Drugs

A team at the University of Leeds collaborated with researchers at Roche Diagnostics to develop the technique, which could help doctors and patients to decide on the best treatment options. They used samples from a previous trial funded by Cancer Research UK to look at the levels of two proteins, known as tumor amphiregulin (AREG)

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma LAUSANNE, Switzerland–(BUSINESS WIRE) APRIL 23, 2021 — ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after

BMS is building up its cell manufacturing footprint and network across the globe. The American pharmaceutical company currently has cell therapy manufacturing facilities in the US: including in Bothwell, WA and Summit, NJ. Last month BMS announced the addition of a new facility in Devens, MA; which has been followed by today’s announcement of the

The Moderna deal is the company’s first firm agreement for 2022: and the deal includes the option for Israel to purchase the company’s variant-specific vaccines,​​ subject to regulatory approval. Meanwhile, Pfizer will also supply Israel with doses in 2022: while elsewhere the company is also in negotiations with the EU for a 1.8 billion mega

The company reported yesterday [April 21] that sales in its pharmaceutical division dipped 9% to CHF 10.6bn (US$11.54bn). The pandemic also served to undermine the pharmaceutical division’s sales, especially for medicines where regular visits to hospitals or health practices are needed, such as infusions. Partly compensating that negativity, however, were the additional sales of medicines

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer London UK 22 April 2021 — GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics License Application. Jemperli is indicated for the treatment of adult

Transforming how vaccines are made In February, the researchers introduced a new biomanufacturing platform​​ – called in vitro conjugate vaccine expression (iVAX) – that they had developed. That platform is designed, they said, to quickly make shelf-stable vaccines at the point of care, ensuring they will not go to waste due to errors in transportation or

This brings the number of doses ordered by the bloc up to 600 million, and is the largest cumulative supply agreement that Pfizer/BioNTech have made globally. A total of 600 million doses represents enough to cover 300 million people: around two-thirds of the EU population. The vaccine will be supplied from BioNTech and Pfizer’s manufacturing sites

GAMUT is a spin-out of the Institut de la Vision in Paris, focused on the research of scientific founder Dr. Deniz Dalkara and her collaborators. It was started in 2020 with seed funding from Advent France Biotechnology. SparingVision’s SPVN06 already addresses mid-stages of rod-cone dystrophies, while GAMUT’s SPVN20 addresses late stages: giving SparingVision the opportunity

The rollout of the vaccine – which had been authorized for use in the EU on March 11 – was put on hold by J&J last week after it became aware of the blood clots. In the US, authorities also recommended a similar pause while the blood clot cases were investigated. Issued today, the EMA

CAR T cell treatment, which has already been approved for some blood cancers, such as certain types of leukemia and lymphoma, is still not completely effective, even in some people who initially respond well to the therapy. One limitation is that the T cells seem to lose their potency after a while, a phenomenon called

ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ — ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug Administration (FDA) approved Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use for the

The aim of the study is to see what kind of immune response is required to stop people being re-infected; as well as investigate how the immune system reacts to re-exposure. As a challenge trial, the study will purposefully infect healthy volunteers with the virus in a carefully controlled environment. The results of the trial,

April 16, 2021 Audience: Consumers April 16, 2021 — Sanit Technologies LLC d/b/a Durisan announces a voluntary recall expansion of its Durisan Antimicrobial Hand Sanitizer, NonAlcohol products in various sizes listed to now include products that have not yet expired. The products are being recalled due to out of specification microbial contamination. The issue was

Launched in February, the world-first ‘Com-Cov’ trial​​ is seeing whether the first dose of one vaccine type can be mixed with a second dose of a different type: thus giving vaccination campaigns more flexibility in the eventuality of a shortfall of one type. Volunteers in the new trial arms will have already received the first

The contract would specify that production of the doses, including production of essential components, would be based in the EU. As of last month, the two companies had signed orders for a combined total of 1.4 billion doses for this year (although this total is expected to rise). The EU’s new mega order, therefore, is

The site will be dedicated to cGMP manufacturing capacity for mammalian biologics, and will be the sixth site across Abzena’s global network. The Sanford site will contain up to 12 x 2000L bioreactors. Phased construction process San Diego-headquartered Abzena specializes in the integrated development and manufacture of complex biologics and bioconjugates. The design of the

PRINCETON, N.J.–(BUSINESS WIRE)– April 16, 2021 Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population1 U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless

Able to obtain millions of data point from individual cells, single-cell analysis achieves unprecedented scale and resolution, heard attendees at a joint symposium run by the American Association for Cancer Research (AACR) and the Chinese Society of Clinical Oncology (CSCO) this week: Changing the Landscape of Cancer Research​. Speakers participating in that AACR 2021 event

A Phase 1 study for a RSV vaccine candidate is also under way. As part of its Vaccine Day this week, the company has updated its vaccine developement timeline and unveiled results from early stage mRNA vaccine trials. HIV vaccines: mRNA-1644 and mRNA-1574​ Moderna expects to begin three phase 1 clinical trials for two HIV vaccine

FDA Approves Nextstellis (drospirenone and estetrol) Oral Contraceptive for Birth Control 15 April 2021, Adelaide, Australia and Liege, Belgium: Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for the novel

The move was expected; it follows Sterling’s strategic investment in the ADC Bio business back in December 2020, with the CDMO then indicating then the possibility it would take on full ownership of the UK firm in early 2021, subject to due diligence. ADC Bio have been at the forefront of antibody-drug bioconjugation and process