During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.
Eli Lilly and Company plans to expand its manufacturing footprint in Indiana by investing $2.1bn in two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.
CPhI North America 2022 host city Philadelphia is set to become one of the world’s biggest cell and gene therapy manufacturing hubs. But it’s just one of many centers of innovation that are helping drive the US pharma and biopharma industry.
The agency has approved an expanded indication for Qelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.
The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.
At the open of the global pharmaceutical industry gathering, a survey of executives from around the globe indicates a rosy mood among professionals in the field.
An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.
US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.
FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports.
As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.
The issue of pricing is a familiar discussion for the pharma industry and Ruchin Kansal, of Virtusa, believes that there is the potential for a win-win situation.
With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.
As Novartis looks to sell a major chunk of its generics portfolio in the US, in-PharmaTechnologist has a look back at some of the stories this year that have signposted larger, on-going trends in the US generics market.
The US State Patent and Trademark Office has granted Teewinot Life Science Corporation its second patent this year covering biosynthetic cannabinoid production methods.
The overhaul of the tax system will allow US pharma firms to access billions in capital, but J&J and Merck & Co. play down any changes in their M&A strategy.
Mutual inspection report recognition is positive, but EU and US FDA alignment on product specs and compendia would help drug firms, says regulatory expert Ajaz Hussain.
China has announced that it will now accept clinical trial data from other countries in a new guideline that aims to reform the management of clinical trials.
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
Patheon could reap the benefits of President Donald Trump’s call for increased drug production in the US by upping capacity utilisation an analyst says.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
AstraZeneca will supply Toprol-XL to Aralez Pharmaceuticals Trading for at least 10 years after selling the US rights to the off-patent beta blocker for $175m.
Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.
If ‘Love is the drug’ should Roxy Music be subject to regulatory scrutiny? Can The Verve say ‘The drugs don’t Work’ without conducting a clinical trial? We explore the harmonious worlds of pharma and music.
Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate, semaglutide, drove the decision.
Raffles PharmaTech has contracted ScinoPharm to make the API for a generic version of the arthritis pain drug celecoxib being developed for the US market.
