Biopharma News

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.

Legacy Pharmaceuticals has entered into a collaboration with SCHOTT to solve a technical challenge of leaching that is occurring with an antiviral drug.

Shareholders have approved the issuance of Bristol-Myers Squibb common stock for the pending $74-billion merger with Celgene.

With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

Adding to an existing $115-million investment, the 700,000-ft2 site in Longmont, CO will expand AveXis’ gene-therapy manufacturing capacity.

XenTech and the Gustave Roussy Cancer Center have signed a strategic collaboration agreement aimed at the development of a collection of tumor explant models from patients with acquired resistance to targeted therapies.

The collaboration will apply artificial intelligence and machine learning to the development of drugs for treating a range of cancers.

Worth up to $605 million, the collaboration will focus on studying a preclinical novel target that could lead to potential new treatments for autoimmune diseases.

PDC*line Pharma has entered into a licensing agreement with LG Chem to develop a lung cancer vaccine in Asia.

Cell Mogrify (Mogrify), has been granted funding by the UK’s innovation agency, Innovate UK, to accelerate regenerative cell therapies.

Merck KGaA opened a collaborative bio/pharma development facility in Molsheim, France and announced an investment plan through 2025 for its Darmstadt, Germany headquarters.

Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.

The companies announced a collaboration to jointly discover and develop treatments to address unmet medical needs in a specific neurological disease.

The company received $4.8 million from the Bill & Melinda Gates Foundation to accelerate global health research in the development of vaccines and antibody-based treatments for infectious diseases.

The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.

The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

The $4.3-billion acquisition is expected to strengthen Roche’s gene therapy pipeline.