A potential treatment for sickle cell disease has come through the “valley of death” of early-stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
GlobalData report reveals the US trails Europe in strengthening its stagnant antibiotics pipeline.
New AbbVie proposal results in discussion with Shire about possible $53 billion deal.
Mylan set to acquire Abbott's non-US developed markets specialty and branded generics business in an all-stock transaction.
Glatt and Innopharma Labs have formed a partnership to provide Glatt's customers access to Innopharma Labs' non-invasive, real-time 3D particle characterizer, Eyecon, which has the ability to generate live particle size and shape information.
Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.
Puncture in container and overwrap cause leak in intravenous solution, leading to recall by Hospira.
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.
The European Medicine Agency details the agency?s recommendations for drug-marketing authorizations for the first half of 2014.
FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
New International Council on Biotechnology Associations advocates biotechnology growth.
Catalent appoints a new country leader and expands facilities.
Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million.
The FDA approved Beleodaq for the treatment of patients with peripheral T-cell lymphoma.
FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy.
The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.
Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.
FDA draft guidances seek to maintain accurate drug information for patients in new media.
Is there potential for growth in Brazil's phytotherapic drug market?
Genentech's $1.7 billion acquisition of Seargon Pharmaceutical includes portfolio of investigational next-generation oral selective estrogen receptor degraders.
Regulators and industry leaders take on the task of securing the drug supply chain.
The oncology center and its manager were charged with obtaining and selling unapproved, potentially counterfeit, cancer-treatment drugs.
FDA releases guidance documents and rules on requirements for compounding human drug products.
Sandoz will supply antibiotic to developing countries as part of the United Nations' Every Newborn Action Plan.
Merck funds Bionomics with $20 million to progress therapies for cognitive impairment caused by central nervous system disorders
The collaboration will use Mersana Therapeutics Fleximer technology for antibody-drug conjugates.
European Medicines Agency clarifies advanced-therapy medicinal products classification.
Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.
Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.
This work marks the first joint project between regulators and HTA bodies on a European level and is part of their ongoing dialogue to support policymaker decisions in the future.