Amneal Pharmaceuticals expects to bring production of some Impax Laboratories’ drugs in-house through a 100,000 sq. ft. expansion at its site in New York state.
The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.
Alexion will close its Rhode Island manufacturing facility as part of a cost cutting plan that will also see it reduce its workforce by 20% over the next year.
Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.
Unilfe has started discussing the wind-down of its prefilled syringe business with customers after deciding to focus on wearable drug delivery technologies.
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.
Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.
Soon PPD and inVentiv will be the only privately-owned top eight CROs, which prompted us to weigh up the firms in the event that either goes public in the near future.
The US FDA approved Afrezza last weekend after deeming that the inhaled insulin drug and the dry powder delivery technology used to get it deep into the lungs is effective.
Catalent has filed an initial public offering (IPO) with the SEC to raise $100m though this could reach upwards of $500m, according to one investment firm.
Aprecia Pharmaceuticals has set out to try and raise money to support the commercial launch of the first drug product that uses its ZipDose delivery tech.
Cubist is issuing a nationwide recall of four lots of its antibiotic injection Cubicin after one of the company’s CMOs had a manufacturing issue that caused glass particulates to contaminate the lots.
Acquisition by private equity group Genstar Capital would allow eResearch Technologies (ERT) a more flexible approach and reduce costs according to CEO Jeff Litwin.
Albany Molecular Research (AMRI) says ‘streamlining’ plan will focus on its drug licensing unit not its contract API research, development and manufacturing services division.
Contract speciality chemical maker Chemspec International says it will ‘go private’ after being taken over by Halogen Limited, a holding company co-owned by members of its management board.
ShangPharma has raised $87m through an IPO on the New York Stock Exchange according to a Bloomberg report, beating the $46m to $53m the Chinese CRO forecast.
US CRO PPD has been busy on both sides of the Atlantic, opening a clinical testing facility in Ireland and, in the US, moving forward with plans to spin-off its compound partnering business as Furiex Pharmaceuticals
Genzyme is outsourcing fill and finish manufacturing of several major drugs to Hospira in response to in-house difficulties at its Allston Landing facility in Boston, Massachusetts, US.
MannKind’s share price tumbled by 31 per cent yesterday, just days after it published encouraging safety data for Afresa, because it revealed a partnership deal is unlikely to occur in 2009.
With Lonza and JLL competing over Patheon Outsourcing-Pharma looks at what the CMO offers to a prospective buyer, analysing its global manufacturing capacity and backlog using interactive maps and graphs.
CRO Averion is planning to become a private company to reduce expenditure on auditor fees, which could realise savings of $805,000 (€561,000), and allow management to better focus on long-term goals.
