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Tag: Pharmaceuticals


Logistics, Process, Regulations

Biden Administration Unveils Plans to Shore-Up Supply Chains

June 8, 2021

Via: Alliance for American Manufacturing

The White House on Tuesday unveiled a report with new initiatives to shore up supply chains for critical resources like semiconductors, batteries, rare earth minerals and pharmaceuticals. This all-of-government approach could bear positive economic implications, create new American jobs, and […]


Industry Focus Areas, Medical

Cleanrooms in Medical Manufacturing

October 16, 2020

Via: Industry Today

The medical industry needs supplies devoid of harmful pathogens. Medical devices, such as retractors, urinary catheters, face masks for oxygen administration, and single-use anoscopes, should provide care without adding risks to patients and other users. Hence, it’s essential to have […]


Industry Focus Areas, Medical, Regulations

J&J’s Legal Losses May Get Worse With 100,000 More Damage Claims

October 14, 2019

Via: Industry Week

Johnson & Johnson has taken some costly beatings in court this year. And it could get worse. Just last week, a jury ordered J&J to pay $8 billion for wrongfully pushing doctors to prescribe the anti-psychotic drug Risperdal. While the […]


Industry Focus Areas, Medical, Regulations

Aerie wins FDA nod for second glaucoma drug

March 14, 2019

Via: Mass Device

Aerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension. The Durham, N.C.-based company’s product is a fixed-dose combination […]


Industry Focus Areas, Medical

Insulet tops estimates with Q4 results

February 26, 2019

Via: Mass Device

Insulet (NSDQ:PODD) posted its fourth-quarter and full-year financial results yesterday after the markets closed, beating estimates on Wall Street. The Acton, Mass.-based company posted profits of $9.9 million, or 17¢ per share, on sales of $164.9 million for the three […]


Industry Focus Areas, Medical

Glooko, Novo Nordisk team up for connected insulin pens

February 25, 2019

Via: Mass Device

Glooko announced this month that it’s teaming up to connect Novo Nordisk‘s (NYSE:NVO) insulin pens with the company’s diasend diabetes management solution. Novo Nordisk plans to launch its connected insulin pens, the NovoPen 6 and NovoPen Echo Plus, in early […]


Industry Focus Areas, Medical

Medtronic wins FDA’s breakthrough status for closed-loop insulin system

February 19, 2019

Via: Mass Device

Medtronic (NYSE:MDT) said today that it won breakthrough status from the FDA for its investigational personalized closed-loop insulin pump system. The company touted its technology as enabling automated insulin delivery in a real-time, adaptable and personalized fashion. Medtronic’s November acquisition […]


Industry Focus Areas, Logistics, Medical, Process

What’s ahead for the drug delivery market in 2019?

January 15, 2019

Via: Mass Device

What were the trends that drove the biopharma and drug delivery markets in 2018? Many of 2018’s key trends revolved around increasing regulatory requirements. However, as the market continues to move toward more personalized medicine, such as cell and gene […]


Industry Focus Areas, Medical

FDA approves Teva’s digital COPD, asthma inhaler

December 26, 2018

Via: Mass Device

Teva (NYSE:TEVA) said this week that the FDA approved its ProAir Digihaler device – a digital inhaler that uses sensors to connect to a companion mobile app for people with asthma and chronic obstructive pulmonary disease. The company’s device features […]


Industry Focus Areas, Medical

Impel NeuroPharma raises $68m for CNS drug-device tech

December 6, 2018

Via: Mass Device

Impel NeuroPharma said today that it raised $67.5 million in a Series D financing round, with investments from KKR, Norwest Venture Partners, Vivo Capital, 5Am Ventures and venBio Partners. The Seattle-based company plans to use the round’s proceeds to support […]


Industry Focus Areas, Medical

Insulet inks deal with Samsung to develop smartphone-controlled Omnipod

November 8, 2018

Via: Mass Device

Insulet (NSDQ:PODD) said this week that it inked a deal with Samsung to develop an Omnipod insulin delivery system that would allow users to control their insulin pump therapy with a Galaxy smartphone. If approved, the system would be the […]


Industry Focus Areas, Medical

Inovio touts intradermal delivery of HIV vaccine

October 26, 2018

Via: Mass Device

Inovio Pharmaceuticals (NSDQ:INO) reported today that its synthetic HIV vaccine, Pennvax-GP, demonstrated durable antibody and T cell immune responses throughout a Phase I trial. The company found that Pennvax-GP plasmids delivered intradermally with Inovio’s Cellectra device triggered equivalent or superior […]


Industry Focus Areas, Medical, Regulations

FDA to review Xeris’ glucagon rescue pen auto-injector

October 24, 2018

Via: Mass Device

Xeris Pharmaceuticals (NSDQ:XERS) said today that the FDA accepted its new drug application for a ready-to-use liquid glucagon rescue pen device. The company’s product is designed to treat severe hypoglycemia in people with diabetes. The FDA is slated to make […]


Industry Focus Areas, Medical

Dance Biopharm raises $24m for inhaled insulin device

September 25, 2018

Via: Mass Device

Privately-held Dance Biopharm said yesterday that it raised $24.5 million in a private equity round to help fund the development of its inhaled insulin product. SternAegis Ventures was the exclusive placement agent for the offering. Molex Ventures, an electronics company […]


Industry Focus Areas, Medical

Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan

September 10, 2018

Via: Mass Device

Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear […]


Industry Focus Areas, Medical

Tandem launches insulin pump with predictive low glucose suspend feature in US

August 20, 2018

Via: Mass Device

Tandem Diabetes Care (NSDQ:TNDM) last week launched its t:slim X2 insulin pump with Basal-IQ technology in the U.S. The company’s latest pump includes a predictive low glucose suspend feature designed to reduce the frequency and duration of hypoglycemia. Using the […]


Industry Focus Areas, Medical

Nanobiotix inks $47m financing to support nanomedicine development

July 30, 2018

Via: Mass Device

Nanobiotix (PAR:NANO.PA) inked a non-dilutive financial deal with the European Investment Bank last week to support the development of its nanoparticle-based cancer therapies. The Paris, France-based company said it landed a five-year loan to borrow up to €40 million ($46.7 […]


Industry Focus Areas, Medical

Manufacturing delays lead to Epipen shortage in U.S.

May 9, 2018

Via: Mass Device

At least 400 people across the U.S. have had trouble getting their hands on an Epipen in recent weeks, according to a survey from the advocacy group Food Allergy Research & Education. Mylan (NSDQ:MYL), which makes the emergency allergy auto-injector, […]


Industry Focus Areas, Medical, Regulations

Following regulatory win, GSK & Innoviva tout data for once-daily triple-med inhaler

September 20, 2017

Via: Mass Device

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) notched a win this week after the FDA approved its once-daily, triple combination therapy for the treatment of chronic obstructive pulmonary disease. Last week, an EU agency recommended the inhaler’s approval. Now, the companies are […]


Industry Focus Areas, Medical

Phillips-Medisize to build drug delivery manufacturing facility in Wisconsin

December 13, 2016

Via: Mass Device

Phillips-Medisize said today that it plans to open an 80,000 square foot drug delivery manufacturing facility at its Menomonie, Wisconsin campus. The facility, which is expected to open in 2017, will manufacture high volume, prefilled drug delivery systems. It will […]