4
Aug
2018
Brand Promotion: Mankind’s OTC brand KABZEND
Mankind Pharma, a quality-driven pharmaceutical company in India, has launched a new over-the-counter (OTC) product – KABZEND Natural Laxative Granules... Read More
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Recently Published Articles
4
Aug
2018
PDL – Depomed’s deal for type 2 diabetes products
PDL BioPharma, Inc. (PDL) announces an amendment to the Royalty Purchase and Sale Agreement (the “Royalty Agreement”) with Depomed, Inc.... Read More
4
Aug
2018
EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease
Roche announced that the European Medicines Agency (EMA) has granted Prime (PRIority MEdicines) designation for the company’s investigational medicine RG6042... Read More
3
Aug
2018
US FDA grants breakthrough therapy status for Lenvima in combo with Keytruda
Eisai Co., Ltd. and Merck, known as MSD outside the United States and Canada, announced that the US Food and... Read More
3
Aug
2018
Case Study: LEO Pharma’s acquisition of Bayer’s dermatology unit
LEO Pharma has entered into a definitive agreement to buy Bayer’s global prescription dermatology unit. The portfolio to be acquired... Read More
31
Jul
2018
Wockhardt sets up $40-million antibiotic manufacturing plant in Jafza, Dubai
Wockhardt, an India-based pharmaceutical company, launched a new facility at Dubai’s Jebel Ali Free Zone (Jafza) on Sunday, marking its... Read More
31
Jul
2018
What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
FAR – Field Alert Report Submission FAR should be submitted using Form FDA 3331a. This is for applicants of new... Read More
31
Jul
2018
EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC
Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use... Read More
31
Jul
2018
Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate
Daiichi Sankyo Company, Limited and Glycotope GmbH have entered into an exclusive worldwide licensing agreement to develop an antibody drug... Read More
31
Jul
2018
Hyrimoz Sandoz’s biosimilar got European marketing approval
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, has announced that the European Commission (EC) granted... Read More
30
Jul
2018
Is COPP and FSC is same?
COPP stands for certificate of pharmaceutical products and FSC stands for free sale certificate. Certificate of a Pharmaceutical Product (COPP)... Read More
30
Jul
2018
Nabriva acurie Zavante to stregthen antibiotic pipeline
Nabriva Therapeutics has acquired Zavante Therapeutics. Under the deal terms announced after the market close Tuesday, San Diego-based Zavante received... Read More
30
Jul
2018
US FDA committee recommends approval malaria drug, Tafenoquine
60 Degrees Pharmaceuticals (60P) has announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug... Read More
26
Jul
2018
What is EMA’s PRIME designation?
The PRIME programme was launched by the EMA in 2016 to provide early and enhanced support to optimize the development... Read More
26
Jul
2018
Sun Pharma launches generic Glumetza tablets in US
Sun Pharmaceutical Industries Ltd announced that one of its wholly owned subsidiaries has launched the generic versions of Glumetza (metformin... Read More
22
Jul
2018
Insight on FDA Approval of Symtuza for Treatment of HIV Infection
The US Food and Drug Administration (FDA) has approved what its manufacturer calls “the first and only complete, darunavir-based single-tablet... Read More
22
Jul
2018
Case Study on USFDA Label Expansion: Novartis’ Kisqali
FDA had approved Kisqali in tandem with an aromatase inhibitor as an initial endocrine-based treatment for pre, peri- or postmenopausal... Read More
22
Jul
2018
Close look into US FDA 510(k) clearance – Adaptiiv’s 3D Bolus Software
Adaptiiv, an innovative medical technology company, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market... Read More
22
Jul
2018
Zavation receives US FDA approval to market Normandy VBR System
Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, has received 510(k) clearance from... Read More
22
Jul
2018
DRL launches generic Nexium 24HR capsules in US market
Dr Reddy’s Laboratories Ltd. announced the launch of the US Food and Drug Administration (FDA) approved esomeprazole magnesium delayed-release capsules... Read More
22
Jul
2018
Case Study: Novartis Pharma’s global licensing deal to develop & commercialise MOR106
MOR106 is an investigational, fully human, IgG1 monoclonal antibody directed against the target IL-17C that was generated in a collaboration... Read More
22
Jul
2018
Geisinger, AstraZeneca partner to create new asthma app suite
Geisinger, an integrated health services organization, and AstraZeneca have partnered to improve asthma care by creating a suite of products... Read More
21
Jul
2018
New Drug Approved in India tilldate 2018
List of New drug approved in India in 2018 Tilldate .No Name of drug Indication Date of issue 1 Tenofovir... Read More
21
Jul
2018
Case Study: Global Recall of Valsartan due to it’s impurity that is carcinogenic
Molecule: Valsartan Category: CVS drug Indication: used to treat high blood pressure and heart failure Present status: Valsartan was originally developed... Read More
19
Jul
2018
ANDA – Self Assessment Test on Abbreviated New Drug Application
Analyse your competency in Abbreviated New Drug Application Submission. Take a short self assessment test.
19
Jul
2018
Roche’s Tecentriq in combo with Avastin receives US FDA breakthrough therapy designation
Roche has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in... Read More
19
Jul
2018
EUSA Pharma acquires global rights to Sylvant from Janssen Sciences for US$ 15 mn
EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, has entered into a definitive agreement with Janssen... Read More
15
Jul
2018
Aurobindo acquires Apotex Inc’s business in 5 European countries for €74 mn
Aurobindo Pharma Limited, step-down subsidiary, Agile Pharma B V (Netherlands), signed a definitive agreement to acquire Canadian pharmaceuticals company Apotex... Read More
15
Jul
2018
What is difference between Proof of concept (PoC) Proof of Principle Studies (PoP) in Drug Discovery?
PoP stands for Proof of Principle studies. PoC stands for Proof of Concept. Both the terminology is used in drug... Read More