NCK Pharma » Knowledge Base

19 Nov 2019

What is USFDA Purple Book? What it’s significance?

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Tags351(a) pathway, 351k, Biosimilar, difference between 351(a) vs. 351(k) pathway, Orange book

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health...

19 Nov 2019

USFDA approved Pfizer’s Abrilada, a biosimilar of Humira

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TagsAbrilada, Adalimumab, humira, Humira Patent Expiry and Biosimilar entry, Hyrimoz, pfizer

The U.S. Food and Drug Administration (FDA) approved Pfizer’s Abrilada, a biosimilar of Humira. Pfizer said the FDA approved Abrilada (adalimumab-afzb) for the...

17 Nov 2019

Pfizer’s Upjohn and Mylan merged business entity will be namea as Viatris

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Tagsglobal pharma deals, Mylan, pfizer, pharma deal, Viatris

The name of the new company to be formed by the merger of Mylan and Upjohn, a division of Pfizer,...

17 Nov 2019

Bayer and Dewpoint Therapeutics co-development deal for cardiovascular and gynecological diseases

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TagsBayer, Dewpoint

Bayer and Dewpoint Therapeutics, a biotechnology company with sites in Boston and Dresden, Germany, today announced an option, research and...

17 Nov 2019

Sandoz to Acquire Japanese Biz of AGI

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Sandoz has entered into an agreement to acquire the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary...

17 Nov 2019

Selumetinib NDA Submission for Neurofibromatosis Type 1 (NF1) granted Priority Review

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TagsAstraZeneca, Merck, MSD, selumetinib

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and...

17 Nov 2019

Insignt on Roche’s Up-to-$1.4Billion Promedior Acquisition

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Roche has agreed to acquire Promedior for up to $1.4 billion. Roche’s deal will give it full rights to Promedior’s...

1 Nov 2019

Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity

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Tags505(b)(2) applications, 505(b)(2) NDA & 505(b)(1) NDA?, Alkermes, Biogen, Vumerity, What is the difference between 505(j) application 505(b)(2) NDA 505(b)(1) NDA?

Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity...

1 Nov 2019

US FDA places partial hold on Novartis’ AVXS-101 intrathecal study

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Tagsclinical hold decision

USFDA placed a partial hold on clinical trials for intrathecal administration of AVXS-101. The announcement follows an AveXis communication to...

29 Oct 2019

Zentiva to acquire CEE pharma business of Alvogen

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TagsAlvogen, CEE Market, Zentiva

Czech drugmaker Zentiva has announced it will buy the Central and Eastern European business of Alvogen, for an undisclosed amount....

29 Oct 2019

Insighht on USFDA approval of Trikafta

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TagsBreakthrough Therapy designation, Breakthrough Therapy designations, Fast Track designation, FDA grants breakthrough therapy designation, priority review, Priority Review Designation, Trikafta, USFDA Priority Review

Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta...

25 Oct 2019

How much is the average ideal royalty rate in pharmaceutical and biopharmaceutical business deal?

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Click here to view the Royalty Chart >> View now

25 Oct 2019

Pharma Licensing: Explore differences between Royalty rate & Royalty base

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Royalty rate : The appropriate royalty rate depends on numerous factors including the relative bargaining strength of the licensor and...

25 Oct 2019

Takeda Divesting Select OTC and Non-core Assets of takeda to Acino

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Tagsdisinvestment in pharma business, divestiment in pharma, Divestment in pharma, Takeda, Takeda acquires shire

Takeda Pharmaceutical Company Limited announced that it has entered into an agreement to divest a portfolio of select over-the-counter (OTC)...

22 Oct 2019

GSK to disinvest Rabipur and Encepur – vaccine for USD 1.1 billion

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TagsGlaxo, GSK, pharma strategic deal, Strategic deal in pharma, vaccine

GlaxoSmithKline (GSK) will sell two travel vaccines to Bavarian Nordic for up to 955 million euros ($1.1 billion), the British...

21 Oct 2019

S. Korea’s Mediforum acquires local pharma firms C-TRI, i-World Pharm

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Tagsglobal pharma deals, pharma deal, pharma strategic deal

South Korean bio-pharma company Mediforum Co. has acquired two local pharmaceutical firms C-TRI and i-World, a move that is expected...

21 Oct 2019

US FDA issued warning letter to Glenmark for Baddi plant

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

The US Food and Drug Administration has issued a warning letter to Glenmark Pharmaceutical Ltd’s manufacturing plant in Baddi, Himachal Pradesh, the...

21 Oct 2019

Alexion acquisition of Achillion: A 1 Billion Pharma Strategic Deal

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TagsAchillion, acquisition in pharma, Alexion Pharmaceuticals, global pharma deals, pharma deal, pharma strategic deal

Achillion focuses on the development of oral small-molecule Factor D inhibitors to treat people with rare diseases affecting the ‘complement...

8 Oct 2019

New Drug Approval Case Study: USFDA approval of Galderma’s Aklief cream

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TagsAklief cream, Galderma

US Food and Drug Administration (FDA) approved Galderma’s Aklief (trifarotene) cream, 0.005% for the topical treatment of acne. Aklief Cream...

6 Oct 2019

Prometheus Biosciences collaboration deal with Takeda for targeted therapies for IBD

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Tagscodevelopment deal in pharma, pharma strategic deal, Prometheus Biosciences, Strategic deal in pharma, Takeda

Prometheus Biosciences, Inc, a biopharmaceutical company, has entered into a global, multi-target strategic collaboration with Takeda Pharmaceutical Company Limited (Takeda)...

3 Oct 2019

Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia

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TagsBiocon, Mylan, Semglee

Biocon Ltd and Mylan N.V. announced the launch of Semglee (insulin glargine solution for injection 100 IU/mL in a 3mL...

3 Oct 2019

USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older

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TagsMabthera, Rituxan, Rituximab

Roche announced that the US Food and Drug Administration (FDA) has approved Rituxan (rituximab), in combination with glucocorticoids, for the...

3 Oct 2019

AstraZeneca divests Losec (omeprazole) and associated brands rights to Cheplapharm Arzneimittel GmbH

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TagsAcimax, Antra, AstraZeneca, Cheplapharm Arzneimittel GmbH, disinvestment in pharma business, Losec, Mepral, Mopral, Omepral, Zoltum

AstraZeneca has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and...

30 Sep 2019

What is indication splitting licensing in pharmaceutical and bio-pharmaceutical business?

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While licensing in pharmaceutical and bio pharmaceutical business, if licenses are issued to different partners based on indications or disease...

30 Sep 2019

Bactiguard entered Licensing deal for Orthorthopedic trauma implants with Zimmer Biomet

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TagsBactiguard, Zimmer Biomet

Bactiguard, a Swedish medical device company with a mission to increase patient safety and save lives, has entered into an...

27 Sep 2019

AstraZeneca to launch QTERN in India with DCGI marketing authorization approval

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TagsAstraZenca, Dapagliflozin, fixed dose, Fixed Dose Combination, QTERN, saxagliptin

AstraZeneca Pharma has received import and market permission in Form 45 (marketing authorization) for QTERN (fixed dose combination of dapagliflozin...

25 Sep 2019

FDA approved Rybelsus (semaglutide): first oral GLP-1 treatment for type 2 diabetes

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The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult...

25 Sep 2019

Bayer received EU marketing authorization for the precision oncology treatment Vitrakvi (larotrectinib)

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TagsBayer, EU marketing authorization, Vitrakvi

Bayer announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment...

25 Sep 2019

Clovis in-licensing deal for cancer program from 3B Pharmaceuticals

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Tags3B Pharmaceuticals, Clovis, global pharma licensing deal, inlicensing in pharma, licensing deal in pharma, Strategic deal in pharma

Clovis Oncology inks an agreement with privately held 3B Pharmaceuticals GmbH for global rights (ex. Europe, Russia, Turkey and Israel)...

25 Sep 2019

Biocon Ltd acquired a R&D facility from Pfizer

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Tagsacquisition in pharma, disinvestment in pharma business, pharma strategic deal

Biocon Ltd has acquired a Chennai-based research and development (R&D) facility from Pfizer Healthcare India Ltd through its subsidiary Biocon...

Recently Published Articles

What is USFDA Purple Book? What it’s significance?

USFDA approved Pfizer’s Abrilada, a biosimilar of Humira

Pfizer’s Upjohn and Mylan merged business entity will be namea as Viatris

Bayer and Dewpoint Therapeutics co-development deal for cardiovascular and gynecological diseases

Sandoz to Acquire Japanese Biz of AGI

Selumetinib NDA Submission for Neurofibromatosis Type 1 (NF1) granted Priority Review

Insignt on Roche’s Up-to-$1.4Billion Promedior Acquisition

Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity

US FDA places partial hold on Novartis’ AVXS-101 intrathecal study

Zentiva to acquire CEE pharma business of Alvogen

Insighht on USFDA approval of Trikafta

How much is the average ideal royalty rate in pharmaceutical and biopharmaceutical business deal?

Pharma Licensing: Explore differences between Royalty rate & Royalty base

Takeda Divesting Select OTC and Non-core Assets of takeda to Acino

GSK to disinvest Rabipur and Encepur – vaccine for USD 1.1 billion

S. Korea’s Mediforum acquires local pharma firms C-TRI, i-World Pharm

US FDA issued warning letter to Glenmark for Baddi plant

Alexion acquisition of Achillion: A 1 Billion Pharma Strategic Deal

New Drug Approval Case Study: USFDA approval of Galderma’s Aklief cream

Prometheus Biosciences collaboration deal with Takeda for targeted therapies for IBD

Biocon, Mylan launch first insulin glargine biosimilar, Semglee in Australia

USFDA approval of Rituxan, in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in paediatric patients 2 years of age and older

AstraZeneca divests Losec (omeprazole) and associated brands rights to Cheplapharm Arzneimittel GmbH

What is indication splitting licensing in pharmaceutical and bio-pharmaceutical business?

Bactiguard entered Licensing deal for Orthorthopedic trauma implants with Zimmer Biomet

AstraZeneca to launch QTERN in India with DCGI marketing authorization approval

FDA approved Rybelsus (semaglutide): first oral GLP-1 treatment for type 2 diabetes

Bayer received EU marketing authorization for the precision oncology treatment Vitrakvi (larotrectinib)

Clovis in-licensing deal for cancer program from 3B Pharmaceuticals

Biocon Ltd acquired a R&D facility from Pfizer

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