News

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.

Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

Under the new partnership, Samsung Biologics will develop and manufacture an antibody for a LegoChem Biosciences ADC candidate.

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

Through a €2.7 billion (US$2.9 billion) acquisition of MorphoSys, Novartis will get pelabresib, a late-stage drug candidate in development for cancer treatment.

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

Purolite and Repligen have commercially launched a new CH1 affinity resin for the purification of specialized mAbs.

The addition of another amino acid recognizer as well as improvements in surface chemistry, reagents, and software expand the proteome coverage of Quantum-Si’s Platinum sequencing platform.

The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

Novo Holdings has entered into a merger agreement with Catalent and will acquire Catalent in a deal valued at $16.5 billion.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

Under a new collaboration, Lonza and Oxford Nanopore aim to commercialize a CGMP-validated test for advanced analysis of mRNA products.

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

IMU Biosciences has secured £11.5 million in its Series A financing round.

The acquisition adds a potential rare disease asset to Sanofi’s alpha-1 antitrypsin deficiency pipeline.

The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.