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FirstWord Lists: The 100 best selling pharmaceutical brands

CommentsFirstWord2016-04-19 09:32 Read   110

The one hundred biggest selling pharmaceutical products generated combined sales of $265 billion in 2015.

Upcoming events – Phase II data for Raptor and The Medicines Company

Trendepvantage2016-04-18 14:20 Read   58

Welcome to your weekly digest of approaching regulatory and clinical readouts. Raptor Pharmaceutical’s efforts to expand the reach of Procysbi are approaching another milestone with the release this quarter of interim data from a phase II/III study in inherited mitochondrial diseases.

AACR – Mage-A3 double-whammy hits Kite

Frontierepvantage2016-04-18 14:14 Read   64

Given its relevance to Kite Pharma, the NCI’s data on an engineered T-cell receptor against Mage-A3 was a keenly awaited AACR presentation, but when it went live on Sunday researchers could boast of no new responses versus what had been presented last November.

West Coast Biotech Roundup: Theranos, Medivation, Juno, and More

EVENTSxconomy2016-04-18 14:05 Read   68

Sean Parker, who made billions of dollars investing in Napster and Facebook, hosted a big party this week with Lady Gaga, John Legend, and a lot of movie stars.

Product-Specific Recommendations for Generic Drug Development

Regulatorfirstword2016-04-18 13:57 Read   95

To successfully develop and manufacture a generic drug product, an applicant should consider that their  product is expected to be:  pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use,  bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient;  and, consequently,  therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug. 

Advent, Baxter preparing bids for India's Gland Pharma: sources

EVENTSreuters2016-04-18 13:51 Read   74

Global buyout firm Advent International and U.S.-based Baxter International (BAX.N) are among suitors preparing to submit separate bids to buy unlisted Indian drugmaker Gland Pharma Ltd, three people with direct knowledge of the matter told Reuters.

The looming threat of avian flu

EVENTSnytimes2016-04-18 13:47 Read   74

Even at a distance, it was obvious that there was something odd about the compost pile behind one of Brad Moline’s long white barns.

Long-term vaccine management system planned

Regulatorenglish.gov.cn2016-04-18 13:39 Read   107

Two government departments started studying the establishment of a long-term vaccine circulation and inoculation management system, according to their spokesmen on April 13.

India M&A sees offshore interest in Gland Pharma

EVENTSfiercepharma2016-04-18 13:33 Read   75

Unlisted Hyderabad-based injectables maker Gland Pharma has drawn interest from outside India, including from Baxter International and Advent International of the U.S. for a company backed by of leveraged buyout firm KKR & Co.

Shire to expand biotechnology manufacturing capacity in Ireland

EVENTSidaireland2016-04-18 13:26 Read   73

Investment to help meet growing demand for rare disease treatments Expected to create 400 jobs in Ireland at new state-of-the-art facility in Co. Meath

Phibro Animal Health Corporation Reiterates Safety of Mecadox®

FrontierGLOBE NEWSWIRE2016-04-18 13:20 Read   68

Today, the Food and Drug Administration (FDA) issued a press release stating its intention to take the initial steps in the process to rescind its approval of Mecadox® (carbadox)

Crestor Developer Sees Sales Doubling On Lower-Priced Drugs

EVENTSbloomberg2016-04-18 12:33 Read   69

Across the pharmaceutical industry, companies have rushed towards medicines with sky-high prices -- making bets in lucrative areas like complex cancer treatments and even gene therapy that could come with a $1 million price tag.