Industry news

Manufactured stem cells to advance clinical research

U.S. National Institute od Health

Researchers supported by the National Institutes of Health developed a clinical-grade stem cell line, which has the potential to accelerate the advance of new medical applications and cell-based therapies for millions of people suffering from such ailments as Alzheimer’s disease, Parkinson’s disease, spinal cord injury, diabetes, and muscular dystrophy. The stem cells were developed by isolating human umbilical cord blood cells following a healthy birth, and coaxing them back into a pluripotent state, or one in which they have the potential to develop into any cell type in the body. Cells developed in this manner are called induced pluripotent stem cells (iPSCs). With NIH support, these cells were manufactured by Lonza, Walkersville, Maryland, and described in a publication by Behnam Baghbaderani, Ph.D., and colleagues in Stem Cell Reports.

Scoring the 5 top phase III drugs in the global pipeline

Arsalan Arif / ENDPOINTS

Their phase III list is dominated by Roche, which is pulling off a string of blockbuster approvals. Regeneron and Sanofi, perhaps the best partners in biotech, have a clear shot with dupilumab. Lilly, which has begun to rack up badly needed successes in Phase III, is expected to score with abemaciclib (though CDK 4/6 will be competitive).

24 June 2016

Epic Sciences Introduces Sensitive HRD Liquid Biopsy Test for PARP Inhibitor Clinical Trials

Epic Sciences unveiled a liquid biopsy test that more sensitively detects cancers susceptible to PARP inhibitors by targeting homologous recombination deficiency (HRD) in individual circulating tumor cells (CTCs). The new test has already been incorporated into numerous clinical studies of HRD-targeted therapeutics in multiple cancer types.

Agencies push bug drug pipeline but development lacks market pull

Marie Powers / BioWorld

Efforts to improve the treatment of multidrug-resistant bacterial infections begin with the pipeline, and pipelines emerge from scientific prowess and dealmaking. Despite public rhetoric about confronting the superbug threat globally, experts contend that the cupboard of innovative treatments to address these pathogens is meager and the supply of scientists needed to restock the shelves is scarce.

Drug resistance specter is fact of life for antibiotics

Anette Breindl / BioWorld

In the justified worries about drug resistance, it tends to get somewhat lost that there is, as yet, no completely untreatable superbug. The colistin resistance gene mcr-1 that was detected on plasmids in China and Europe in 2015, and in the US in 2016, has not yet met up with a bacterium that is resistant to all other drugs.

Study: Shorter, higher-dose radiotherapy effective for prostate cancer

Amirah Al Idrus / Fierce Medical Device

A shorter course of radiotherapy with fewer sessions and higher dosage is as effective as the standard of care in treating prostate cancer, a U.K. study found. Switching over to this shorter schedule would not only benefit patients, but also help the National Health Service save tens of millions of pounds.

Sean Parker finds a big role to play in cancer R&D: The disruptive billionaire

John Carroll / ENDPOINTS

In biotech, where everything is uncertain, execs like to be as predictable as possible. Scripts are maintained, nasty surprises are avoided whenever possible and speed is fine, so long as you stick to your schedule and don’t look like you’re in too much of a hurry.

India ups direct foreign investment cap in drug companies to 74% from 49%

EJ Lane / Fierce Pharma

Prospects for higher foreign portfolio and overseas company investment in Indian drug firms brightened as the government moved to raise the direct shareholding cap to 74%.

China pilot eyes easier marketing authorization

EJ Lane / Fierce Pharma

A pilot program to widen eligibility for drug marketing authorization approval by the China FDA will help small and innovative companies get drugs to market at a lower cost.

U.K. biotech holds its breath as voters decide whether to split from EU

Ben Adams / Fierce Biotech

As U.K. voters head to the polls on Thursday for the EU referendum, uncertainty for life sciences looms large. FierceBiotech talks to biotech execs, regulators and trade groups to assess the mood ahead of Thursday’s vote.