Last week in pharma… 9th September

Last week’s news, Linda Robbie is named as CRO BioAgilytix’ COO, Torkel Gren of Recipharm and Dr Jnanadeva Bhat of ACG-Worldwide share key developments in capsules, and more. 

Developments in pharmaceutical capsules

Next generation capsule shells are not only vegan but have a lower moisture content, offering greater performance consistency and maximising product shelf life, says formulation expert. The second most commonly used pharmaceutical dosage form, capsules, are anticipated to be a $5.2B market by 2030, growing from a 2020 value of around $2.4B. Here experts Torkel Gren of Recipharm and Dr Jnanadeva Bhat of ACG-Worldwide share key developments in capsules by answering four key questions.

Linda Robbie named as CRO BioAgilytix’ COO
Privately-held USA-based contract research organization (CRO) BioAgilytix has named Linda Robbie its new Chief Operating Officer. Dr Robbie has more than 25 years of experience with biomarker assay technologies, including 20 years spent in scientific leadership positions. She joined BioAgilytix’ leadership team when the company was acquired by another firm in November 2019 in the role of Vice President and General Manager of Boston operations.

Green light for cancer drugs developed by AI specialist Owkin
AI biotech company Owkin has announced that two first-in-class rapid, affordable AI-based diagnostic solutions designed to improve outcomes for patients with breast cancer and colorectal cancer have been approved for use in Europe. Owkin’s RlapsRisk BC and MSIntuit CRC have received approval for diagnostic use across the European Union.

Meriem Sefta, Chief Diagnostics Officer at Owkin, explained: “Our mission is to use AI to find the right treatment for every patient. Novel drugs allow us to personalize treatments to patients’ individual disease characteristics, promising a new era of precision medicine. But one roadblock that doctors face is finding these patients rapidly, accurately and efficiently.”

CPHI Report Predicts Significant Shifts in Global Outsourcing Strategies
The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.

“This report highlights that innovators need to meet contract services partners sooner, plan much earlier and far further into development,” said Orhan Caglayan, Brand Director at CPHI Frankfurt.

Can biosimilars finally make a mark in the US?
Copycat biologic drugs have had limited impact despite high expectations. Recent articles suggest that the next few years could prove important.

“I think when the first ones came out… there was hope for deeper discounts and more rapid adoption,” said Sonia Oskouei, Vice President of biosimilars at drug distributor Cardinal Health.

Also in the news

Singapore sling: Catalent will invest $2.2M in a clinical supply facility. Along with the increased capacity, the site will grow its specialized secondary packaging capability for ULT products, allowing it to support more extensive packaging campaigns, Catalent said.

AstraZeneca, Merck’s Lynparza rejected by NICE in prostate cancer over pricing- again.

Swissmedic approves first bivalent COVID-19 booster vaccine in Switzerland. Moderna’s Spikevax Bivalent Original/Omicron (mRNA-1273.214) is authorised from age 18.

A top European regulatory official will address regulatory professionals on 11 September in Phoenix at the Regulatory Affairs Professional Society’s (RAPS) annual conference, Convergence.

CDMO trends

Some developments of note in the contracting sector:

Biotimize has opened a $30M Series A funding round and says the investment will allow the firm to build the first biological CDMO in Brazil.

Prestige Brings In New Management As It Consolidates CDMO Control – Prestige Biopharma says it is acting to “consolidate group competitiveness” by taking an increased share in Prestige Biologics, at the same time as a new CEO was appointed for the CDMO.

Societal CDMO Awarded Two New CDMO Service Contracts focused on supporting ongoing clinical development programs for novel therapeutic candidates.