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24 Jun 2019

Glenmark’s licensing deal with Novartis to distribute three respiratory drugs in Brazil

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TagsGlenmark, Latam pharma market, Onbrize, Seebri, Ultibro

Glenmark Farmacêutica, has entered into an exclusive partnership agreement with Novartis to distribute latter’s three respiratory products in Brazil. Under...

24 Jun 2019

What is CRL – Complete Response Letter by USFDA?

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TagsComplete Response Letter, usfda

Complete response letter is issued by USFDA to new drug / abbreviated application holder, if they determines that we will...

24 Jun 2019

Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women

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TagsAmag, Amag Terminate Ferumoxytol Accord for EU, new drug approval, Vyleesi

U.S. Food and Drug Administration (FDA) has approved Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist, to treat acquired, generalized hypoactive...

24 Jun 2019

FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

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TagsDEXTENZA, sNDA, sNDA USFDA, supplemental New Drug Application

U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of...

21 Jun 2019

A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan

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TagsBreztri Aerosphere, Drug approval in Japan, drug regulatory body in japan

AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy...

21 Jun 2019

Case Study: Why Pfizer acquiring Array Biopharma?

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Tagsacquisition in pharma, pfizer

Pfizer Inc. and Array BioPharma Inc. have entered into a definitive merger agreement under which Pfizer will acquire Array, a...

17 Jun 2019

Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant

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Tags483, 483 OBSERVATION, 483 observations, fda 483 observation, FORM 483, form 483 observation

The US Food and Drug Administration has pointed out data integrity lapses at Aurobindo Pharma Limiteds finished dosages plant at...

14 Jun 2019

USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti

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TagsAmgen, Biosimilar, Kanjinti, MAB, trastuzumab

The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was...

14 Jun 2019

What is vertical integration?

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TagsBackward integration, Forward integration in pharmaceutical, vertical integration

Vertical integration is a strategy where a firm acquires business operations within the same production vertical. It can be forward...

14 Jun 2019

Pharma Case Study : Vertical Integration – Relevium’s acquisition of Lifeline Pharma SAS

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TagsBackward integration, Forward integration in pharmaceutical, vertical integration

Relevium Technologies Inc., is pleased to announce that Biocannabix Health Corporation, a wholly-owned subsidiary of Relevium has executed on June...

10 Jun 2019

Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet

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Tagscase study new drug approval, NDA, Slynd, usfda

Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration...

6 Jun 2019

USFDA accepted triple drug FDC empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes

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Tagsempagliflozin, Fixed Dose Combination, linagliptin, NDA, triple drug

Boehringer Ingelheim and Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has accepted the New...

1 Jun 2019

What is meaning of OEM in medical device industry?

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OEM means original equipment manufacturer. But coming to regularly pronounced medical device industry terminology it is misleading. OEMs are manufacturers...

31 May 2019

Case analysis: Can marketing authorization can be revoked?

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TagsEU marketing authorization

Yes. Marketing authorization can be revoked and it generally carried out, in case of safety issued observed with the molecule....

31 May 2019

Luye Pharma’s Rykindo NDA Filing Accepted by the US FDA

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TagsNDA, Rykindo, usfda

Rykindo, Luye Pharma’s innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S....

27 May 2019

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

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TagsBreakthrough Therapy designations, Fast Track designation, priority review, Priority Review Designation, tafamidis, tafamidis meglumine, usfda, USFDA Priority Review, Vyndamax, Vyndaqel

U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease...

27 May 2019

Top 10 Generic Company Globally in 2018 (by revenue)

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Tags2018 Top 10 generic companies

Here you can preview top 10 global generic companies by revenue. Data is presented in USD million. Click here to...

26 May 2019

Top 10 Global Pharmaceutical Company in 2018

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TagsAbbVie, Bayer, Eli Lilly, novartis, pfizer, Roche, Sanofi, top 10 pharmaceuticals globally

24 May 2019

Take a self competency test in authorized generics

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Tagsmcq in drug regulatory afffairs, MCQ test in regulatory affairs

In the U.S., prescription drugs approved by the federal Food and Drug Administration (FDA) are granted a specified period of...

24 May 2019

GSK’s Shingrix received chinese approval for shingles vaccine

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Tagschina FDA, China Food and Drug Administration, GSK, Shingrix, vaccine

GaxoSmithKline (GSK) has secured approval from China’s National Medical Products Administration (NMPA) for Shingrix vaccine to prevent shingles (herpes zoster)...

24 May 2019

Bayer to launch Baycox Iron injection combination in Europe

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TagsBaycox, Bayer, toltrazuril

Bayer launches Baycox Iron (36 mg/ml toltrazuril plus 182 mg/ml gleptoferron) suspension for injection for piglets across Europe following marketing...

24 May 2019

Health Canada approves Biocon and Mylan’s trastuzumab biosimilar ‘Ogivri’ for HER2-positive cancers

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TagsBiocon, Biosimilar, Health Canada, Mylan, Ogivri, trastuzumab

Biocon and Mylan have received the clearance from Health Canada for the latter’s biosimilar Herceptin: trastuzumab co-developed under the brand...

23 May 2019

Case Study – A close look into Eli Lilly’s pricing strategy for Insulin Lispro injection in US market

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Tagsauthorized generic, Eli Lilly

Eli Lilly and Company’s has announced that its Insulin Lispro Injection is now available for order in pharmacies for people...

21 May 2019

Takeda, Frazier Healthcare Partners to launch Phathom Pharma

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TagsFrazier Healthcare, Phathom Pharma, Takeda, Vonoprazan

Takeda Pharmaceutical and Frazier Healthcare Partners have announced a collaboration to launch Phathom Pharmaceuticals, a biopharmaceutical company focused on the...

10 May 2019

Can a new drug rejected by USFDA, can get EU approval?

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TagsEU, usfda, volanesorsen, Waylivra

Yes it can be. US and EU regulatory body work independently, without any influence of each other. Review of the...

10 May 2019

Novatis’s Xiidra acquisition from Takeda for USD 5.3 billion

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Tagsacquisition in pharma, Novatis, Takeda, Xiidra

Novartis has entered into an agreement with Takeda Pharmaceutical Company Limited to acquire the assets associated with Xiidra (lifitegrast ophthalmic...

2 May 2019

FDA approval of first medical device for treatment of ADHD

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TagsMedical device approval

The U.S. Food and Drug Administration permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD)....

2 May 2019

Sanofi’s Praluent got much needed boost with USFDA new indication approval

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TagsPraluent

The Food and Drug Administration (FDA) has approved Praluent (alirocumab; Sanofi and Regeneron), a proprotein convertase subtilisin kexin type 9...

2 May 2019

Calixar licensing agreement with Regeneron

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TagsCalixar, drug licensing, licensing deal in pharma, Regeneron

Calixar SAS, a biotechnology company specialized in native membrane protein stabilization, has entered into an exclusive licensing agreement with Regeneron...

2 May 2019

Sandoz licensing agreement with EirGenix to commercialize trastuzumab biosimilar

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Sandoz, a Novartis division and a global leader in biosimilars, has entered into an agreement to commercialize a proposed trastuzumab...

Recently Published Articles

Glenmark’s licensing deal with Novartis to distribute three respiratory drugs in Brazil

What is CRL – Complete Response Letter by USFDA?

Case Study: Vyleesi™ (Bremelanotide Injection) for HSDD in Premenopausal Women

FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

A triple-combination therapy for COPD – Breztri Aerosphere’s of AstraZeneca received approval in Japan

Case Study: Why Pfizer acquiring Array Biopharma?

Case analysis: 483 observations – Data Integrity issues in Aurobindo Pharma’s finished dosage formulation plant

USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti

What is vertical integration?

Pharma Case Study : Vertical Integration – Relevium’s acquisition of Lifeline Pharma SAS

Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet

USFDA accepted triple drug FDC empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes

What is meaning of OEM in medical device industry?

Case analysis: Can marketing authorization can be revoked?

Luye Pharma’s Rykindo NDA Filing Accepted by the US FDA

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

Top 10 Generic Company Globally in 2018 (by revenue)

Top 10 Global Pharmaceutical Company in 2018

Take a self competency test in authorized generics

GSK’s Shingrix received chinese approval for shingles vaccine

Bayer to launch Baycox Iron injection combination in Europe

Health Canada approves Biocon and Mylan’s trastuzumab biosimilar ‘Ogivri’ for HER2-positive cancers

Case Study – A close look into Eli Lilly’s pricing strategy for Insulin Lispro injection in US market

Takeda, Frazier Healthcare Partners to launch Phathom Pharma

Can a new drug rejected by USFDA, can get EU approval?

Novatis’s Xiidra acquisition from Takeda for USD 5.3 billion

FDA approval of first medical device for treatment of ADHD

Sanofi’s Praluent got much needed boost with USFDA new indication approval

Calixar licensing agreement with Regeneron

Sandoz licensing agreement with EirGenix to commercialize trastuzumab biosimilar

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