News

NewAge Industries is adding cleanrooms at its Pennsylvania headquarters.

AMRI reinforces positioning as a CDMO with name change and acquires the formulation and fill/finish company, Integrity Bio, and biologics company, LakePharma.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

GlaxoSmithKline and Alector have partnered to co-develop two mAbs for a range of neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

Exscientia has been given funding from the COVID-19 Therapeutics Accelerator to accelerate the optimization of a new class of COVID-19 drugs created using its AI drug design platform.

MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.

V. Ashok has been appointed as ACG's new group chief financial officer.

Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.

Recipharm has signed a memorandum of understanding (MOU) with His Majesty the King of Morocco, the Moroccan government, and a consortium of leading banks from the country, for fill/finish capacity in the country.

The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

LGM Pharma will offer contract analytical testing and stability services to pharmaceutical developers and manufacturers.

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

Vaccines define the path to putting the pandemic in the rear-view mirror.

Five therapeutic candidates for the treatment of COVID-19 are identified as promising by the European Commission.

The acquisition of Intermountain Life Sciences will double Cytiva’s capacity for buffers and liquid cell culture media at its manufacturing site in Logan, Utah.

The extended manufacturing agreement between Pinteon and Lonza enables future clinical production of PNT001, a novel Tau antibody therapeutic that targets Alzheimer's disease and traumatic brain injury.

Selexis and KBI Biopharma will use integrated services to advance Immatics’ TCR bispecifics drug development program to the IND stage.