Wednesday, April 21, 2021

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Novartis signs initial agreement with Roche to reserve capacity and implement the technology transfer for the production of Roche’s Actemra/RoActemra®

April 15, 2021: Novartis has signed an initial agreement with Roche to reserve capacity and implement the technology transfer for the production...

FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19

April 14, 2021: "During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture...

U.S. FDA Approves Trodelvy® for Treatment of Metastatic Urothelial Cancer

April 13, 2021: Gilead Sciences, Inc. announced that the U.S. FDA has granted accelerated approval of Trodelvy® (sacituzumab govitecan-hziy) for use in adult...

Myovant, Pfizer strats dosing in Relugolix Contraceptive study

April 12, 2021: "Myovant Sciences and Pfizer Inc. announced that the first participant has been dosed in the Phase 3 SERENE study...

AZ’s Tagrisso approved in China in early lung cancer

April 14, 2021: "AstraZeneca’s Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal...

Sanofi continues to strengthen its vaccines manufacturing capacities in Singapore

April 12 2021: Sanofi announced a €400 million investment over five years to create a unique vaccine production center in Singapore, pushing...

AZ’s Update on the DARE-19 Phase III trial for Farxiga in COVID-19

April 12, 2021: "AstraZeneca and Saint Luke’s Mid America Heart Institute today announced high-level results of the primary analysis from the DARE-19...

FDA Authorizes Device that Uses AI to Detect Potential Signs of Colon Cancer

April 09, 2021: "The U.S. FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on...

Lilly and Incyte announce results from baricitinib’s COV-BARRIER study in hospitalized COVID-19 patients

April 8, 2021: Eli Lilly and Company and Incyte announced results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily...

BMS Announces Opdivo plus Yervoy in Esophageal Squamous Cell Carcinoma

April 8, 2021: "Bristol Myers Squibb announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab)plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in...

FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies

April 08, 2021: "Protecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration’s...

Sanofi completes Kymab acquisition

April 09 2021: "Sanofi announced today the successful completion of its acquisition of Kymab Group Ltd., adding KY1005 to its pipeline, a fully human...

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Chemotherapy-free treatment option to be offered to patients with England’s most common leukaemia

April 21, 2021: A brand new oral treatment for an incurable blood cancer has been recommended for NHS use by NICE.

GW Pharma receives EU approval for EPIDYOLEX® for treatment of seizures

April 20, 2021: "GW Pharmaceuticals, a world leader in discovering, developing and delivering regulatory approved cannabis-based medicinesannounces that the European Commission has...

Amgen Successfully Completes Acquisition Of Five Prime Therapeutics

April 16, 2021: "Amgen announced that it has successfully completed its previously announced tender offer to purchase all outstanding shares of...

JCVI issues new advice on COVID-19 vaccination for pregnant women

April 16, 2021: There have been no specific safety concerns identified with any brand of coronavirus (COVID-19) vaccines in relation to pregnancy.