• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Sublingual films

Mylan launches generic sublingual film for opioid dependence

February 22, 2019 By Sarah Faulkner

Mylan logo - updated

Mylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film. The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan. Sales for buprenorphine and naloxone […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: Dr. Reddy's Laboratories, indivior, Mylan

FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film

January 31, 2019 By Fink Densford

sunovion

Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Sublingual films Tagged With: Sunovion Pharmaceuticals

Dr. Reddy’s notches win for generic Suboxone sublingual film

November 21, 2018 By Sarah Faulkner

gavel

Shares in Dr. Reddy’s Laboratories (NYSE:RDY) shot up yesterday after the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that blocked the company from selling a generic verson of Indivior‘s (LON:INDV) Suboxone buprenorphine and naloxone sublingual film. Dr. Reddy’s said it plans to resume launch activities for the product, which won FDA […]

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: Dr. Reddy's Laboratories, indivior

AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller

October 22, 2018 By Sarah Faulkner

AcelRx logo - updated

Shares in AcelRx (NSDQ:ACRX) fell last week after U.S. Sen. Ed Markey (D-Mass) called on the FDA to reject the drugmaker’s opioid painkiller, Dsuvia. The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl. “Even in […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pain Management, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: AcelRx

Sunovion touts pivotal Ph3 trial for Parkinson’s drug

January 30, 2018 By Sarah Faulkner

sunovion

Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: Acorda Therapeutics, Sunovion Pharmaceuticals

Fast-dissolving opioid dependence tablet wins EU recommendation

September 15, 2017 By Sarah Faulkner

Orexo, Mundipharma

Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies […]

Filed Under: Drug-Device Combinations, Featured, Pain Management, Pharmaceuticals, Regulatory/Compliance, Sublingual films Tagged With: mundipharma, orexo

BioDelivery Sciences beats Q2 rev estimates, misses on EPS

August 10, 2017 By Sarah Faulkner

BioDelivery Sciences International

Shares in BioDelivery Sciences International (NSDQ:BDSI) fell today after the pharmaceutical company beat sales estimates but missed earnings expectations on Wall Street with its second quarter results. The Raleigh, N.C.-based company posted a net loss of -$14.9 million on sales of $8.7 million for the 3 months ended June 30, paring losses by 9.7% on sales […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Pain Management, Pharmaceuticals, Sublingual films, Wall Street Beat Tagged With: BioDelivery Sciences International

FDA accepts AcelRx’s NDA for Dsuvia pain reliever

February 27, 2017 By Sarah Faulkner

AcelRx Pharmaceuticals

AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]

Filed Under: Featured, Food & Drug Administration (FDA), Pain Management, Regulatory/Compliance, Sublingual films Tagged With: AcelRx

BioDelivery reacquires license to buprenorphine film

December 8, 2016 By Sarah Faulkner

BioDelivery reacquires license to buprenorphine film

BioDelivery Sciences International (NSDQ:BDSI) said today that it reacquired the license to the Belbuca (buprenorphine) buccal film from Endo Pharmaceuticals. Malvern, Penn-based Endo Pharmaceuticals licensed the worldwide manufacturing and marketing rights to the opioid patch from BioDelivery in 2012. Belbuca, a once-daily opioid, is indicated for the management of severe pain. The small, peppermint-flavored film works by […]

Filed Under: Featured, Pain Management, Sublingual films, Wall Street Beat Tagged With: BioDelivery Sciences International, Endo Pharmaceuticals

Lupin, MonoSol Rx ink licensing deal for pediatric products

October 11, 2016 By Sarah Faulkner

MonosolRx, Lupin

Lupin Pharmaceutical (NSE:LUPIN) said last week that it inked a licensing agreement with MonoSol Rx to develop pediatric products using MonoSol’s drug-delivery technology. Warren, N.J.-based MonoSol touts its dissolvable film, PharmaFilm, as a quick-dissolving system that’s easy to administer and masked by taste. The sublingual film is designed to support pediatric populations that often have trouble swallowing […]

Filed Under: Drug-Device Combinations, Featured, Pediatrics, Pharmaceuticals, Sublingual films Tagged With: Lupin Pharmaceutical, MonoSol Rx

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Footer

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Design & Outsourcing
Medical Tubing + Extrusion

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery News
Advertise with us
About
Contact us
Privacy
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2021 · WTWH Media LLC and its licensors. 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 WTWH Media.

Advertise | Privacy Policy | RSS