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A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.

Samsung BioLogics signs $55.5 million agreement to manufacture tildrakizumab for Sun Pharma.

Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.

The agency announced a plan to eliminate its existing orphan designation request backlog.

The company has broken ground on a R&D and process development facility in Missouri.

The conference will return to the EU and is featuring its Start-Up Hub and Pharmapack Awards.

The directorate highlights its 2016 achievements.

Quattroflow’s EZ-Set Pump Chamber Replacing System for its single-use pumps allows users to change chambers quickly by hand.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

An NIH study examined a dissolving microneedle technology as a way to deliver the influenza vaccine to patients.

BIO report measures decade-long investment and acquisition trends for emerging biotech companies.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The companies expanded their alliance to develop plasmid DNA drugs.

Sartorius Stedim Biotech expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

The company successfully produced cell-based influenza vaccines at a commercial scale in its facility in NC.

The company announced that it has completed its 100th program using the pAVEway protein expression system, which was originally introduced to the market in 2007.

The annual meeting of the Honeywell Users Group for the Americas will discuss industrial automation.

FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.

Charlie Baker announced a plan to invest up to $500 million in the MA life-science industry.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

The organization released principles related to workforce development, diversity, and inclusion that it believes are key to the biotechnology industry.

The RT-PCR kit can simultaneously screen samples for Zika, dengue, and chikungunya arbovirus RNAs.

The company announced its new ISQ EC Single Quadrupole mass spectrometer and the new range of Thermo Scientific MAbPac RP 1-mm columns.

The company was granted patent rights to the use of CRISPR in a genomic integration method for eukaryotic cells.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.