NCK Pharma » Recent updates

Insight on Alteogen’s non-exclusive licensing deal for ALT-B4 to a top 10 global pharma

Posted on05 Dec 2019

Tagsbiopharma, biopharma business development, drug licensing, global pharma licensing deal, inlicensing in pharma, outlicensing in pharma

Comments0

South Korean company Alteogen Inc. signed a nonexclusive global license agreement with a top 10 global pharmaceutical company for its recombinant human hyaluronidase enzyme, ALT-B4, in exchange for an up-front...

Pharma Strategic Deal: Astellas Pharma to acquire Audentes Therapeutics for about $3 billion

Posted on05 Dec 2019

TagsAstellas, Astellas Pharma, biopharma business development, Pharma Business Development, pharma strategic deal

Comments0

Astellas Pharma Inc. anannounced that they have entered into a definitive agreement for Astellas to acquire Audentes at a price of US$60.00 per share in cash, representing a total equity...

Pharma Business Development – Competency Test. Check your competency

Posted on04 Dec 2019

Tagsbiopharma business development, MCQ test in pharma business development, Pharma Business Development

Comments0

Pharma Business Development – Competency Test. Check your competency

Case study: Novartis to acquire The Medicines Company for $9.7 billion, get hold of inclisiran, a cholesterol drug

Posted on02 Dec 2019

Tagsacquisition in pharma, brand acquisition, inclisiran, novartis

Comments0

Novartis, a one of the leading global pharmaceutical company, to acquire The Medicines Company for $9.7 billion. Strategic reasoning of the deal: The Medicine Company has the brand, inclisiran, has...

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

Posted on19 Nov 2019

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

Comments0

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act). The Purple Book includes the...

USFDA approved Pfizer’s Abrilada, a biosimilar of Humira

Posted on19 Nov 2019

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

Comments0

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 treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis,...

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

Posted on17 Nov 2019

TagsBayer, Dewpoint

Comments0

Bayer and Dewpoint Therapeutics, a biotechnology company with sites in Boston and Dresden, Germany, today announced an option, research and license agreement worth up to USD 100 million. The partnership...

Sandoz to Acquire Japanese Biz of AGI

Posted on17 Nov 2019

Comments0

Sandoz has entered into an agreement to acquire the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary of Aspen Pharmacare Holdings Ltd. The acquisition consists of shares...

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

Posted on17 Nov 2019

TagsAstraZeneca, Merck, MSD, selumetinib

Comments0

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA)...

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

Posted on17 Nov 2019

Comments0

Roche has agreed to acquire Promedior for up to $1.4 billion. Roche’s deal will give it full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases—a pipeline anchored...

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

Posted on01 Nov 2019

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?

Comments0

Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical...

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

Posted on01 Nov 2019

Tagsclinical hold decision

Comments0

USFDA placed a partial hold on clinical trials for intrathecal administration of AVXS-101. The announcement follows an AveXis communication to health authorities and clinical trial investigators based on findings from...

Zentiva to acquire CEE pharma business of Alvogen

Posted on29 Oct 2019

TagsAlvogen, CEE Market, Zentiva

Comments0

Czech drugmaker Zentiva has announced it will buy the Central and Eastern European business of Alvogen, for an undisclosed amount. Alvogen CEE (Central and Eastern European) markets more than 200...

Insighht on USFDA approval of Trikafta

Posted on29 Oct 2019

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

Comments0

Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta earned this approval only three months after the application was...

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

Posted on25 Oct 2019

Comments0

Click here to view the Royalty Chart >> View now

Pharma Licensing: Explore differences between Royalty rate & Royalty base

Posted on25 Oct 2019

Comments0

Royalty rate : The appropriate royalty rate depends on numerous factors including the relative bargaining strength of the licensor and the licensee, profit potential, the size of the territory, how...

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

Posted on25 Oct 2019

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

Comments0

Takeda Pharmaceutical Company Limited announced that it has entered into an agreement to divest a portfolio of select over-the-counter (OTC) and prescription pharmaceutical assets in a number of Near East,...

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

Posted on22 Oct 2019

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

Comments0

GlaxoSmithKline (GSK) will sell two travel vaccines to Bavarian Nordic for up to 955 million euros ($1.1 billion), the British firm said on Monday, as it looks to bolster its...

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

Posted on21 Oct 2019

Tagsglobal pharma deals, pharma deal, pharma strategic deal

Comments0

South Korean bio-pharma company Mediforum Co. has acquired two local pharmaceutical firms C-TRI and i-World, a move that is expected to help it expedite its initial public offering (IPO) process...

US FDA issued warning letter to Glenmark for Baddi plant

Posted on21 Oct 2019

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

Comments0

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

Recent updates

Insight on Alteogen’s non-exclusive licensing deal for ALT-B4 to a top 10 global pharma

Pharma Strategic Deal: Astellas Pharma to acquire Audentes Therapeutics for about $3 billion

Pharma Business Development – Competency Test. Check your competency

Case study: Novartis to acquire The Medicines Company for $9.7 billion, get hold of inclisiran, a cholesterol drug

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

USFDA approved Pfizer’s Abrilada, a biosimilar of Humira

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

KPE-C-080 Certificate Course in Pharma Business Development & Licensing

KPE-C-079 KPE’s 1 Week Fundamental Training on Drug Discovery to Commercialization Pathway

KPE-C-077 – Fundamental Training on Data Integrity in pharmaceutical and biopharmaceutical industry

KPE-C-064N KPE’s 1 Month Certificate Course in Pharma Sales Management

KPE-C-103 Executive Program in Global Drug Regulatory Affairs [EPGDRA]

KPE-C-075 Fundamental Training on Pharma Marketing Plan Development

KPE-C-074 Fundamental Training on Monoclonal Antibody

KPE-C-073 Fundamental Training on Regulatory Affairs Advance Strategic Planning

KPE-C-072 Fundamental Training on 505B(2) Application Submission

KPE-C-071 Advance Diploma in Drug and Medical Device Regulatory Affairs (DRA + MDRA Dual Specialization)

KPE-C-046 KPE’s Certificate Course in Drug Regulatory Affairs

KPE-C-070 KPE’s 1 Week Certificate Course in Drug Regulation & Registration in Brazil

Certification Courses

Corporate Training

Your form has been submitted

Server Side Error

Error

Recent updates

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Please sign in first

Not a member?

Certification Courses

Corporate Training