Recent updates

Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study

Posted on19 Sep 2018

TagsAlmirall, case study on drug discovery to commercialization, Drug Discovery and Development Pathway, MAB, Tildrakizumab

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Brand Name: Ilumetri Biomolecule: Tildrakizumab Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease. Biologic Development to Commercialization...

Consequences and progress of Takeda-Shire Buyout

Posted on15 Sep 2018

Tagsacquisition in pharma, pharma acquisition, Shire, Takeda

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Takeda announced in April it would buy Shire in the largest-ever overseas acquisition by a Japanese company. Although Shire is based in Ireland, most of its operations are in Massachusetts,...

Indian health ministry banned 329 controversial fixed dose combination with immediate effect

Posted on14 Sep 2018

Tagsbanned fixed dose combination in india, CDSCO, DCGI, India's Health Ministry has banned 344 fixed dose drugs

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The ministry of health and family welfare has prohibited the manufacture for sale, sale or distribution for human use of 329 fixed dose combinations (FDCs) with immediate effect. Earlier, the...

Pharma aaquisition: Aurobindo to acquire dermatology and oral solids businesses from Sandoz Inc. for $900 million

Posted on06 Sep 2018

Tagsacquisistion in pharma, acquisition in pharma, acquisition of injectable business, global pharma deals, global pharma licensing deal

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Aurobindo Pharma’s US based subsidiary Aurobindo Pharma USA Inc has entered into a definitive agreement with Sandoz Inc., USA, a Novartis division, to acquire its dermatology and oral solids businesses...

Market Launch and brand positioning of Volini Maxx

Posted on30 Aug 2018

TagsLine extension pharma brand, pharma brand positioning, volini, volini maxx

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Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd, has launched Volini Maxx, a strongest pain relief spray. The company has signed Virat Kohli, captain of Indian cricket...

Grünenthal’s Duzallo: EU marketing authorization and Brand Positining

Posted on30 Aug 2018

TagsDuzallo, Grünenthal

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Duzallo EU Marketing Authorization Grünenthal announced that the European Commission (EC) has followed the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and granted Duzallo marketing...

USFDA approval of patisiran, first-of-its kind targeted RNA-based therapy

Posted on21 Aug 2018

TagsOnpattro, patisiran, siRAN, USFDA new drugs approval

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The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is...

Digital Strategy for pharma brand promotion: Merck launch map4health

Posted on21 Aug 2018

Tagsdigital marketing in pharma, Digital Strategy for pharma brand promotion

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Healthy Interactions, a global leader in health education, in collaboration with Merck, known as MSD outside the United States and Canada, announced the launch of map4health – a digital platform...

Insight on Novo Nordisk’s acquisition of Bristol, UK-based Ziylo for $800 million

Posted on17 Aug 2018

TagsNovo nordisk, pharma acquisition

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Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the...

AstraZeneca’s Lynpraza got DCGI (India) marketing approval

Posted on17 Aug 2018

TagsAstraZenca, AstraZeneca, CDSCO, DCGI, Lynpraza, olaparib

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AstraZeneca Pharma India has received Import & Market permission for olaparib (Lynparza )100 mg and 150 mg tablets in India by the Drug Controller General of India (DCGI). The receipt...

Pharma Packaging > How to convert IU to mg?

Posted on17 Aug 2018

TagsPharma Packaging

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You will be finding the certain formulation is highlighting ingredients in IU. For example in case of Vitamin D preparation vitamin D3 unit will be IU. Refer below – An...

Brand Promotion: Mankind’s OTC brand KABZEND

Posted on04 Aug 2018

Tagsbrand ambassador, KABZEND, Mankind

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Mankind Pharma, a quality-driven pharmaceutical company in India, has launched a new over-the-counter (OTC) product – KABZEND Natural Laxative Granules to help relieve constipation. Mankind Pharma has chosen veteran actor...

PDL – Depomed’s deal for type 2 diabetes products

Posted on04 Aug 2018

TagsDepomed, Invokamet XR, Jentadueto XR, PDL BioPharma, Synjardy XR

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PDL BioPharma, Inc. (PDL) announces an amendment to the Royalty Purchase and Sale Agreement (the “Royalty Agreement”) with Depomed, Inc. (Depome”) under which PDL acquired all of Depomed’s remaining rights...

EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease

Posted on04 Aug 2018

TagsEMA prime designation, Roche

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Roche announced that the European Medicines Agency (EMA) has granted Prime (PRIority MEdicines) designation for the company’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with...

Insight on Bayer’s EU approval of new treatment regimen for Eylea

Posted on03 Aug 2018

TagsBayer, Eylea, Regeneron

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Bayer has received European Commission approval of a new treatment approach for Eylea to enable clinicians to combine proactive treatment with early extension of the injection interval for patients with...

Case Study: LEO Pharma’s acquisition of Bayer’s dermatology unit

Posted on03 Aug 2018

TagsAdvantan, Bayer, Bepanthen, Canesten, Desonate, leo pharma, Nerisona, rosacea, Skinore, Travocort, Travogen

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LEO Pharma has entered into a definitive agreement to buy Bayer’s global prescription dermatology unit. The portfolio to be acquired includes branded topical prescription treatments for acne, fungal skin infections...

What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?

Posted on31 Jul 2018

TagsANDA, Field Alert Report (FAR) Submission for NDAs and ANDAs, NDA, usfda

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FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The...

EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC

Posted on31 Jul 2018

TagsCHMP, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency, KEYTRUDA

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Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...

Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate

Posted on31 Jul 2018

TagsDaiichi, Daiichi Sankyo, gatipotuzumab

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Daiichi Sankyo Company, Limited and Glycotope GmbH have entered into an exclusive worldwide licensing agreement to develop an antibody drug conjugate (ADC) by combining Daiichi Sankyo’s proprietary ADC technology with...

Hyrimoz Sandoz’s biosimilar got European marketing approval

Posted on31 Jul 2018

TagsAdalimumab, biosimilar of sandoz, Hyrimoz, sandoz, tumor necrosis factor

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Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz (adalimumab) for use in all...

Recent updates

Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study

Consequences and progress of Takeda-Shire Buyout

Indian health ministry banned 329 controversial fixed dose combination with immediate effect

Pharma aaquisition: Aurobindo to acquire dermatology and oral solids businesses from Sandoz Inc. for $900 million

Market Launch and brand positioning of Volini Maxx

Grünenthal’s Duzallo: EU marketing authorization and Brand Positining

USFDA approval of patisiran, first-of-its kind targeted RNA-based therapy

Digital Strategy for pharma brand promotion: Merck launch map4health

Insight on Novo Nordisk’s acquisition of Bristol, UK-based Ziylo for $800 million

AstraZeneca’s Lynpraza got DCGI (India) marketing approval

Pharma Packaging > How to convert IU to mg?

Brand Promotion: Mankind’s OTC brand KABZEND

PDL – Depomed’s deal for type 2 diabetes products

EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease

Insight on Bayer’s EU approval of new treatment regimen for Eylea

Case Study: LEO Pharma’s acquisition of Bayer’s dermatology unit

What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?

EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC

Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate

Hyrimoz Sandoz’s biosimilar got European marketing approval

KPE-C-075 Fundamental Training on Pharma Marketing Plan Development

KPE-C-074 Fundamental Training on Monoclonal Antibody

KPE-C-073 Fundamental Training on Regulatory Affairs Advance Strategic Planning

KPE-C-072 Fundamental Training on 505B(2) Application Submission

KPE-C-071 Advance Diploma in Drug and Medical Device Regulatory Affairs (DRA + MDRA Dual Specialization)

KPE-C-046 KPE’s Certificate Course in Drug Regulatory Affairs

KPE-C-070 KPE’s 1 Week Certificate Course in Drug Regulation & Registration in Brazil

KPE – C- 023N KPE’s Advance Diploma in Pharmaceutical Product Management and Regulatory Affairs (Dual Specialization)

KPE-C-069 KPE’s 1 Month Certificate Course in Drug Registration in Latin American (Latam) Countries

KPE-C-068 – 1 Month Certificate Course in CE Marking for Medical Devices

KPE–C-065 KPE’s 1 Week Certificate Course in Pharmaceutical IPR and R&D

KPE-C-063 KPE’s 1 Month Certificate Course in Digital Pharma Marketing

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