News

The collaboration will see Shimadzu and UMG develop new clinical laboratory methods using LC-MS for TDM analysis.

MGI and Imperial College will jointly operate a CEC designed to provide European customers with first-hand experience with various automation and sequencing instruments.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.

Under this deal, Merck, known as MSD outside of the United States and Canada, will select Veeva products for industry-specific software and data.

Johnson & Johnson’s acquisition of Abiomed, a provider of heart pump technologies, is designed to bolster their position in the medical technology sector.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Lonza and Singzyme will use Singzyme’s enzymatic conjugation platform to develop novel bioconjugates.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA keeps its user fees but fails to gain important reforms.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

The newly formed partnership between CSafe and BioLife will expand cold chain supply chain solutions for the cell and gene therapy market.

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Cambrex has expanded its stability storage business, Q1 Scientific, in Ireland and Belgium.

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.

Aragen’s new 12,000 ft² facility will include various dosage form capabilities, including oral solids, liquids, topicals, and films.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

AAPS will exclusively advise RX Global on scientific focus areas for Interphex 2023, which is set to take place at the Javits Center in New York City next spring.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

Gilead and MacroGenics will work together on bispecific antibodies for the treatment of blood cancers.

Ebvallo (tabelecleucel) would be the first EMA-approved therapy for patients with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Takeda’s dengue vaccine is designed to prevent disease caused by virus serotypes 1, 2, 3, and 4 in individuals four and older.