The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.
A representative from IFF Pharma Solutions talks about significant challenges in drug development and improvements the industry can implement to overcome them.
Cambrex to scale up its solid form screening and crystallization process development facility in Edinburgh to answer market demand for larger scale crystallization.
AAPS PharmSci 360 is a new conference this year, created in response to a desire for “fresh science,” specifically with chemical and biomolecular components. So what can you expect?
Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.
Following on from the success of last year's survey, Outsourcing-Pharma is running another 'state of the industry' survey to gauge views about the current state of the pharmaceutical contract services industry.
AMRI will support the development and manufacture of active pharmaceutical ingredients (API) and drug product for Phase I clinical studies under a seven-year contract with the NIH.
The Chinese contract research and development company WuXi AppTec has raised more than $353m in its initial public offering of common stock on the Shanghai Stock Exchange.
A new method for determining the crystal structures of organic salts – which make up 40% of all APIs – could “greatly speed up” the drug development process, say researchers.
At DCAT Week, contract manufacturing and development companies from across the globe shared updates and news – from multi-million dollar investments to new business structures and areas of focus.
Partnering with CMOs makes sense for emerging biotechs, says Ardelyx exec James Kanter, who relies on networking and clear communication guidelines to manage third-party relationships.
CordenPharma has revamped its executive leadership team, Recipharm has named the head of its new global development organization, and several new CEOs have been appointed.
Scientist.com is working to implement an improved contractual landscape ahead of GDPR implementation in May, in order to ensure global compliance among sponsors and CROs.
The San Diego-CA-based contract research, development, and manufacturing organization (CDMO), BioDuro, has announced a cooperation agreement with Porton Pharma Solutions.
Ipca Laboratories, a fully-integrated Indian pharmaceutical company, has purchased an NC-based CMO in a $9.65m deal that will enable it to manufacture small volume APIs for the US market.
Outsourcing models examined, market shifts scrutinized, and trial tribulations analyzed – take a look back at some of the top reports published in 2017.
By Sudip S. Parikh, PhD, senior vice president & managing director, DIA Americas
The healthcare product development ecosystem is undergoing massive changes. Significant transformations are underway in how drugs and medical devices are researched, developed, manufactured, and approved.
AMRI has more than doubled its bulk Active Pharmaceutical Ingredient (API) aseptic manufacturing capacity in response to an increasing need for sterile API and an evolving pharma pipeline, says CCO.
This month’s roundup includes new CEOs at Bioclinica and Comprehend Systems, several hires at Parexel's consulting division, and new roles – and new offices – for two service providers.
This month’s round up includes Adent’s new product management director who joins the company from Eli Lily and a new CEO at Clinipace, as the CRO’s co-founder steps down after 14 years.
Sponsors using a single-source outsourcing partner could potentially save up to $45m through reduced time to market, according to a recent Tufts study.
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.
The global pharmaceutical contract services industry continues to face several challenges and changes, from ubiquitous consolidation among all industry players to uncertainty in a turbulent political climate.
ScinoPharm has emphasised its compliance with waste water treatment rules, weeks after being contracted to supply API for Melinta Therapeutics’ antibiotic Baxdela.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
This month’s roundup includes new executive leadership teams, hires on both sides of the Atlantic for CRO Smithers Viscient, a new VP and medical director at Clinipace, among others.
The International Air Transport Association (IATA) has certified a DHL air freight station in Leipzig, Germany for the cold storage and shipment of APIs and finished pharmaceuticals.
The expanded facility features an additional 4,200 square feet of space to enhance its microbiology, sterility testing, and microbial ID service offerings.
Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.
In the absence of a CRO, the 200 patient NeoART study is relying on the UK NHS, crowdfunding and charity to trial an antimalarial generic for late stage bowel cancer.
