BC Extra | Feb 1, 2020
Company News

Alnylam’s Givlaari, Novo’s Rybelsus among CHMP’s latest recommendations

Among a series of recommendations issued Friday, EMA’s CHMP backed approval of what would be Alnylam’s second approved RNAi drug in the EU, as well as an oral diabetes therapy that Novo Nordisk is relying...
BioCentury | Jan 29, 2020
Product Development

Industry leaders applaud CVS zero co-pay diabetes drug access

CVS is answering the call to decrease the cost burden of diabetes medications on patients with a new plan that eliminates co-pays, and industry leaders committed to the social contract are applauding the news as...
BC Extra | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic  FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease....
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Jan 10, 2020
Company News

Boehringer continues fibrosis drive via acquisition of Enleofen assets

The acquisition of Enleofen’s preclinical IL-11 inhibition platform is the latest in a string of deals by Boehringer to build out its fibrosis tool kit, giving the German pharma therapies against a new target for...
BC Innovations | Dec 11, 2019
Product Development

The writing has been on the wall for Sanofi’s diabetes, CV business for years

One hundred days after taking the helm as CEO, Paul Hudson has outlined a plan to get Sanofi to 30% margins by 2022 that hinges largely on the success of Dupixent and five other priority...
BC Extra | Nov 16, 2019
Company News

Nov. 15 Company Quick Takes: Qiagen continues climb after confirming takeout offers; plus Fetroja, selumetinib, PharmAbcine, semaglutide

Qiagen confirms acquisition interest  Qiagen N.V. (NYSE:QGEN; Xetra:QIA) said Friday it is reviewing its strategic alternatives after receiving several “non-binding indications of interest for the acquisition” of the diagnostics company. Since acquisition rumors emerged Wednesday,...
BC Extra | Nov 13, 2019
Clinical News

Hua Phase III diabetes data make good on glucokinase but disappoint investors

Hua’s announcement that glucokinase activator dorzagliatin met its endpoints in a Phase III diabetes study marks a watershed moment for a target whose disease-modifying potential was long stymied by the limitations of previous compounds. Yet...
BC Extra | Nov 9, 2019
Financial News

Nov. 8 Financial Quick Takes: First day of trading for BrightGene, Tot; plus argenx, Agios and AiCure

BrightGene shines in STAR debut   BrightGene Bio-Medical Technology Co. Ltd. (Shanghai:688166) gained RMB17.90 (141%) to RMB30.61 in its first day of trading on Shanghai’s STAR board. The company raised RMB521.1 million ($74.1 million) in...
BC Extra | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
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