BioCentury | Feb 15, 2020
Product Development

WHO mapping out COVID-19 vaccines

...an unprecedented pace. Priorities out of the WHO meeting include drafting a target product profile (TPP...
...been developed” provide a starting point for COVID-19. Defining a target product profile Defining a TPP...
...those potential candidates.” There was debate at the WHO meeting about the definition of a TPP...
BioCentury | Mar 1, 2019
Company News

NICE rebuffs BioMarin's ultra-orphan therapy

The U.K.'s NICE did not recommend Brineura cerliponase alfa from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) due to uncertainty around the therapy's long-term efficacy and concerns NHS would be unable to implement the rare disease biotech's proposed...
BioCentury | Feb 22, 2019
Company News

NICE nixes BioMarin's ultra-orphan therapy for lack of long-term data

The U.K.'s NICE did not recommend Brineura cerliponase alfa from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) due to uncertainty around the therapy's long-term efficacy and concerns NHS would be unable to implement the rare disease biotech's proposed...
BioCentury | Sep 25, 2018
Politics & Policy

Canada balks at U.S. demand for 10 years of biologics exclusivity

...treaty negotiated by the Obama administration (see “Trans-Pacific Dreams” ). President Donald Trump has rejected TPP...
BioCentury | Aug 28, 2018
Politics & Policy

Revised NAFTA deal includes 10-year biologics protection

...deliver to patients." PhRMA and BIO publicly stated that the biologics exclusivity provisions in the TPP...
BioCentury | Aug 3, 2018
Politics & Policy

Safety, trade concerns weigh on China biotechs

...entire process of vaccine R&D, production and distribution. Brian Yang, director of business development at TPP...
...incentivize Western healthcare companies to establish and enter the Chinese market in a big way.” TPP...
BioCentury | Jan 5, 2018
Politics, Policy & Law

Seeking odd couples

...included 12 years of exclusivity for biologic drugs. He worked to torpedo the Trans-Pacific Partnership (TPP...
BioCentury | Nov 30, 2017
Company News

BioMarin sells Priority Review voucher for $125M

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) agreed to sell its rare pediatric disease Priority Review voucher for $125 million to an undisclosed buyer. BioMarin received the voucher in April when FDA approved Brineura cerliponase alfa to treat...
BioCentury | Jun 2, 2017
Clinical News

EC approves Brineura for CLN2

The European Commission approved Brineura cerliponase alfa (BMN 190) from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease. In April, FDA approved Brineura, making it the...
BioCentury | Jun 1, 2017
Clinical News

EC approves Spinraza, Brineura

The European Commission approved a pair of new drugs for rare diseases: Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) to treat spinal muscular atrophy (SMA); and Brineura cerliponase alfa from BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to treat...
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