Pharmaceutical Technology Editors

AbbVie will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF).

Research from Massachusetts Institute of Technology suggests that small chips could replace standard lab-scale spectrometry equipment for many applications.

The company added a new EUR 63-million (US$72-million) packaging center at its manufacturing site in Darmstadt, Germany.

The investment in the company’s Mississauga, Canada, laboratory includes an expansion of existing cell/tissue culture capabilities, flow cytometry, mass spectrometry facilities, and more.

GiroNEX's new precision powder dispensing technology may provide the pharmaceutical industry with increased ability to offer patient-specific dosing.

AstraZeneca and Innate Pharma further expand oncology collaboration with a new multi-term agreement.

The company will complete an expansion of its secondary packaging capabilities at its Ravensburg, Germany site by 2020.

The agency has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza.

A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.

An advanced combination polymer for enteric coatings has been launched by Evonik and will be showcased during AAPS PharmSci 360 in Washington D.C.

Dr C. Frank Bennett, has been announced as a recipient of the Breakthrough Prize in Life Sciences in recognition of his contribution to the discovery and development of the first drug approved for the treatment of spinal muscular atrophy (SMA).

The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.

Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.

The companies will work together to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications in a deal with $100 million.

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy.

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

The new guidance, Rare Diseases: 2 Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

Clovis Oncology and Lonza celebrated the grand opening of a dedicated production train at Lonza’s Visp, Switzerland site for manufacturing Rubraca (rucaparib).

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

The company will collaborate with GlycoBac to offer an insect cell line for the development of viral vaccines and gene therapies.

The company was awarded for excellence in innovation for Parteck MXP Excipient and modified amino acids.

Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).