existing
molecules (such as baclofen, gabapentin etc). The NCE
pipeline appears to be in its early stages, with market
launch a few years away.
Update on key products (NDDS) – Three lead drugs:
1) levetiracetam XR 1000/1500 mg (505(b)(2) filing with
USFDA is now targeted for F1Q13), 2) baclofen GRS
(Special Protocol Assessment, SPA, agreement has
been received from FDA and patient enrollment for
Phase 3 studies is targeted in F4Q12) and 3) BAK-free
latanoprost (Phase III patient enrollment over in US).
These timelines imply that the first product launch in the
US is likely in 2H13. SPARC continues to validate its
underlying technology platforms by launching drugs in
the domestic market (six proprietary launches, seven
generic launches so far).
Other milestones for CY12: IND filing with USFDA for
two drugs – Octreotide Depot Inj (1 month) and Dry
Powder Inhaler (Salmeterol and Fluticasone
combination); paclitaxel (with carboplatin) Phase I
results in US and clinical progress of second WRAP
based drug, cardiovascular agent (and its combination)
With 11 treatments in Phase I trials, 8 in Phase II, and 13 in Phase III, Bayer has a strong pipeline.
By far the most interest currently, given that the latest reports came out October 21st, is riociguat (BAY 63-2521),
which has had good news from its ongoing Phase III clinical trials of the treatment for pulmonary arterial hypertension, also known as PAH. PAH is a progressive condition that overburdens the heart.
Trials indicate subjects had improved heart function and could better tolerate physical exercise. Patients on riociguat improved their walking distance by 36 meters on average, while those on placebo showed no improvement.
Professor Hossein Ardeschir Ghofrani of University Hospital Giessen, the principal investigator, was quite pleased with the results and explained the value of the measurement. “The six-minute walk distance test is a well-validated clinical measure in patients with PAH, and therefore, the results of the PATENT-1 trial are encouraging. . .These data from the PATENT study suggest that riociguat may be a potential treatment option both for patients who have never been treated for PAH as well as for those who have received prior treatment.”
Hossein A. Ghofrani
Associate Professor of Internal Medicine,
MD (University of Giessen) 1995 Research interests: pulmonary hypertension, ischaemia-reperfusion, experimental therapeutics, clinical trials
http://www.uni-giessen.de/cms/fbz/fb11/forschung/graduierte/mbml/faculty
Although Bayer put forth no sales estimate for the treatment, analysts predicted 2017 sales from riociguat of $480 million
BAYER PIPELINE AS ON OCT 25 2013
phase 1
| Project | Indication |
|---|---|
| CDK-Inhibitor (BAY 1000394) | Cancer |
| Mesothelin-ADC (BAY 94-9343) | Cancer |
| PSMA Bi TE Antibody (BAY 2010112) | Cancer |
| PI3K-Inhibitor (BAY 1082439) | Cancer |
| FGFR2 Antibody (BAY 1179470) | Cancer |
| HIF-PH (BAY 85-3934) | Anemia |
| Partial Adenosine A1 Agonist(BAY 1067197) | Heart Failure |
| Vasopressin Receptor Antagonist(BAY 86-8050) | Heart Failure |
| sGC Stimulator (BAY 1021189) | Heart Failure |
| S-PRAnt (BAY 1002670) | Symptomatic uterine fibroids |
| BAY 1026153 | Endometriosis |
phase2
| Project | Indication |
|---|---|
| PI3K-Inhibitor (BAY 80-6946) | Cancer |
| Regorafenib | Cancer |
| Refametinib (MEK-Inhibitor) | Cancer |
| Radium-223-Dichloride | Cancer |
| Sorafenib | Additional Indications |
| MR-Antagonist (BAY 94-8862) | Congestive Heart Failure (CHF) |
| MR-Antagonist (BAY 94-8862) | Diabetic Nephopathy |
| Riociguat (sGC Stimulator) | Pulmonary Hypertension |
| Neutrophil Elastase Inhibitor(BAY 85-8501) | Bronchiectasis |
phase 3
| Project | Indication |
|---|---|
| Sorafenib | Breast Cancer |
| Sorafenib | Adjuvant HCC |
| Sorafenib | Adjuvant RCC |
| Regorafenib | HCC 2nd line |
| Rivaroxaban | Major Adverse Cardiac Events |
| Rivaroxaban | CHF and CAD |
| peg rFVIII(BAY 94-9027) | Hemophilia |
| Aflibercept | Myopic choroidal neovascularization (mCNV) |
| Aflibercept | Diabetic Macular Edema (DME) |
| LCS 16 | Contraception |
| Vaginorm | Vulvovaginal atrophy (VVA) |
| Sodium Deoxycholate | Submental fat removal |
| Cipro DPI | Lung infection |
| Tedizolid | Skin and Lung Infections |
| Amikacin Inhale | Gram-negative pneumonia |
Sorafenib tosylate
https://newdrugapprovals.wordpress.com/2013/07/16/nexavar-sorafenib/
TEDIZOLID PHOSPHATE
Leverkusen, October 8, 2013 – Following the recent commercial introduction of five new drugs to address the medical needs of patients with various diseases, Bayer is now accelerating the development of further five promising drug candidates which are currently undergoing phase I and II clinical studies. The company today announced that it plans to progress these five new highly innovative drug candidates in the areas of oncology, cardiology, and women’s health into phase III clinical studies by 2015.
“Our Pharma research and development has done a tremendous job of bringing five new products to the market offering physicians and patients new treatment alternatives for serious diseases”, said Bayer CEO Dr. Marijn Dekkers. “Following our mission statement ‘Science For A Better Life’, the five chosen further drug candidates all have the potential to impact the way diseases are treated for the benefit of patients.”
Bayer CEO Dr. Marijn Dekkers
“Our research and development activities are strongly focused on areas where treatment options are not available today or where true breakthrough innovations are missing”, said Prof. Andreas Busch, member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery at Bayer HealthCare. “Our drug development pipeline holds a number of promising candidates which we want to bring to patients who need them urgently”, said Kemal Malik, member of the Bayer HealthCare Executive Committee, Chief Medical Officer and Head of Pharmaceutical Development at Bayer HealthCare. “Furthermore we are continuing to expand the range of indications for all our recently launched products Xarelto, Stivarga, Xofigo, Riociguat as well as Eylea and further refine the profile of these drugs in specific patient populations.”
Cl 223Ra Cl
Xofigo
https://newdrugapprovals.wordpress.com/2013/09/21/xofigo-injection-recommended-for-approval-in-eu/
The five mid-stage candidates have been selected for accelerated development based on positive “proof-of-concept” data from early clinical studies. Three of them are development compounds in the area of cardiology or the cardio-renal syndrome: Finerenone (BAY 94-8862) is a next generation oral, non-steroidal Mineralocorticoid Receptor antagonist which blocks the deleterious effects of aldosterone. Currently available steroidal MR antagonists have proven to be effective in reducing cardiovascular mortality in patients with heart failure but have significant side effects that limit their utilization. Finerenone is currently in clinical Phase IIb development for the treatment of worsening chronic heart failure, as well as diabetic nephropathy.
Finerenone (BAY 94-8862)
The second drug candidate in the area of cardiology is an oral soluble guanylate cyclase (sGC) stimulator (BAY 1021189). The start of a Phase IIb study in patients with worsening chronic heart failure is expected later this year.
For the cardio-renal syndrome, a Phase IIb program with the investigational new drug Molidustat (BAY 85-3934) is under initiation in patients with anemia associated with chronic kidney disease and/or end-stage renal disease. Molidustat is a novel inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) which stimulates erythropoietin (EPO) production and the formation of red blood cells. Phase I data have shown that inhibition of HIF-PH by Molidustat results in an increase in endogenous production of EPO.
Molidustat (BAY 85-3934)
In oncology, Copanlisib (BAY 80-6946), a novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor, was selected for accelerated development. Copanlisib demonstrated a broad anti-tumor spectrum in preclinical tumor models and promising early clinical signals in a Phase I study in patients with follicular lymphoma. A Phase II study in patients with Non-Hodgkin’s lymphoma is currently ongoing.
Bayer has also made good progress in the development of new treatment options for patients with gynecological diseases: sPRM (BAY 1002670) is a novel oral progesterone receptor modulator that holds the promises of long-term treatment of patients with symptomatic uterine fibroids. Based on promising early clinical data the initiation of a Phase III study is planned for mid-2014.
Initiation of further studies with recently launched products
Bayer has successfully launched five new pharmaceutical products, namely Xarelto™, Stivarga™, Xofigo™, Eylea™, and Riociguat, which has very recently been approved in Canada under the trade name Adempas™.
Regorafenib, stivarga
Bayer’s Eylea (aflibercept),
https://newdrugapprovals.wordpress.com/2013/06/01/lucentis-rival-one-step-away-from-nhs-approval/
Xarelto has been approved globally for five indications across seven distinct areas of use, allowing doctors to treat patients in a greater variety of venous and arterial thromboembolic conditions than any other novel oral anticoagulant. The company continues to study the use of Xarelto for the treatment of further cardiovascular diseases. Ongoing clinical Phase III studies include COMPASS and COMMANDER-HF. The COMPASS study will assess the potential use of Xarelto in combination with aspirin, or as a single treatment to prevent major adverse cardiac events (MACE) in nearly 20,000 patients with atherosclerosis related to coronary or peripheral artery disease. The COMMANDER-HF study will evaluate the potential added benefit of Xarelto in combination with single or dual-antiplatelet therapy to help reduce the risk of death, heart attack and stroke in approximately 5,000 patients with chronic heart failure and coronary artery disease, following hospitalization for exacerbation of their heart failure.
In order to answer medically relevant questions for specific patient populations Bayer has initiated a range of additional Xarelto studies in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with stent placement (PIONEER-AF-PCI), cardioversion (X-VERT) or an AF ablation procedure (VENTURE-AF).
As an extension to the Xarelto clinical trial programme, a number of real-world studies are designed to observe and further evaluate Xarelto in everyday clinical practice. These include the XAMOS study of more than 17,000 orthopaedic surgery patients, which confirmed the clinical value of oral, once-daily Xarelto in routine clinical practice in adults following orthopaedic surgery of the hip or knee. XANTUS is designed to collate data on real-world protection with Xarelto in over 6,000 adult patients in Europe with non-valvular AF at risk of stroke while XANAP is designed to collate data on real-world protection with Xarelto in over 5,000 adult patients in Europe and Asia with non-valvular AF at risk of stroke. XALIA will generate information from over 4,800 patients treated for an acute DVT with either Xarelto or standard of care.
In the area of oncology, Stivarga has been approved in 42 countries for use against metastatic colorectal cancer that is refractory to standard therapies, and additionally for gastrointestinal stromal tumor (GIST) in the US and Japan. Bayer is now planning to assess Stivarga in earlier stages of colorectal cancer as well as other cancer types. A Phase III trial in patients with colorectal cancer after resection of liver metastases is currently under initiation. Based on early clinical data Bayer has also initiated a Phase III study in liver cancer in patients who have progressed on sorafenib treatment.
Furthermore, the anti-cancer drug Xofigo (radium 223 dichloride) is a first-in-class alpha-pharmaceutical which is designed for use in prostate cancer patients with ‘bone metastases’ (secondary cancers in the bone) to treat the cancer in the bone and to help extend their lives. Xofigo is approved in the US for the treatment of patients with advanced castrate-resistant prostate cancer with symptomatic bone metastases. In addition, the European CHMP recently gave a positive opinion for radium 223 dichloride for the same use. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.
Based on the excellent Phase III results for Xofigo in patients with castration resistant prostate cancer and symptomatic bone metastases Bayer is looking to expand the use of Xofigo to earlier stages of the disease, and plans to initiate a Phase III study in combination with the novel anti-hormonal agent abiraterone. In addition, early stage signal-generating studies in other cancer forms where bone metastases are important causes of morbidity and mortality are planned.
In the area of pulmonary hypertension Adempas (Riociguat) is the first member of a novel class of compounds – so-called ‘soluble guanylate cyclase (sGC) stimulators’ – being investigated as a new and specific approach to treating different types of pulmonary hypertension (PH). Adempas has the potential to overcome a number of limitations of currently approved treatments for pulmonary arterial hypertension (PAH) and addresses the unmet medical need in patients with chronic thromboembolic pulmonary hypertension (CTEPH). It was approved for the treatment of CTEPH in Canada in September 2013, making it the world’s first drug approved in this deadly disease.
Riociguat has already shown promise as a potential treatment option beyond these two PH indications. An early clinical study was conducted in PH-ILD (interstitial lung disease), a disease characterized by lung tissue scarring (fibrosis) or lung inflammation which can lead to pulmonary hypertension, and, based on positive data, the decision was taken to initiate Phase IIb studies in PH-IIP (idiopathic pulmonary fibrosis), a subgroup of PH-ILD. Moreover, scientific evidence was demonstrated in preclinical models that the activity may even go beyond vascular relaxation. To prove the hypothesis Bayer is initiating clinical studies in the indication of systemic sclerosis (SSc), an orphan chronic autoimmune disease of the connective tissue affecting several organs and associated with high morbidity and mortality. If successful, Riociguat has the potential to become the first approved treatment for this devastating disease.
In the area of ophthalmology, Eylea (aflibercept solution for injection) is already approved in Europe and several additional countries for the treatment of neovascular (wet) age-related macular degeneration and for macular edema following central retinal vein occlusion. In September, Bayer HealthCare and Regeneron Pharmaceuticals presented data of the two phase III clinical trials VIVID-DME and VISTA-DME of VEGF Trap-Eye for the treatment of diabetic macular edema (DME) at the annual meeting of the Retina Society in Los Angeles and at the EURetina Congress in Hamburg, Germany. Both trials achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks. Bayer plans to submit an application for marketing approval for the treatment of DME in Europe in 2013.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 54,900 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
| Emcure Pharmaceuticals Limited | ||
| ITBT Park Phase II | ||
| Hinjwadi, PUNE, INDIA |
Among the vast ocean of literature on organic chemistry , you will find a pearl in the form of Emcure
we are treated to excellent reading material and important communications in our field
hats off to this team
Dr. Mukund K. Gurjar serves as the Chief Scientific Officer of Emcure Pharmaceuticals Limited and serves as its Director of Research & Development.
Dr. Gurjar has been closely associated with Drugs and Pharmaceutical Sciences since 1975 and is a distinguished Researcher in the country. He has carried out extensive work in the field of new chemical entities (NCEs). Dr. Gurjar has been an Executive Director of Emcure Pharmaceuticals Ltd. since 2001.
He serves as Deputy Director at National Chemical Laboratory, Pune. Dr. Gurjar served as Non-Executive Director of Cipla Limited since January 19, 2002 until August 27, 2007.
Dr. Gurjar has the distinction of being one of the 43 scientists from India who have been mentioned in the Institute of Scientific Information of Chemists and has more than 500 citations. Dr. Gurjar has obtained Master of Science degree in Organic Chemistry and Ph.D. in chemistry from the Nagpur University. He also obtained the second Ph.D. degree from the London University, UK.
He is a leading Fellow at various National and International Academies
LINKS
http://www.emcure.co.in/bod.asp
http://www.ias.ac.in/php/fell_detail.php3?name=Gurjar&intials=Mukund&year=28-08-1952
http://www.researchgate.net/profile/Mukund_Gurjar/
| About EMCURE : Company Profile as quoted by COMPANY WEBSITE |
|
The Company was incorporated as Emcure Pharmaceuticals Private Limited on April 16, 1981 as a private limited company under the Companies Act, 1956.Emcure Pharmaceuticals is a fast growing Indian pharmaceutical company engaged in developing, manufacturing and marketing a broad range of pharmaceutical products globally. Our core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which we commercialize through our marketing infrastructure across geographies and relationships with multi-national pharmaceutical companies.Emcure Pharmaceuticals is ranked as the 14th largest pharmaceutical company (Source: IMS Health India, Secondary Stockist Audit (“SSA”), March 2013) in India in terms of market share based on the domestic sales of pharmaceutical products. We believe that our competitive advantage in the domestic market lies in our established presence in all major therapeutic areas including blood related, cardiology, pain and analgesics, HIV, gynecology, nephrology, anti-infective, and vitamins, minerals and nutrients products. We have also recently entered the oncology and diabetes therapeutic areas.Emcure Pharmaceuticals have a well-diversified income base thanks to our business in the international markets. We have our own sales and marketing infrastructure in the United States through our subsidiary, Heritage. We sell our portfolio of branded generic products to the Rest of World. Our products are currently shipped to over 65 countries, where we have established our presence by focusing on important alliances with local and multi-national companies that enjoy a leadership position in the therapeutic areas on which we focus. We have subsidiaries in Dubai, Brazil, South Africa, Singapore and Nigeria and branch offices in Russia and Morocco.Emcure Pharmaceuticals…….quote………. are focus our research and development efforts on developing a portfolio of differentiated products across several platforms, including chiral molecules and biosimilars, and novel drug delivery systems. We have a portfolio of 11 chiral molecules, eight of which we launched for the first time in India. We also have capabilities to develop complex products, including difficult iron preparations, oncology drugs and controlled release products. Our portfolio of in-house manufactured five commercialized biosimilars including TNK-tPA, which we launched for the first time in India, and our brand Vintor is ranked no. 1 in erythropoietin market (Epoetin Alfa Recombinant) (Source: IMS Health India, SSA, March 2013).
|
..
http://www.scripintelligence.com/awards/categories/
Deciding on a shortlist from so many deserving entries was never going to be an easy process for our independent judging panel, but they rose to the challenge and this list represents the best of the best.
Best Company in an Emerging Market – Sponsored by Clinigen Group
Best Technological Development in Clinical Trials
Best Partnership Alliance
Financing Deal of the Year
Best Advance in an Emerging Market
Clinical Advance of the Year – Sponsored by Quintiles
Licensing Deal of the Year
Executive of the Year
Biotech Company of the Year
Best Contract Research Organization
Management Team of the Year
Best New Drug – Sponsored by INC Research
Pharma Company of the Year – Sponsored by ICON
http://www.bioinfomedical.com/index.php
Prof. Dr. Rafael Boritzer
P.O.Box 88355, Honolulu, Hawaii 96830 U.S.A.
http://www.bioinfomedical.com/index.php
we are marketers of non-branded recombinant proteins with a primary mission of high quality, low priced material for encouraging biopharma research and development outside of North America. We try to integrate our supply services with education of our clients’ with industry videos and information.
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BioInfoMedical was established in 1989 by a team of experienced medical specialists, world-known scientists and marketing professionals. The company has two operating divisions:
InfoMedical Biotechnology and InfoMedical Consulting.
InfoMedical Biotechnology provides products and services used in gene, protein and cell research, drug discovery and development, as well as in biopharmaceutical manufacturing.
InfoMedical Consulting assists companies in strategic market expansion, industry research, environmental analysis, and developing successful market plans for worldwide business-winners.
We are proud to serve our customers around the globe. Our clients are: academic research institutions, biotechnology and pharmaceutical companies, medical research centers, hospitals, reference laboratories, agricultural and chemical companies, as well as leading private and governmental business organizations.
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see a video of DR RAFI
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http://www.bioinfomedical.com/index.php
Boston, MA–(Marketwire) – While patent expirations on many top selling medicines are spurring the research-based drug industry to embrace new development paradigms to replenish sparse R&D pipelines, drug developers need to more fully identify and address root causes of R&D inefficiency, according to the Tufts Center for the Study of Drug Development.
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New Drug Approvals 