Dosage Forms

Biotech-based therapies and a move to single-use processes highlight recent industry changes.

ISPE measures impact of biotechnology and globalization on personalized medicine.

Advancements in cell culture and protein technology have opened the door for new therapies.

Pharma’s test of continuous manufacturing is starting with oral solid-dosage forms.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

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

The directorate highlights its 2016 achievements.

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.

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.

Takeda inaugurated expanded capacity of solid-dosage drugs at its site in Oranienburg, Germany.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

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 need for flexibility and higher quality are driving advances in parenteral manufacturing and fill/finish equipment.

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

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

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.

At an industry seminar hosted by Leistritz Extrusion, experts explained the use of extrusion equipment to mix polymeric excipients with APIs for solubility enhancement and for multifunctional and specialty dosage forms, including implants.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

Takeda will build a new production facility at its existing Grange Castle site in Ireland.

As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.

Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.