Johns Hopkins researchers are touting microdevices that can latch onto intestinal mucosa and release drugs into the body. Led by engineering professor David Gracias and gastroenterologist Dr. Florin Selaru, the team of researchers and biomedical … [Read More...] about Johns Hopkins researchers tout medicine-delivering microdevices
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Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...] about Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
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Biden’s COVID-19 response will make manufacturers busy
Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic. In one of his first official acts as president, Joe Biden announced a … [Read More...] about Biden’s COVID-19 response will make manufacturers busy
Mylan must face EpiPen racketeering lawsuit
A federal judge in Minnesota has decided that Mylan must face a lawsuit accusing it of paying bribes and kickbacks to pharmacy benefit managers and of conspiring to fix prices on its EpiPen device. Drug wholesalers Rochester Drug CoOperative and … [Read More...] about Mylan must face EpiPen racketeering lawsuit
EmblemHealth to provide coverage for Senseonics’ Eversense CGM
Senseonics (NYSE:SENS) announced that EmblemHealth is now providing coverage for its Eversense continuous glucose monitoring system. Germantown, Md.-based Senseonics said in a news release that the immediately effective decision adds to the number … [Read More...] about EmblemHealth to provide coverage for Senseonics’ Eversense CGM
Eitan Medical lands FDA clearance for infusion pump system upgrade
Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories. The Sapphire … [Read More...] about Eitan Medical lands FDA clearance for infusion pump system upgrade
Senseonics announces $50M from stock offering
Senseonics (NYSE:SENS) announced that it entered into securities purchase agreements worth gross proceeds of approximately $50 million. Germantown, Md.-based Senseonics' purchase agreements are with several healthcare-focused investors, as well as … [Read More...] about Senseonics announces $50M from stock offering
BD stock up on Street-beating preliminary quarterly revenue numbers
Becton Dickinson (NYSE:BDX) today announced that it brought in $5.3 billion in revenue for its first quarter ended Dec. 31, 2020, beating the nearly $4.7 billion expected by Wall Street analysts. The announcement of the preliminary unaudited Q1 … [Read More...] about BD stock up on Street-beating preliminary quarterly revenue numbers
Locate Bio lands FDA breakthrough nod for bone infection device
Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a … [Read More...] about Locate Bio lands FDA breakthrough nod for bone infection device
PerkinElmer to acquire Oxford Immunotec
PerkinElmer (NYSE:PKI) and Oxford Immunotec announced today that they agreed to terms under which the former will acquire the latter. Under the agreement, London-based Oxford Immunotec's shareholders will be entitled to receive $22 for each … [Read More...] about PerkinElmer to acquire Oxford Immunotec
Evonik buys polymers business from Durect Corp.
Evonik said today that it has acquired the Lactel PLGA-based polymers business from Durect Corp. All Durect employees associated with the Lactel business in Birmingham, Ala., accepted the offer to join Evonik in similar roles, according to Essen, … [Read More...] about Evonik buys polymers business from Durect Corp.
How Dexcom CEO Kevin Sayer is leading the company forward
Like most companies in 2020, Dexcom (NSDQ:DXCM) faced a number of challenges brought on by COVID-19, public unrest and more. Dexcom chairman, president & CEO Kevin Sayer had to prioritize the health of his employees over all else, while also … [Read More...] about How Dexcom CEO Kevin Sayer is leading the company forward
In case you missed it
- BREAKING: BD orders for COVID-19 vaccine injection devices surpass 1 billion
- BD is playing a crucial role delivering COVID-19 vaccines: Here’s how
- Roche, Diabeloop partner on insulin pump management
- Bigfoot Biomedical appoints commercial team
- Pear Therapeutics closes $80M Series D
- Canada approves Abbott Freestyle Libre 2 for adults and children
- BD to put $1.2B into drug-delivery plant expansions
- Canada approves Tandem Diabetes Caree’s advanced hybrid closed-loop insulin pump
- Appeals court nixes GSK’s petition for new trial in Vectura patent spat
- Alaris remediation could cost BD up to $244M
- Brooklyn spending $500K on BioBAT research and manufacturing space
- Baxter lands major DoD contract
- Baxter wins Canadian clearance for infusion system
- Biolinq names new CEO
- Medtronic launches ‘smart’ insulin pen
Clinical Trials
Johns Hopkins researchers tout medicine-delivering microdevices
Johns Hopkins researchers are touting microdevices that can latch onto intestinal mucosa and release drugs into the body. Led by engineering professor David Gracias and gastroenterologist Dr. Florin Selaru, the team of researchers and biomedical engineers designed and tested shape-changing microdevices that they say can mimic the way the parasitic hookworm affixes itself to an […]
Abbott touts Xience DES study results
A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]
TriSalus names new chief medical officer
TriSalus today said it appointed Steven Katz as chief medical officer. Katz will be responsible for overseeing the company’s clinical development strategy in the treatment of solid tumors. He has served as TriSalus’s chief medical advisor and chairperson of its scientific advisory board since 2018. “We are thrilled to have Steven join TriSalus as a […]
Thermo Fisher to manufacture Inovio COVID-19 vaccine candidate
Inovio Pharmaceuticals (NSDQ:INO) announced that Thermo Fisher Scientific (NYSE:TMO) will manufacture its COVID-19 vaccine candidate. Plymouth Meeting, Pa.-based Inovio said in a news release yesterday that Thermo Fisher signed a letter of intent to manufacture the INO-4800 COVID-19 vaccine candidate, joining a consortium of third-party manufacturers that aim to produce 100 million doses of Inovio’s vaccine by […]
Study: Medtronic’s drug-coated balloon reduces dialysis interruptions
Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment. Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can […]
