home

With Biotechnology Companies Leading the Way, Six Venture-Backed IPOs Recorded in First Quarter

Commentsyahoo2016-04-05 09:13 Read   91

Six venture-backed initial public offerings (IPOs) raised $574.5 million in the first quarter of 2016, according to the Exit Poll Report by Thomson Reuters and the National Venture Capital Association (NVCA)

Infographic: FDA has drastically cut down drug approval times

Commentsmedcitynews2016-04-02 12:37 Read   99

The Food and Drug Administration has halved its approval time for new drugs since 2009, as illustrated in a colorful new infographic from the California Life Sciences Association and Boston Consulting Group.

Will SCOTUS take up Sandoz' pivotal biosim case? New briefs call on court to weigh in

CommentsFierce pharma2016-04-01 11:00 Read   152

Biosimilars advocates are lining up behind Sandoz to persuade the U.S. Supreme Court to take up its case against Amgen ($AMGN). The closely watched legal tussle, over Sandoz's biosim copy Amgen's blockbuster Neupogen, could define the timeline for biosimilars' paths to market.

Jazz Pharmaceuticals Announces FDA Approval of Defitelio® (defibrotide sodium) for the Treatment of Hepatic Veno-Occlusive Disease (VOD) with Renal or Pulmonary Dysfunction Following Hematopoietic Stem-Cell Transplantation (HSCT)

Commentspr newswire2016-04-01 10:02 Read   383

azz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) granted marketing approval for Defitelio® (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.

ACOG: OB/GYNs 'essential' in vaccine education, immunization

Commentshelio2016-03-30 13:58 Read   122

The American College of Obstetricians and Gynecologists is urging obstetrician-gynecologists to provide immunizations in their practices in a committee opinion recently released by the organization.

Moseda Joins Telus and Apple in the $20B Patient Home Monitoring Sector

Commentsthelifesciencesreport2016-03-30 12:57 Read   96

Because chronic conditions are difficult to manage by patients at home, with complications, hospitalizations and other expensive interventions sometimes necessary, they account for more than 75% of healthcare costs worldwide.

Weekly Market Movers: Global Majors & Industry (to 24 Mar 2016)

CommentsEP Vantage2016-03-29 11:04 Read   150

EvaluatePharma’s EventAnalyzer delivers a weekly global round up of key events driving company valuations.

FDA Does Not Grant Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection)

CommentsBusinesswire2016-03-29 09:01 Read   148

We are disappointed with the agency’s decision regarding orphan drug exclusivity for BENDEKA, which we believe to be incorrect

Leishmaniasis treatment Impavido available in the US

CommentsHEALIO2016-03-28 11:11 Read   621

Impavido, the only FDA-approved oral treatment for visceral, mucosal and cutaneous leishmaniasis, is now available in the United States, according to press release.

Week in Review: Origin-Centrillion Offers $1.5 Billion for Affymetrix

CommentsChinabio2016-03-28 09:36 Read   147

Origin Technologies, a US company with deep China connections, has raised its bid to acquire Affymetrix (NSDQ: AFFX), a US microarray company, to $17 per share (see story).

UPDATED: FDA's internal review of Acadia's Parkinson's drug raises safety, benefit concerns

CommentsFDA2016-03-28 09:29 Read   136

Acadia's regulatory and research crew will face some tough questions come Tuesday's FDA advisory committee review of its Parkinson's antipsychotic drug pimavanserin ($ACAD), but a scan of the agency's internal review document issued today suggests that the door is still open to a possible approval.

How to Trade Sarepta Therapeutics Ahead of ADCOM: Chen Lin SRPT

Commentsthelifesciencesreport2016-03-25 10:28 Read   166

Sarepta Therapeutics Inc. (SRPT:NASDAQ) is scheduled to have its FDA Advisory Committee Meeting (ADCOM) to review eteplirsen as a treatment for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping on April 25, a little over a month from now. According to newsletter writer Chen Lin, this is a huge binary event for the company.