NCK Pharma » Recent updates

Insignht on USFDA approval of Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women

Posted on21 Mar 2019

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The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug...

Johnson & Johnson’s Spravato (esketamine) For Treatment-Resistant Depression

Posted on14 Mar 2019

Tagsesketamine, REMS, Spravato

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The U.S. Food & Drug Administration Tuesday approved Johnson & Johnson’s ketamine-derived nasal spray Spravato for treatment-resistant depression. The approval means ketamine—an anesthetic abused as a party drug but promoted...

GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry

Posted on11 Mar 2019

TagsAdvair, Advair diskus, Wixela Inhub

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Mylan has launched its generic version of GlaxoSmithKline’s respiratory blockbuster, Advair, at a 70% discount compared with the GlaxoSmithKline’s respiratory blockbuster, Advair. Cheaper competition to off-patent Advair has been delayed...

Takeda subsidiary Millennium Pharmaceuticals Inc, sues Aurobindo to block generic Velcade

Posted on11 Mar 2019

TagsANDA, Auribindo, Takeda

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A U.S. unit of Japan’s Takeda Pharmaceutical Co has sued generic drugmaker Aurobindo Pharma Ltd over its plans to make a cheaper version of Takeda’s cancer drug Velcade. In a...

US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL

Posted on11 Mar 2019

TagsAbbVie, sNDA, sNDA USFDA

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AbbVie announced that the US Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational...

In India, insight on the ban of OTC sale of skin medications containing hydroquinone from April 1

Posted on11 Mar 2019

TagsCDSCO

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Come April and pharmacies in the country have to stop selling topical medications containing hydroquinone, a bleaching agent for reducing skin pigmentation, without a doctor’s prescription. The health ministry has...

In India, Prices of 390 cancer drugs slashed by upto 87%

Posted on11 Mar 2019

TagsCDSCO, DPCO, NPPA, price control guidelines of 108 formulations

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The maximum retail price of 390 non-scheduled cancer medicines have been reduced by up to 87 per cent, which would result in annual savings of around Rs 800 crore for...

Roche receives US FDA approval for Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Posted on02 Mar 2019

Tagsherceptin, Herceptin Hylecta, Roche, trastuzumab

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Roche announced that the US Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with...

Roche to acquire U.S.-Based Gene Therapy Specialist Spark @ $4.8 Billion

Posted on26 Feb 2019

Tagsacquisition in pharma, Roche

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Swiss drugmaker Roche agreed to buy Philadelphia-based Spark Therapeutics for $4.8 billion. Spark works to create gene therapies for genetic diseases, including blindness, haemophilia, lysosomal storage disorders and neurodegenerative diseases....

Novartis licenses lipoprotein-lowering CVD drug AKCEA-APO(a)-LRx

Posted on26 Feb 2019

TagsAkcea, AKCEA-APO(a)-LR, drug licensing, Ionis Pharmaceuticals, novartis, outlicensing in pharma

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Excited by strong phase II data, Novartis is exercising its option to license Akcea Therapeutics’ AKCEA-APO(a)-LRx, a treatment to reduce the risk of cardiovascular disease in people living with elevated...

Key Understanding on Price monitoring and research units (PMRUs) intiative in India

Posted on23 Feb 2019

TagsCDSCO, NPPA, PMRUs, Price monitoring and research units

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PMRUs intitative is adopted by The National Pharmaceutical Pricing Authority (NPPA). Under the initiative NPPA facilitates price monitoring and research units (PMRUs) in states and union territories to ensure ground-level...

Merck to acquire immunotherapy company, Immune Design for US$ 300 million

Posted on22 Feb 2019

TagsImmune Design, immunotherapy company, Merck KGaA

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Merck and Immune Design announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for US$ 5.85 per share in...

Abbott, Novo Nordisk partner to provide integrated digital solution to people with diabetes using insulin

Posted on22 Feb 2019

TagsAbbott, Novo nordisk

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Abbott, a global healthcare leader and Novo Nordisk announced a non-exclusive partnership that will integrate insulin dose data from Novo Nordisk pre-filled and durable connected pens directly into the digital...

USFDA approves Novo Nordisk’s Esperoct for haemophilia A treatment

Posted on22 Feb 2019

TagsEsperoct, Novo nordisk

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Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for Esperoct for the treatment of adults and children with haemophilia A. Esperoct...

GSK’s disinvestment of Chiron Behring to Bharat Biotech

Posted on16 Feb 2019

Tagsacquisition in pharma, Bharat Biotech, Chiron Behring Vaccines, disinvestment in pharma business, GSK, Hoechst AG

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Bharat Biotech’s recent plans to acquire Chiron Behring Vaccine Private Limited from GlaxoSmithKline Asia, is expected to boost the company’s rabies vaccine manufacturing capacity from the current 10 million doses...

FDA approved Cablivi (caplacizumab-yhdp) for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura

Posted on12 Feb 2019

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The USFDA approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura...

Insight on EU’s safety features of unique identifier & anti-tampering device on outer packaging require for medicines

Posted on12 Feb 2019

Tagsanti tampering packaging, importance of packaging in branding, packaging innovation in pharma, unique identifier in packaging

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As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode)...

Recordati received exclusive rights to commercialize Juxtapid in Japan from Aegerion Pharmaceuticals

Posted on07 Feb 2019

TagsAegerion, HoFH, Juxtapid, Novelion Therapeutics, orphan drug, orphan drug designation, rare disease

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Recordati announces the signing of a license agreement with Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics Inc., for the exclusive rights to commercialize Juxtapid®, currently approved for the treatment...

Glenmark Specialty S.A’s exclusive licensing agreement with Grandpharma (China) Co. Ltd for commercializing Ryaltris in China

Posted on07 Feb 2019

TagsGlemark outlicensing, global pharma licensing deal, licensing deal in pharma, outlicensing in pharma

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Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, announced that its Swiss subsidiary, Glenmark Specialty S.A, has entered into an exclusive licensing agreement with Grandpharma (China) Co. Ltd for...

USFDA approved first generic of Advair Diskus

Posted on31 Jan 2019

TagsAdvair

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The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four...

Recent updates

Insignht on USFDA approval of Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women

Johnson & Johnson’s Spravato (esketamine) For Treatment-Resistant Depression

GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry

Takeda subsidiary Millennium Pharmaceuticals Inc, sues Aurobindo to block generic Velcade

US FDA grants breakthrough therapy status to AbbVie’s venetoclax in combo with obinutuzumab for untreated adults patients with CLL

In India, insight on the ban of OTC sale of skin medications containing hydroquinone from April 1

In India, Prices of 390 cancer drugs slashed by upto 87%

Roche receives US FDA approval for Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers

Roche to acquire U.S.-Based Gene Therapy Specialist Spark @ $4.8 Billion

Novartis licenses lipoprotein-lowering CVD drug AKCEA-APO(a)-LRx

Key Understanding on Price monitoring and research units (PMRUs) intiative in India

Merck to acquire immunotherapy company, Immune Design for US$ 300 million

Abbott, Novo Nordisk partner to provide integrated digital solution to people with diabetes using insulin

USFDA approves Novo Nordisk’s Esperoct for haemophilia A treatment

GSK’s disinvestment of Chiron Behring to Bharat Biotech

FDA approved Cablivi (caplacizumab-yhdp) for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura

Insight on EU’s safety features of unique identifier & anti-tampering device on outer packaging require for medicines

Recordati received exclusive rights to commercialize Juxtapid in Japan from Aegerion Pharmaceuticals

Glenmark Specialty S.A’s exclusive licensing agreement with Grandpharma (China) Co. Ltd for commercializing Ryaltris in China

USFDA approved first generic of Advair Diskus

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

KPE – C- 023N KPE’s Advance Diploma in Pharmaceutical Product Management and Regulatory Affairs (Dual Specialization)

KPE-C-069 KPE’s 1 Month Certificate Course in Drug Registration in Latin American (Latam) Countries

KPE-C-068 – 1 Month Certificate Course in CE Marking for Medical Devices

KPE–C-065 KPE’s 1 Week Certificate Course in Pharmaceutical IPR and R&D

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