Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances.

Development 242

Development Bioequivalency Generic Drugs Production 242

Druggist

MARCH 25, 2021

Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). A box of Cerelle or Cerazette pills comes with three blister blisters, each of which contains 28 mini-pills (note you may be prescribed just one blister = 28 pills). Both pills are taken in the same way.

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

AUGUST 5, 2020

In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults.

Trials 52

Trials Medicine Production Containment 52

The Pharma Data

FEBRUARY 1, 2021

This approval expands Biogen’s industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of Plegridy, and follows the European Commission’s marketing authorization for the IM administration in December 2020. “At Chief Medical Officer at Biogen. percent vs. 32.1 Source: Biogen.

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40