Ramarketing news round-up 

In this week’s news, EMA set to become a digital hub, Spain gets first device assessor and more.

EMA aims to become digital hub for EU regulators

The European Medicines Agency (EMA) plans to become a digital hub for the European medicines regulatory network.

The Amsterdam-based regulator announced the plan this week, writing that it aims to modernize its capabilities and become more customer-centric, agile and innovative. The project will make use of cloud technology.

First Spanish device assessor named

Spain’s National Center for the Certification of Medical Devices (CNCps) has become the first group in the country designated to assess products under the EU Medical Device Regulation (MDR).
 
The center which has links to Spanish medicines regulator AEMPS was the only notified Spanish body designated under the old directives.

Also in the news

A CDMO contracted by the Government of former US president Donald Trump during the early days of the pandemic is still to meet its major deadlines according to Politico.

Endpoints reported that that the California state government is to manufacture its own insulin while politicians debate a price cap for the lifesaving drug.

Hemogenyx Pharmaceuticals has opened its new cell therapy laboratory at the Mink Building in West Harlem’s Manhattanville Factory District of New York City, adjacent to Columbia University and City College. 

TFF Pharmaceuticals has announced a significant expansion of its R&D operations through the lease of a new research and development facility located in Austin, Texas.

RAPS reported that UK Medicines and Healthcare products Regulatory Agency (MHRA) missed multiple targets due to resource constraints, Brexit backlogs, and additional reasons.

CDMO trends

Some developments of note in the contracting sector: 

Xenetic Biosciences has hired Catalent Pharma Solutions to make its recombinant protein, Human DNase I, which is being developed to treat cancers.

Societal CDMO has amended its license and supply agreement with Lannett for Verapamil PM and Verelan SR products.

Thoughtworks has signed a multi-year agreement to help PCI Pharma Services client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies.

Piramal Pharma Solutions business celebrated the official inauguration of a new active pharmaceutical ingredient (API) plant at the company’s site in Aurora, Ontario.

Almac announced plans to expand its US headquarters in Montgomery County, Pennsylvania, in a move which is creating 355 additional jobs.

Exyte is building an mRNA competence center at the Halle Biotech site of Wacker Chemie AG.

GenScript ProBio and ACT Therapeutics have entered into a strategic partnership to develop new CAR-T cell therapies. 

Granite Bio and ProBioGen have announced the closure of a Master Services Agreement to support the development of Granite Bio’s mAb pipeline.

Our top picks of the week

Celegence acquires Qdossier a supplier of end-to-end services. The acquisition will see Celegence enhance its extensive network of regulatory consultants for the pharmaceutical industry.

Risk-based process design and advanced control technologies are key to cost-efficient sterile injectable manufacturing. Processing environments is technically and financially challenging reports Fabio Stevanon, Director, Global Injectables Platform, CordenPharma International.

Recipharm steps up to support development of Transpire’s inhaled treatments for asthma. Transpire Bio has brought Recipharm on board to help with the development of TRB-1 and TRB-2.

Abzena names Dr. Jeffrey Mocny as Scientific Lead. Mocny has extensive experience with biopharmaceutical regulations.

Will biotech see an uptick in M&A? After two years of pandemic disruption, a certain level of normality is returning to the health care industries. However, the aftermath is also leaving biotech with ‘significant challenges’.