MakroCare

makrocare.com

MakroCare is a knowledge and technology-enabled drug development partner and functional provider to global Pharma, Biotech and Device companies. Our 15+ years experience and constant innovation solve customer's challenges in Regulatory Affairs, Clinical Research and Medical Affairs.

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PHARMACY MARKET

AQUESTIVE THERAPEUTICS RECEIVES FDA ACCEPTANCE OF NEW DRUG APPLICATION (NDA) FOR LIBERVANT™ (DIAZEPAM) BUCCAL FILM IN PEDIATRIC PATIENTS

GlobeNewswire | September 12, 2023

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Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and ...

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Research

EDEVIATION THE LATEST PROTOCOL DEVIATIONS CLOUD SOFTWARE SOLUTION

eDeviation | April 21, 2021

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Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol devi...

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BEIGENE REPORTS POSITIVE PHASE III INTERIM ANALYSIS FOR LUNG CANCER DRUG

MedCity News | April 14, 2020

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Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday. Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with ...

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MAYNE PHARMA ANNOUNCES FDA FILING ACCEPTANCE OF NEW DRUG APPLICATION FOR E4/DRSP IN THE US

Mayne Pharma, Mithra | June 24, 2020

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Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021. Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is...

Read More
news image

PHARMACY MARKET

AQUESTIVE THERAPEUTICS RECEIVES FDA ACCEPTANCE OF NEW DRUG APPLICATION (NDA) FOR LIBERVANT™ (DIAZEPAM) BUCCAL FILM IN PEDIATRIC PATIENTS

GlobeNewswire | September 12, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and ...

Read More
news image

Research

EDEVIATION THE LATEST PROTOCOL DEVIATIONS CLOUD SOFTWARE SOLUTION

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management. The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations. Protocol devi...

Read More
news image

BEIGENE REPORTS POSITIVE PHASE III INTERIM ANALYSIS FOR LUNG CANCER DRUG

MedCity News | April 14, 2020

Interim results from a Phase III clinical trial have shown that patients receiving a cancer immunotherapy drug for a form of lung cancer on top of chemotherapy were more likely than those receiving chemotherapy alone to survive without their disease worsening, the company developing the drug said Monday. Beijing-based BeiGene reported an improvement in progression-free survival (PFS) among first-line patients with non-squamous non-small-cell lung cancer (NSCLC) receiving tislelizumab along with ...

Read More
news image

MAYNE PHARMA ANNOUNCES FDA FILING ACCEPTANCE OF NEW DRUG APPLICATION FOR E4/DRSP IN THE US

Mayne Pharma, Mithra | June 24, 2020

Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021. Developed by Mithra Pharmaceuticals SA (Mithra), E4/DRSP is a novel combined oral contraceptive pill containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP). E4 is a naturally occurring estrogen that is...

Read More

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Events

C-Suite On Deck

Responsive image

Feature market insights and perspectives from top C-Level executives, elite technology influencers and thought leaders from your company here. This signature initiative has garnered immense support...

Contact Us