NCK Pharma » Recent updates

Market Exclusivity Case Study: XIFAXAN (rifaximin)

Posted on07 May 2020

Tags505(j) ANDA, ANDA, Bausch, MARKET EXCLUSIVITY, Patent infringement case, sandoz

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Bausch Health Companies Inc. along with its wholly owned subsidiary, Salix Pharmaceuticals, which is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment...

Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility

Posted on07 May 2020

Tags483, 483 observations, Alembic, Aleor Dermaceuticals, EIR

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Aleor Dermaceuticals Ltd. (Aleor), a 60:40 joint venture between Alembic Pharmaceuticals Ltd. (Alembic) and Orbicular Pharmaceutical Technologies Pvt. Ltd. (Orbicular), has received Establishment Inspection Report (EIR) from the United States...

Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar

Posted on07 May 2020

TagsBausch + Lomb, Ranibizumab, Ranibizumab biosimilar, Stada, Xbrane Signs Deal With Helvetic BioPharma for its Lead Ranibizumab Biosimilar

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Bausch + Lomb announced an exclusive licensing agreement with Stada Arzneimittel and its development partner Xbrane Biopharma to develop and commercialize a biosimilar candidate to Lucentis in the U.S. and...

Valneva And Pfizer to Co-Develop and Commercialize Lyme Disease Vaccine, Vla15

Posted on05 May 2020

Tagspfizer, Valneva

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Valneva SE, a specialty vaccine company, and Pfizer Inc. today announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical...

Ipsen agreement with IRICoR & Université de Montréal to acquire exclusive license for discovery-stage oncology programme

Posted on05 May 2020

TagsDrug Discovery and Development Pathway, Ipsen

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Ipsen, a global specialty-driven biopharmaceutical group, IRICoR, a pan-Canadian research commercialization center focused on drug discovery, and Université de Montréal, announced they entered into an option agreement by which Ipsen...

Global Licensing Agreement Case study: ProThera Biologics and Takeda to Develop Novel Plasma-Derived Therapy Based on Inter-alpha Inhibitor Proteins (IAIP)

Posted on24 Apr 2020

Tagscodevelopment deal in pharma, licensing deal in pharma, ProThera Biologics, Takeda

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ProThera Biologics, Inc. and Takeda Pharmaceutical Company Limited have entered into a global licensing agreement to develop a novel plasma-derived Inter-alpha Inhibitor Proteins (IAIP) therapy for the treatment of acute...

Glenmark Foundation rolls out tele-health solution to expand access to quality patient care

Posted on24 Apr 2020

TagsCSR campaign in pharma

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Glenmark Foundation, the CSR arm of Glenmark Pharmaceuticals along with its NGO partners, has launched a tele-health solution in partnership with its NGO partner Institute for Global Development (IGD) through...

Florio GmbH introducing new digital platform aiming to improve the lives of people with haemophilia

Posted on24 Apr 2020

Tagsdigital marketing in pharma

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Swedish Orphan Biovitrum AB (publ) (Sobi) has announced the launch by its affiliate, Florio GmbH, of Florio, a digital medical device designed with the aim to improve the quality of...

Gilead Sciences, Second Genome ink collaboration strategic deal in biomarker and inflammatory bowel disease drug discovery

Posted on08 Apr 2020

Tagsgilead, Gilead Sciences, Strategic deal in pharma

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Gilead Sciences, Inc and Second Genome, a leader in microbiome science, announced that the companies have entered into a four-year strategic collaboration to identify biomarkers associated with clinical response in...

Who determines when a prescription medicine should be switched to OTC status?

Posted on07 Apr 2020

TagsBenadryl rx to otc switch, OTC drugs, otc monograph, Rx to otc switch, what is OTC monograph?

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Technically, anyone could submit a Citizen’s Petition to FDA to switch a product from Rx to OTC status. However, the holder of the approved new drug application (NDA)—the company that...

Case Study: US FDA approves erythroid maturation agent, Reblozyl

Posted on07 Apr 2020

TagsAcceleron Pharma, BMS, Reblozyl

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Bristol Myers Squibb and Acceleron Pharma Inc, a biopharmaceutical company, announced the US Food and Drug Administration (FDA) has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent (EMA),...

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

Posted on06 Apr 2020

Tagscompassionate use, Expanded access, expanded access compassionate use, gilead, Gilead Sciences

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During an extraordinary virtual meeting held on April 2, 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus...

Evox partnership with Takeda Pharmaceutical for rare disease

Posted on29 Mar 2020

Tagsorphan drug, orphan drug design, rare disease, Takeda

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Evox Therapeutics Ltd, a leading exosome therapeutics company, announced the signing of a rare disease-focused partnership with Takeda Pharmaceutical Company Limited. The multi-target collaboration is focused on developing up to...

What are the difference between FDA 483 and Warning Letter?

Posted on27 Mar 2020

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

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

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

Posted on26 Mar 2020

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

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U.S. Food and Drug Administration (FDA) has approved ZEPOSIA® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease,...

AstraZeneca and Silence Therapeutics co-development siRNA therapeutics

Posted on26 Mar 2020

TagsAstraZeneca, codevelopment deal in pharma, global pharma deals

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AstraZeneca will collaborate with Silence Therapeutics to discover, develop and commercialise small interfering RNA (siRNA) therapeutics for the treatment of cardiovascular (CV), renal, metabolic and respiratory diseases. This multi-target collaboration...

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

Posted on21 Mar 2020

TagsUSFDA inspection

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The US FDA announced that it will no longer be able to inspect domestic production facilities in wake of risk posed by the continuing spreading of novel coronavirus across the...

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

Posted on21 Mar 2020

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

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US FDA has approved a supplemental New Drug Application (sNDA) for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) for the treatment of people with chronic hepatitis C infection (HCV)...

A case based understanding in co-development deal

Posted on21 Mar 2020

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

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In a Co-Development Agreement the intellectual property is typically licensed by the licensor to the alliance partner, and as well, the two partners together jointly undertake the further development of...

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

Posted on21 Mar 2020

TagsProbiotics, Why Probiotics are combined with Prebiotics?

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UK-based life sciences business OptiBiotix Health said that its unit ProBiotix Health has signed a licensing agreement with Bulgarian pharmaceutical marketing company Velinoff Pharma for distribution of several of its...

Recent updates

Market Exclusivity Case Study: XIFAXAN (rifaximin)

Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility

Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar

Valneva And Pfizer to Co-Develop and Commercialize Lyme Disease Vaccine, Vla15

Ipsen agreement with IRICoR & Université de Montréal to acquire exclusive license for discovery-stage oncology programme

Global Licensing Agreement Case study: ProThera Biologics and Takeda to Develop Novel Plasma-Derived Therapy Based on Inter-alpha Inhibitor Proteins (IAIP)

Glenmark Foundation rolls out tele-health solution to expand access to quality patient care

Florio GmbH introducing new digital platform aiming to improve the lives of people with haemophilia

Gilead Sciences, Second Genome ink collaboration strategic deal in biomarker and inflammatory bowel disease drug discovery

Who determines when a prescription medicine should be switched to OTC status?

Case Study: US FDA approves erythroid maturation agent, Reblozyl

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

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

Executive Program in Biopharma Business Development and Strategic Management

KPE-C-062 KPE’s Certificate Course in Selling Skills for Medical Representatives

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)

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