Group items tagged Drugs - PharmaMics

How drug and device start-ups get the jump on the competition by employment of best pra... - 0 views

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shared by Hellan George on 11 Jan 16 - No Cached

Hellan George on 11 Jan 16

Best Practices (BPs), while employed in a variety of industries, is especially valuable in the growing drug/device (DD) combination products industry. Read the article to know how drug and device start-ups get the jump on the competition by employment of best practices.

<div class="cArrow"> </div><div class="cContentInner">Best Practices (BPs), while employed in a variety of industries, is especially valuable in the growing drug/device (DD) combination products industry. Read the article to know how drug and device start-ups get the jump on the competition by employment of best practices. </div>

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Pluristem files orphan drug application to US FDA for preeclampsia - 0 views

regulatoryaffairs.pharmaceutical-business-review.com/...or-preeclampsia-210214-4182176

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shared by Alex Parker on 24 Feb 14 - No Cached

Alex Parker on 24 Feb 14

PBR Staff Writer Published 21 February 2014 Israel-based Pluristem Therapeutics has submitted its application to the US Food and Drug Administration seeking Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 21 February 2014 Israel-based Pluristem Therapeutics has submitted its application to the US Food and Drug Administration seeking Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.</div>

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Development of drug candidates for rheumatoid arthritis - 1 views

Under a basic research program specific and Brain Korea 21 program, a joint research team from the Catholic University and St. Vincent Hospital of Korea announced in February 2009 that it would soo...

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started by Pharma Mics on 12 Apr 09 no follow-up yet

Best Practices, LLC's CEO shares his views and insights on New Drug Launch Evolution - 0 views

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shared by Hellan George on 19 Nov 15 - No Cached

Hellan George on 19 Nov 15

At Pharma CI Conference 2015 in New Jersey, Best Practices, LLC's CEO, Chris Bogan discussed the topic: Blockbuster Drugs Launch Evolution: Mapping Market - Entry Changes That Cause New Products to Stumble or Soar.

<div class="cArrow"> </div><div class="cContentInner">At Pharma CI Conference 2015 in New Jersey, Best Practices, LLC's CEO, Chris Bogan discussed the topic: Blockbuster Drugs Launch Evolution: Mapping Market - Entry Changes That Cause New Products to Stumble or Soar.</div>

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OctreoPharm's OPS202 gets EMA orphan drug designation for management of GEP-NETs - 0 views

regulatoryaffairs.pharmaceutical-business-review.com/...manage-gep-nets-300114-4168590

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shared by Alex Parker on 31 Jan 14 - No Cached

Alex Parker on 31 Jan 14

Germany-based OctreoPharm Sciences has received Orphan Drug Designation from the European Medicines Agency (EMA) for OPS202 as a diagnostic agent for the management of patients with gastro-entero-pancreatic-neuroendocrine tumors

<div class="cArrow"> </div><div class="cContentInner">Germany-based OctreoPharm Sciences has received Orphan Drug Designation from the European Medicines Agency (EMA) for OPS202 as a diagnostic agent for the management of patients with gastro-entero-pancreatic-neuroendocrine tumors</div>

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Spectrum's cancer drug Beleodaq gets FDA priority review - 0 views

drugdelivery.pharmaceutical-business-review.com/...priority-review-070214-4173700

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shared by Alex Parker on 10 Feb 14 - No Cached

Alex Parker on 10 Feb 14

US-based Spectrum Pharmaceuticals has announced that its new drug application (NDA) for Beleodaq has been accepted for filing by the FDA

<div class="cArrow"> </div><div class="cContentInner">US-based Spectrum Pharmaceuticals has announced that its new drug application (NDA) for Beleodaq has been accepted for filing by the FDA</div>

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BioMarin selects NAGLU fusion protein drug candidate BMN 250 to treat Sanfilippo B synd... - 0 views

drugdiscovery.pharmaceutical-business-review.com/...ippo-b-syndrome-120214-4175652

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shared by Alex Parker on 12 Feb 14 - No Cached

Alex Parker on 12 Feb 14

US-based BioMarin Pharmaceutical has selected a new drug development candidate, BMN 250, for the treatment of Sanfilippo B syndrome or Mucopolysaccharidosis type IIIB (MPS IIIB).

<div class="cArrow"> </div><div class="cContentInner">US-based BioMarin Pharmaceutical has selected a new drug development candidate, BMN 250, for the treatment of Sanfilippo B syndrome or Mucopolysaccharidosis type IIIB (MPS IIIB).</div>

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DesignMedix gets $3m NIH grant to develop low-cost malaria drug - 1 views

drugdiscovery.pharmaceutical-business-review.com/...st-malaria-drug-160414-4215927

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shared by Alex Parker on 17 Apr 14 - No Cached

Alex Parker on 17 Apr 14

US-based biotech startup DesignMedix has received a grant of $3m from the National Institutes of Health (NIH) to continue the development and manufacturing of a new anti-malarial drug.

<div class="cArrow"> </div><div class="cContentInner">US-based biotech startup DesignMedix has received a grant of $3m from the National Institutes of Health (NIH) to continue the development and manufacturing of a new anti-malarial drug.</div>

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New Prostate Cancer Drug Promising in Early Trials - 2 views

It's early in the process, but researchers say early trials of a new drug for treating advanced prostate cancer are producing encouraging results. read more .. in www.pharmamics.blogspot.com

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started by Pharma Mics on 08 Apr 09 no follow-up yet

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GlaxoSmithKline's once-weekly diabetes drug Eperzan gets marketing approval in Europe - 1 views

drugdelivery.pharmaceutical-business-review.com/...roval-in-europe-270314-4204343

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shared by Alex Parker on 27 Mar 14 - No Cached

Alex Parker on 27 Mar 14

PBR Staff Writer Published 27 March 2014 The European Commission (EC) has granted marketing authorization for GlaxoSmithKline's (GSK's) once-weekly diabetes treatment, Eperzan (albiglutide). The drug is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 27 March 2014 The European Commission (EC) has granted marketing authorization for GlaxoSmithKline's (GSK's) once-weekly diabetes treatment, Eperzan (albiglutide). The drug is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.</div>

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Goodwin, Aspyrian partner for cGMP manufacturing of new antibody drug conjugate - 1 views

manufacturing.pharmaceutical-business-review.com/...-drug-conjugate-250314-4203321

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shared by Alex Parker on 26 Mar 14 - No Cached

Alex Parker on 26 Mar 14

PBR Staff Writer Published 25 March 2014 US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 25 March 2014 US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.</div>

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Otsuka- Lundbeck's schizophrenia drug Abilify Maintena gets Health Canada clearance - 0 views

regulatoryaffairs.pharmaceutical-business-review.com/...roved-in-canada-140214-4177946

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shared by Alex Parker on 17 Feb 14 - No Cached

Alex Parker on 17 Feb 14

Otsuka and Lundbeck has received approval from Health Canada to use its intramuscular (IM) once-monthly injectable formulation 'Abilify Maintena' for the maintenance treatment of schizophrenia in stabilized adult patients.

<div class="cArrow"> </div><div class="cContentInner">Otsuka and Lundbeck has received approval from Health Canada to use its intramuscular (IM) once-monthly injectable formulation 'Abilify Maintena' for the maintenance treatment of schizophrenia in stabilized adult patients.</div>

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Vertex gets FDA approval for Kalydeco sNDA - 0 views

regulatoryaffairs.pharmaceutical-business-review.com/...r-kalydeco-snda-240214-4182411

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shared by Alex Parker on 24 Feb 14 - No Cached

Alex Parker on 24 Feb 14

PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).</div>

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Edison's EPI-743 gets FDA fast track status to treat Friedreich's Ataxia - 1 views

regulatoryaffairs.pharmaceutical-business-review.com/...reat-friedreichs-ataxia-180314

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shared by Alex Parker on 18 Mar 14 - No Cached

Alex Parker on 18 Mar 14

US-based Edison Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead drug EPI-743 to treat patients with Friedreich's ataxia.

<div class="cArrow"> </div><div class="cContentInner">US-based Edison Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead drug EPI-743 to treat patients with Friedreich's ataxia.</div>

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KYTHERA files NDA for ATX-101 to reduce unwanted submental fat - 1 views

drugdelivery.pharmaceutical-business-review.com/...d-submental-fat-130514-4265243

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shared by Alex Parker on 13 May 14 - No Cached

Alex Parker on 13 May 14

US-based KYTHERA Biopharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin.

<div class="cArrow"> </div><div class="cContentInner">US-based KYTHERA Biopharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin.</div>

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PSM-262A New Product Launch Spend Medical Affairs Only.pdf - 0 views

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shared by Hellan George on 17 Nov 15 - No Cached

Hellan George on 17 Nov 15

This report summary is an overview of the full report published by Best Practices, LLC. The report includes insights and information about the new pharmaceutical drugs launch spend in medical affairs in the US market.

<div class="cArrow"> </div><div class="cContentInner">This report summary is an overview of the full report published by Best Practices, LLC. The report includes insights and information about the new pharmaceutical drugs launch spend in medical affairs in the US market.</div>

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Group items tagged

How drug and device start-ups get the jump on the competition by employment of best pra... - 0 views

Pluristem files orphan drug application to US FDA for preeclampsia - 0 views

Development of drug candidates for rheumatoid arthritis - 1 views

Best Practices, LLC's CEO shares his views and insights on New Drug Launch Evolution - 0 views

OctreoPharm's OPS202 gets EMA orphan drug designation for management of GEP-NETs - 0 views

Spectrum's cancer drug Beleodaq gets FDA priority review - 0 views

BioMarin selects NAGLU fusion protein drug candidate BMN 250 to treat Sanfilippo B synd... - 0 views

DesignMedix gets $3m NIH grant to develop low-cost malaria drug - 1 views

New Prostate Cancer Drug Promising in Early Trials - 2 views

buy Xopenex inhalation solution online - order levalbuterol at cheap price - 0 views

GlaxoSmithKline's once-weekly diabetes drug Eperzan gets marketing approval in Europe - 1 views

Goodwin, Aspyrian partner for cGMP manufacturing of new antibody drug conjugate - 1 views

Otsuka- Lundbeck's schizophrenia drug Abilify Maintena gets Health Canada clearance - 0 views

Vertex gets FDA approval for Kalydeco sNDA - 0 views

Edison's EPI-743 gets FDA fast track status to treat Friedreich's Ataxia - 1 views

KYTHERA files NDA for ATX-101 to reduce unwanted submental fat - 1 views

Buy Azelex Cream Online, Generic azelex cream at Discount Prices - 0 views

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