Copanlisib (BAY 80-6946), Bayer’s novel, oral phosphatidylinositol-3 kinases (PI3K) inhibitor

10 10 2013

New Drug Approvals

Copanlisib (BAY 80-6946)

1032568-63-0, cas no

MW: 480.5262

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.

PI3K inhibitor BAY 80-6946
A phosphoinositide 3-kinase (PI3K) inhibitor with potential antineoplastic activity. PI3K inhibitor BAY 80-6946 inhibits the activation of the PI3K signaling pathway, which may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis and dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents.

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Molidustat (BAY 85-3934), Bayer’s drug under initiation in patients with anemia associated with chronic kidney disease and/or end-stage renal disease.

10 10 2013

New Drug Approvals

Molidustat

UNII-9JH486CZ13, cas no 1154028-82-6, MW: 314.3076

2-(6-morpholin-4-ylpyrimidin-4-yl)-4-(triazol-1-yl)-1H-pyrazol-3-one

Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors

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.

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…

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BAYER- sPRM (BAY 1002670) Vilaprisan is a novel oral progesterone receptor modulator that holds the promises of long-term treatment of patients with symptomatic uterine fibroids

10 10 2013

New Drug Approvals

WP_000066.jpg

http://www.who.int/medicines/publications/druginformation/issues/Proposed-List_109.pdf   str is available in this link

20,20,21,21,21-pentafluoro-17-hydroxy-11β-[4-
(methanesulfonyl)phenyl]-19-nor-17α-pregna-4,9-dien-3-one
progesterone receptor antagonist

BAY 1002670, vilaprisan

1262108-14-4

C27H29F5O4S544.574

http://www.who.int/medicines/publications/druginformation/issues/Proposed-List_109.pdf   str is available in this link

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.

selective progesterone receptor modulator (SPRM) is an agent that acts on the progesterone receptor. A characteristic that distinguishes such substances from receptor full agonists (such as progesterone) and full antagonists (such as mifepristone) is that their action differs in different tissues (agonist in some while antagonist in others). This mixed agonist/antagonist profile of action leads to selective…

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Chelsea Therapeutics Announces FDA Advisory Committee to Review Northera

10 10 2013

New Drug Approvals

droxidropa

CHARLOTTE, N.C., Oct. 9, 2013 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to market Northera (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) will be reviewed by the Cardiovascular and Renal Drug Advisory Committee (CRDAC). The meeting is tentatively scheduled for January 14, 2014   read more here————

http://www.drugs.com/nda/northera_131009.html

old article cut paste

FDA Deems Resubmission a Complete Response; PDUFA Date Set as
February 14, 2014

CHARLOTTE, N.C., Sept. 4, 2013 (GLOBE NEWSWIRE) — Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission seeking approval to market NORTHERA(TM) (droxidopa), an orally active synthetic precursor of norepinephrine

read all at

http://www.pharmalive.com/chelsea-therapeutics-announces-fda-acceptance-of-northera-nda-resubmission

L-DOPS (L-threo-dihydroxyphenylserine…

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GT Biologics obtains FDA orphan drug designation for paediatric Crohn’s drug

10 10 2013

New Drug Approvals

GT Biologics, a developer of live biotherapeutics for the treatment of autoimmune diseases, has received orphan drug designation from the US Food and Drug Administration (FDA) for its lead product candidate, Thetanix.

read all at

http://www.pharmaceutical-technology.com/news/newsgt-biologics-obtains-fda-orphan-drug-designation-for-paediatric-crohns-drug?WT.mc_id=DN_News

 

read all on

Bacteroides thetaiotaomicron

http://microbewiki.kenyon.edu/index.php/Bacteroides_thetaiotaomicron

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Orexigen files obesity drug Contrave for approval in Europe

5 10 2013

New Drug Approvals

Orexigen files obesity drug Contrave for approval in Europe

Orexigen Therapeutics  has submitted the Marketing Authorization Application (MAA) for Contrave, an investigational weight-loss drug to the European Medicines Agency (EMA). 

OREXIGNEThe La Jolla, CA-based  drug firm is using the EMA’s centralised procedure to seek approval for Contrave  Orexigen (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. The company filed the application after meeting with the European agency to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. Orexigen and the European regulator have also agreed upon an investigation plan in children and adolescents.

read all at

http://www.pharmatopics.com/2013/10/orexigen-files-obesity-drug-contrave-approval-europe/

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Orexigen files obesity drug Contrave for approval in Europe

5 10 2013

New Drug Approvals

Orexigen files obesity drug Contrave for approval in Europe

Orexigen Therapeutics  has submitted the Marketing Authorization Application (MAA) for Contrave, an investigational weight-loss drug to the European Medicines Agency (EMA). 

OREXIGNEThe La Jolla, CA-based  drug firm is using the EMA’s centralised procedure to seek approval for Contrave  Orexigen (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification. The company filed the application after meeting with the European agency to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. Orexigen and the European regulator have also agreed upon an investigation plan in children and adolescents.

read all at

http://www.pharmatopics.com/2013/10/orexigen-files-obesity-drug-contrave-approval-europe/

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Green Chemistry @ MUN

Less solvent, Less waste, Less energy

Inspiring Science

Casting light on great ideas

Your mom is like science?

Practical scientific analogy education and outreach

DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Syntheticnature

Total Synthesis and general organic chemistry

pharmupdates.wordpress.com/

News and articles on the Pharmaceutical Industry

Combinatorics and more

Gil Kalai's blog

Organic chemistry teaching

Just another WordPress.com weblog

Seven Spheres

Aqua Terra Ignis et Aer

The Molecular Circus

How molecules make the world go round

Chemtips

Because Organic Chemistry is Hard Enough

The Heterocyclist

A blog about heterocyclic chemistry

travellingbeets

Travelling Stories & Photographs From One Travel Lover To Another

The Sacred Lives of Objects

Seeing and Being Seen in the Modern Museum

Earth mY homE

Seeing the Surroundings

One Person, One World.

Tibet, Human Rights, Injustice, Animal Abuse, Child Abuse

France Outdoors

Experience Culture, Physical Activity and Nature on Every Trip

Grind Your Wheat

a chronicle of our nomadic wanderings

Green Chemistry @ MUN

Less solvent, Less waste, Less energy

Inspiring Science

Casting light on great ideas

Your mom is like science?

Practical scientific analogy education and outreach

DRUG REGULATORY AFFAIRS INTERNATIONAL

Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker

Syntheticnature

Total Synthesis and general organic chemistry

pharmupdates.wordpress.com/

News and articles on the Pharmaceutical Industry

Combinatorics and more

Gil Kalai's blog

Organic chemistry teaching

Just another WordPress.com weblog

Seven Spheres

Aqua Terra Ignis et Aer

The Molecular Circus

How molecules make the world go round

Chemtips

Because Organic Chemistry is Hard Enough

The Heterocyclist

A blog about heterocyclic chemistry

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Travelling Stories & Photographs From One Travel Lover To Another

The Sacred Lives of Objects

Seeing and Being Seen in the Modern Museum

Earth mY homE

Seeing the Surroundings

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