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19 Apr 2018

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

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

Endo International plc announced that its subsidiaries, Par Pharmaceutical, Inc. and Par Sterile Products, LLC, have received a Notice Letter...

19 Apr 2018

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

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TagsNexium, Nexium generic drug

AstraZeneca K.K. and Daiichi Sankyo Company Limited announced the launch of proton pump inhibitor Nexium 10 mg and 20 mg...

19 Apr 2018

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

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Tagsacquisition in pharma, brand acquisition

Biogen Inc. will acquire from Pfizer Inc. a Phase 2b-ready compound designed to treat cognitive impairment associated with schizophrenia. Biogen...

8 Apr 2018

Plaque psoriasis drug Tremfya receives Australian & Brazilian approvals

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TagsANVISA, Janssen, MAB, TGA, Tremfya

MorphoSys AG, a late-stage, biopharmaceutical company, announced that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been...

8 Apr 2018

Deal Insight: Daiichi Sankyo, DarwinHealth R&D agreement

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Tagsdrug licensing, inlicensing in pharma, outlicensing in pharma

Daiichi Sankyo Company, Limited and DarwinHealth announced they have entered into a research agreement providing Daiichi Sankyo with exclusive access...

8 Apr 2018

US FDA approval of Sonoma Pharma’s antimicrobial post-therapy gel

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Tags510(k), Medical device approval

Sonoma Pharmaceuticals, Inc., a specialty pharmaceutical company, has received a new 510(k) clearance from the US Food and Drug Administration...

5 Apr 2018

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

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TagsAkynzeo, Glenmark, Helsinn Group

Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, and Helsinn Group (“Helsinn”), a Swiss pharmaceutical group focused on building...

5 Apr 2018

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

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TagsAubagio, Denopsy, Teriflunomide

Natco Pharma launched a generic version of Teriflunomide for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS),...

28 Mar 2018

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

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

Swiss drugmaker, Novartis agreed to sell GSK its stake in their consumer health joint venture for $13bn. GlaxoSmithKline will be...

25 Mar 2018

US FDA approves Novartis’ Tasigna to treat children with rare form of leukemia

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Novartis announced that the US Food and Drug Administration (FDA) expanded the indication for Tasigna (nilotinib) to include treatment of...

25 Mar 2018

AstraZeneca receives EU approval for Lokelma to treat adults with hyperkalaemia

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TagsAstraZeneca, Lokelma

AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment...

25 Mar 2018

What is the significance of Phase 2b Clinical Trial?

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Tagsclinical trial, Phase 2b trial, Phase IIb clinical trial

In clinical trial, Phase 1 and 2 trials establish proof-of-concept, and phase 3 trials establish the efficacy and safety of...

19 Mar 2018

Brand Positioning: GSK Consumer Healthcare Ltd launches Horlicks Protein+

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

GSK Consumer Healthcare Ltd, the maker of Horlicks, is making another attempt to diversify. The company is set to launch...

19 Mar 2018

Case Study: Lundbeck acquires Prexton Therapeutics

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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...

19 Mar 2018

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

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

Dr Reddy’s Laboratories received the US Food and Drug Administration has issued a Form 483 with four observations after inspecting...

28 Feb 2018

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

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Tagsemtricitabine, Hetero, Tafero-EM, tenofovir alafenamide

Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, announced the launch of the...

28 Feb 2018

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

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TagsEli Lilly, Verzenio

Eli Lilly and Company has announced that the US Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination...

28 Feb 2018

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

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TagsBevacizumab, Cipla, Roche, Syndyma, tocilizumab

Cipla Ltd and Roche Pharma India has entered an agreement under which Cipla will promote and distribute tocilizumab and Syndyma,...

15 Feb 2018

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

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TagsAstraZenca, AstraZeneca, Forxiga, Xigduo XR

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

15 Feb 2018

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

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TagsAlzheimer, verubecestat

US pharma giant Merck & Co has halted a Phase III trial of verubecestat (MK-8931) in people with prodromal Alzheimer’s...

15 Feb 2018

Astellas to acquire Universal Cells for up to $102.5M

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TagsAstellas, Astellas Pharma

Astellas Pharma has acquired Seattle, WA-based Universal Cells, Inc. and its Universal Donor Cell technology enabling the creation of cell...

31 Jan 2018

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

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TagsAblynx, Novo nordisk, pharma acquisition, Sanofi

French drugmaker Sanofi has agreed to acquire Belgian biotech company Ablynx for 3.9 billion euros ($4.8 billion). This is second...

29 Jan 2018

Lupin enters Indian OTC market

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TagsOTC drugs, otc market

India’s second largest drug company Lupin Ltd has also entered the growing Over the Counter (OTC) market in the country....

29 Jan 2018

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

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TagsLUTATHERA, novartis, pharma acquisition

Advanced Accelerator Applications S.A., a Novartis company and leader in nuclear medicine theragnostics, today announced that it has received US...

18 Jan 2018

Pharma Case Study: Backward Integration: Ipca Laboratories acquisition of Pisgah Labs Inc.

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TagsBackward integration, Ipca, Pisgah Labs

What is backward integration? Backward integration strategy employed to expand profits and gain greater control over production of a product whereby...

17 Jan 2018

Licensing Case Study: Nuvo Ireland’s acquisition of US rights for Resultz from Piedmont Pharma

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Tagsglobal pharma deals, global pharma licensing deal, Nuvo Ireland, Piedmont Pharma, Resultz

Nuvo Pharmaceuticals Inc. (Nuvo), a commercial healthcare company with a portfolio of commercial products and pharmaceutical manufacturing capabilities, announced that...

17 Jan 2018

USFDA approval of Lynparza to Treat BRCA-mutated Metastatic Breast Cancer

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TagsLynparza, olaparib

The U.S. Food and Drug Administration (FDA) has approved Lynparza (olaparib) for a difficult-to-treat form of metastatic breast cancer. Patients...

28 Dec 2017

What is the meaning and significance of ‘First to File’ Generics?

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Tags505(j) ANDA, 505(j) is ANDA, Abbreviated New Drug Application, ANDA, First to FFile Generics

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended...

27 Dec 2017

Janssen enters license agreement with chinese company legend biotech to develop CAR-T anti-cancer therapy

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TagsCFDA, global pharma licensing deal, inlicensing in pharma, Janssen

Janssen Biotech, a Janssen Pharmaceutical Company of Johnson & Johnson has announced that it has entered into a worldwide collaboration...

27 Dec 2017

Mallinckrodt to acquire Sucampo Pharmaceuticals for $1.2 billion

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Tagsacquisition in pharma, Mallinckrodt, pharma acquisition, Sucampo

Mallinckrodt plc, a leading global specialty pharmaceutical company, and Sucampo Pharmaceuticals, Inc., a global biopharmaceutical company, have entered into an...

Recently Published Articles

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

US FDA approval of Sonoma Pharma’s antimicrobial post-therapy gel

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

US FDA approves Novartis’ Tasigna to treat children with rare form of leukemia

AstraZeneca receives EU approval for Lokelma to treat adults with hyperkalaemia

What is the significance of Phase 2b Clinical Trial?

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

Lupin enters Indian OTC market

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

Pharma Case Study: Backward Integration: Ipca Laboratories acquisition of Pisgah Labs Inc.

Licensing Case Study: Nuvo Ireland’s acquisition of US rights for Resultz from Piedmont Pharma

USFDA approval of Lynparza to Treat BRCA-mutated Metastatic Breast Cancer

What is the meaning and significance of ‘First to File’ Generics?

Janssen enters license agreement with chinese company legend biotech to develop CAR-T anti-cancer therapy

Mallinckrodt to acquire Sucampo Pharmaceuticals for $1.2 billion

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