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4102 News Found

NMPA approves CStone's NDA for Cejemly
Drug Approval | December 21, 2021

NMPA approves CStone's NDA for Cejemly

The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients


Shilpa Medicare launch Prucalshil for treatment of constipation
Drug Approval | December 21, 2021

Shilpa Medicare launch Prucalshil for treatment of constipation

Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


Novartis collaborates with BeiGene to strengthen immunotherapy pipeline
Biotech | December 21, 2021

Novartis collaborates with BeiGene to strengthen immunotherapy pipeline

Innovative market development collaboration also signed, expanding the availability of select Novartis oncology products in regions across China currently not covered by Novartis


U.S. FDA approves ANI’s rifabutin capsules, launch soon
Drug Approval | December 21, 2021

U.S. FDA approves ANI’s rifabutin capsules, launch soon

The capsules are the generic version of the reference listed drug Mycobutin


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Merck’s tepmetko receives positive CHMP opinion in Europe
Biotech | December 20, 2021

Merck’s tepmetko receives positive CHMP opinion in Europe

The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping


TeleRay and Radiobotics to provide radiology AI
News | December 20, 2021

TeleRay and Radiobotics to provide radiology AI

TeleRay partners with Radiobotics, adding Artificial Intelligence to their pre-existing integrated best-in-class medical image and patient information distribution platform


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease


Alloy Therapeutics acquires deepCDR Biologics to bring ML into drug discovery
Digitisation | December 17, 2021

Alloy Therapeutics acquires deepCDR Biologics to bring ML into drug discovery

The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles