Drug Delivery

Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna (NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer…

Merck (NYSE:MRK) has agreed to supply the U.S. government with the biological therapeutic CD24Fc if FDA authorizes the use of the drug.   The drug played a central role in Merck’s decision to acquire privately held OncoImmune, which had touted CD24Fc as its “lead compound.”  Merck plans on renaming the CD24Fc therapy MK-7110. (We recently profiled the…

By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do…

AstraZeneca (NYSE:AZN) announced that it entered into a definitive agreement to acquire Alexion Pharmaceuticals (NSDQ:ALXN), expanding its presence in the rare-disease and immunology drugs space. The acquisition price for Boston-based Alexion is set to total approximately $39 billion, or $175 per share, according to a news release. The boards of both companies unanimously approved the acquisition and,…

The U.S. FDA tonight authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), providing a much-hoped-for tool to roll back the deadly coronavirus pandemic. The FDA authorization came a day after an advisory commission for the agency provided an upbeat assessment of the two companies’ vaccine. The agency is also coordinating with the CDC and the…

Guerbet (EPA:GBT), which specializes in medical imaging including contrast agents, has received FDA approval for its Optiray imaging bulk package, which can be used to fill sterile disposable syringes for use with CT imaging.  The imaging bulk package is intended to reduce the number of single-dose vials when used with a power injector and contrast […]

The International Journal of Surgery Case Reports has published a case study on the use of the humanized antibody Keytruda (pembrolizumab) and tavokinogene telseplasmid (TAVO) from OncoSec (NSDQ:ONCS) for treating metastatic melanoma. The study involved a patient with stage IIB, pT3b melanoma who initially underwent tumor resection but experienced regional recurrence and later disease progression […]

Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to…

The Federal Circuit Court has rejected Glaxo Smith Kline’s (NYSE:GSK) petition for a new trial in a patent case brought by British inhaler company Vectura. The circuit court upheld a May 2019 jury verdict in U.S. District Court for the District of Delaware, awarding Ventura $89.7 million damages for the period from August 2016 through December 2018 for an…

Tandem Diabetes Care (NSDQ:TNDM) shares took a hit after hours today on third-quarter results that were mixed compared to the consensus forecast. The San Diego-based insulin delivery and diabetes technology company posted losses of -$9.4 million, or -15¢ per share, on sales of $123.6 million for the three months ended Sept.30, 2020, for a bottom-line slide […]

Teva (NYSE: TEVA) reported third-quarter results today, which matched analysts’ consensus forecast. The company will maintain its guidance for the rest of the year. The company, which has dual headquarters in Israel and Parsippany, N.J., reported a loss of $4.3 billion or $3.97 per share on revenue of $3.9 billion for the quarter ended September […]

By Timothy Herr, Emergo Group Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical […]

Insulet (NSDQ:PODD) posted third-quarter results after market close yesterday that beat analysts’ consensus for the company. The Acton, Mass.-based tubeless insulin pump manufacturer announced profits of $11.6 million or $0.17 per share on sales of $234 million for the three months ended September 30, 2020, for a bottom-line gain of 13.5% on sales growth of 21% compared […]

Qosina (Ronkonkoma, N.Y.) is touting the variety of SmartSite swabbable needle-free injection sites that it offers. The needle-free injection sites feature an ergonomic design and a smooth, flat top that can be easily disinfected, according to Qosina. Said the company: ” These components are equipped with a valve, that when activated, forms an airtight seal […]

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…

CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9…

Executives from nine different drug companies today announced a pledge to ensure safety with a potential COVID-19 vaccine. The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE)  and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as…

Nestlé (VTX:NESN) announced today that it entered into a definitive agreement to acquire food allergy treatment developer Aimmune Therapeutics (NSDQ:AIMT). Under the agreement, Nestlé Health Science (NHSc) would acquire Aimmune with a cash offer for $34.50 per share, totaling approximately $2.6 billion. The per-share price for Aimmune represents a 174% premium to the company’s closing share…

AstraZeneca has denied news reports that it’s involved in talks with U.S. authorities about an emergency use authorization for its COVID-19 vaccine candidate. The denial comes after recent news reports claiming the Trump administration is eyeing a plan to fast-track the vaccine candidate, AZD1222, before the Nov. 3 presidential election. “AstraZeneca has not discussed emergency…

The Corona Accelerated R&D in Europe (CARE) consortium today announced its launch to accelerate the development of COVID-19 treatments. Supported by the Innovative Medicines Initiative, the new consortium has collected $92.7 million (€77.7 million) in grant funding in an effort to conduct a 5-year project, bringing together 37 partners from Belgium, China, Denmark, France, Germany,…

  Novartis (NYSE:NVS) and Alexion Pharmaceuticals (NSDQ:ALXN) were charged with violations of the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). The Securities & Exchange Commission (SEC) announced that the pharmaceutical companies both committed violations and both agreed to pay millions of dollars to settle the charges. Novartis settled to…

Respira Technologies (West Hollywood, Calif.) announced the launch of a pharmaceutical-focused commercial development program for its RespiRx drug-delivery device platform. RespiRx is a portable, handheld vibrating mesh nebulizer designed for local and systemic treatment and can operate in any position held by the patient. Current-generation nebulizers are gravity-fed, which limits usage and can lead to…

Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform. The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents. Propeller sensors…

Fountain Therapeutics, a biopharmaceutical company building a pipeline of therapeutics to treat age-related diseases by reversing cellular age, closed on an additional $6 million in a Series A, bringing its total to $11 million. Khosla Ventures led the round that drew capital from Nan Fung Life Sciences, the provider of initial $5 million in 2018.…

Phlow announced today that it received $354 million in U.S. government funding to manufacture essential medicines at risk of shortage, including those involved in the COVID-19 pandemic response. Richmond, Va.-based Phlow’s manufacturing is being funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of Assistant Secretary for Preparedness and Response…