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Amarin endures another FDA delay as Vascepa languishes

support for the design of Vascepa's ANCHOR study, leading the company to file an appeal. The FDA told ...

Sarepta jumps on fresh optimism for an early approval

of eteplirsen back in November. Sarepta had believed it could file an NDA without embarking on Phase III trial ...

Astellas and Takeda continue to advance vaccine strategies

selling a freeze-dried live attenuated chickenpox vaccine in Japan. Astellas' release (PDF) ...

U.K. under pressure to reimburse Novartis' Bexsero; Hepatitis B vaccine uptake in China drops;

to develop live attenuated Bordetella pertussis vaccine technology. Item > As many as 70 Pakistani health ...

BIO and Sanofi are pushing the FDA to tweak its drug shortage rule for vaccines

Strong demand for flu vaccines in Canada has left authorities scrambling for supplies this winter, but in general preventive vaccines have suffered less severe shortages than drugs in recent years. The Biotechnology Industry Organization (BIO) argues this is evidence the current system for vaccines works and has ...

Zafgen rolls out positive PhIIa results for obesity drug; Mass General, Broad Institute and Amgen partner on bowel disease;

treatment response and help prevent metastasis.  Story > Microlin Bio files for a $25M IPO to advance ...

FDA staffers again wary of ACS use for J&J's Xarelto; Teva: We'll move 45% of Copaxone users to new formula; Gedeon Richter dismisses talk of Forest buyout;

Microlin Bio files for a $25M IPO to advance cancer Dx and Rx treatments.  Story > Dutch research ...

Aduro's combo cancer vaccine combo posts positive survival benefits

vaccines. But it faces a huge hurdle in Phase III. "The significant improvement in survival in patients ...

Merck recall depletes supplies of new cholesterol drug

after the drugmaker recalled one lot of its Gardasil HPV vaccine because of a chance that a small number ...

Boston Scientific reaffirms renal denervation commitment; Ariad and Medinol begin stent trial;

could predict treatment response and help prevent metastasis.  Story > Microlin Bio files for a $25M ...

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