IPP Bureau
Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
By IPP Bureau - August 22, 2022
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
DCGI approves AstraZeneca 's Olaparib film-coated tablets
By IPP Bureau - August 20, 2022
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
Shilpa Medicare completes clinical studies of high concentration biosimilar Adalimumab
By IPP Bureau - August 20, 2022
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
Godrej reveals how to win the war against Malaria through strategic collaboration
By IPP Bureau - August 20, 2022
~96% decline reported in Malaria cases in Madhya Pradesh, due to public-private-people partnership
European Medicines Agency accepts Menarini’s application for Elacestrant
By IPP Bureau - August 20, 2022
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
Swissmedic approves Kapruvia with additional regulatory decisions expected in H2 2022
By IPP Bureau - August 20, 2022
Therapy recently approved in Canada under the brand name KORSUVA
Merck, Starpharma expand partnership to develop antibody drug conjugates
By IPP Bureau - August 19, 2022
DEP® ADCs exploit the unique potential of Starpharma's DEP® technology to provide enhanced characteristics to ADCs i
WuXi STA breaks ground for second manufacturing facility in US
By IPP Bureau - August 19, 2022
This biopharmaceutical facility is one most significant private sector investment ever in the Middletown region
Strides receives USFDA approval for Naproxen Sodium OTC Softgel capsules
By IPP Bureau - August 19, 2022
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
Lupin receives approval from U.S. FDA for Rufinamide Tablets USP
By IPP Bureau - August 19, 2022
The product will be manufactured at Lupin's facility in Goa, India.
QPharma launches Ti OrderPoint 2
By IPP Bureau - August 19, 2022
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
Tavneos recommended by England’s NICE for the treatment of AAV
By IPP Bureau - August 19, 2022
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
CureVac, GSK start Phase 1 clinical study of omicron-targeting COVID-19 vaccine candidate
By IPP Bureau - August 19, 2022
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
Jemincare inks licensing deal for prostate cancer drug with Roche
By IPP Bureau - August 19, 2022
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
Growing investment in biotech startups likely to make CAR-T therapies affordable in India, says GlobalData
By IPP Bureau - August 19, 2022
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.