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29 Nov 2018

Insight on USFDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor

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TagsBayer, larotrectinib, neurotrophic receptor tyrosine kinase, TRK inhibitor, Vitrakvi

The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment...

29 Nov 2018

Case Study: Pfizer’s Lyrica’s patent extension with paediatric exclusivity

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TagsAllena’s oxalate decarboxylase to treat paediatric hyperoxaluria gets US FDA orphan drug status, approval of an additional pediatric indication, pediatric exclusivity

USFDA granted 6-month pediatric exclusivity to Lyrica, which helps to Lyrica to extent the patent expiration by additional 6 month....

29 Nov 2018

What is pediatric exclusivity?

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Tagsapproval of an additional pediatric indication, pediatric exclusivity

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a...

21 Nov 2018

Case Study: Insight on DRL-Indivior Suboxone Patent Battle

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TagsANDA, ANDA approval, at-risk launch, Indivior, Suboxone

June 2018 : DRL got the generic approval for Suboxone Dr Reddy’ s Laboratories received approval from the USFDA for...

15 Nov 2018

Grünenthal entering into US market with acquisition of US based Averitas Pharma

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Tagsacquisition in pharma, portfolio management in pharma

Grünenthal has acquired the US-based pharmaceutical company Averitas Pharma, thereby extending its commercial footprint to the United States. Averitas Pharma...

15 Nov 2018

Pharma Disinvestment deal: AstraZeneca to divest Synagis US rights to Sobi

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TagsAstraZeneca, palivizumab, Synagis

AstraZeneca has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection...

15 Nov 2018

Pharma R&D Deal Termination: Daiichi Sankyo & GSK’s vaccine JV in Japan

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TagsDaiichi Sankyo, Glaxo, global pharma deals, GSK, pharma deal

Daiichi Sankyo Company, Limited announced that Daiichi Sankyo and GlaxoSmithKline K.K have agreed to dissolve their joint venture company, Japan...

12 Nov 2018

Insight on Strides – SUDA Pharma Strategic Deal

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TagsStrides Arcolab, SUDA Pharma

Strides Pharma Science’s wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore has entered into an exclusive product development, licensing...

12 Nov 2018

How much is the ideal royalty payment in pharmaceutical industry?

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Tagsdrug licensing, inlicensing in pharma, outlicensing in pharma

A royalty payment is made to the legal owner of the property, patent, copyrighted work, or franchise by licensees or...

10 Nov 2018

Hikma Pharmaceuticals and Vectura codevelopment and commercialization of GSK’s Breo Ellipta generics

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TagsBreo Ellipta, Ellipta, GSK, Hikma

Hikma Pharmaceuticals and Vectura have signed a deal to develop and market generic versions of GlaxoSmithKline’s Ellipta portfolio, utilising the...

10 Nov 2018

Pharma acquisition Insight: Hikma Pharmaceuticals to acquire Medlac Pharma

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TagsHikma, Medlac Pharma, vietnam pharma market

Hikma Wednesday said it had a deal to buy Medlac Pharma Italy Co., a Vietnamese injectables manufacturing company established a...

9 Nov 2018

Secarna enters co-development pact with MetP Pharma for transnasally delivered antisense oligonucleotide-based CNS therapeutics

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Tagscodevelopment deal in pharma, Strategic deal in pharma

Secarna Pharmaceuticals (Secarna), a new breed of biopharmaceutical company, has entered into a co-development agreement with MetP Pharma (MetP), a...

9 Nov 2018

Glenmark’s anti-myeloma drug to start phase 1 trial in solid tumors

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TagsGlenmark, Investigational New Drug, Phase I clinical trial

Glenmark Pharmaceuticals on Thursday said it will launch phase 1 trial in solid tumors for its bispecific antibody GBR 1342,...

9 Nov 2018

Glenmark’S Exclusive Collaboration Agreement with SCD Pharmaceuticals, South Korea for Ophthalmic Solution Products

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TagsANDA, Glenmark, pharma strategic deal

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced it has entered into an exclusive agreement with Sam Chun Dang Pharm....

6 Nov 2018

Pfizer gets US FDA approval for Lorbrena for previously-treated ALK-positive metastatic NSCLC

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Pfizer Inc announced that the US Food and Drug Administration (FDA) has approved Lorbrena [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma...

6 Nov 2018

Quick Look in Unichem – Optimus deal

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TagsOptimus, Unichem

Unichem Laboratories (Unichem), a Rs. 670 crore pharma major, has entered into an agreement to acquire 20% equity stake in...

6 Nov 2018

Novartis R&D portfolio update

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Tagsbrolucizumab, canikinumab, cosentyx, crizanlizumab, Entresto, Gilenya, novartis, NSCLC, ofatumumab, R&D portfolio

Novartis took strong action to focus the company and its capital towards the Innovative Medicines Division, resulting in an industry...

6 Nov 2018

Bristol-Myers Squibb, Infinity Pharma ink clinical collaboration deal

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TagsBMS, Bristol-Myers Squibb, clinical collaboration deal, Infinity Pharma

Bristol-Myers Squibb Company and Infinity Pharmaceuticals, Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with...

16 Oct 2018

Adalimumab Biosimilar Litigation: Sandoz’s settlement with AbbVie

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TagsAbbVie, Adalimumab, biosimilar of sandoz, humira, Hyrimoz, sandoz

Sandoz, a Novartis division and the global leader in biosimilars, announced a global resolution of all intellectual property (IP) related...

15 Oct 2018

Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix

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TagsBrintellix, CDSCO, codevelopment deal in pharma, comarketing deal in pharma, copromotion deal in pharma, DCGI, Lundbeck, vortioxetine

Lundbeck India Private Limited (LIPL) announces the launch of Brintellix (vortioxetine) in India for the treatment of patients suffering from...

4 Oct 2018

Eyevance Pharmaceuticals Acquires Worldwide Rights to NEXAGON®

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Tagsdrug licensing, Eyevance Pharmaceuticals, FRESHKOTE, NEXAGON, outlicensing in pharma, ZERVIATE

Eyevance Pharmaceuticals, a Fort Worth-based pharmaceutical company committed to developing and commercializing innovative and impactful ophthalmic products, announced a worldwide...

3 Oct 2018

Case Study: USFDA The Limited Population Pathway and approval of Arikayce

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TagsArikayce, LAPD, The Limited Population Pathway for Antibacterial and Antifungal Drugs, USFDA new drugs approval

The US Food and Drug Administration late Friday granted accelerated approval of Arikayce (amikacin liposome inhalation suspension), developed by US...

3 Oct 2018

Dr. Reddy’s sells Cloderm cream to EPI Health

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Tagsacquisition in pharma, brand acquisition, Cloderm, Dr. Reddy’s Laboratories, DRL, EPI Health

Dr. Reddy’s Laboratories’ wholly owned U.S. subsidiary Promius Pharma has sold rights of Cloderm (clocortolone pivalate) cream and its authorised...

3 Oct 2018

DRL to disinvest antibiotics plant to Abu Dhabi-based Neopharma

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Tagsacquisition in pharma, Dr. Reddy’s Laboratories, neopharma

Dr Reddy’s Laboratories on Monday announced the closure of the sale of its antibiotic manufacturing facility and related assets in...

3 Oct 2018

Case Study: Product Recall due to labeling error

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Tagsclass i recall, FDA's role in product recall, medicine labeling, Product Recall, Produt recall, What is class i Recall

Endo Pharmaceuticals Inc, is voluntarily recalling two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets 100 count bottle pack to...

19 Sep 2018

Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study

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TagsAlmirall, case study on drug discovery to commercialization, Drug Discovery and Development Pathway, MAB, Tildrakizumab

Brand Name: Ilumetri Biomolecule: Tildrakizumab Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing...

15 Sep 2018

Consequences and progress of Takeda-Shire Buyout

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Tagsacquisition in pharma, pharma acquisition, Shire, Takeda

Takeda announced in April it would buy Shire in the largest-ever overseas acquisition by a Japanese company. Although Shire is...

14 Sep 2018

Indian health ministry banned 329 controversial fixed dose combination with immediate effect

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Tagsbanned fixed dose combination in india, CDSCO, DCGI, India's Health Ministry has banned 344 fixed dose drugs

The ministry of health and family welfare has prohibited the manufacture for sale, sale or distribution for human use of...

6 Sep 2018

Pharma aaquisition: Aurobindo to acquire dermatology and oral solids businesses from Sandoz Inc. for $900 million

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Tagsacquisistion in pharma, acquisition in pharma, acquisition of injectable business, global pharma deals, global pharma licensing deal

Aurobindo Pharma’s US based subsidiary Aurobindo Pharma USA Inc has entered into a definitive agreement with Sandoz Inc., USA, a...

30 Aug 2018

Market Launch and brand positioning of Volini Maxx

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TagsLine extension pharma brand, pharma brand positioning, volini, volini maxx

Sun Pharma Consumer Healthcare, a division of Sun Pharmaceutical Industries Ltd, has launched Volini Maxx, a strongest pain relief spray....

Recently Published Articles

Insight on USFDA Approves Vitrakvi® (larotrectinib), the First Ever TRK Inhibitor

Case Study: Pfizer’s Lyrica’s patent extension with paediatric exclusivity

What is pediatric exclusivity?

Case Study: Insight on DRL-Indivior Suboxone Patent Battle

Grünenthal entering into US market with acquisition of US based Averitas Pharma

Pharma Disinvestment deal: AstraZeneca to divest Synagis US rights to Sobi

Pharma R&D Deal Termination: Daiichi Sankyo & GSK’s vaccine JV in Japan

Insight on Strides – SUDA Pharma Strategic Deal

How much is the ideal royalty payment in pharmaceutical industry?

Hikma Pharmaceuticals and Vectura codevelopment and commercialization of GSK’s Breo Ellipta generics

Pharma acquisition Insight: Hikma Pharmaceuticals to acquire Medlac Pharma

Secarna enters co-development pact with MetP Pharma for transnasally delivered antisense oligonucleotide-based CNS therapeutics

Glenmark’s anti-myeloma drug to start phase 1 trial in solid tumors

Glenmark’S Exclusive Collaboration Agreement with SCD Pharmaceuticals, South Korea for Ophthalmic Solution Products

Pfizer gets US FDA approval for Lorbrena for previously-treated ALK-positive metastatic NSCLC

Quick Look in Unichem – Optimus deal

Novartis R&D portfolio update

Bristol-Myers Squibb, Infinity Pharma ink clinical collaboration deal

Adalimumab Biosimilar Litigation: Sandoz’s settlement with AbbVie

Case Study – Quick Look up at DCGI approval of Lundbeck’s Brintellix

Eyevance Pharmaceuticals Acquires Worldwide Rights to NEXAGON®

Case Study: USFDA The Limited Population Pathway and approval of Arikayce

Dr. Reddy’s sells Cloderm cream to EPI Health

DRL to disinvest antibiotics plant to Abu Dhabi-based Neopharma

Case Study: Product Recall due to labeling error

Tildrakizumab (Ilumetri): Discovery, Development to Commercialization Case Study

Consequences and progress of Takeda-Shire Buyout

Indian health ministry banned 329 controversial fixed dose combination with immediate effect

Pharma aaquisition: Aurobindo to acquire dermatology and oral solids businesses from Sandoz Inc. for $900 million

Market Launch and brand positioning of Volini Maxx

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