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18 Sep 2019

Pharma acquisition case study: Lundbeck to acquire Alder BioPharmaceuticals for US$ 1.95 billion

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TagsAlder BioPharmaceuticals, Lundbeck, pharma acquisition

H. Lundbeck A/S (Lundbeck) and Alder BioPharmaceuticals (Alder) announced a definitive agreement for Lundbeck to acquire Alder. About the deal:...

18 Sep 2019

Insight on submission of USFDA sBLA of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)

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TagsJanssen, Janssen Biotech, Janssen Pharma, MorphoSys AG, sBLA, supplemental Biologics License Application, Tremfya

MorphoSys AG, a clinical-stage biopharmaceutical company, announced that its licensee Janssen Research & Development, submitted a supplemental Biologics License Application...

18 Sep 2019

Mitsubishi Tanabe Pharma, Daiichi Sankyo enters licensing agreement for ALS treatment agent edaravone in Brazil

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TagsDaiichi Sankyo, drug licensing, licensing deal in pharma, Mitsubishi Tanabe Pharma

Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo announced that they have concluded a licensing agreement covering commercialization rights in Brazil...

12 Sep 2019

Alexion’s inlicensing deal for Amyloidosis Candidate In Japan

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TagsAlexion Pharmaceuticals, drug licensing, global pharma licensing deal, inlicensing in pharma

Alexion Pharmaceuticals announced a license agreement with BridgeBio Pharma’s subsidiary Eidos Therapeutics. Per the terms of the deal, Alexion will...

12 Sep 2019

Insight on Boehringer Ingelheim’s new indication approval for Ofev to slow the rate of decline in pulmonary function in patients with Ssc-ILD

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TagsFDA Approves Boehringer Ingelheim’s OFEV® (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis, new indication approval, USFDA approval of Ofev

Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) approved Ofev (nintedanib) as the first and only medicine...

12 Sep 2019

Sanofi India announces sale of its Ankleshwar facility to Zentiva

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Tagsdisinvestment in pharma business

Sanofi India Ltd announced sale of its manufacturing facility at Ankleshwar in Gujarat to Zentiva Pvt Ltd. Incorporated in May...

12 Sep 2019

What are DACH region? Which countries are part of DACH region?

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TagsDACH, GCC drug market, Latam pharma market, MENA

The DACH region is part of Europen. DACH region comprises of Austria, Germany, and Switzerland. DACH countires are basically German Speaking...

12 Sep 2019

Strides Pharma acquires stake in Fairmed Healthcare for extensive growth in DACH region

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Tagsacquisition in pharma, DACH, Fairmed Healthcare AG, Strides Arcolab, strides aspen, Strides Shasun

Strides Pharma Science Limited has announced its acquisition of majority stake in Fairmed Healthcare AG. Strides Pharma Global Pvt Ltd...

12 Sep 2019

GSK to acquire Celiac-Focused Sitari Pharmaceuticals

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Tagsceliac disease, Glaxo, GSK, Sitari Pharmaceuticals

GlaxoSmithKline will acquire San Diego-based Sitari Pharmaceuticals and its transglutaminase 2 small molecule program for celiac disease. Sitari, a preclinical-stage...

12 Sep 2019

Takeda recalled of NATPARA (a parathyroid hormone) in US

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TagsNATPARA, Product Recall, Takeda, What is class i Recall, What is the difference between Market withdrawal and Product Recall?

Takeda Pharmaceutical Company Limited, on 6 Sep 2019, announced that the company is issuing a US recall for all doses...

8 Sep 2019

Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab

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Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement...

8 Sep 2019

Boehringer Ingelheim’s KRAS and Lupin’s MEK inhibitor compound (LNP3794) – Licensing, development and Commercialization Agreement

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TagsBoehringer Ingelheim, KRAS inhibitors, Lupin, MEK inhibitor

Boehringer Ingelheim and Lupin Limited (Lupin) announced a licensing, development and commercialization agreement for Lupin’s MEK inhibitor compound (LNP3794) as...

8 Sep 2019

Sumitomo Dainippon and Roivant’s strategic alliance to develop new medicine

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Tagspharma strategic deal, Strategic deal in pharma, Sumitomo Dainippon

Sumitomo Dainippon Pharma Co, Ltd, a leading Japanese pharmaceutical company, and Roivant Sciences Ltd, a technology-enabled healthcare company, have entered...

8 Sep 2019

GSK, INNOVAX and Xiamen University’s Global co-developmennt alliance for cervical cancer vaccine

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INNOVAX, a subsidiary of China’s YangShengTang Group, and Xiamen University signed a global alliance partnership agreement on Friday with British...

29 Aug 2019

Insight on USFDA approval of new add-on drug, Nourianz (istradefylline), to treat off episodes in adults with Parkinson’s disease

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Tagsnew drug approval, Nourianz

The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients...

27 Aug 2019

Pharma brand acquisition case study: Amgen to acquire Celgene’s Otezla

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TagsAmgen, Celgene, Otezla, pharma brand case study

Amgen announced today that it has entered into an agreement with Celgene Corporation in connection with its previously announced merger...

17 Aug 2019

Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)

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TagsAbbVie, Regeneron, Rheumatoid arthritis market, RINVOQ, Sanofi, upadacitinib, US FDA accepts Sanofi and Regeneron's sarilumab BLA for review

U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for...

8 Aug 2019

GSK grants exclusive technology license for Ebola vaccines to Sabin Vaccine Institute

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TagsGSK, What is Technology Licensing?

GSK and the Sabin Vaccine Institute (Sabin), a non-profit organization, announced exclusive agreements for Sabin to advance the development of...

8 Aug 2019

Turalio: USFDA approval of first therapy for rare joint tumor

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Tagsblack box warning, Breakthrough Therapy designation, Breakthrough Therapy designations, meaning of black box warning, priority review, Priority Review Designation, REMS, USFDA Priority Review

U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial...

8 Aug 2019

Case Study: The Mylan-Upjohn,Pfizer Merger

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Tagsauthorized generic, Mylan, pfizer

Pfizer, the world’s largest drugmaker, plans to combine its off-patent drug business and combine it with generic-drug maker Mylan. Pfizer...

7 Aug 2019

Take a Self Competency Test in European Drug Regulatory Affairs

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Effective regulatory strategic planning is a challenging as different regions and countries need to follow different regulatory requirements for Marketing...

17 Jul 2019

Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals

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Tags483, 483 observations, FORM 483, USFDA warning letter

The U.S. Food and Drug Administration (FDA) inspected drug manufacturing facility, Strides Pharma Science Limited at Unit-II, R. S. No.:...

17 Jul 2019

Case Study : Rituxan – A Brand which Pharma Industry reckon

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TagsRituxan, Rituximab

Brand Name: Rituxan Company: Roche 2017 U.S. sales: $4.41 billion Disease: Blood cancers, rheumatoid arthritis Dosage form: Injection for Intravenous Use Rituxan (rituximab)...

17 Jul 2019

In which class should be register the food supplement?

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TagsFOOD SUPPLEMENT, OTC drugs

International trademark classes Food Supplement should be in class 5 (same class of pharmaceuticals). Major Class: Food supplements belongs to...

17 Jul 2019

Cipla’s JV with Jiangsu Acebright Pharma in China

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TagsStrategic deal in pharma

Cipla, a Rs. 15,900 crore plus fourth largest Indian pharma company, has entered into a joint venture agreement with Jiangsu...

17 Jul 2019

US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab

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Tagscrizanlizumab, MAB, monoclonal antibody, priority review, Priority Review Designation, USFDA Priority Review

Novartis announced the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) and has granted Priority...

15 Jul 2019

Case Study: Gilead and Galapagos – R&D collaboration

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Tagscodevelopment deal in pharma, Filgotinib, Galapagos, Gliead, R&D collaboration

Gilead Sciences, Inc. and Galapagos NV have entered into a 10-year global research and development collaboration. Through this agreement, Gilead...

8 Jul 2019

How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?

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Tagsdata integrity, data integrity in pharma, Data integrity issues, What is the meaning of Data Integrity issue in pharmaceutical industry?

Drug Regulatory Body encourages to demonstrate that organization have effectively remediated problems by investigating to determine the problem’s scope and...

7 Jul 2019

AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data

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TagsAstraZeneca, clinical trial, Forxiga

AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to...

7 Jul 2019

US FDA warning letter: Repackers distributing API for violations of cGMP violation requirements

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Tags483, 483 OBSERVATION, 483 observations, API industry, fda 483 observation, form 483 observation, USFDA warning letter

The US Food and Drug Administration (FDA) has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B...

Recently Published Articles

Pharma acquisition case study: Lundbeck to acquire Alder BioPharmaceuticals for US$ 1.95 billion

Insight on submission of USFDA sBLA of Tremfya (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA)

Mitsubishi Tanabe Pharma, Daiichi Sankyo enters licensing agreement for ALS treatment agent edaravone in Brazil

Alexion’s inlicensing deal for Amyloidosis Candidate In Japan

Insight on Boehringer Ingelheim’s new indication approval for Ofev to slow the rate of decline in pulmonary function in patients with Ssc-ILD

Sanofi India announces sale of its Ankleshwar facility to Zentiva

What are DACH region? Which countries are part of DACH region?

Strides Pharma acquires stake in Fairmed Healthcare for extensive growth in DACH region

GSK to acquire Celiac-Focused Sitari Pharmaceuticals

Takeda recalled of NATPARA (a parathyroid hormone) in US

Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab

Boehringer Ingelheim’s KRAS and Lupin’s MEK inhibitor compound (LNP3794) – Licensing, development and Commercialization Agreement

Sumitomo Dainippon and Roivant’s strategic alliance to develop new medicine

GSK, INNOVAX and Xiamen University’s Global co-developmennt alliance for cervical cancer vaccine

Insight on USFDA approval of new add-on drug, Nourianz (istradefylline), to treat off episodes in adults with Parkinson’s disease

Pharma brand acquisition case study: Amgen to acquire Celgene’s Otezla

Case Study: USFDA approval of AbbVie’s RINVOQ (upadacitinib)

GSK grants exclusive technology license for Ebola vaccines to Sabin Vaccine Institute

Turalio: USFDA approval of first therapy for rare joint tumor

Case Study: The Mylan-Upjohn,Pfizer Merger

Take a Self Competency Test in European Drug Regulatory Affairs

Strides Pharma received USFDA warning letter for significant violations of CGMP regulations for finished pharmaceuticals

Case Study : Rituxan – A Brand which Pharma Industry reckon

In which class should be register the food supplement?

Cipla’s JV with Jiangsu Acebright Pharma in China

US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab

Case Study: Gilead and Galapagos – R&D collaboration

How data integrity related problems should be addressed in Pharmaceutical and Biopharmaceutical Industry?

AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data

US FDA warning letter: Repackers distributing API for violations of cGMP violation requirements

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