Kelly Davio

February 06, 2019

One emerging method to monitor potential differences is to apply aptamers: single-stranded DNA or RNA oligonucleotides. Aptamers can bind to various targets, and because they have a defined fold that can recognize a target with high affinity, they can be used as surrogate antibodies.

February 05, 2019

Results from the phase 3 REFLECTIONS B327-02 study in patients with HER2-positive metastatic breast cancer (MBC) were first presented in abstract form, but have now been reported in detail.

February 04, 2019

On Friday, Fresenius Kabi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its MSB11022, a biosimilar adalimumab referencing Humira. The CHMP issued its opinions for the marketing of 2 brand names of the drug: Idacio and Kromeya.

February 03, 2019

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. During the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, stakeholders gathered to discuss new directions in providing digital information to patients.

February 01, 2019

On Thursday, HHS proposed a rule intended to reduce patients’ out-of-pocket costs for prescription drugs by blocking rebates and discounts given to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations and encouraging discounts given directly to patients.

February 01, 2019

Biosimilars are often described as lagging behind generic drugs because there are fewer in the market and they have lower acceptance and uptake. However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development.

January 31, 2019

One of the most time-sensitive topics at this week’s Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, was preparing for the United Kingdom’s upcoming withdrawal from the European Union.

January 31, 2019

On the opening day of the Medicines for Europe (MFE) 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, representatives of the generics and biosimilars industry and regulators gathered to discuss the opportunities and challenges posed by the globalization of medicine development and manufacture.

January 31, 2019

While the body of reassuring data on the safety and efficacy of biosimilars continues to grow, worrisome information about stakeholders’ levels of awareness of these products is also coming to light, and January 2019 saw the publication of a spate of studies showing low levels of patient and provider education on biosimilars.

January 30, 2019

By 2023, the segment of the biologics market in the United States that faces competition from biosimilars will have grown 3 times larger than in 2019, resulting in nearly 10% cumulative savings, says IQVIA.