Group items tagged drugs - medindia

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

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

health pharma news

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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Drug Therapy for Inherited Kidney Disease on the Anvil | MedIndia - 0 views

med india on 31 Oct 11

Patients with an inherited kidney disease may be helped by a drug that is currently available for other uses, scientists at UC Santa Barbara have discovered.

<div class="cArrow"> </div><div class="cContentInner">Patients with an inherited kidney disease may be helped by a drug that is currently available for other uses, scientists at UC Santa Barbara have discovered.</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

health medical news

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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Aegis awarded its first patent for oral delivery of nucleotide-based drugs - 0 views

processandproduction.pharmaceutical-business-review.com/...ide-based-drugs-060214-4172952

health medical news pharma

shared by Alex Parker on 06 Feb 14 - No Cached

Alex Parker on 06 Feb 14

Aegis Therapeutics has been awarded its first patent for oral delivery of nucleotide analog based drugs based upon the company's patented Intravail transmucosal absorption enhancer technology

<div class="cArrow"> </div><div class="cContentInner">Aegis Therapeutics has been awarded its first patent for oral delivery of nucleotide analog based drugs based upon the company's patented Intravail transmucosal absorption enhancer technology</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

health news medical pharma

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

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

health news medical pharma

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

health news medical pharma

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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Malaria- A Review of Recent Guidelines in the Indian Context | MedIndia - 0 views

med india on 09 Dec 11

Microscopy of blood smears remains the gold standard for confirmation of diagnosis of malaria.

<div class="cArrow"> </div><div class="cContentInner">Microscopy of blood smears remains the gold standard for confirmation of diagnosis of malaria. </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

health medical news pharma

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

health medical news pharma day

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

health news medical pharma daily

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

health news medical pharma

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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Effect of Psoriasis and Its Treatment on Pregnancy | MedIndia - 0 views

med india on 10 Nov 11

Pregnancy often results in a temporary improvement in psoriasis. On the other hand, psoriasis and its treatment can adversely affect pregnancy.

<div class="cArrow"> </div><div class="cContentInner">Pregnancy often results in a temporary improvement in psoriasis. On the other hand, psoriasis and its treatment can adversely affect pregnancy.</div>

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Bristol-Myers Squibb gets FDA breakthrough designation for daclatasvir-based regimen - 0 views

regulatoryaffairs.pharmaceutical-business-review.com/...r-based-regimen-250214-4183423

health medical news pharma breakthroughs

shared by Alex Parker on 25 Feb 14 - No Cached

Alex Parker on 25 Feb 14

PBR Staff Writer Published 25 February 2014 Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 25 February 2014 Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).</div>

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Novartis announces acquisition of CoStim Pharmaceuticals - 0 views

processandproduction.pharmaceutical-business-review.com/...pharmaceuticals-180214-4179543

health news pharma

shared by Alex Parker on 19 Feb 14 - No Cached

Alex Parker on 19 Feb 14

Novartis has acquired CoStim Pharmaceuticals, an immuno-oncology company developing monoclonal antibody drugs that enable a patient's own immune system to better fight cancer.

<div class="cArrow"> </div><div class="cContentInner">Novartis has acquired CoStim Pharmaceuticals, an immuno-oncology company developing monoclonal antibody drugs that enable a patient's own immune system to better fight cancer.</div>

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Boehringer's Pradaxa gets FDA approval for DVT, PE treatment - 1 views

regulatoryaffairs.pharmaceutical-business-review.com/...vt-pe-treatment-090414-4211375

health news medical pharma

shared by Alex Parker on 09 Apr 14 - No Cached

Alex Parker on 09 Apr 14

Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

<div class="cArrow"> </div><div class="cContentInner">Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).</div>

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Evotec, Debiopharm to research and develop new cancer treatments - 1 views

contractresearch.pharmaceutical-business-review.com/...ncer-treatments-030414-4208083

health news pharma medical

shared by Alex Parker on 04 Apr 14 - No Cached

Alex Parker on 04 Apr 14

Germany based drug discovery firm Evotec has entered into a research collaboration and licensing deal with Swiss biopharmaceutical firm Debiopharm Group to research and develop new cancer treatments

<div class="cArrow"> </div><div class="cContentInner">Germany based drug discovery firm Evotec has entered into a research collaboration and licensing deal with Swiss biopharmaceutical firm Debiopharm Group to research and develop new cancer treatments</div>

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Tetraphase's eravacycline gets FDA fast track status - 1 views

regulatoryaffairs.pharmaceutical-business-review.com/...st-track-status-030414-4208894

health news medical pharma

shared by Alex Parker on 04 Apr 14 - No Cached

Alex Parker on 04 Apr 14

The US Food & Drug Administration (FDA) has granted fast track designations for both the intravenous (IV) and oral formulations of Tetraphase Pharmaceuticals' lead antibiotic candidate, eravacycline.

<div class="cArrow"> </div><div class="cContentInner">The US Food & Drug Administration (FDA) has granted fast track designations for both the intravenous (IV) and oral formulations of Tetraphase Pharmaceuticals' lead antibiotic candidate, eravacycline.</div>

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FDA approves GSK's Incruse Ellipta to treat airflow obstruction in COPD patients - 1 views

regulatoryaffairs.pharmaceutical-business-review.com/...n-copd-patients-010514-4256177

health news medical pharma daily

shared by Alex Parker on 01 May 14 - No Cached

Alex Parker on 01 May 14

PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

<div class="cArrow"> </div><div class="cContentInner">PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.</div>

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Group items tagged

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

Drug Therapy for Inherited Kidney Disease on the Anvil | MedIndia - 0 views

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

Aegis awarded its first patent for oral delivery of nucleotide-based drugs - 0 views

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

Malaria- A Review of Recent Guidelines in the Indian Context | MedIndia - 0 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

Effect of Psoriasis and Its Treatment on Pregnancy | MedIndia - 0 views

Bristol-Myers Squibb gets FDA breakthrough designation for daclatasvir-based regimen - 0 views

Novartis announces acquisition of CoStim Pharmaceuticals - 0 views

Boehringer's Pradaxa gets FDA approval for DVT, PE treatment - 1 views

Evotec, Debiopharm to research and develop new cancer treatments - 1 views

Tetraphase's eravacycline gets FDA fast track status - 1 views

FDA approves GSK's Incruse Ellipta to treat airflow obstruction in COPD patients - 1 views

FDA approves Xolair for treatment of chronic hives - 1 views

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