Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Stryker Slips After Negative FDA Panel Ruling

By Pharmaceutical Processing | April 1, 2009

NEW YORK (AP) — Stryker Corp. shares declined Wednesday after a Food and Drug Administration panel recommended against approving Stryker’s OP-1 bone growth putty for sale. In a meeting late Tuesday, the panelists voted six to one that the product should not be approved for sale because it was not convinced OP-1 is as effective as current bone graft techniques. Panelists were also concerned about the design of clinical studies intended to support OP-1, and had reservations about its safety. Stryker shares gave up 98 cents, or 2.9 percent, to $33.06 in afternoon trading. The FDA is not required to follow the recommendations of its panels, but it often does. Stifel Nicolaus analyst Gregory Simpson said expected the decision, as there was not much reason for the panel to support the drug. “We thought the company’s accumulation, analysis, and presentation of the data, and really the entire clinical trial process, was sloppy and poorly done,” he wrote in a note to clients. Simpson said he does not think the Kalamazoo, Mich.-based company will give up on the drug because it is still conducting studies of OP-1 in several indications. Stryker did not immediately respond to calls seeking comment.

Related Articles Read More >

Diverse factory workers in yellow PPE suits checking production data with clipboard in modern industrial facility, Quality control inspector wearing masks and hairnets working in food or pharma plant
ISO 9001, 14001 and 45001 revisions: What changes and when to start
Artis BioSolutions announces new center of excellence in Spain
Bristol Myers Squibb’s RazyeBio to build $173 million Indiana facility 
Bristol Myers Squibb to build new plant in Houston 
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2026 Arrowfly LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE