Lupin responds to US FDA’s OAI letter
Lupin is in the process of sending further updates of its corrective actions to the US FDA and remains hopeful of a positive…
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Pall Corporation in agreement with ARTeSYN Biosolutions
Under the agreement, Pall Biotech will distribute ARTeSYN’s standard hardware and liner components off the shelf
Kiran Mazumdar-Shaw conferred with honorary doctorate from Deakin University, Australia
She was recognised for her pioneering entrepreneurial role in the field of biotechnology and for her sustained significant…
Roche’s Tecentriq notches win in breast cancer with US approval
The FDA’s OK was based on a trial that showed the drug cocktail helped stave off the disease’s advance by a median 7.4 months,…
Bayer Roundup cancer trial goes to jury after closing arguments
Hardeman’s lawyer, during her closing arguments had said Hardeman had “extreme” exposure to Roundup, spraying the chemical more…
National Cancer Institute chief Norman Sharpless to serve as acting FDA head
Cancer experts and advocates praised the appointment of Sharpless as acting FDA chief after Scott Gottlieb’s abrupt resignation…
Regeneron/Sanofi wins US approval for expanded use of skin drug
The US Food and Drug Administration said it approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SA’s eczema drug…
SPARC inks research collaboration pact with China’s HitGen
Under the terms of the agreement, HitGen will receive upfront payment and will be eligible for certain milestone payments
Lilly’s combo therapy succeeds in late-stage lung cancer study
Lung cancer is the leading cause of cancer death among both men and women, according to the American Cancer Society
Piramal announces MITIGO and generic cinacalcet hydrochloride tablets in US
While Piramal Critical Care has announced MITIGO (Morphine Sulfate Injection, USP – Preservative-free), Pirmal Enterprises's…
Laurus Labs receives two approvals from US FDA
Receives a final approval for Hydroxychloroquine tablets
Indian defence lab develops ‘combat drugs’ to reduce casualties
The spectrum includes bleeding wound sealants, super absorptive dressings and glycerated salines, all of which can save lives
CDSCO directs Johnson & Johnson to pay Rs 74.5 lakh to first patient with faulty hip implant
This is the first case where M/s Johnson & Johnson has been directed to pay compensation for its faulty ASR hip implant
USFDA concludes inspection of Unichem Lab’s Ghaziabad facility
The inspection was successfully conducted from March 3-8, 2019, without any USFDA form 483 being issued
GoI introduces nicotine replacement gum Nirmal under PMBJP
Nirmal will be available in various districts across the country in Pradhan Mantri Janaushadhi Kendras
West Pharma opens new digital technology centre in Bengaluru
The centre will enhance customer engagement through digital marketing, digital manufacturing and automations to accelerate…
Biocon gets six observations from USFDA after inspection of its Bengaluru plant
The United States Food and Drug Administration (USFDA) concluded a pre-approval inspection of Biocon's insulin drug substance…
Marksans Pharma gets eight observations from USFDA for its Goa facility
The inspection of the facility took place between February 25 to March 6, 2019 resulting in a Form 483 with eight observations
Lupin gets USFDA nod to market its cholesterol lowering drug
The company has received nod from the US health regulator to market its generic Atorvastatin Calcium tablets, used for lowering…
Suven plans to buy US-based Rising Pharmaceuticals’ assets
Suven Life Sciences through its joint venture partner, Shore Suven Pharma, has entered into a 'stalking-horse' asset purchase…