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15 Oct 2018

Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix

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TagsBrintellix, CDSCO, codevelopment deal in pharma, comarketing deal in pharma, copromotion deal in pharma, DCGI, Lundbeck, vortioxetine

Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from...

4 Oct 2018

Eyevance Pharmaceuticals Acquires Worldwide Rights to NEXAGON®

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Tagsdrug licensing, Eyevance Pharmaceuticals, FRESHKOTE, NEXAGON, outlicensing in pharma, ZERVIATE

Eyevance Pharmaceuticals, a Fort Worth-based pharmaceutical company committed to developing and commercializing innovative and impactful ophthalmic products, announced a worldwide...

3 Oct 2018

Case Study: USFDA The Limited Population Pathway and approval of Arikayce

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TagsArikayce, LAPD, The Limited Population Pathway for Antibacterial and Antifungal Drugs, USFDA new drugs approval

The US Food and Drug Administration late Friday granted accelerated approval of Arikayce (amikacin liposome inhalation suspension), developed by US...

3 Oct 2018

Dr. Reddy’s sells Cloderm cream to EPI Health

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Tagsacquisition in pharma, brand acquisition, Cloderm, Dr. Reddy’s Laboratories, DRL, EPI Health

Dr. Reddy’s Laboratories’ wholly owned U.S. subsidiary Promius Pharma has sold rights of Cloderm (clocortolone pivalate) cream and its authorised...

3 Oct 2018

DRL to disinvest antibiotics plant to Abu Dhabi-based Neopharma

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Tagsacquisition in pharma, Dr. Reddy’s Laboratories, neopharma

Dr Reddy’s Laboratories on Monday announced the closure of the sale of its antibiotic manufacturing facility and related assets in...

3 Oct 2018

Case Study: Product Recall due to labeling error

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Tagsclass i recall, FDA's role in product recall, medicine labeling, Product Recall, Produt recall, What is class i Recall

Endo Pharmaceuticals Inc, is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets 100 count bottle pack to...

19 Sep 2018

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

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

Brand Name: Ilumetri Biomolecule: Tildrakizumab Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing...

15 Sep 2018

Consequences and progress of Takeda-Shire Buyout

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Tagsacquisition in pharma, pharma acquisition, Shire, Takeda

Takeda announced in April it would buy Shire in the largest-ever overseas acquisition by a Japanese company. Although Shire is...

14 Sep 2018

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

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

The ministry of health and family welfare has prohibited the manufacture for sale, sale or distribution for human use of...

6 Sep 2018

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

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

Aurobindo Pharma’s US based subsidiary Aurobindo Pharma USA Inc has entered into a definitive agreement with Sandoz Inc., USA, a...

30 Aug 2018

Market Launch and brand positioning of Volini Maxx

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

Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd, has launched Volini Maxx, a strongest pain relief spray....

30 Aug 2018

Grünenthal’s Duzallo: EU marketing authorization and Brand Positining

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TagsDuzallo, Grünenthal

Duzallo EU Marketing Authorization Grünenthal announced that the European Commission (EC) has followed the positive opinion of the Committee for...

21 Aug 2018

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

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TagsOnpattro, patisiran, siRAN, USFDA new drugs approval

The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused...

21 Aug 2018

Digital Strategy for pharma brand promotion: Merck launch map4health

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Tagsdigital marketing in pharma, Digital Strategy for pharma brand promotion

Healthy Interactions, a global leader in health education, in collaboration with Merck, known as MSD outside the United States and...

17 Aug 2018

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

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TagsNovo nordisk, pharma acquisition

Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX...

17 Aug 2018

AstraZeneca’s Lynpraza got DCGI (India) marketing approval

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TagsAstraZenca, AstraZeneca, CDSCO, DCGI, Lynpraza, olaparib

AstraZeneca Pharma India has received Import & Market permission for olaparib (Lynparza )100 mg and 150 mg tablets in India...

17 Aug 2018

Pharma Packaging > How to convert IU to mg?

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TagsPharma Packaging

You will be finding the certain formulation is highlighting ingredients in IU. For example in case of Vitamin D preparation...

4 Aug 2018

Brand Promotion: Mankind’s OTC brand KABZEND

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Tagsbrand ambassador, KABZEND, Mankind

Mankind Pharma, a quality-driven pharmaceutical company in India, has launched a new over-the-counter (OTC) product – KABZEND Natural Laxative Granules...

4 Aug 2018

PDL – Depomed’s deal for type 2 diabetes products

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

PDL BioPharma, Inc. (PDL) announces an amendment to the Royalty Purchase and Sale Agreement (the “Royalty Agreement”) with Depomed, Inc....

4 Aug 2018

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

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TagsEMA prime designation, Roche

Roche announced that the European Medicines Agency (EMA) has granted Prime (PRIority MEdicines) designation for the company’s investigational medicine RG6042...

3 Aug 2018

US FDA grants breakthrough therapy status for Lenvima in combo with Keytruda

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TagsBreakthrough Therapy designation, KEYTRUDA, Lenvima, Lenvima/Keytruda combination therapy, What is A breakthrough therapy, What is breakthrough therapy

Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, announced that the US Food and...

3 Aug 2018

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

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TagsBayer, Eylea, Regeneron

Bayer has received European Commission approval of a new treatment approach for Eylea to enable clinicians to combine proactive treatment...

3 Aug 2018

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

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

LEO Pharma has entered into a definitive agreement to buy Bayer’s global prescription dermatology unit. The portfolio to be acquired...

31 Jul 2018

Wockhardt sets up $40-million antibiotic manufacturing plant in Jafza, Dubai

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TagsWockhardt

Wockhardt, an India-based pharmaceutical company, launched a new facility at Dubai’s Jebel Ali Free Zone (Jafza) on Sunday, marking its...

31 Jul 2018

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

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

FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new...

31 Jul 2018

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

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

Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use...

31 Jul 2018

Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate

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TagsDaiichi, Daiichi Sankyo, gatipotuzumab

Daiichi Sankyo Company, Limited and Glycotope GmbH have entered into an exclusive worldwide licensing agreement to develop an antibody drug...

31 Jul 2018

Hyrimoz Sandoz’s biosimilar got European marketing approval

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

Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted...

30 Jul 2018

Is COPP and FSC is same?

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Tagscertificate of pharmaceutical product, copp, free sale certificate, fsc

COPP stands for certificate of pharmaceutical products and FSC stands for free sale certificate. Certificate of a Pharmaceutical Product (COPP)...

30 Jul 2018

Nabriva acurie Zavante to stregthen antibiotic pipeline

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Tagsacquisition in pharma, fosfomycin, Nabriva

Nabriva Therapeutics has acquired Zavante Therapeutics. Under the deal terms announced after the market close Tuesday, San Diego-based Zavante received...

Recently Published Articles

Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix

Eyevance Pharmaceuticals Acquires Worldwide Rights to NEXAGON®

Case Study: USFDA The Limited Population Pathway and approval of Arikayce

Dr. Reddy’s sells Cloderm cream to EPI Health

DRL to disinvest antibiotics plant to Abu Dhabi-based Neopharma

Case Study: Product Recall due to labeling error

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

US FDA grants breakthrough therapy status for Lenvima in combo with Keytruda

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

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

Wockhardt sets up $40-million antibiotic manufacturing plant in Jafza, Dubai

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

Is COPP and FSC is same?

Nabriva acurie Zavante to stregthen antibiotic pipeline

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