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Recent Industry Update
- Brand Promotion: Mankind’s OTC brand KABZEND
- PDL – Depomed’s deal for type 2 diabetes products
- EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease
- In clinical research, is observational study is also known as interventional study?
- US FDA grants breakthrough therapy status for Lenvima in combo with Keytruda
- Insight on Bayer’s EU approval of new treatment regimen for Eylea
- Case Study: LEO Pharma’s acquisition of Bayer’s dermatology unit
- Wockhardt sets up $40-million antibiotic manufacturing plant in Jafza, Dubai
- What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
- EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC
- Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate
- Hyrimoz Sandoz’s biosimilar got European marketing approval
- Is COPP and FSC is same?
- Nabriva acurie Zavante to stregthen antibiotic pipeline
- US FDA committee recommends approval malaria drug, Tafenoquine
- What is EMA’s PRIME designation?
- Sun Pharma launches generic Glumetza tablets in US
- Insight on FDA Approval of Symtuza for Treatment of HIV Infection
- Case Study on USFDA Label Expansion: Novartis’ Kisqali
- Close look into US FDA 510(k) clearance – Adaptiiv’s 3D Bolus Software
- Zavation receives US FDA approval to market Normandy VBR System
- DRL launches generic Nexium 24HR capsules in US market
- Case Study: Novartis Pharma’s global licensing deal to develop & commercialise MOR106
- Geisinger, AstraZeneca partner to create new asthma app suite
- New Drug Approved in India tilldate 2018
- Case Study: Global Recall of Valsartan due to it’s impurity that is carcinogenic
- ANDA – Self Assessment Test on Abbreviated New Drug Application
- Roche’s Tecentriq in combo with Avastin receives US FDA breakthrough therapy designation
- EUSA Pharma acquires global rights to Sylvant from Janssen Sciences for US$ 15 mn
- Aurobindo acquires Apotex Inc’s business in 5 European countries for €74 mn
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