Drug Development

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Cycle and Aprecia will use Aprecia's 3DP Technology to improve rare disease drug formulations.

The agency published guidance on the research and development of individualized therapies.

MJR PharmJet's MicroJet Reactor technology is a continuous process for producing nanoparticles with tightly controlled particle size and particle size distribution.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

The low viscosity of Colorcon’s Opadry QX, even at solid levels as high as 35%, reduces coating and preparation time compared to traditional hydroxypropyl methylcellulose-based coatings.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

The method developed by Cambrex uses standard plant equipment and requires only two synthetic steps and one recrystallization, minimizing waste and use of solvents.

Orbis Biosciences’ Optimµm Platform delivers microparticulate dosage forms with controlled-release and taste-masked properties in a single manufacturing step.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Aero Pump’s preservative-free Multidose Eye Dropper System with SideActuationDevice received the CPhI Pharma Award for Excellence in Pharma: Packaging.

The acquisition deepens Astellas’ involvement in the development of a pipeline of therapeutics focused on mitochondrial function.

Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.

Modified-release lipid-based formulations in softgel capsules can address physiochemical and pharmacokinetic challenges posed by drug compounds.

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

Is pharma up to the task of developing knowledgeable, motivated employees?

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Medherant has developed an improved instrument for testing drug release from transdermal patches.

The company has opened a new California facility that, combined with its existing site in Foster City, CA, will quadruple its laboratory footprint for gene therapy products.

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.