NCK Pharma » Knowledge Base

6 Apr 2020

Case Study: Compassionate use of remdesivir of Gilead for COVID-19

Posted Byadmin

Comments0

During an extraordinary virtual meeting held on April 2, 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the...

3 Apr 2020

Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China

Posted Byadmin

Comments0

TagsJapan drug regulatory affairs

Eisai Co Ltd and Seikagaku Corporation, an R&D-oriented pharmaceutical company, announced that the companies have entered into an agreement for...

3 Apr 2020

Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.

Posted Byadmin

Comments0

TagsDPCO, medical device company, NPPA, price regulation in india, Price regulation of medical devices

The central government on Tuesday notified all medical devices sold in the country will be treated as drugs under the...

29 Mar 2020

Evox partnership with Takeda Pharmaceutical for rare disease

Posted Byadmin

Comments0

Tagsorphan drug, orphan drug design, rare disease, Takeda

Evox Therapeutics Ltd, a leading exosome therapeutics company, announced the signing of a rare disease-focused partnership with Takeda Pharmaceutical Company...

27 Mar 2020

What are the difference between FDA 483 and Warning Letter?

Posted Byadmin

Comments0

Tags483, 483 observations, fda 483 observation, usfda 483 form, USFDA warning letter, warning

483 observation or FDA 483 and warning letter seems to be same, nut there is difference between the FDA form...

26 Mar 2020

New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19

Posted Byadmin

Comments0

Tagscase study of new drug approval, new drug approval, Ozanimod

U.S. Food and Drug Administration (FDA) has approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms...

26 Mar 2020

AstraZeneca and Silence Therapeutics co-development siRNA therapeutics

Posted Byadmin

Comments0

TagsAstraZeneca, codevelopment deal in pharma, global pharma deals

AstraZeneca will collaborate with Silence Therapeutics to discover, develop and commercialise small interfering RNA (siRNA) therapeutics for the treatment of...

21 Mar 2020

US FDA halts the regular plant inspection due to Covid-19 spread

Posted Byadmin

Comments0

TagsUSFDA inspection

The US FDA announced that it will no longer be able to inspect domestic production facilities in wake of risk...

21 Mar 2020

Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older

Posted Byadmin

Comments0

TagsEpclusa, gilead, Gilead Sciences, Gilead's Sofosbuvir, Meaning of supplemental new drug application (snda), What is supplemental new drug application (snda)?

US FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for...

21 Mar 2020

A case based understanding in co-development deal

Posted Byadmin

Comments0

Tagsco-development deal, drug licensing, inlicensing in pharma, outlicensing in pharma, Pfizer and Merck KGaA to co-develop and co-commercialize avelumab

In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well,...

21 Mar 2020

ProBiotix Health has signed a distribution licensing agreement with Velinoff Pharma in Bulgaria

Posted Byadmin

Comments0

TagsProbiotics, Why Probiotics are combined with Prebiotics?

UK-based life sciences business OptiBiotix Health said that its unit ProBiotix Health has signed a licensing agreement with Bulgarian pharmaceutical...

20 Mar 2020

RIBOMIC – AJU Pharma licensing deal for RBM-007 in age-related macular degeneration

Posted Byadmin

Comments0

Tagsdrug licensing, global pharma licensing deal, outlicensing in pharma

RBOMIC has finalized the license agreement with AJU PHARM CO., LTD., Korean pharmaceutical company. This deal is for RBM-007 licensing...

19 Mar 2020

Regeneron, Sanofi initiates clinical trial in Kevzara to treat COVID-19

Posted Byadmin

Comments0

Tagsclinical trial, COVID-19, Kevzara, monoclonal antibody, Regeneron, Sanofi, sarilumab, US FDA accepts Sanofi and Regeneron's sarilumab BLA for review

Regeneron Pharmaceuticals and Sanofi have started a clinical programme evaluating Kevzara (sarilumab) in patients hospitalized with severe coronavirus (COVID-19) infection....

19 Mar 2020

Cipla launches GLYCOHALE respule

Posted Byadmin

Comments0

TagsCipla, Respiratory

Cipla has annouced the introduction of Glycohale Respules. This helps Cipla to strengthen the Respiratory portfolio. Glycopyrrolate inhalation is indicated...

17 Mar 2020

What is USFDA Emergency Use Authorization (EUA)?

Posted Byadmin

Comments0

TagsCOVID-19, USFDA emergency use authorization

Under Emergency use authorization USFDA allows unapproved medical products (e.g. pharmaceutical, biopharmaceutical, diagostic tests, medical devices etc.) to use in...

17 Mar 2020

USFDA granted emergency use authorization to Thermo Fisher’s diagnostic test to detect COVID-19

Posted Byadmin

Comments0

TagsCOVID-19, USFDA emergency use authorization

Thermo Fisher Scientific, the world leader in serving science, announced that the US Food and Drug Administration (FDA) has issued...

9 Mar 2020

USFDA shooting up warning letters to marketers for Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Posted Byadmin

Comments0

Tags483, 483 OBSERVATION, fda 483 observation, USFDA warning letter

Center for Drug Evaluation and Research (CDER), of United States Food and Drug Administration have busy time in monitoring illogical...

6 Mar 2020

Sun Pharma launched “Take on acne” campaign

Posted Byadmin

Comments0

TagsDisease awareness campaign, PATIENT AWARENESS CAMPAIGN, Sanofi Pasteure's Patient Awareness Initiative for influenza

Sun Dermatology, a division of Sun Pharmaceutical Industries, Inc., USA, which is a wholly owned subsidiary of Sun Pharmaceutical Industries...

5 Mar 2020

AstraZeneca disinvest hypertension medicines to Atnahs Pharma

Posted Byadmin

Comments0

TagsAstraZenca, AstraZeneca, disinvestment in pharma business

AstraZeneca divest its global commercial rights of Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic...

28 Feb 2020

Case Study: AstraZeneca to sublicense its global rights to Movantik

Posted Byadmin

Comments0

Tagsdisinvestment in pharma business, Pharma Business Development

AstraZeneca has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill)....

28 Feb 2020

Beximco and Mylan’s licensing deal for biosimilar in Bangladesh

Posted Byadmin

Comments0

TagsBeximco Pharmaceuticals, licensing deal in pharma, Mylan, mylan licensing deal, Ogivri, trastuzumab

Under the terms of the agreement, Beximco Pharma will receive the exclusive rights to launch Mylan’s portfolio of key monoclonal...

Hikma and Glenmark's licensing deal for Ryaltris

28 Feb 2020

Insight on Hikma and Glenmark’s Exclusive Licensing Agreement for Commercialising Ryaltris Nasal Spray in the US

Posted Byadmin

Comments0

Tagsdrug licensing, Glemark outlicensing, Glenmark, global pharma licensing deal, Hikma, inlicensing in pharma, Ryaltris

Hikma Pharmaceuticals PLC and Glenmark Specialty S.A., a Swiss subsidiary of Glenmark Pharmaceuticals, a global innovative pharmaceutical company signed of...

25 Feb 2020

Stada acquired 15 OTC brands of GSK

Posted Byadmin

Comments0

Tagsconsumer healthcare, Glaxo, GSK, OTC drugs, otc market, Stada

Stada Arzneimittel AG has acquired 15 consumer healthcare products, including those specializing in vitamins, cold treatments, and sore throat medication,...

18 Feb 2020

Case Study : Rx-to-OTC switch of Voltaren arthritis pain

Posted Byadmin

Comments0

TagsBenadryl rx to otc switch, Example of rx to otc switch

In this article we will be understanding about the Rx-to-OTC switch of Voltaren arthritis pain. It is one of the...

9 Feb 2020

Analysis of Business Deal: Collegium Pharma acquired of U.S. Rights to Nucynta Franchise for $375M

Posted Byadmin

Comments0

TagsCollegium Pharma, Pharma Business Development

Collegium Pharmaceutical, a specialty pharmaceutical company, has entered into a definitive agreement to acquire the U.S. rights to the Nucynta...

9 Feb 2020

Cipla to acquire four women’s health brands from Wanbury

Posted Byadmin

Comments0

Tagsbrand acquisition, Cipla

Cipla has acquired four brands, namely CPink, CDense, Productiv and Folinine, to further strengthen its presence in women’s health portfolio....

9 Feb 2020

Insight on Curis, Aurigene collaboration for development and commercialization of CA-170

Posted Byadmin

Comments0

TagsAurigene, Curis

Curis, a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, announced that it has...

9 Feb 2020

Nestlé, Valbiotis partners to develop & commercialize plant-derived active substance, TOTUM-63 to reduce risk of developing type 2 diabetes

Posted Byadmin

Comments0

Tagsbiopharma business development, Nestlé, pharma strategic deal, Valbiotis

Nestlé Health Science and Valbiotis, a research and development company committed to scientific innovation for preventing and combating metabolic diseases,...

9 Feb 2020

Strides to acquire 18 ANDAs from Pharmaceutics International

Posted Byadmin

Comments0

TagsStrides Arcolab, Strides Shasun

Strides Pharma Science Ltd’s subsidiary Strides Pharma Global Pte. Limited has entered into a definitive asset transfer and licensing agreement...

9 Feb 2020

CODA Biotherapeutics acquired 3 clinical stage assets from Attenua

Posted Byadmin

Comments0

Tagsbiopharma business development, CODA Biotherapeutics, Pharma Business Development, pharma strategic deal, Strategic deal in pharma

CODA Biotherapeutics, a preclinical-stage biopharmaceutical company developing a gene therapy-mediated chemogenetic platform, announced it has completed the acquisition of Attenua,...

Recently Published Articles

Case Study: Compassionate use of remdesivir of Gilead for COVID-19

Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China

Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.

Evox partnership with Takeda Pharmaceutical for rare disease

What are the difference between FDA 483 and Warning Letter?

New Drug Approval Case Study: USFDA approval of Zeposia, delayed market launch likely due to COVID-19

AstraZeneca and Silence Therapeutics co-development siRNA therapeutics

US FDA halts the regular plant inspection due to Covid-19 spread

Gilead’s Epclusa receives US FDA approval to treat chronic hepatitis C infection for children ages 6 & older

A case based understanding in co-development deal

ProBiotix Health has signed a distribution licensing agreement with Velinoff Pharma in Bulgaria

RIBOMIC – AJU Pharma licensing deal for RBM-007 in age-related macular degeneration

Regeneron, Sanofi initiates clinical trial in Kevzara to treat COVID-19

Cipla launches GLYCOHALE respule

What is USFDA Emergency Use Authorization (EUA)?

USFDA granted emergency use authorization to Thermo Fisher’s diagnostic test to detect COVID-19

USFDA shooting up warning letters to marketers for Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

Sun Pharma launched “Take on acne” campaign

AstraZeneca disinvest hypertension medicines to Atnahs Pharma

Case Study: AstraZeneca to sublicense its global rights to Movantik

Beximco and Mylan’s licensing deal for biosimilar in Bangladesh

Insight on Hikma and Glenmark’s Exclusive Licensing Agreement for Commercialising Ryaltris Nasal Spray in the US

Stada acquired 15 OTC brands of GSK

Case Study : Rx-to-OTC switch of Voltaren arthritis pain

Analysis of Business Deal: Collegium Pharma acquired of U.S. Rights to Nucynta Franchise for $375M

Cipla to acquire four women’s health brands from Wanbury

Insight on Curis, Aurigene collaboration for development and commercialization of CA-170

Nestlé, Valbiotis partners to develop & commercialize plant-derived active substance, TOTUM-63 to reduce risk of developing type 2 diabetes

Strides to acquire 18 ANDAs from Pharmaceutics International

CODA Biotherapeutics acquired 3 clinical stage assets from Attenua

Certification Courses

Corporate Training

Your form has been submitted

Server Side Error

Error