18
Jun
2018
What is PIC/S? Is India part of PIC/S?
What is PIC/S? The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the... Read More
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Recently Published Articles
18
Jun
2018
Sun Pharma’s got clearance For Halol Facility From US Regulator
Sun Pharma received the EIR or Establishment Inspection Report from the US Food and Drug Administration (FDA) for its Halol... Read More
19
May
2018
USFDA approval of Amgen’s Aimovig for preventive treatment of migraine in adults
Amgen has got US Food and Drug Administration (FDA) approval for Aimovig (erenumab-aooe) for the preventive treatment of migraine in... Read More
18
May
2018
What is placebo effect in clinical trial?
A placebo is a substance or treatment with no active therapeutic effect. Common placebos include inert tablets (like sugar pills),... Read More
18
May
2018
“A Phase 3 trial is randomized, double-blind, and placebo-controlled” – What it signifies?
“A Phase 3 trial is randomized, double-blind, and placebo-controlled” – What it signifies? We sometime confuse the terminologies of clinical... Read More
18
May
2018
US WorldMeds’ Lucemyra received US FDA approval for management of opioid withdrawal symptoms
US WorldMeds announced that the US Food and Drug Administration (FDA) approved Lucemyra (lofexidine) for mitigation of opioid withdrawal symptoms... Read More
17
May
2018
Alcon Cares Project 100 commits to reducing cataract blindness globally
Alcon, the global leader in eye care and a division of Novartis, has announced Alcon Cares Project 100, which aims... Read More
17
May
2018
Licensing Deal: Hikma Pharma launches Basilea’s antibiotic Zevtera in Saudi Arabia
Basilea Pharmaceutica Ltd. announced that its partner Hikma Pharmaceuticals LLC has launched Basilea’s hospital antibiotic Zevtera (ceftobiprole) in Saudi Arabia... Read More
15
May
2018
Medical Science Liaison (MSL) – A Career Option for Healthcare Professionals !
What is The Medical Science Liaison (MSL)? The Medical Science Liaison (MSL) is a specific job related role within the healthcare... Read More
15
May
2018
A close look into New Drug Development Timeline – Fingolimod
Fingolimod is an immunomodulating drug, mostly used for treating multiple sclerosis (MS). It has reduced the rate of relapses in... Read More
9
May
2018
Big Pharma Acquisition: Takeda to acquire Shire for $62 billion
Takeda Pharmaceutical Co. of Japan has finalized an agreement to buy Shire PLC, the second-biggest biotech employer in Massachusetts, for... Read More
8
May
2018
Quick look into Roche’s Tecentriq US FDA priority review grant
USFDA has accepted the Roche’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq. (atezolizumab), in combination with... Read More
7
May
2018
What is an open-label trial?
Open-label trial or open trial, is a type of clinical trial in which both the researchers and participants know which... Read More
7
May
2018
US FDA approves use of Tafinlar & Mekinist together to treat BRAF-positive anaplastic thyroid cancer
The US Food and Drug Administration (FDA) approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic... Read More
7
May
2018
PaxVax’s chikungunya vaccine receives US FDA fast track designation
PaxVax, a leading independent specialty vaccine company, has received Fast Track designation from the US Food and Drug Administration (FDA)... Read More
19
Apr
2018
Para IV notice: Endo International gets Paragraph IV notification on Vasostrict
Endo International plc announced that its subsidiaries, Par Pharmaceutical, Inc. and Par Sterile Products, LLC, have received a Notice Letter... Read More
19
Apr
2018
AstraZeneca, Daiichi Sankyo to introduce Nexium 10 & 20 mg granules for suspension, Sachet, in Japan
AstraZeneca K.K. and Daiichi Sankyo Company Limited announced the launch of proton pump inhibitor Nexium 10 mg and 20 mg... Read More
19
Apr
2018
Biogen to acquire Pfizer’s Phase 2b – ready compound
Biogen Inc. will acquire from Pfizer Inc. a Phase 2b-ready compound designed to treat cognitive impairment associated with schizophrenia. Biogen... Read More
8
Apr
2018
Plaque psoriasis drug Tremfya receives Australian & Brazilian approvals
MorphoSys AG, a late-stage, biopharmaceutical company, announced that country subsidiaries of its licensee Janssen reported that Tremfya (guselkumab) has been... Read More
8
Apr
2018
Deal Insight: Daiichi Sankyo, DarwinHealth R&D agreement
Daiichi Sankyo Company, Limited and DarwinHealth announced they have entered into a research agreement providing Daiichi Sankyo with exclusive access... Read More
8
Apr
2018
US FDA approval of Sonoma Pharma’s antimicrobial post-therapy gel
Sonoma Pharmaceuticals, Inc., a specialty pharmaceutical company, has received a new 510(k) clearance from the US Food and Drug Administration... Read More
5
Apr
2018
Glenmark and Helsinn Group’s exclusive licensing deal for launch of Akynzeo in India and Nepal
Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, and Helsinn Group (“Helsinn”), a Swiss pharmaceutical group focused on building... Read More
5
Apr
2018
Natco launched a generic version of Teriflunomide tablets for the treatment of relapsing and remitting forms of multiple sclerosis in India
Natco Pharma launched a generic version of Teriflunomide for the treatment of relapsing and remitting forms of multiple sclerosis (RRMS),... Read More
28
Mar
2018
Case Study: GSK to acquire Novartis’s consumer healthcare stake for $13bn
Swiss drugmaker, Novartis agreed to sell GSK its stake in their consumer health joint venture for $13bn. GlaxoSmithKline will be... Read More
25
Mar
2018
US FDA approves Novartis’ Tasigna to treat children with rare form of leukemia
Novartis announced that the US Food and Drug Administration (FDA) expanded the indication for Tasigna (nilotinib) to include treatment of... Read More
25
Mar
2018
AstraZeneca receives EU approval for Lokelma to treat adults with hyperkalaemia
AstraZeneca announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment... Read More
25
Mar
2018
What is the significance of Phase 2b Clinical Trial?
In clinical trial, Phase 1 and 2 trials establish proof-of-concept, and phase 3 trials establish the efficacy and safety of... Read More
19
Mar
2018
Brand Positioning: GSK Consumer Healthcare Ltd launches Horlicks Protein+
GSK Consumer Healthcare Ltd, the maker of Horlicks, is making another attempt to diversify. The company is set to launch... Read More
19
Mar
2018
Case Study: Lundbeck acquires Prexton Therapeutics
Lundbeck has agreed to acquire Prexton Therapeutics for up to €905 million ($1.1 billion), in a deal that adds a... Read More