NCK Pharma » Knowledge Base

17 Apr 2019

Drug Department asking for documents to be notarizerd. What does it means? How documents should be notarized?

Posted Byadmin

Comments0

TagsCDSCO, CDSCO audit, drug dossier, what is export documentation

Notary means a person authorized to perform certain legal formalities, especially to draw up or certify contracts, deeds, and other...

17 Apr 2019

Amedment in Schedule-V of D&C Rules: Revise ‘free salicylic acid’ content in drugs containing aspirin [CDSCO]

Posted Byadmin

Comments0

The Union health ministry will soon amend Schedule-V of the Drugs and Cosmetics (D&C) Rules, 1945 to revise the limit...

17 Apr 2019

Plenity, weight management drug, received USFDA approval

Posted Byadmin

Comments0

TagsPlenity, Usfda approval of new drugs

Gelesis, a biotechnology company developing first-in-class hydrogel therapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI)...

17 Apr 2019

Roche to launch emicizumab (Hemlibra) in India for people with haemophilia A on World Haemophilia Day

Posted Byadmin

Comments0

Tagsemicizumab, Hemlibra, MAB, monoclonal antibody, Roche

Roche announced that emicizumab (Hemlibra) has been approved in India for haemophilia A with factor VIII inhibitors. It is indicated...

4 Apr 2019

Emcure launched first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) in India

Posted Byadmin

Comments0

TagsEisai, Emcure, Eribilin, Halaven

Emcure Pharmaceuticals announced the launch of first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast...

3 Apr 2019

DRL sells brand Sernivo; grants Promiseb and Trianex US marketing rights to Encore Dermatology

Posted Byadmin

Comments0

TagsDr. Reddy’s Laboratories, DRL, Encore Dermatology, Promius, Sernivo

Dr. Reddy’s Laboratories Limited through its wholly owned subsidiary Promius Pharma, LLC, announces the sale of its rights for Sernivo...

3 Apr 2019

Novartis’ Cosentyx received CFDA (Chainese) approval to treat adults with plaque psoriasis

Posted Byadmin

Comments0

TagsCFDA, cosentyx, Cosentyx for plaque psoriasis, novartis, Novartis got approval for Cosentyx

Novartis, a global leader in immuno-dermatology and rheumatology, announced that the China Health Authority NMPA approved Cosentyx (secukinumab), the first-in-class...

1 Apr 2019

Why user documents asked while submitting trademark for registration?

Posted Byadmin

Comments0

Suppose you want to file a pharmaceutical trademark, department may ask for the user documents. User documents are proof that...

1 Apr 2019

How forced degradation can be achieved?

Posted Byadmin

Comments0

Degradation can be achieved by exposing the drug, for extended period of time, to extremes of pH (HCl or NaOH...

1 Apr 2019

What is ANOVA method?

Posted Byadmin

Comments0

Tagsstability study

ANOVA – Analysis of Variance Statistical method Analysis of variance (ANOVA) is a statistical technique that is used to check if...

1 Apr 2019

What is a Stability-indicating assay method?

Posted Byadmin

Comments0

Tagsanalytical method, Forced degradation, stability study, Stability-indicating assay method, stress testing

A Stability-indicating assay method can be defined as “Validated quantitative analytical method that can detect the change with time in...

1 Apr 2019

CDSCO rejects Cipla’s application for marketing US-based MannKind Corporation’s inhaled insulin, branded Afrezza; Local climical trial is compulsory

Posted Byadmin

Comments0

TagsAfrezza, CDSCO, Exubera, MannKind

An expert panel of the Central Drugs Standard Control Organisation (CDSCO) has insisted that a local clinical trial should be...

28 Mar 2019

Check Your Competency in Data Integrity

Posted Byadmin

Comments0

Tagsdata integrity, data integrity in pharma, Data integrity issues, What is the meaning of Data Integrity issue in pharmaceutical industry?

Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle. Over the last few years...

28 Mar 2019

Novartis’s Multiple Sclerosis Drug Mayzent received USFDA approval

Posted Byadmin

Comments0

TagsGilenya, Mayzent, novartis, siponimod

Swiss pharma giant Novartis snagged regulatory approval in the United States for its new multiple sclerosis treatment Mayzent (siponimod) and...

28 Mar 2019

European Medicines Agency recommends marketing authorization approval of Bayer’s Baycox Iron injection for piglets

Posted Byadmin

Comments0

TagsEMA, summary of product characteristics

The Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency has, by consensus, adopted a positive...

28 Mar 2019

EU regulation and directive – key differentiation

Posted Byadmin

Comments0

Regulations have binding legal force throughout every Member State and enter into force on a set date in all the...

28 Mar 2019

DCGI making it mandatory to include warning in the package insert and promotional literature SGLT2 inhibitor drugs

Posted Byadmin

Comments0

TagsCDSCO, SGLT2 inhibitors

SGLT2 inhibitors SGLT2 inhibitors, medicines that lower blood sugar by causing kidneys to remove sugar from the body through urine,...

28 Mar 2019

Lilly, ImmuNext licensing deal for R&D collaboration

Posted Byadmin

Comments0

TagsImmuNext, Lilly

Eli Lilly and Company and ImmuNext, Inc. announced a global licensing and research collaboration focused on the study of a...

25 Mar 2019

2018’s Top 6 pharma global brands in sales

Posted Byadmin

Comments0

TagsAvastin, herceptin, humira, KEYTRUDA, Mabthera, Opdivo, Rituxan

Top brands sales globally FY 2018 in US Million dollar SL Brand Company 2018 1 Humira AbbVie 19,936 2 Keytruda...

21 Mar 2019

Insignht on USFDA approval of Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women

Posted Byadmin

Comments0

Tagsbrexanolone, REMS, Zulresso

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum...

14 Mar 2019

Johnson & Johnson’s Spravato (esketamine) For Treatment-Resistant Depression

Posted Byadmin

Comments0

Tagsesketamine, REMS, Spravato

The U.S. Food & Drug Administration Tuesday approved Johnson & Johnson’s ketamine-derived nasal spray Spravato for treatment-resistant depression. The approval...

11 Mar 2019

GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry

Posted Byadmin

Comments0

TagsAdvair, Advair diskus, Wixela Inhub

Mylan has launched its generic version of GlaxoSmithKline’s respiratory blockbuster, Advair, at a 70% discount compared with the GlaxoSmithKline’s respiratory...

11 Mar 2019

Takeda subsidiary Millennium Pharmaceuticals Inc, sues Aurobindo to block generic Velcade

Posted Byadmin

Comments0

TagsANDA, Auribindo, Takeda

A U.S. unit of Japan’s Takeda Pharmaceutical Co has sued generic drugmaker Aurobindo Pharma Ltd over its plans to make...

11 Mar 2019

US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL

Posted Byadmin

Comments0

TagsAbbVie, sNDA, sNDA USFDA

AbbVie announced that the US Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for...

11 Mar 2019

In India, insight on the ban of OTC sale of skin medications containing hydroquinone from April 1

Posted Byadmin

Comments0

TagsCDSCO

Come April and pharmacies in the country have to stop selling topical medications containing hydroquinone, a bleaching agent for reducing...

11 Mar 2019

In India, Prices of 390 cancer drugs slashed by upto 87%

Posted Byadmin

Comments0

TagsCDSCO, DPCO, NPPA, price control guidelines of 108 formulations

The maximum retail price of 390 non-scheduled cancer medicines have been reduced by up to 87 per cent, which would...

2 Mar 2019

Roche receives US FDA approval for Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Posted Byadmin

Comments0

Tagsherceptin, Herceptin Hylecta, Roche, trastuzumab

Roche announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under...

2 Mar 2019

Ascent Meditech launches www.flamingohealth.com, e-commerce platform

Posted Byadmin

Comments0

TagsAscent Meditech

Ascent Meditech Limited, a leading player in orthopaedic soft goods, mobility, wound-care and healthcare products, has launched its e-commerce platform...

26 Feb 2019

Roche to acquire U.S.-Based Gene Therapy Specialist Spark @ $4.8 Billion

Posted Byadmin

Comments0

Tagsacquisition in pharma, Roche

Swiss drugmaker Roche agreed to buy Philadelphia-based Spark Therapeutics for $4.8 billion. Spark works to create gene therapies for genetic...

26 Feb 2019

Novartis licenses lipoprotein-lowering CVD drug AKCEA-APO(a)-LRx

Posted Byadmin

Comments0

TagsAkcea, AKCEA-APO(a)-LR, drug licensing, Ionis Pharmaceuticals, novartis, outlicensing in pharma

Excited by strong phase II data, Novartis is exercising its option to license Akcea Therapeutics’ AKCEA-APO(a)-LRx, a treatment to reduce...

Recently Published Articles

Drug Department asking for documents to be notarizerd. What does it means? How documents should be notarized?

Amedment in Schedule-V of D&C Rules: Revise ‘free salicylic acid’ content in drugs containing aspirin [CDSCO]

Plenity, weight management drug, received USFDA approval

Roche to launch emicizumab (Hemlibra) in India for people with haemophilia A on World Haemophilia Day

Emcure launched first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) in India

DRL sells brand Sernivo; grants Promiseb and Trianex US marketing rights to Encore Dermatology

Novartis’ Cosentyx received CFDA (Chainese) approval to treat adults with plaque psoriasis

Why user documents asked while submitting trademark for registration?

How forced degradation can be achieved?

What is ANOVA method?

What is a Stability-indicating assay method?

CDSCO rejects Cipla’s application for marketing US-based MannKind Corporation’s inhaled insulin, branded Afrezza; Local climical trial is compulsory

Check Your Competency in Data Integrity

Novartis’s Multiple Sclerosis Drug Mayzent received USFDA approval

European Medicines Agency recommends marketing authorization approval of Bayer’s Baycox Iron injection for piglets

EU regulation and directive – key differentiation

DCGI making it mandatory to include warning in the package insert and promotional literature SGLT2 inhibitor drugs

Lilly, ImmuNext licensing deal for R&D collaboration

2018’s Top 6 pharma global brands in sales

Insignht on USFDA approval of Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women

Johnson & Johnson’s Spravato (esketamine) For Treatment-Resistant Depression

GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry

Takeda subsidiary Millennium Pharmaceuticals Inc, sues Aurobindo to block generic Velcade

US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL

In India, insight on the ban of OTC sale of skin medications containing hydroquinone from April 1

In India, Prices of 390 cancer drugs slashed by upto 87%

Roche receives US FDA approval for Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Ascent Meditech launches www.flamingohealth.com, e-commerce platform

Roche to acquire U.S.-Based Gene Therapy Specialist Spark @ $4.8 Billion

Novartis licenses lipoprotein-lowering CVD drug AKCEA-APO(a)-LRx

Your form has been submitted

Server Side Error

Error