Pharmaceutical Technology Editors

The company has filed an NDA for lurbinectedin and is seeking accelerated approval for treatment of relapsed small cell lung cancer.

The rapid-onset CNS neuroactive nasal spray is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations.

Through the acquisition, Merck will gain access to ArQule’s lead investigational candidate, ARQ 531, a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase II dose expansion study for the treatment of B-cell malignancies.

Through the collaboration, Charles River plans to expand its suite of authentic human cells by utilizing Bit Bio’s target discovery, validation, and screening services to further the development of therapies with a higher chance of success in patients.

Catalent recently completed the clinical production of Bridge’s opioid addiction development therapeutic product and investigational new drug, BT-219, which will be used with Catalent’s Zydis orally disintegrating tablet technology.

Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.

Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.

Life science and healthcare business accelerator, Start Codon, and membership organization, One Nucleus, have partnered up to support the life science ecosystem in the United Kingdom.

Swiss-based specialist pharma R&D company, MetP Pharma, has been granted a Notice of Allowance from the Unites States Patent and Trademark Office (USPTO) for its patent titled, “Treatment of Demyelineating Diseases.”

Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.

According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.

With support from academia, patient advocacy organizations, private and nonprofit companies, government organizations, and clinical trial networks funded by the NIH, a new plan was developed to focus on HBV biology, sharing tools and resources, and strategy creation.

The acquisition boosts Sanofi’s pipeline of immuno-oncology product candidates with a lead candidate in development for treating solid-tumor-type cancers.

Under the restructuring, Sanofi will gain sole global rights to Kevzara (sarilumab) and sole ex-US rights to Praluent (alirocumab), while Regeneron will gain sole US rights to Praluent.

The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.

GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

The new technical service center at the Memphis International Airport will service inbound and outbound traffic for the company’s CSafe RKN and CSafe RAP active container systems.

The expansion will enhance the company’s specialty drug product capabilities.

The new software lets users choose the volume and cell concentration from initial cell preparation through transduction to final resuspension, without compromising cell viability and virus stability.

The app, CURE ID, is designed to allow the clinical community to report their experiences treating infectious diseases with novel uses of existing FDA-approved drugs.

The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

Expert poll highlights strength of US pharma sector and advances by emerging markets.

A drug discovery company based in the United Kingdom, Lunac Therapeutics, has been awarded funding worth £3.14 million (US$4.11 million) under Innovate UK’s Biomedical Catalyst program.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

BioMed X has announced the successful completion of its first joint research project in the fields of COPD and IPF that it had undertaken with Boehringer Ingelheim.

Data released by the Cell and Gene Therapy Catapult (CGT Catapult) have shown that demands for specialist skills and investment in the cell and gene therapy industry in the United Kingdom are set to increase in the near future.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Iontas has entered into a collaboration agreement with Adaptate Biotherapeutics for the generation and optimization of antibodies for novel immune-oncology targets.