QA/QC

Antag Therapeutics gets FDA clearance to start clinical trials with new obesity drug

10-Oct-2024 By Clara Rodriguez Fernandez

The FDA decision will enable Antag Therapeutics to initiate the clinical development of its lead candidate drug, a first-in-class treatment for obesity.

CluePoints sponsors RBQMLive 2024, focusing on risk-based quality management

11-Sep-2024 By Liza Laws

CluePoints, the leading provider of risk-based quality management (RBQM) and data quality oversight software, has announced the full agenda and speaker line-up for the highly anticipated RBQMLive 2024.

Creyon Bio secures second patent for AI-powered oligonucleotide engineering

10-Sep-2024 By Liza Laws

Creyon Bio Inc., a clinical-stage biotechnology company specializing in AI and machine learning-enabled oligonucleotide-based medicines (OBMs), recently announced the issuance of its second US patent.

Reimagine Care and Memorial Hermann boost cancer care engagement

03-Sep-2024 By Liza Laws

Reimagine Care, the leading provider of on-demand cancer care, and Memorial Hermann Health System, one of Texas's largest not-for-profit health systems, have announced an ambitious multi-year expansion of their pioneering partnership.

‘We’re here and we’re ready’ - Dalgety secures UK licence to supply medical cannabis

29-Aug-2024 By Liza Laws

Dalgety, one of the UK's leading medical cannabis cultivators, has achieved a significant milestone by securing a Home Office licence to supply medical cannabis within the UK.

Nasal powder shows promise in boosting immune defense

27-Aug-2024 By Liza Laws

The INNA-051 formulation is designed to enhance the body’s natural immune response, targeting individuals aged 60 and over who are at increased risk for complications from respiratory viral infections.

Ayvakit's explosive 185% revenue growth: A game-changer in rare disease treatment

20-Aug-2024 By Liza Laws

Ayvakit, a groundbreaking therapy developed by Blueprint Medicines, has witnessed a remarkable 185% year-over-year revenue growth in the second quarter of this year (2024).

Lonza boosts clinical services with new bottling capabilities

15-Aug-2024 By Liza Laws

Lonza, a global leader in the pharmaceutical, biotech, and nutraceutical markets, has announced a significant expansion of its clinical manufacturing services at its small molecules site in Bend, Oregon.

Boosting pharma security: Systech's track and trace tech

14-Aug-2024 By Liza Laws

In the fight against counterfeit pharmaceuticals, Systech stands at the forefront with its advanced track and trace technology.

How nuVizz transforms pharma supply chains: Insights from its CEO, Guru Rao

14-Aug-2024 By Liza Laws

In the ever-evolving world of pharmaceutical logistics, nuVizz has emerged as a key player, delivering innovative solutions that streamline the delivery management process.

Improving clinical supply chains: An in-depth conversation with IQVIA's Stefan Duerr

14-Aug-2024 By Liza Laws

In the intricate world of clinical trials, the integrity and efficiency of the drug supply chain are paramount.

How CDMOs can optimize operations and balance costs ahead of the 2032 BioSecure Act

02-Aug-2024 By Liza Laws

As the BioSecure Act approaches its 2032 implementation, Contract Development and Manufacturing Organizations (CDMOs) must prepare for significant industry shifts.

AI revolution in pharma: Qinecsa's James Bellamy unveils groundbreaking PV tech insights

26-Jul-2024 By Liza Laws

In a candid interview at the DIA conference, James, leader of the Solutions Consulting team at Qinecsa, shared his insights into the evolving landscape of pharmacovigilance (PV) technology.

FDA approves Rusan Pharma’s manufacturing facility in India, paving the way for expanded US presence

23-Jul-2024 By Liza Laws

Rusan Pharma Private Limited has announced that its active pharmaceutical ingredient (API) manufacturing facility in Ankleshwar, Gujarat, has been granted Good Manufacturing Practice (GMP) approval by the FDA.

Avista and Hamilton Lane join forces to Propel growth and innovation at Cosette Pharmaceuticals

19-Jul-2024 By Liza Laws

Avista, a New York-based private equity firm focused on healthcare, and Hamilton Lane, a global private markets investment management firm, have announced that funds managed by Hamilton Lane have acquired a significant equity interest in Cosette Pharmaceuticals...

Nipro's $397.8M investment brings 232 new jobs to Greenville, NC with exciting new facility

18-Jul-2024 By Liza Laws

Japanese medical devices company, Nipro Medical Corporation, a giant in the healthcare and medical device industry, has announced a major investment of $397.8 million to establish its first North American manufacturing center of excellence in Greenville,...

Blow-fill-seal technology: Realizing a new frontier in sterile packaging

12-Jul-2024 By Liza Laws

Blow-fill-seal (BFS) technology has long been a cornerstone of pharmaceutical manufacturing, relied on for packaging sterile liquid medications, including but not limited to ophthalmic and respiratory drug products.

NIH awards Cellibre $2M to advance sustainable cannabinoid ingredient production

12-Jul-2024 By Liza Laws

Cellibre, a leader in sustainable biochemical manufacturing, has secured a $2 million grant from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH).

Esteve Pharmaceuticals expanding Girona plant to enhance the production of APIs

12-Jul-2024 By Liza Laws

Esteve Pharmaceuticals has announced a substantial investment of €100 million ($108 million) to build a new manufacturing unit at its Girona plant.

ReciBioPharm’s Edita Botonjic-Sehic on analytics, AI, and continuous RNA manufacturing

12-Jul-2024 By Liza Laws

RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.

Andelyn Biosciences selected to manufacture clinical grade AAV9-CSA vector to treat Cockayne syndrome

12-Jul-2024 By Liza Laws

Andelyn Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been chosen by UMass Chan Medical School to manufacture clinical-grade AAV9-CSA vector using its suspension AAV Curator Platform...

Ketaki Patwardhan - from experiments with her dad to excipients and manufacturing at Roquette

11-Jul-2024 By Liza Laws

Ketaki Patwardhan, a global technical developer at Roquette, has built a remarkable career in the pharmaceutical industry by leveraging her curiosity and passion for science.

Could this be the end of condoms and will men embrace the hormone-free birth control pill?

11-Jul-2024 By Liza Laws

In an exclusive interview, Akash Bakshi, CEO of YourChoice Therapeutics, delves into the inspiration and journey behind developing a hormone-free birth control pill for men.

Overcoming barriers to opioid treatment: Challenges and innovations in methadone and buprenorphine

10-Jul-2024 By Liza Laws

The growing opioid crisis in the US has been exacerbated by various systems and biases, preventing individuals from accessing critical treatments like methadone and buprenorphine.

dsm-firmenich launches CBtru, revolutionizing CBD drug development with enhanced bioavailability

09-Jul-2024 By Liza Laws

dsm-firmenich has announced the launch of CBtru – an advanced formulated cannabidiol (CBD) drug product intermediate designed for oral solid delivery formats.

Esteve invests €100 million in Spanish API manufacturing muscle

02-Jul-2024 By Jonathan Smith

The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).

Inside the FDA's Accelerated Approval: How it’s extending lives and improving patient care

25-Jun-2024 By Liza Laws

Last week, OSP had the pleasure of speaking with Ginny Beakes-Read at the DIA Global conference.

Novo Nordisk announces $4.1BN investment to expand US manufacturing capacity

25-Jun-2024 By Liza Laws

Yesterday (June 24) Novo Nordisk unveiled plans to invest $4.1 billion (approximately €3.8 billion) in a new manufacturing facility in Clayton, North Carolina.

Geopolitical tensions between the US and China and the effect on life sciences

20-May-2024 By Liza Laws

Caroline Shleifer is the founder and CEO of RegASK, the global, AI-driven solution for curated regulatory intelligence.

Front Line Medical Technologies achieves CE marking for transforming aortic occlusion

23-Apr-2024 By Liza Laws

In a remarkable development, Front Line Medical Technologies Inc., an innovator in trauma care medical devices, has announced the attainment of CE marking for its COBRA-OS (Control of Bleeding, Resuscitation, Arterial Occlusion System).

Quotient Sciences new platform disrupts conventional drug development processes

23-Apr-2024 By Liza Laws

At CPhI North America, Quotient Sciences is looking forward to reconnecting with its customers and giving them a preview of how we are looking to expand Translational Pharmaceutics further within the US.

Catching up with LGM Pharma ahead of CPhI North America to find out about its pipeline

19-Apr-2024 By Liza Laws

LGM Pharma is a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical, biotechnology, and compounding pharmacy industries.

New IQVIA research reveals growing trend as pharma embraces combined PV solutions

17-Apr-2024 By Liza Laws

Archana Hegde joined IQVIA in 2015 and has been in various leadership roles implementing technology solutions to support critical business processes.

DCAT 2024

Bormioli Pharma leading the way with sustainable pharmaceutical packaging

17-Apr-2024 By Liza Laws

Bormioli Pharma creates pharmaceutical packaging for drug stability, safety, and sustainability, partnering with global health leaders and says it stands at the forefront of sustainability.

Celadon securing contracts for supply of pharma-grade medicinal cannabis

14-Dec-2023 By Liza Laws

Celadon Pharmaceuticals has today (December 14) announced its first supply of it pharmaceutical-grade breakthrough cannabis-based medicine.

Symbiosis Pharmaceutical Services granted MHRA license following £1 million investment

07-Dec-2023 By Liza Laws

Symbiosis Pharmaceutical Services can now test small molecule, biological and advanced therapeutical medicinal products (ATMP) following a £1 million investment.

Sun Pharma facility placed on FDA import alert

13-Dec-2022 By Ben Hargreaves

The company’s Gujarat facility has been listed under import alert, after an inspection earlier this year found it was not cGMP compliant.

Lilly deploys AI-powered tech to expedite drug approval process

18-May-2022 By Jenni Spinner

The pharmaceutical company is partnering with Yseop to install the software company’s Augmented Analyst, designed to elevate and accelerate data analysis.

Veeva launches Vault CTMS with Bristol Myers Squibb

17-May-2022 By Jenni Spinner

The pharmaceutical company reportedly opted to implement the cloud software provider's clinical trial management system to help streamline its processes.

FDA outlines benefit-risk approach to drug or biologic product quality assessment

10-May-2022 By Jane Byrne

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

CPhI North America 2022

Pharma growth, partnerships focus of 2022 CPhI North America

04-May-2022 By Jenni Spinner

A leader from the organizer of the pharmaceutical event discusses what’s in store for the upcoming conference, and for the drug development industry itself.

MyMeds&Me acquisition paves path for pharmacovigilance expansion

14-Apr-2022 By Jenni Spinner

The company’s recent purchase by Drug Safety and Pharmacovigilance Services Solutions reportedly will fuel expansion of its Reportum PV platform technology.

Big pharma experts join forces to drive automation of data workflow

05-Apr-2022 By Nick Taylor

Leaders from some of the industry’s most notable companies are working together to streamline and automate IDMP workflow and come up with various standards.

Tech Innovations: March 2022

17-Mar-2022 By Jenni Spinner

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

The right tech can fill gap between lab scientist and data: ACD/Labs

16-Mar-2022 By Jenni Spinner

An expert from the R&D tech provider discusses how automation, integration, and other tools can help with effective access and analysis of lab information.

People on the Move: March 2022

03-Mar-2022 By Jenni Spinner

This month’s announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.

scope 2022

Data history visibility keeps clinical studies on track: Almac

01-Mar-2022 By Jenni Spinner

Experts from the clinical tech firm talk data challenges and how monitoring technology can enable sites and sponsors to better manage audit trail reviews.

rare disease day 2022

Lilly planning $700m genetic medicine development center

24-Feb-2022 By Jenni Spinner

The pharmaceutical company’s Lilly Institute for Genetic Medicine reportedly will focus on developing RNA-based therapeutics in a ‘state-of-the-art’ facility.

SCOPE 2022

Risk-based quality management ‘perfect’ for DCTs: CluePoints

26-Jan-2022 By Jenni Spinner

A leader from the RBQM solutions specialists offers a preview of his SCOPE 2022 presentation on tools suited to decentralized trial design and management.

More than ever expected of today’s data managers: IQVIA

13-Jan-2022 By Jenni Spinner

With the amount of available data increasing and technology evolving, says a company leader, the job of data manager is more demanding than ever before.