Randi Hernandez

A drug price hike like that of the one seen in the highly publicized case of Turing Pharmaceuticals' Daraprim is prompting a public outcry and is demonizing the industry for those who see Martin Shkreli as representative of all pharmaceutical executives. But capping drug price increases may affect actual patient costs less than imagined, and may have a bigger impact on pharmacy benefit managers and insurance companies.

Hillary Clinton unveiled a new plan on Sept. 22 during a community forum in Des Moines, Iowa to tackle high drug prices. The plan reveal was a follow-up to a tweet from the presidential candidate a day prior, on Sept.

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.

The Biosimilars Forum argues that the assignment of a unique Healthcare Common Procedure Coding System (HCPCS) for each biosimilar product is in alignment with the intent of Congress.

  The European Medical Contract Manufacturing (EMCM) organization announced it will team up with VCC Medical NV for a unique personalized medicine initiative-the aseptic manufacture of a biologic therapeutic from the tissue of a patient’s tumor.

  Sandoz announced on Sept. 3, 2015 that despite the barriers erected by competitor Amgen, Sandoz officially launched Zarxio (filgrastim-sndz), its biologic version of Amgen’s neutropenia medication Neupogen (filgrastim). To complement the drug launch, Sandoz is also launching Sandoz One Source, a patient services center providing support for and information on the medication.

The investigational monoclonal antibody targets interleukin-17 and is in clinical trials for the treatment of plaque psoriasis.

Focusing on niche and specialty service offerings gives contract biomanufacturing organizations an opportunity to differentiate in a crowded market.

When should CMOs and their pharma clients share the details of their partnerships with outside parties?

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

The company announced plans to begin PIONEER, a Phase IIIa program comprising seven trials of approximately 8000 people with type 2 diabetes.

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

The company adds a few new arguments-as well as new stakeholder support-to its Citizen Petition on biosimilar naming.

WuXi said its biologics manufacturing business will be one of the company’s key growth drivers over the next several years.

  Juno Therapeutics shared some of its business strategies related to process development and manufacturing in a second-quarter earnings call on Aug. 12, 2015. According to CEO Hans Bishop, the company believes its progress in the manufacture of chimeric antigen receptor (CAR or CAR-T) T-cell products will drive the company’s success for all of its product candidates and will be especially important for JCAR015, its investigational treatment for acute lymphoblastic leukemia (ALL). FDA cleared the investigational new drug application for JCAR015 on July 30, 2015.

The company closed its Zebulon-based plant after routine testing of a cooling tower revealed the presence of the bacterium responsible for Legionnaire’s disease.

FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

European Union regulators said Pfizer must divest its infliximab biosimilar candidate and some sterile injectables for the merger with Hospira to be completely approved.

The company’s purification platform is thought to reduce the number of purification steps that are currently required for the manufacture of complex therapeutics.

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.

  The provisions in the Trans-Pacific Partnership (TPP) dealing with patent exclusivity periods are diametrically opposed to the main goals originally outlined in the Biologics Price Competition and Innovation Act of 2009 in the Patient Care Protection and Affordable Care Act, the Biosimilars Council wrote in an open letter to President Obama on July 27, 2015.

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

A new study published in JAMA Internal Medicine found that manufacturers do not report a portion of adverse events to FDA within the federally mandated time frame of 15 days.