The Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.

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.

The CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria-Palynziq (pegvaliase).

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.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

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

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

The companies will use GeoVax’s vaccine technology to develop malaria vaccine candidates.

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 FDA commissioner plans to leave the agency in April.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

The Tandem 4.0 augmented reality-enhanced collaboration tool from Apprentice.io has a new user experience and user interface design.

AST will unveil its multi-format robotic filling system, the GENiSYS R, at INTERPHEX.

The Marchesini Group will introduce the CMP pharma inspection system to the US market at INTERPHEX 2019.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Do patients get what they pay for when they demand cheaper drugs?

As drug pricing comes under the microscope internationally, it appears that collaboration with all stakeholders is key to tackling the issue.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

A new report that has been published prior to CPhI Japan has stated that there will be rapid growth in the Japanese pharma market during 2019.

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.

The ABPI has responded to the UK government’s recently published plans on improvements to services for people with rare diseases

GHO Capital, a European specialist investor in healthcare, announced its acquisition of Sterling Pharma Solutions, which specializes in complex and difficult-to-manufacture APIs.

STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.

Abbott and Novo Nordisk have entered into a non-exclusive partnership aimed at providing an integrated digital solution for diabetic patients using insulin,