News

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.

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, 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.

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.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The US Department of Health and Human Services has published its proposed rule on the disclosure of drug prices, just in time for the November mid-term elections.

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.

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

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

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

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

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.

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

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

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).

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

The new facility will include comprehensive mammalian process development and manufacturing capabilities.

Roche has acquired Tusk Therapeutics in a deal worth up to EUR 659 million (US$762 million).

The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.

The companies signed a three-year clinical manufacturing agreement to manufacture GlaxoSmithKline’s specific peptide enhanced affinity receptor T-cell receptor therapy for United States, Canadian, and European clinical trials.