Tag: drug manufacturing

May 23, 2023

The launch of Ayvakit in indolent systemic mastocytosis, or ISM, is being closely watched by investors and analysts. Blueprint brought two drugs to market in recent years — Ayvakit and the cancer drug Gavreto — and since expanded use of […]

May 15, 2023

The U.S. Food and Drug Administration on Friday approved the first nonhormonal medication aimed at easing menopause hot flashes. The new pill, called Veozah (fezolinetant), is a neurokinin 3 (NK3) receptor antagonist. “It works by binding to and blocking the […]

May 15, 2023

Preliminary results for the MenABCWY candidate were presented by the company at the European Society for Paediatric Infectious Diseases congress in Lisbon, Portugal. Invasive meningococcal disease (IMD) is an uncommon but serious illness that can cause life-threatening complications or even […]

May 11, 2023

Cellular Origins, a TTP Company focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies (CGTs), entered into a collaborative partnership with ScaleReady, a joint venture between Bio-Techne, Fresenius Kabi and Wilson Wolf that brings together process […]

May 8, 2023

OBiO Technology Corp., a provider of gene and cell therapy-focused biotechnology, entered into a strategic commercial manufacturing collaboration with Chinagene, a developer of clinical genetic diagnosis, and gene therapy drugs. Under the agreement, OBiO will provide contract development and manufacturing […]

May 3, 2023

Forge Biologics, a manufacturer of genetic medicines, will collaborate with Labcorp, a global life sciences company, on gene therapy development and manufacturing. Under the alliance, gene therapy clients will have access to manufacturing capabilities, drug development services, and coordinated scientific […]

May 2, 2023

FDA released a new draft guidance that provides recommendations aimed at sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. This specific guidance refers to a DCT as a clinical […]

April 25, 2023

Biogen has stopped or paused several drug programs as part of a larger effort to cut costs and prioritize certain research. The decision, disclosed Tuesday in the company’s latest earnings report, comes as sales of its marketed medicines for brain […]

April 18, 2023

A single dose of either Pfizer’s or Moderna’s updated COVID-19 vaccines will be recommended in most cases moving forward, after the Food and Drug Administration on Tuesday updated its authorizations of the shots to simplify the recommended regimens. Adults or […]

April 18, 2023

In 2018, FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of New Drugs (OND) developed a research program to centralize and enhance its regulatory science research activities. In more recent years, the OND Research Program (OND-RP) published its first […]

April 14, 2023

Mirikizumab is one of a slate of anticipated drug launches Lilly is relying on to add billions more to its yearly sales totals. Others include the fast-selling diabetes drug Mounjaro — which could soon be cleared as a weight-loss treatment […]

April 12, 2023

Meissner, a company focused on advanced microfiltration and therapeutic manufacturing systems, announced on April 6, 2023 that it will invest nearly $250 million in a new manufacturing facility in Athens-Clarke County, Ga. The new facility will be located at the […]

April 7, 2023

In an important update to its policies for conducting clinical trials to support accelerated approval of important oncology and other lifesaving therapies, FDA is articulating a preference for randomized controlled trials (RCTs), as opposed to single-arm studies, to support fast […]

March 22, 2023

The Food and Drug Administration may have an easier time deciding how to approach a closely watched medicine for ALS it is reviewing, after a group of agency advisers appeared to support a conditional approval during a meeting Wednesday. The […]

March 17, 2023

Sandoz, the generics and biosimilars division of Novartis, announced on March 9, 2023 that it has signed a memorandum of understanding to build a new biologics production plant in Lendava, Slovenia. The company expects to invest at least $400 million […]

March 13, 2023

Migraine sufferers will soon have a new treatment option that works more quickly and may be safer for people at risk of heart attack or stroke. The U.S. Food and Drug Administration has approved Pfizer Inc.’s zavegepant (Zavzpret), a nasal […]

March 2, 2023

Allergic reactions to the Pfizer or Moderna COVID vaccines are very rare, and a new study questions whether many of those that do occur are even real. In a small new study of 16 people who said they’d experienced an […]

January 24, 2023

Eli Lilly will invest $450 million in a North Carolina manufacturing plant to meet growing demand for its diabetes drugs Mounjaro and Trulicity, the company said Tuesday. The investment in the Research Triangle Park plant will expand filling, device assembly […]

November 10, 2022

Cancer cells acquire genetic changes that allow them to grow and proliferate unchecked. Researchers at the Dana-Faber Cancer Institute and colleagues have now found another difference between cancer cells and normal cells. The team analyzed public datasets comprising thousands of […]

October 31, 2022

Lannett Company, Inc. has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino, the company’s branded topical anesthetic product, at its main plant in Seymour, IN. The company previously manufactured Numbrino and other liquid drug products […]