Hemispherx Biopharma has hired Avrio Biopharmaceuticals to make Ampligen while it continues to try and win US approval for rejected candidate chronic fatigue syndrome (CFS) drug candidate.
Regulatory approvals are driving interest in West's Smartdose and Crystal Zenith delivery technologies, the firm says ahead of the launch of a monthly-dose version of Amgen's Repatha.
As part of a recent survey, 62% of respondents said they are more likely to engage a clinical research organization (CRO) partner for clinical research than they were five years ago.
Cambrex has said it will invest around $20m in its Pharma 4 API facility before the end of the year in an effort to get ahead of the capacity utilisation curve.
US FDA warnings and Venezuela's economic crisis have contributed to “a challenging quarter” for Dr Reddy’s, with its API business being particularly affected.
Scientists at AstraZeneca’s former R&D site in Alderley Park will play a key role in researching antibiotics and the spread of resistance under an initiative launched by US President Barack Obama.
A restructuring programme which closed two US facilities and slashed hundreds of jobs has paid off says Amgen, attributing increased margins to better manufacturing efficiencies.
Inovio Pharmaceuticals and GeneOne Life Science have dosed the first patient in the multi-center, phase I clinical trial of the companies’ Zika vaccine.
Symbiosis Pharmaceutical Services is preparing for increasing growth in the outsourcing sector with “a major investment” at its sterile filling facility underway and a recent hire in the US.
Crown Bioscience has expanded its San Diego facility to create its US Center of Excellence for Oncology in order to support increasing demand for oncology research studies.
GSK will pump £275m ($360m) into its UK manufacturing network and says the country has a “leading position in life sciences” despite the recent Brexit vote.
According a recent survey, while there is a disconnect between Sponsors and Providers in some areas, the industry as a whole agrees that there is room for improvement.
The US FDA says it identified “significant deviations” from manufacturing standards a facility in Denmark operated by allergy immunotherapy developer ALK-Abello (ALK).
The US FDA will not approve the candidate eye pain eye treatment Dextenza until developer Ocular Therapeutix addresses concerns about how the product is made.
A recent FDA Advisory Committee vote could allow researchers to use continuous glucose monitoring (CGM) systems in place of traditional methods, providing “a myriad of customized data,” says Quintiles.
Medisafe is launching Medisafe for Pharma after completing several pilots over the past year and a half - one of several new applications that have emerged as the industry focuses on patient centricity.
The acquisition of Compass Research expands Bioclinica’s access to several specialized populations with neurodegenerative disorders and other diseases.
Micro Labs completes repeat studies and predicts drugs will be back on the market in autumn
Sandoz is repeating bioequivalence studies and Teva is withdrawing an antimalarial after the EMA recommended that drugs trialled by Semler Research Centre should be suspended.
Acquisitions, higher demand for sterile liquid processing and a surge in Thyrosafe orders helped Recipharm offset pricing pressure in Portugal and lower UK sales in Q2.
The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
SK Capital has rejigged the senior teams at opiate API maker Noramco and raw material supplier Tasmanian Alkaloids just weeks after buying the firms from Johnson & Johnson (J&J).
The Medicines Company announced last week that its Angiomax patent has been upheld – an 'important court decision' which affirms that working with CMOs won’t invalidate a company's patent.
European authorities want to revise the guidelines covering first-in-human studies in light of the French trial in which one man died and others were hospitalised earlier this year.
The end-to-end reimbursement tool from Medidata uses clinical trial data to calculate costs and make payments to investigative sites in real time, all in the cloud.
MSM Poly LLC has signed a non-binding agreement to buy IP that underpins Ineos’ Barex resins, which are used to make pharmaceutical and food packaging.
The 280,000-square-foot facility will be built in Burlington, Massachusetts and will include a customer collaboration laboratory and training center, in addition to office space.
Ethical principles for conducting research involving humans were originally detailed in 1978 – today, a new report is urging Congress to make updates to the decades old document.
