This week in pharma… 26th August

25th August, 2022

ramarketing news round-up 

Lonza introduces X-Ray powder diffraction capability, SD Biosensor agrees to buy Meridian Bioscience for $1.53B and more!

Lonza Introduces X-Ray Powder Diffraction Capability at Monteggio Site

Lonza has expanded the range of particle engineering services offered by its Monteggio (CH) site through the introduction of X-ray powder diffraction (XRPD). This rapid analytical technique provides additional information about the polymorph and solid-state properties of active pharmaceutical ingredients (APIs).

The expert team at the Monteggio (CH) site uses a range of analytical techniques to investigate the solid state of crystalline materials. The addition of XRPD complements Lonza’s comprehensive analytical toolbox, allowing the generation of critical data across drug discovery, development, and manufacturing. The XRPD instrument began operations in Q2 2022.

FDA grants orphan drug and fast track designations to SDT for brain cancer

Northwell Health’s North Shore University Hospital in Long Island, New York, is currently enrolling patients in the multi-center Phase 1 clinical trial. The First-in-Human trial will evaluate the safety, optimal dosage, and efficacy of Alpheus’ SDT platform in patients with recurrent high-grade glioma.

“The diffuse nature of glioblastomas, often across the hemisphere, makes it an extremely challenging disease to treat. There are very few effective options, leading to poor patient outcomes, and a universally fatal disease,” commented Michael Schulder, MD, Director of the Brain Tumor Center and Primary Investigator (PI) for the clinical trial at Northwell Health’s Institute for Neurology and Neurosurgery.

Alpheus Medical’s proprietary, investigational SDT treatment is an innovative, non-invasive drug-device combination that targets cancer cells throughout the entire hemisphere using low-intensity, diffuse ultrasound. The SDT is administered in an outpatient setting and does not require imaging. The multi-center trial (NCT05362409) is designed to study the safety and optimal application of Alpheus’ SDT treatment, as well as efficacy, and is planned to enrol up to 33 patients.

Stem cells could repair spinal cord injuries

Researchers have identified latent stem cells that could respond to spinal cord injuries. Scientists from the Francis Crick Institute, UK and the Institute of Molecular Medicine, Portugal have identified a group of latent stem cells in the central nervous system. In their study, which was recently published in Developmental Cell, they tested how these cells respond in healthy mice and those with spinal cord injuries.

The cells were identified by chance when the team used a fluorescence tool to look for dendritic cells in the brain. The ependymal cells that the tool identified were found to arise from embryonic progenitor cells that shared the same protein as dendritic cells on their surface, which revealed them to the scientists.

The scientists found that in healthy mice, these cells stay still and waft small hairs on their surface to help the flow of cerebrospinal fluid. However, in injured mouse spinal cords, these cells responded by dividing, migrating towards the damaged area and differentiating into astrocytes, one of the major cell types of the nervous system.

FDA-led studies assess risk information on social media 

How should pharma companies use the limited character space in a promotional tweet? While including risk information in the body of a post made patients more likely to recognize potential dangers, new FDA-led research suggests it also made them less likely to pursue more information.

The FDA said in draft guidance back in 2014 that if a company promotes a drug on social media, it should also include the most serious risks in the body of that post – regardless of character-space limitations (CSL). Regulators told drugmakers to include a link devoted solely to the communication of risks.

That makes marketing tricky on channels like Twitter, where most posts are limited to just 280 characters. So in 2016, the FDA announced plans to launch four studies to determine whether simply linking to risk information is sufficient.

2 biotechs swoop into monkeypox scene with new R&D licensing pact

Lytic Solutions has circled in on NightHawk Biosciences’ monkeypox vaccine science, penning a licensing deal with the ultimate goal of developing a vaccine that will address a potential monkeypox pandemic.

Financials for the R&D deal – reported in an August 21 Securities and Exchange Commission filing were not disclosed.

Under the pact, Lytic Solutions – a Madison, Wisconsin-based biotech that offers affinity reagents and molecular biology tools for researchers will fund Nighthawk’s efforts to develop a new subunit monkeypox vaccine. Subunit vaccines use protein pieces from the target virus to trigger immunity.  

Nighthawk – a small Delaware biotech focused on immune disease treatments currently touts a customizable vaccine platform, dubbed RapidVax, that is applicable in several indications. The biotech also has several oncology assets in its pipeline, with the most advanced candidate a phase 2 cell therapy for non-small cell lung cancer.

Market activity, trends, and other topics of note:

SD Biosensor agrees to buy Meridian Bioscience for $1.53bn

In an all-cash transaction valued at approximately $1.53B, a consortium led by bio-diagnostic company SD Biosensor, Inc. and investment firm SJL Partners LLC is to acquire global provider of diagnostic testing solutions and life science raw materials Meridian Bioscience, Inc.

DNA and Gene Cloning Services Market worth $12.15 Billion by 2030 – Exclusive Report by InsightAce Analytic

According to the company’s newest research, the Global DNA and Gene Cloning Services Market is worth US$ 2.80B in 2021 and is predicted to reach US$ 12.15B in 2030, with a promising CAGR of 18.22%  between 2022 and 2030.

Many scientific processes begin with gene synthesis and cloning. DNA amplification by subcloning and polymerase chain reaction are two standard techniques for genetic cloning. The method of DNA cloning is simply recombinant DNA technology, which combines DNA from two organisms into a single molecule.

Alcon swoops on Aerie, striking $770M buyout to expand eye drug pipeline

Alcon is buying in pipeline prospects to support its expansion into the eye drug market, striking a $770M takeover of Aerie Pharmaceuticals to add two approved therapies and a clutch of investigational treatments for retinal and ocular surface diseases. 

Bain invests in life sciences company

Management consulting group Bain and Co. is partnering with the life sciences company Trinity Life Sciences.

The partnership follows a partnership between Trinity and Kohlberg and Co. and Trinity’s acquisition of data science company D Cube Analytics. Bain and Co. will take a minority investment in Trinity Life Sciences, according to the Aug. 8 Bain and Co. news release.