IPP Bureau

Ascletis announces IND approval of Oral RdRp Inhibitor ASC10 for COVID-19 by China NMPA
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

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