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Former FDA Commissioner lays out roadmap for building out excess capacity to deal with pandemic situations

The CPHI Festival of Pharma is well underway! Tune into this podcast in which Informa Markets Head of Pharma Content, Tara Dougal, and Pharma Editor, Gareth Carpenter review some of the highlights of the first few days as well as a preview of what's co...

Pharmapack Awards winners and industry leaders will meet up in a live webinar at CPHI Festival of Pharma to discuss the evolution of next-generation products in pharma packaging, administration & drug delivery devices.

In your quest to meet the regulatory requirements for your oral solids project, you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. Experts in the Pfizer CentreOne global network, Gillian M...

In a compressed timeframe, producing large quantities of pharmaceutical glass containers to deliver the coronavirus vaccine around the world is a critical factor for a successful global response. Type 1 glass is a proven and widely available solution f...

The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year.

Our first in a series of monthly podcasts looks back at the key points covered in five webinars we hosted in May showcasing the pharma industry's response to the COVID-19 pandemic

In this podcast, Global Pharma Insights speaks to Stefan Schmidinger, Partner at Kemiex AG on how trading and procurement of active pharmaceutical ingredients has been affected by the global coronavirus pandemic

Following on from the success of the inaugural iPitch launch in 2019, iNova Pharmaceuticals is delighted to announce the launch of a new round of iPitch challenges for 2020.

Stevanato Group, SCHOTT, and Gerresheimer confirm their readiness to support future COVID-19 vaccine with pharmaceutical containers.

The company will provide CDMO capabilities, capacities, and expertise to support the US government’s Warp Speed Program to pave the way for innovators to advance COVID-19 programs.

Our content has now moved to our new Global Pharma Insights website, providing the very latest news and information covering all aspects of the pharmaceutical supply chain. Please click the link below to access this article.

Indian contract development and manufacturing organisation, Suven Pharmaceuticals, has warned it cannot export finished products due to a shortage of raw materials following the country’s recent lockdown to fight the COVID-19 pandemic.

Zenith Technologies CEO, Joe Haugh, takes us through how the business has evolved this year, to better meet the needs of its customers, as well as the trends they see shaping the industry through 2020 and beyond.

Agreement will facilitate clinical trial translations in China.

The programme will include the launch of next-generation respiratory inhalers, which will use near-zero Global Warming Potential propellants.

No need to draw blood; researchers develop smart technology to diagnose diabetes and treat diabetic retinopathy.

The past 12 months have been busy as many companies fought to comply with serialization regulations.

Smart tags on pills set to improve supply chain security and patient adherence.

The US pharmaceutical industry continues to lead its global peers in terms of innovation and competitiveness, while still ranking high in overall growth potential despite its mature status, according to the results of a survey of 350 global pharmaceuti...

Unprecedented levels of investment cited as a major force driving the expansion.

The largest area of growth has been within biotechnology companies, where job openings increased by 35%.

Companies and individuals from across the whole pharma supply chain recognised for their excellence and commitment.

CPHI Worldwide's Annual Report suggests repeat offenders of regulatory infringements should be barred from importing into the US.

One of the first digital manufacturing facilities in the world to use continuous, intensified biologics production technology.

Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.

Collaboration aims to provide a connected device experience for millions of people living with diabetes using insulin.

Growing population, increase in non-communicable diseases and major investment in new hospitals, clinics and treatments driving growth.

The potential for generics to support the healthcare needs of China is significant.

Australian researchers produce early-stage vaccine which is inhaled into the lungs.

Pipeline of new drugs has helped drive increased innovation in packaging and drug delivery devices.

Utilising the current data environment and its data pools for the benefit of advancing research.

The benefits of this innovation include the ability to instantly and unequivocally authenticate products when suspect events.

The transaction will allow the new company to expand the geographic reach of Mylan's existing broad product portfolio and future pipeline.

Opening of continuous manufacturing facilities and expansion of production building will boost capabilities to accelerate the supply of new breakthrough medicines to patients globally.

Company's customers to have immediate access to Niro PSD2 and PSD4 spray driers, which are supported by dedicated clean area facilities for both solvent and aqueous processing of potent or non-potent drug formulations.

Industry leaders give voice to issues and trends shaping the biotech sector, including the importance of collaboration.

Data exchange, investment costs, resources and hardware identified as some of the biggest challenges.

Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.

India predicted to be one of the world’s ‘fastest growing bio’ hubs in 2019, fuelled by new biosimilars production.

The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals.

Patient-centricity, eco-friendly and smart packaging trends marked as the biggest growth drivers and innovations in 2019.

End-to-end industrial production of innovative medical technology products.

2019 will mark Uniplast's debut at this year's edition of CPHI Worlwide in Frankfurt, where it will showcase its expertise in plastic packaging.

The CDMO invested EUR 35 million into its operations and launched a 3-year programme to provide a compliant serialisation solution for its customers.

Teething problems are no stranger to the implementation of new regulations, but with the EU FMD, Brexit came like a set of wisdom teeth – late, painful and problematic.

New report highlights Germany, France and Switzerland as tier-one nations for ‘drug delivery innovation’, and warns the challenge will be to scale-up and approve promising prototypes.

Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect.

The automated NevoLine bioproduction system that facilitates safer, faster and closed bioprocessing in a much smaller footprint.

Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.

A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.

Restrictive guidelines have led many to buy CBD products online, leading to a boom in production with many products going to market without sufficient quality control.

Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.

The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.

With only a month to go, it really is too late to start trying to develop an in-house solution.

Eight of the top ten pharma nations reporting improving market conditions.

Accepting more complexity and risk is key for those generics companies seeking competitive differentiation by diversifying their product portfolios.

Therapeutic ADC market expected to reach $4 billion by 2023.

Companies new to CPHI to showcase an exciting range of products and services ranging from electroceuticals to refrigerant alternatives.

While not quite an endangered species, the past fifteen years have not been easy ones for many European mould makers. Many, but not all, and IGS GeboJagema is a case in point – a case that shows the difference automation and focus can make. By Karen La...

The new Primary Care and China & Emerging Markets global business units are expected to launch at the beginning of 2019.

China is harmonizing to ICH standards at feverish pace and will force poor quality manufacturers out of market.

Novel, dual-acting product revitalizes and protects skin against blue light and environmental aggressors around the clock.

US, Germany and Japan revealed as tier one nations in all categories with Sweden ranking the best of the rest.

CPHI Annual Report expert sees CDMOs as potentially a source of process innovation but warns both regulator and license holders need to move past regulatory diktats.

With only 6 months left in which to become EU FMD-compliant, how can companies make the best use of their now limited options?

Now less than a year away from when the UK officially leaves the EU, the main goal remains the same - maintaining access to new drugs for patient health.

One company's positive approach to Brexit preparations, despite the lack of definition.

The EMA needs to provide more action and guidance to help UK pharmaceutical manufacturers, says Thomas Beck, senior vice president, quality management, Recipharm.

To meet new PV regulations, the industry has to face a "multitude of unknowns and an ever-moving target".

FDF launches at CPHI Korea as country set to become regional hub.

Packaging technology is not a core Bosch business.

Experts warn bio industry needs to do more to create a sustainable pipeline of talent.

2018 event prepares for surge in international attendees as MAH nears national rollout.

Postponement printing is presenting interesting benefits for the pharmaceutical supply chain.

Recipharm's Staffan Widengren, Director Corporate Projects, discusses why CMOs should be focusing on the value-added opportunities presented by serialisation.

NIH-funded study finds omega-3 fails to yield beneficial results in the clinic.

Global analysis will rank each major biomanufacturing country’s market growth potential, innovation and competitiveness.

Manufacturing high potency drugs - the challenges and innovations to mitigate the risks.

Customers to have the option of one partner from concept to market for their encapsulated drug products

Gaining GLP/GMP accreditation to provide greater assurance of data integrity for clients looking to take their compounds to IND.

Screening for new marine-derived functional ingredients and bringing new patented products to the market.

Packaging innovation shows a clear focus on patient compliance and ease-of-use.

What does a good supplier look like? Andrew Ramage, Microbiology Product Specialist at Cherwell Laboratories, advises how to take the guesswork out of the search.

A new analytical tool, Electrical Asymmetrical Flow Field-Flow Fractionation (EAF4) is showing much promise in biopharmaceutical and nanoparticle applications.

A summary and highlights of new drug therapy approvals and other drug therapy advances in 2017 by FDA's CDER.

Total cost base to be reduced by $3 billion by the end of 2019.

Drug trials provide mind-blowing results.

MSD's announcement to establish UK Discovery Centre in London an 'endorsement' of the government's Industry Strategy.

Controlled-release technologies will continue to be focal point, whereas techniques to improve solubility are likely to gain popularity.

Company's decision affects approximately 225 staff, specialised in tablet manufacturing, and in sachet and stick pack filling, primarily for powders and granules.

19 winners chosen from 200 entries, received from nearly 30 countries worldwide.

Semaglutide receives positive 16-0 vote in favour of approval from FDA Advisory Committee.

CDMO, Micro-Sphere partners with German machine manufacturer Harro Höfliger for the latest step in its 21 million CHF (€19 million) investment into its facility in Switzerland.

The importance of ensuring a facility has the right capabilities when selecting a CMO to handle high potency ingredients.

Warning letter cites Meridian Medical Technologies' failure to thoroughly investigate multiple serious component and product failures of EpiPen products.

In connection with the $60 million settlement, the company has also resolved several private whistle-blower cases related to the government's investigation.

Mylan will reclassify EpiPen Auto-Injector for purposes of the Medicaid Drug Rebate Program and pay the rebate applicable to innovator products effective as of 1 April 2017.

Bolt-on acquisition adds value to other areas of Lonza’ business, including Health & Nutrition ingredients and excipients.

AI thought to have massive potential to reduce the cost associated with the discovery of new drugs.

Collaborations result in development of Corning Valor Glass.

Company announces investments, the sale of several products and a proposal to close a UK manufacturing site.

The patch can dramatically reduce the cost of vaccination, as self-administration can eliminate the need to have health workers oversee the process.

Discontinuation due to the vaccine supplier’s (GSK) decision to discontinue global production.

Status marks the company as the first multi-site excipient supplier to achieve global EXCiPACT accreditation across its production facilities.

New production method for solid dispersions of docetaxel and paclitaxel.

Amgen has announced that the 27,564-patient Repatha (evolocumab) cardiovascular outcomes study, FOURIER, established for the first time that maximally reducing low-density lipoprotein cholesterol (LDL-C) levels with Repatha, beyond what is possible wit...

Settlement provides Mylan with global licenses for its trastuzumab product.

Innovation is being driven increasingly by smaller, possibly more agile, companies.

Modified baker’s yeasts cause an immune response and the production of lymphocyte killers, which detect and eliminate cancerous cells.

The molecule, which is a PPMO, will likely be ready for testing in humans in about 3 years.

Therapies targeted at this novel mechanism have the potential for disease-modification because they will address the genetic root cause of AD.

Ariad stockholders to receive $24.00 per share in cash.

Authorized generic offered at more than 50% below wholesale acquisition cost of EpiPen auto-injector.

Acquisition will make Lonza a fully integrated solutions provider in oral delivery technologies and active ingredients to the consumer healthcare and nutrition markets.

Company will also close its Hopewell, New Jersey site and will not renew its lease at the Lake Union Steam Plant site in Seattle, Washington.

Pharma giant says it complied with established competition law.

Lilly's solanezumab fails to meet primary endpoint of Phase III study.

Bococizumab deemed unlikely to provide value to patients, physicians, or shareholders.

New treatment elicits two-pronged immune response that destroys tumors in mice.