BioWorld
  • BioWorld Home
  • About Us
  • Contact BioWorld

BioWorld Perspectives

news, analysis, debates, commentary and camaraderie related to the development of biotechnology drugs
  • Blog Home
  • Editorial Staff
  • About BioWorld
  • Contact Us
  • Log In

Biosimilar regulation: 1984 v. 2014

February 19, 2014 – 8:06 pm | By Mari Serebrov | No comments yet

It’s 1984. The year opens with the demise of Ma Bell, as the Bell System is broken into smaller, regional telephone companies. The idea is to end Ma’s nationwide monopoly, but the result is a handful of smaller monopolies since there…

Share

Read more
Posted in Biosimilar, BLA, Drug Approval, Drug pricing |

Drug pricing: Are we paying for efficacy or innovation?

February 12, 2014 – 10:12 pm | By Jennifer Boggs | No comments yet

Blog 2-12-14

What if we paid professional athletes only when they won? What if spectators got their tickets refunded whenever the home team lost? That might make that $1,300 Super Bowl ticket a little easier to purchase. And, hey, perhaps that might…

Share

Read more
Posted in Drug Approval, Drug pricing, IND, Investigational New Drug Application, New Drug Application, Reimbursement |

Happy Holidays! BioWorld’s 7th Annual Biotech Gift Guide

December 9, 2013 – 1:40 pm | By Marie Powers | No comments yet

Blog12-9-13

Who needs Black Friday and Cyber Monday, anyway? True biotech aficionados know they can find the perfect gift for everyone on their holiday list in BioWorld’s 7th Annual Biotech Holiday Gift Guide. Shoppers, start your engines. Personal Health Last year,…

Share

Read more
Posted in Uncategorized | Tagged CEO, DNA, No Big Deal, Personal Health

An Asia Strategy is Not Optional

October 30, 2013 – 7:49 am | By Lynn Yoffee | No comments yet

BioWorld-Asia-banner-320x86

“If you plan to be around five or 10 years from now, you have to have a Chinese strategy.” That poignant comment in a BioWorld Today article came from Joshua Boger in 2011. The founder and former CEO of Vertex…

Share

Read more
Posted in Asia, Biosimilar, Biotechnology, China | Tagged Asia, Australia, China, WHO

Patient Experience Still Undervalued in Regulating Drugs

October 28, 2013 – 2:54 pm | By Marie Powers | No comments yet

W

As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The…

Share

Read more
Posted in BLA, Clinic, clinical study report, Clinical Trial, Clinical Trial Design, European Medicines Agency, FDA, NDA, New Drug Application, Patient, Phase I, Phase II, Phase III | Tagged CRL, FDA, ODAC, RCC

The FDA Should Provisionally Approve Vascepa

October 21, 2013 – 2:36 pm | By Catherine Shaffer | No comments yet

Amarin blog 10-21-13

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) rocked the biotech industry last week by voting 9 to 2 against approval of Amarin Pharmaceuticals Inc.’s fish-oil derived omega-3 supplement Vascepa in the supplemental indication of mixed dyslipidemia. The drug…

Share

Read more
Posted in adcom, Cardiovascular, Drug Approval, FDA | Tagged Amarin Pharmaceuticals Inc, ANCHOR, EMDAC, FDA

A $100B Market Cap: Now That’s a Big Deal for Biotech

October 9, 2013 – 3:24 pm | By Peter Winter | No comments yet

B

Remember the heady days about eight years ago when Amgen Inc. and Genentech Inc., prior to its acquisition by Basel, Switzerland-based Roche AG, both vied for top spot in terms of market capitalization? At that time, both companies briefly commanded…

Share

Read more
Posted in Biotechnology, market capitalization | Tagged Amgen Genentech, Amgen Inc, Gilead Amgen, Switzerland

Bug Juice: Antibiotics’ Slow Drip Turns to Flow

October 3, 2013 – 10:43 am | By Randy Osborne | No comments yet

Blog 10-3-13

I’m terrified of hospitals. Not so many years ago, this would have been an absurd remark. With doctors and high-tech medical care all around, a hospital seemed like one of the safer places in the world to be. But then,…

Share

Read more
Posted in antibiotics, Methicillin-resistant Staphylococcus aureus, multidrug resistance | Tagged Dual Endpoint Plucked, FDA, MRSA, Paul Edick

It’s How You Look at the Vial

October 1, 2013 – 12:07 pm | By Mari Serebrov | No comments yet

blog 10-1-13

What’s in a biosimilar name? That depends on whether the vial is half empty or half full. Seeing it as half full, many generic makers focus on the similarities between a follow-on and its reference biologic. Because of those similarities,…

Share

Read more
Posted in Biologic, Biosimilar, FDA, FOB, Follow-on biologic | Tagged FDA, INN

Spittin’ Image: Or, How I Am Probably Going to Die

August 9, 2013 – 3:21 pm | By Randy Osborne | No comments yet

“Once you obtain your genetic information, the knowledge is irrevocable,” warn the service terms at saliva-testing firm 23andMe.com. The news wasn’t so bad, except for Alzheimer’s. Also, I’m sort of related to Stephen Colbert. Of course, 23andMe, of Mountain View,…

Share

Read more
Posted in DNA, genetics, Genomics, Personalized medicine | Tagged AD, Cilantro Lover, DNA, Really Good Genes
« Previous 1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22 Next »

About this Blog

BioWorld Perspectives is the official blog for news, analysis, debates, commentary and camaraderie related to the development of biotechnology drugs.

Join the Conversation

Sign up for our blog!

Advertise Here!

Categories

  • Accelerated approval (3)
  • acquisition (1)
  • acute kidney injury (1)
  • adcom (4)
  • Addyi (1)
  • aging (3)
  • AIDS (1)
  • Alzheimer's (1)
  • antibiotics (4)
  • Antibody (2)
  • Asia (1)
  • Autism (1)
  • Big pharma (31)
  • bioethics (8)
  • Biologic (11)
  • biopharmaceutical (12)
  • Biosimilar (15)
  • Biotech conferences (13)
  • Biotechnology (103)
  • Biotechnology Industry Organization (14)
  • BLA (5)
  • Books (5)
  • Cancer (20)
  • Cardiovascular (3)
  • China (6)
  • chronic fatigue syndrome (3)
  • Clinic (6)
  • clinical study report (3)
  • Clinical Trial (23)
  • Clinical Trial Design (4)
  • Collaboration (6)
  • compassionate use (1)
  • Complete Response Letter (4)
  • Congress (5)
  • corporate tax (2)
  • Deals (7)
  • Diabetes (1)
  • direct to consumer (1)
  • DNA (4)
  • Drug Approval (19)
  • drug importation (2)
  • Drug pricing (17)
  • Ebola (1)
  • embryonic stem cell research (2)
  • emerging markets (3)
  • epilepsy (2)
  • ethics (5)
  • European Medicines Agency (6)
  • evolution (1)
  • executive salaries (1)
  • FDA (39)
  • Financing (26)
  • Flu (1)
  • FOB (2)
  • Follow-on biologic (3)
  • FTC (1)
  • Gene Therapy (5)
  • generic (3)
  • genetics (7)
  • Genomics (10)
  • gift guide (1)
  • Healthcare reform (7)
  • HIV (1)
  • human germline engineering (2)
  • immunotherapy (4)
  • IND (3)
  • Initial public offering (1)
  • innovation (1)
  • Investigational New Drug Application (4)
  • IPO (6)
  • License (3)
  • M&A (8)
  • market capitalization (1)
  • Methicillin-resistant Staphylococcus aureus (1)
  • mitochondria (1)
  • multidrug resistance (2)
  • mutation (1)
  • National Institutes of Health (2)
  • NDA (4)
  • neurology (4)
  • neuroprostheses (1)
  • neuroprosthetic (1)
  • New Drug Application (9)
  • Obesity (1)
  • OIG (1)
  • Orphan disease (8)
  • pandemic (1)
  • partnering (2)
  • patent cliff (2)
  • Patents (6)
  • Patient (7)
  • patient assistance program (2)
  • PDUFA (5)
  • Personalized medicine (7)
  • Pharmaceutical (22)
  • Phase I (6)
  • Phase II (5)
  • Phase III (7)
  • Pipeline (6)
  • Precision medicine (4)
  • Preclinical (2)
  • prostate cancer (1)
  • R&D (1)
  • Rare disease (3)
  • Reimbursement (12)
  • REMS (1)
  • RNAi (2)
  • SEC (2)
  • sequestration (2)
  • Series A (1)
  • Shareholder value (1)
  • siRNA (2)
  • social media (2)
  • Stem cell (2)
  • Summer reading (5)
  • Supplemental new drug application (2)
  • TB (1)
  • traumatic brain injury (1)
  • Tuberculosis (2)
  • Type 2 Diabetes (1)
  • Uncategorized (22)
  • Vaccine (5)
  • venture captial (9)
  • Video (5)
  • virus (3)

Recent Posts

  • If no one reads it, what’s the purpose of a drug label?
  • The opioid crisis: A venture in need of a GAIN?
  • Real-world optics of biopharma price hikes
  • Science for the season: BioWorld’s 11th annual Holiday Gift Guide
  • Drug quality from a patient’s perspective

Tags

ABH Amgen Inc ASCO BIO Biotechnology Industry Organization bioworld BRIC Celgene Corp CEO China Clovis Oncology Inc Cynthia Robbins Roth Day Four Day Three Day Two Dendreon Corp DNA EST EU FDA HCV HIV IPO Janssen Labs Mama Namibia Mari Serebrov MBA Morgan Healthcare Conference New York New York Times NIH Nobel Prize PDUFA Pfizer Inc PR RNA Roche ROI San Diego San Francisco Seattle Genetics Inc SEC UK VC Vivus Inc

Calendar

April 2018
M T W T F S S
« Mar    
 1
2345678
9101112131415
16171819202122
23242526272829
30  
clarivate.com | BioWorld.com | bioworldmedtech.com
© Copyright 2018 | BioWorld Perspectives