Recent updates

Para IV notice: Endo International gets Paragraph IV notification on Vasostrict

Posted on19 Apr 2018

TagsPara IV, Para IV Filing, Para iv notice, propofol Paragraph IV certification

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Endo International plc announced that its subsidiaries, Par Pharmaceutical, Inc. and Par Sterile Products, LLC, have received a Notice Letter dated April 16, 2018 advising that Eagle Pharmaceuticals, Inc. (Eagle)...

AstraZeneca, Daiichi Sankyo to introduce Nexium 10 & 20 mg granules for suspension, Sachet, in Japan

Posted on19 Apr 2018

TagsNexium, Nexium generic drug

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AstraZeneca K.K. and Daiichi Sankyo Company Limited announced the launch of proton pump inhibitor Nexium 10 mg and 20 mg granules for suspension, Sachet, (generic- esomeprazole magnesium hydrate). Nexium 10...

Biogen to acquire Pfizer’s Phase 2b – ready compound

Posted on19 Apr 2018

Tagsacquisition in pharma, brand acquisition

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Biogen Inc. will acquire from Pfizer Inc. a Phase 2b-ready compound designed to treat cognitive impairment associated with schizophrenia. Biogen will pay an upfront fee of $75 million to gain...

Plaque psoriasis drug Tremfya receives Australian & Brazilian approvals

Posted on08 Apr 2018

TagsANVISA, Janssen, MAB, TGA, Tremfya

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MorphoSys AG, a late-stage, biopharmaceutical company, announced that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been approved for the treatment of adults living with moderate to...

Deal Insight: Daiichi Sankyo, DarwinHealth R&D agreement

Posted on08 Apr 2018

Tagsdrug licensing, inlicensing in pharma, outlicensing in pharma

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Daiichi Sankyo Company, Limited and DarwinHealth announced they have entered into a research agreement providing Daiichi Sankyo with exclusive access to DarwinHealth’s proprietary novel cancer target database in order to...

Glenmark and Helsinn Group’s exclusive licensing deal for launch of Akynzeo in India and Nepal

Posted on05 Apr 2018

TagsAkynzeo, Glenmark, Helsinn Group

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Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, and Helsinn Group (“Helsinn”), a Swiss pharmaceutical group focused on building quality cancer care products, are pleased to announce that they...

Natco launched a generic version of Teriflunomide tablets for the treatment of relapsing and remitting forms of multiple sclerosis in India

Posted on05 Apr 2018

TagsAubagio, Denopsy, Teriflunomide

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Natco Pharma launched a generic version of Teriflunomide for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS), under its brand Denopsy. This is the first oral medicine...

Case Study: GSK to acquire Novartis’s consumer healthcare stake for $13bn

Posted on28 Mar 2018

Tagsacquisition in pharma, brand acquisition, GSK, novartis, OTC drugs, otc monograph, pharma acquisition

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Swiss drugmaker, Novartis agreed to sell GSK its stake in their consumer health joint venture for $13bn. GlaxoSmithKline will be getting the full control of products including Sensodyne toothpaste, Panadol...

AstraZeneca receives EU approval for Lokelma to treat adults with hyperkalaemia

Posted on25 Mar 2018

TagsAstraZeneca, Lokelma

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AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised...

Brand Positioning: GSK Consumer Healthcare Ltd launches Horlicks Protein+

Posted on19 Mar 2018

Tagsbrand positioning, Horlicks, Horlicks Protein+, pharma brand positioning

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GSK Consumer Healthcare Ltd, the maker of Horlicks, is making another attempt to diversify. The company is set to launch Horlicks Protein+, a protein supplement aimed at working men. The...

Case Study: Lundbeck acquires Prexton Therapeutics

Posted on19 Mar 2018

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Lundbeck has agreed to acquire Prexton Therapeutics for up to €905 million ($1.1 billion), in a deal that adds a Phase II Parkinson’s disease candidate to the Lundbeck’s pipeline focused...

DRL’s API plant in Medak and Biocon’s Malaysian Plant got USFDA 483 observations

Posted on19 Mar 2018

Tags483, 483 OBSERVATION, 483 observations, fda 483 observation, form 483 observation, usfda 483 form

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Dr Reddy’s Laboratories received the US Food and Drug Administration has issued a Form 483 with four observations after inspecting its active pharmaceutical ingredients facility in Medak, Telangana. Last week...

New Launch: Hetero launches – Tafero-EM – FDC combo of ‘emtricitabine & tenofovir alafenamide’ in India

Posted on28 Feb 2018

Tagsemtricitabine, Hetero, Tafero-EM, tenofovir alafenamide

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Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, announced the launch of the first generic fixed-dose combination (FDC) of ‘emtricitabine (200mg) and tenofovir...

Case Study: Lilly’ US FDA approval of Verzenio in combination with aromatase inhibitor to treat advanced breast cancer

Posted on28 Feb 2018

TagsEli Lilly, Verzenio

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Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for...

Cipla – Roche Deal – Cipla will promote and distribute Roche’s tocilizumab and Syndyma in India

Posted on28 Feb 2018

TagsBevacizumab, Cipla, Roche, Syndyma, tocilizumab

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Cipla Ltd and Roche Pharma India has entered an agreement under which Cipla will promote and distribute tocilizumab and Syndyma, the 2nd brand of Roche’s cancer therapy bevacizumab in India....

AstraZeneca launches once-daily Xigduo XR tablets for comprehensive management of type 2 diabetes in India

Posted on15 Feb 2018

TagsAstraZenca, AstraZeneca, Forxiga, Xigduo XR

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AstraZeneca Pharma India Limited (AstraZeneca India) has announced the launch of its innovative anti-diabetic combination once-daily therapy Xigduo XR for treatment of adults with type 2 diabetes. Xigduo XR Xigduo...

MSD’s verubecestat fails in Phase 3 Alzheimer’s trial

Posted on15 Feb 2018

TagsAlzheimer, verubecestat

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US pharma giant Merck & Co has halted a Phase III trial of verubecestat (MK-8931) in people with prodromal Alzheimer’s disease (AD) based on a recommendation by the external Data...

Astellas to acquire Universal Cells for up to $102.5M

Posted on15 Feb 2018

TagsAstellas, Astellas Pharma

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Astellas Pharma has acquired Seattle, WA-based Universal Cells, Inc. and its Universal Donor Cell technology enabling the creation of cell therapy products that do not require human leukocyte antigen (HLA)...

Case Study: Sanofi’s acquisition of Ablynx for $4.8 bn

Posted on31 Jan 2018

TagsAblynx, Novo nordisk, pharma acquisition, Sanofi

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French drugmaker Sanofi has agreed to acquire Belgian biotech company Ablynx for 3.9 billion euros ($4.8 billion). This is second deal of Sanofi after Bioverativ in this current month. Why...

Novatis’ LUTATHERA® Approval: First FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT)

Posted on29 Jan 2018

TagsLUTATHERA, novartis, pharma acquisition

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Advanced Accelerator Applications S.A., a Novartis company and leader in nuclear medicine theragnostics, today announced that it has received US Food and Drug Administration (FDA) approval of its new drug...

Recent updates

Para IV notice: Endo International gets Paragraph IV notification on Vasostrict

AstraZeneca, Daiichi Sankyo to introduce Nexium 10 & 20 mg granules for suspension, Sachet, in Japan

Biogen to acquire Pfizer’s Phase 2b – ready compound

Plaque psoriasis drug Tremfya receives Australian & Brazilian approvals

Deal Insight: Daiichi Sankyo, DarwinHealth R&D agreement

Glenmark and Helsinn Group’s exclusive licensing deal for launch of Akynzeo in India and Nepal

Natco launched a generic version of Teriflunomide tablets for the treatment of relapsing and remitting forms of multiple sclerosis in India

Case Study: GSK to acquire Novartis’s consumer healthcare stake for $13bn

AstraZeneca receives EU approval for Lokelma to treat adults with hyperkalaemia

Brand Positioning: GSK Consumer Healthcare Ltd launches Horlicks Protein+

Case Study: Lundbeck acquires Prexton Therapeutics

DRL’s API plant in Medak and Biocon’s Malaysian Plant got USFDA 483 observations

New Launch: Hetero launches – Tafero-EM – FDC combo of ‘emtricitabine & tenofovir alafenamide’ in India

Case Study: Lilly’ US FDA approval of Verzenio in combination with aromatase inhibitor to treat advanced breast cancer

Cipla – Roche Deal – Cipla will promote and distribute Roche’s tocilizumab and Syndyma in India

AstraZeneca launches once-daily Xigduo XR tablets for comprehensive management of type 2 diabetes in India

MSD’s verubecestat fails in Phase 3 Alzheimer’s trial

Astellas to acquire Universal Cells for up to $102.5M

Case Study: Sanofi’s acquisition of Ablynx for $4.8 bn

Novatis’ LUTATHERA® Approval: First FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT)

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

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

KPE-C-063 KPE’s 1 Month Certificate Course in Digital Pharma Marketing

KPE-C-062 KPE’s 1 Month Certificate Course in Selling Skills for Medical Representatives

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