NCK Pharma » Knowledge Base

28 Nov 2020

Case Study: Clinical basis of MHLW approval of Astellas’s Evrenzo to treat anemia of CKD in adult patients not on dialysis

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Astellas Pharma Inc. and FibroGen, Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo (roxadustat) for...

28 Nov 2020

Covid 19 Vaccine development and commercialization status | More than 50 vaccine candidate under development

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More than 50 covid-19 vaccine candidate is currently under development. Here you can have the close look into the development...

28 Nov 2020

PostEra codevelopment deal with NeuroLucent for Alzheimer’s disease

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Tagscodevelopment deal in pharma, Drug development, drug development project

Biotechnology company PostEra announced a collaboration with NeuroLucent, a Chicago-based company focused on developing novel treatments for Alzheimer’s disease and...

28 Nov 2020

AbbVie, Eisai received new indication approval for Humira to treat pyoderma gangrenosum

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Tags2015 sales of Humira, humira, pyoderma gangrenosum

AbbVie GK and Eisai Co, Ltd announced an approval of additional indication of Humira, a fully human anti-TNFa monoclonal antibody,...

20 Nov 2020

Pfizer submitted application for emergency use of Covid vaccine

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TagsCovid vaccine, COVID-19, vaccine

US drugmaker Pfizer Inc, which has developed a vaccine against coronavirus, is now seeking the emergency use tag from the...

20 Nov 2020

Take Self Competency Test in Esxport Documentation

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Tagsmcqs in pharma export documentation

You can take a short and quick competency test on pharmaceutical export.

20 Nov 2020

Insight on VFMCRP, Fresenius Kabi distribution agreement for Veltassa to treat hyperkalemia in China

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TagsChronic Kidney Disease, CKD, Fresenius Kabi, Hyperkalemia, Veltassa, VFMCRP, Vifor Pharma

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Fresenius Kabi announced an agreement to develop, register and distribute Veltassa for...

20 Nov 2020

US FDA grants priority review status to Sanofi’s BLA for avalglucosidase alfa to treat Pompe disease

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Tagsavalglucosidase alfa, Biological License Application, biological products, priority review, Priority Review Designation, USFDA Priority Review

The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for avalglucosidase alfa...

30 Oct 2020

Case Study on Gliead’s Blockbuster Veklury – Sales and Strategic Planning

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Tagsgilead, Gilead Sciences, pharma strategic deal, Remdesivir, Strategic deal in pharma, strategic management in pharma, Veklury

FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients 12 years...

30 Oct 2020

Sanofi and Merck to conduct phase 2 trial of THOR-707 in combo with Keytruda

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TagsKEYTRUDA, MSD, Phase 2 trial, Sanofi

Sanofi has entered into an agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US...

30 Oct 2020

MHRA UK inititated rolling review process of Moderna’s mRNA Covid-19 vaccine

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TagsCOVID-19, EU drug regulatory affairs, Moderna Therapeutics, nCoV-19 vaccine, vaccine

Moderna, a biotechnology company, announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has started...

28 Oct 2020

Understanding on India’s Revised Patent Rules On Priority filing w.e.f 19 October, 2020

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Tagspatent, Patent Act

The Indian Patent office has issued a notification that the Patents (Amendment) Rules, 2020, was released and enforced on 19...

28 Oct 2020

Insight of BioInvent’s licensing deal of anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals

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Tagsglobal pharma licensing deal, licensing deal in pharma

BioInvent licenses anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals for Greater China region. BioInvent have entered into an exclusive licensing agreement...

24 Oct 2020

Pfizer’s Hospital Business acquires Arixa Pharma

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Tagsacquisition in pharma, Arixa Pharma, pfizer, Strategic deal in pharma

Arixa Pharmaceuticals, a company developing next-generation oral antibiotics for drug-resistant Gram-negative infections announced that Pfizer’s Hospital Business has agreed to...

24 Oct 2020

Insight on Veklury’s clinical and strategic pathway for USFDA approval for Covid-19

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TagsCOVID-19, priority review, Priority Review Designation, Remdesivir, usfda, usfda accelerated approval, USFDA Priority Review, Veklury

USFDA approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and...

22 Oct 2020

Case Study: Rinvoq’s brand Dermatology market expansion strategy

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TagsAbbVie, JAK inhibitor, RINVOQ

Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Rinvoq is the...

30 Sep 2020

Sobrera, Recipharm Collaborate to Advance Alcohol Use Disorder Treatment

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Tagscodevelopment deal in pharma, Recipharm, Sobrera

Sobrera Pharma, and Recipharm have entered into an agreement for the formulation development and manufacturing of SO-001, a new oral...

30 Sep 2020

Centaur Pharma launches WOXheal to treat diabetic foot ulcers

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TagsCentaur, diabetic foot ulcers, WOXheal

Centaur Pharmaceuticals announced the launch of a new chemical entity (NCE) – WOXheal for the treatment of diabetic foot ulcers,...

30 Sep 2020

FSD Pharma gets US FDA nod to begin phase 2 study of FSD201 to treat COVID-19

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TagsCOVID-19, Phase 2b trial

FSD Pharma announced that the US Food and Drug Administration (FDA) has authorized the initiation of a phase 2 study...

30 Sep 2020

AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations

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TagsAbbVie, Elezanumab, Fast Track designation, MAB, monoclonal antibody, orphan drug

AbbVie announced that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab...

30 Sep 2020

USFDA granted expanded access to investigational ERK inhibitor ulixertinib

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TagsExpanded access, expanded access compassionate use, expanded access ebola, expanded access mechanism, expanded access program vs compassionate use

The US Food and Drug Administration has granted expanded access to BioMed Valley Discoveries’ investigational ERK inhibitor ulixertinib for patients...

15 Sep 2020

Case Study – Strategic Insight on Gilead and Immunomedics $21 Billion Deal

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Gilead Sciences Inc. agreed to acquire Immunomedics Inc. for about $21 billion, a substantial premium for the maker of a...

15 Sep 2020

Insight on USFDA approval of pralsetinib to treat non-small lung cancer

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TagsBlueprint Medicines Corporation, pralsetinib

Blueprint Medicines Corporation, a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that...

15 Sep 2020

What is hybrid clinical trial?

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A hybrid trial is a type of clinical trial which includes both traditional and pragmatic clinical trial elements. Randomized controlled trials...

15 Sep 2020

Strides Pharma to acquire 54% stake in SteriScience

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Tagsacquisition in pharma, Strides Arcolab, strides aspen, Strides Shasun

Strides Pharma Science will invest Rs 135 crore over the next 24 months to acquire around 54 percent stake in...

15 Sep 2020

Aurobindo Pharma partners with BIRAC to develop Covid-19 vaccine

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TagsAurobindo, covi9 19 vaccine, COVID-19

Aurobindo Pharma is developing a vaccine for COVID-19 through its wholly-owned US subsidiary, Auro Vaccines. The vaccine candidate is based...

11 Aug 2020

Insight on First approved COVID-19 vaccine Sputnik V

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TagsCOVID-19, Gamaleya National Research Centre, nCoV-19 vaccine, Sputnik V

Russia has announced the launch of first approved covid-19 vaccine. The Covid-19 vaccine brand name is Sputnik V. Sputnik V...

7 Aug 2020

Novavax and Serum Institute of India – licensing agreement for Development and Commercial Collaboration

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TagsCOVID-19, nCoV-19 vaccine, Novavax, serum institute

Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a license agreement with Serum...

7 Aug 2020

Novavax reports positive results from phase 1 trial of COVID-19 vaccine candidate, NVX-CoV2373 with Matrix-M

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TagsCOVID-19, nCoV-19 vaccine

Novavax, a late-stage biotechnology company, announced phase 1 data from its phase 1/2 randomized, observer-blinded, placebo-controlled trial of its COVID-19...

7 Aug 2020

Lupin gets exclusive rights to market and distribute 2 complex injectable assets from ForDoz Pharma

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TagsForDoz Pharma, inlicensing in pharma, Lupin

Pharma major Lupin Limited announced that its US based wholly-owned subsidiary Lupin Pharmaceuticals Inc., has entered into an agreement with...

Recently Published Articles

Case Study: Clinical basis of MHLW approval of Astellas’s Evrenzo to treat anemia of CKD in adult patients not on dialysis

Covid 19 Vaccine development and commercialization status | More than 50 vaccine candidate under development

PostEra codevelopment deal with NeuroLucent for Alzheimer’s disease

AbbVie, Eisai received new indication approval for Humira to treat pyoderma gangrenosum

Pfizer submitted application for emergency use of Covid vaccine

Take Self Competency Test in Esxport Documentation

Insight on VFMCRP, Fresenius Kabi distribution agreement for Veltassa to treat hyperkalemia in China

US FDA grants priority review status to Sanofi’s BLA for avalglucosidase alfa to treat Pompe disease

Case Study on Gliead’s Blockbuster Veklury – Sales and Strategic Planning

Sanofi and Merck to conduct phase 2 trial of THOR-707 in combo with Keytruda

MHRA UK inititated rolling review process of Moderna’s mRNA Covid-19 vaccine

Understanding on India’s Revised Patent Rules On Priority filing w.e.f 19 October, 2020

Insight of BioInvent’s licensing deal of anti-FcγRllB antibody BI-1206 to CASI Pharmaceuticals

Pfizer’s Hospital Business acquires Arixa Pharma

Insight on Veklury’s clinical and strategic pathway for USFDA approval for Covid-19

Case Study: Rinvoq’s brand Dermatology market expansion strategy

Sobrera, Recipharm Collaborate to Advance Alcohol Use Disorder Treatment

Centaur Pharma launches WOXheal to treat diabetic foot ulcers

FSD Pharma gets US FDA nod to begin phase 2 study of FSD201 to treat COVID-19

AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations

USFDA granted expanded access to investigational ERK inhibitor ulixertinib

Case Study – Strategic Insight on Gilead and Immunomedics $21 Billion Deal

Insight on USFDA approval of pralsetinib to treat non-small lung cancer

What is hybrid clinical trial?

Strides Pharma to acquire 54% stake in SteriScience

Aurobindo Pharma partners with BIRAC to develop Covid-19 vaccine

Insight on First approved COVID-19 vaccine Sputnik V

Novavax and Serum Institute of India – licensing agreement for Development and Commercial Collaboration

Novavax reports positive results from phase 1 trial of COVID-19 vaccine candidate, NVX-CoV2373 with Matrix-M

Lupin gets exclusive rights to market and distribute 2 complex injectable assets from ForDoz Pharma

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