Another Philips respiratory devices recall receives a Class I label

The FDA announced today that it is labeling another Philips Respironics recall as Class I, its most serious classification.

The new recall involves 386 ventilators distributed from Aug. 6, 2020, to Sept. 1, 2021. The BiPAP machines may contain plastic in their motors that could release volatile organic compounds (VOCs). On top of the risk of users inhaling dangerous VOCs, the plastic could also cause device failure.

At this time, the FDA is not aware of any reports of serious injury or death. The BiPAP machines can treat both adults and children at home and in clinical environments, including hospitals and sleep laboratories.

Mounting troubles for Philips Respironics

The latest serious recall comes as Philips continues to grapple with a deadly recall that involves more than a million CPAPs, ventilators and other respiratory devices. Problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a de…

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Surgalign launches new family of interbody fusion devices

The Fortilink-C interbody fusion implant. [Image from Surgalign]Surgalign (Nasdaq:SRGA) announced today that it expanded its Fortilink product portfolio with a new family of interbody fusion devices.

Deerfield, Illinois-based Surgalign’s new devices feature TiPlus technology. The implants include Fortilink-A with TiPlus for anterior lumbar interbody fusion (ALIF) procedures.

Additionally, the product family includes Fortilink-TC and -TS with TiPlus for posterior lumbar interbody fusion (PLIF/TLIF). It also features Fortilink-C with TiPlus technology for anterior cervical discectomy and fusion (ACDF) procedures.

“TiPlus is a great new offering that significantly bolsters the interbody solutions I can offer to my patients, based on their specific clinical need,” said Dr. Jon White, an orthopaedic spine surgeon at Hoag Orthopedic Institute in Irvine, California. “The acid-etched surface and optimized pore size allows for both bone ongrowth and ingrowth, …

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Actylis launches with focus on raw materials and performance ingredients for life sciences and specialty chemicals 

The company Actylis made its debut today, integrating specialty ingredient specialist Aceto with 10 specialty ingredient manufacturing and sourcing companies.

Port Washington, New York–based company will serve customers in various industries, including pharmaceutical and biopharmaceutical companies. It will also offer materials to companies specializing in nutrition, cosmetics, agriculture and specialty chemicals markets.

Among the specialty ingredient manufacturing and sourcing companies integrated in the merger are A&C, A&C Bio Buffer, Biotron Laboratories, Cascade Chemistry, Finar, Inter-Actifs, IsleChem, Pharma Waldhof, Syntor Fine Chemicals and Talus.

Actylis bio buffer facility. [Picture: Keith Wiseman]

The consolidation of those companies plus Aceto “enables us to offer customers across diverse locations and industries highly flexible, customized solutions addressing their s…
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Analysts are bullish on Eli Lilly with its ‘transformative’ drugs

UBS recently issued a report upgrading Eli Lilly (NYSE:LLY) to a “Buy” rating as its diabetes and Alzheimer’s drugs present lucrative opportunities.

According to the report, the pharmaceutical giant’s Mounjaro (tirzepatide) “could be the biggest drug ever.” The type 2 diabetes treatment received FDA approval in May. GlobalData said at the time that tirzepatide could quickly become a mega-blockbuster. Annual sales of the drug could approach $14 billion by 2030, according to Mizuho Securities.

UBS analysts agree, tossing aside previous concerns around data and approval for the drug. Results for the Surmount-1 trial represented a “best-in-class” dataset that included greater than 20% weight loss and other “underappreciated metrics.”

According to UBS, Eli Lilly could hit heights of $25 billion in peak sales for Mounjaro.

The company is investigating tirzepatide for potential indications inclu…

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Pulmatrix completes patient dosing for inhaled migraine treatment

iSperse technology. [Image from Pulmatrix]Pulmatrix (Nasdaq:PULM) announced today that all subjects completed dosing in a trial of its orally inhaled migraine treatment.

Lexington, Massachusetts-based Pulmatrix is evaluating PUR3100 in a Phase 1 trial using the patented iSperse technology. All subjects completed dosing of the novel orally inhaled formulation of dihydroergotamine (DHE). The company expects Phase 1 data in the fourth quarter of this year.

Get the full story at our sister site, Drug Delivery Business News.

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BD, CerTest launch monkeypox diagnostic for lab research in U.S.

The BD Max system. [Image from BD]BD (NYSE:BDX) and CerTest Biotec announced today that they made their monkeypox virus assay commercially available for global research.

The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. The molecular polymerase chain reaction (PCR) assay is now available globally for research applications only.

Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June.

The CDC began tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus earlier this year. Monkeypox is said to cause a rash and lesions and is mainly shared through direct physical contact. The CDC warns it can also be transmitted via respiratory secretions during prolonged, face-to-face contact.

To date, the CDC reports 24,846 U.S. monkeypox cases and one related d…

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FDA clears nano-pulse stimulation tech for treating hyperplasia from Pulse Biosciences

The CellFX system. [Image from Pulse Biosciences]Pulse Biosciences (Nasdaq:PLSE) announced today that the FDA granted 510(k) clearance for its CellFx system with expanded indication.

The new indication covers the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. Clearance followed positive clinical data from an investigational device exemption (IDE) study of the system.

CellFX uses Pulse Biosciences’ proprietary nano-pulse stimulation (NPS) technology. NPS technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.

Hayward, California-based Pulse Biosciences said CellFX represents the first commercial product to use NPS technology to treat a variety of conditions. The company is pursuing development in cardiology, oncology, gastroenterology, and other medical specialties.

Pulse Biosciences also received FDA clearance for two additional treatm…

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Smith+Nephew announces first clinical use of Legion revision knee handheld robotics tech

The Cori surgical robot system for knee replacement. [Image from Smith+Nephew]Smith+Nephew (NYSE:SNN) today announced the first cases for revision knee replacement using the Cori surgical robot system.

Dr. Thorsten Seyler of Duke University performed the first cases on Aug. 17, 2022. Seyler used the combination of Smith+Nephew’s handheld Cori robotic technology with the Legion revision knee system. The system uses image-free smart mapping to eliminate the need for pre-operative CT/MRI scans. It also eliminates the potential for image distortion due to in situ components from the primary procedure.

London-based Smith+Nephew said in a news release that surgeons can build patient-specific 3D models of the joint. They can also register anatomy and bony defects after implant extraction. With the system, surgeons can intra-operatively gap balance in real-time, and accurately precision mill for final placement of components.

Smith+Nephew said it is the first…

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Ultomiris wins approval in Europe for generalized myasthenia gravis

The complement C5 inhibitor Ultomiris (ravulizumab) from AstraZeneca (LON:AZN) has won approval in Europe as adjunctive therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. 

The regulatory nod represents the first approval for a long-acting C5 complement inhibitor for treating gMG in Europe. 

While myasthenia gravis is a chronic autoimmune, neuromuscular disease associated with weakness of skeletal muscles, in gMG, the weakness extends to ocular muscles along with limb and respiratory muscles. 

The onset of gMG is often age-related, frequently beginning in women before 40 and for men after 60. 

There are approximately 89,000 patients in Europe with gMG.  

AZN shares ticked up 0.55% to £9,989.00. 

In July, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the drug for gMG. CHMP based its decision on data from the Phase 3 CHAMPI…

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U.S. government earmarks $1.6 billion to battle opioid crisis and overdose epidemic

[Photo by Karolina Grabowska from Pexels]

The U.S. Department of Health and Human Services (HHS) has awarded more than $1.6 billion as a part of an initiative to battle the drug overdose epidemic.

SAMHSA’s State Opioid Response (SOR), Tribal Opioid Response (TOR) grant programs and Health Resources and Services Administration (HRSA)’s rural communities opioid response programs will lead the new initiative.

The government plan will expand access to the opioid mu receptor antagonist naloxone, and improve access to opioid treatment programs. It also includes provisions to reduce abuse of stimulants such as cocaine and methamphetamine that contribute to the overdose epidemic.

The government initiative will also provide funding for law enforcement in high-intensity drug trafficking areas.

Drug-involved overdose deaths have surged in recent years, according to federal statistics.

In 2020…

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Women in Pharma: Ensysce Biosciences’ CEO aims to combat prescription drug abuse

Lynn Kirkpatrick, the CEO of Ensysce Biosciences (La Jolla, California), oversees the development of novel medicines to reduce or eliminate prescription drug abuse.

Its oxycodone prodrug candidate PF614 is now in a Phase 2 clinical trial. It is designed to offer similar pain relief as current prescription opioids with a limited risk of drug abuse and addiction.

Kirkpatrick has helped the company win FDA’s Fast Track designation for PF614.

She became President and CEO of Ensysce Biosciences Inc. in January 2009.

In the following interview, Kirkpatrick provides an overview of the company’s approach to combat opioid abuse and offers advice on how to succeed in the pharmaceutical industry.

Could you provide an overview of your background and what led you to Ensysce?

Lynn Kirkpatrick

Kirkpatrick: My background started in pharmacy, then medicinal chemistry and pharmacology. …

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Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits

Steris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions.

Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators past and present.

RELATED: EPA flags high-cancer-risk EtO sterilization facilities across the country

The analysts believe Steris can manage any EtO legal liabilities due to the company’s size, diversification and balance sheet, but said investors are looking forward to Steris estimating and reserving cash for potential liabilities.

“Since breast and blood cancers are relatively common, we worry that attorneys could have success in finding additional people willing to file more lawsuits,” the analysts wrote. “We expect the risk of lawsuits and any n…

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