Bankruptcy among biotechs is on the rise, with a spike in the number of cases in the past couple of years, highlighting struggles to secure financing and recover financially.
The International Coalition of Medicines Regulatory Authorities is calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making, with harmonization of real-world data and RWE terminologies, convergence of RWD and RWE guidance, and best practice, readiness and transparency key areas of focus.
The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical device (SaMD) technologies that are powered by artificial intelligence (AI) and machine learning (ML).
As Thomas B. Cueni of the IFPMA recently stated, voluntary "technology transfer partnerships have been the cornerstone in the fight against COVID-19" in ways that offer new and exciting opportunities for pharma. The need for the adoption of connected technologies that was exacerbated by the pandemic is expected to complete a shared vision.
As the war between Russia and Ukraine enters its fourth week, major pharmaceutical companies have stepped up to support humanitarian efforts in Ukraine by making multimillion-dollar donations. Yet there is mixed response from these companies about continuing their business with Russia.
The Federal Trade Commission and the New York Attorney General Letitia James filed a complaint in federal court against Vyera Pharmaceuticals, Martin Shkreli and Kevin Mulleady, seeking to ban the Vyera owners from the pharmaceutical industry.
Last year marked a major commercial inflection point for the digital therapeutics (DTx) market, adding pressure on pharmaceutical companies to help DTx become a standard part of care delivery. DTx and pharma are a natural fit for a joint effort. Together, the digital health evolution turns into a revolution.
Although several proposals in the July 19 Berlin Declaration on equitable access to pandemic countermeasures may prove unrealistic, a commitment by IFPMA members to quickly scale up manufacturing for high volume global supply could establish a foundation on which to build capacity for future pandemics.
The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018. The de novo premarket review pathway, has increasingly attracted interest in the medical device ecosystem, particularly after the quick turnaround for Apple’s granted de novo classification requests last September.
After gaining a landmark FDA approval for Zynteglo, bluebird will make the $2.8 million gene therapy available to β-thalassemia patients via an outcomes-based pricing arrangement with payers that could refund up to 80% of the cost, not counting an upfront payment. The therapy is the first ex vivo lentiviral vector gene therapy approved in the U.S. for β-thalassemia patients who require regular red blood cell transfusion.
When it was revealed during antitrust litigation of a merger that would create the largest payer in the country that one of the companies had created an integration team kept secret from the other, District Judge Amy Berman Jackson asked: “How do you work on integration without talking to the person you’re integrating with?”
Navigation Sciences Inc. has enrolled the initial patient in the first-in-human clinical feasibility trial of the Navisci system designed for surgeons to be able to remove probable early-stage lung tumors in minimally invasive surgery, integrating augmented reality (AR) and advanced software with surgical instruments
There is a lot of hype around using artificial intelligence (AI) technologies in care provider settings. Last week, the University of Pittsburgh Medical Center (UPMC) partnered with Microsoft, an expert in AI tools, to launch the first project under the new Healthcare NeXT initiative aimed at improving clinicians’ workflow, signaling continued interest and investment in the healthcare AI space.
Xilis Inc. closed $70 million in series A financing on July 8 to reduce drug development costs leveraging its technology, with the goal of advancing precision medicine through targeted drug discovery and development. The financing was led by Mubadala Capital with participation from new investors that include GV, formerly Google Ventures, and others.
Wide-ranging disruptions are already taking shape, from those affecting interaction models to new regulatory guidance and more aggressive production capacities and timelines. Some of these changes are likely to be long-lasting and with this comes challenges as well as opportunities. It is critical to prepare by evaluating all available resources and move quickly toward positive change and innovation.
A new 3D printing technique has allowed University of Nottingham researchers to tailor-make artificial body parts and other medical devices that are both implantable and bacteria-resistant. The multi-materials manufactured in the study were also adapted to 3D printing technology that is able to offer devices that can better meet the need of the patient and minimize the surgeries led by device failure that increase the risk of infections.
An action plan will be rolled out in the coming months to define the FDA’s approach to modernizing its technology infrastructure and framework, FDA Principal Deputy Commissioner Amy Abernethy said during a Thursday keynote at the Office of the National Coordinator for Health Information Technology’s (ONC) 3rd interoperability forum.
The three-year transition period for ISO 13485:2016 officially ended Thursday and as of Friday all ISO 13485:2003 certificates are now null and void, regardless of their original expiration date. The role of the revised standard plays into major regulatory initiatives worldwide aimed at international harmonization
Drug prices increased for 686 drug products during the first few weeks of 2020, the latest data from the Centers for Medicare and Medicaid Services shows, signaling it’s business as usual for industry. On Tuesday, CMS updated its National Average Drug Acquisition Cost (NADAC) data and the GoodRx team posted its analysis of 491 drugs.
Neovasc Inc. has hit pause on its Tiara transfemoral mitral valve replacement (TF) program and is cutting its workforce by more than 40%, citing the additional time and substantial investment required to develop the program and the associated costs. The changes are expected to extend its cash runway from about 18 months to more than three years
The US raised “serious concerns” with several issues regarding the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) and called on the EU to delay MDR/IVDR implementation by three years. In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry.
At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to become an independent regulatory agency.
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device.
As cyberattacks on U.S. hospitals continue to increase with health care’s growing reliance on technology, a new report from the U.S. Office of Inspector General (OIG) has flagged Medicare’s requirements for being silent on the cybersecurity of networked medical devices.
2020 will be another blockbuster year for life sciences mergers and acquisitions, according to a recent report from Ernst & Young Health Sciences and Wellness. And companies' interest in deepening their focus on a therapeutic area will continue to drive new deals this year.
By Natalie Tomlin and Ana Mulero
Capital News Service
LANGLEY PARK — Maria Sorto, who is originally from El Salvador, had just moved into an apartment complex in Langley Park when she was approached by a man with a business proposition: He wanted to operate a brothel out of her new home.
“He said, ‘We can become partners,’” Sorto said in Spanish. “I told him no — that in my apartment, I was not going to do that….”
But others were willing. On Friday nights, after receiving their paychecks, men would swarm into the apartment buildings in search of drugs and prostitutes, she said.
Sorto moved to Hyattsville a couple months ago.
Community members and law enforcement officials say Langley Park, located just inside the Capital Beltway in Prince George’s County, is rife with prostitution and human trafficking.
“Throw a rock anywhere in Langley Park and you get a brothel,” said Christine White, a University of Maryland criminologist and chair of the research committee for the Prince George’s County Human Trafficking Task Force.
Even so, law enforcement officials have said they’ve had trouble catching traffickers there, citing the language barrier, elusive perpetrators and scared victims.
More than three-quarters of the Langley Park population of nearly 19,000 are Hispanic or Latino, and 70 percent are foreign-born residents, according to the most recent U.S. Census Bureau report. It’s a landing spot for Central American immigrants who are here illegally.
Maryland Assistant U.S. Attorney Rachel Yasser said Latino brothels are sometimes hidden within the community, with traffickers changing locations frequently.
However, to residents of Langley Park, amid a vast sea of low-rise apartment buildings, there’s little that’s hidden about the problem.
The Rev. Roberto Cortés, pastor of St. Mark the Evangelist Catholic Church in Hyattsville, said church members and friends complain frequently about prostitution and sex trafficking in Langley Park and the surrounding area. On occasion, he has heard from a victim too.
Cortés recalled that a woman from Langley Park walked into his church about a year ago and told him that she was forced to work as a prostitute in Langley Park and had stayed in the business to support her family.
“She was thrown into it and she was forced into it but then she needed the money,” he said.
Cortés never saw the woman again.
He said Langley Park often serves as a starting point for newcomers rather than a place to establish a family. Many residents remain quiet and tolerate the illegal activity within their neighborhoods because they view Langley Park as a temporary living situation, he said.
Alvarado Diaz was one of several residents interviewed by Capital News Service who said he was concerned about brothels in the apartment complexes. He said prostitution in the area is just one of many disruptive problems faced by the community. There are gangs, and the crime rate is high, he said.
Diaz has lived in Langley Park for 35 years and has spent 18 of those years working as a carpenter for the Maryland-National Capital Park and Planning Commission. He moved to Maryland from Santa Tecla, El Salvador, when he was 15 years old and three years later began living in what Diaz described as a “lovely” neighborhood of mostly elderly residents who genuinely cared about one another.
Today the community is younger, less educated and many residents are here illegally, he said. “They come here, they don’t have papers, nobody wants to hire them, so it’s easy money.”
Victims are reluctant to come forward, police and advocates say, because many are here illegally and they blame themselves for their situation.
The need for undocumented residents to earn a living, coupled with the demand for commercial sex, is what keeps the business thriving despite community-wide disapproval, police and advocates say.
Many residents said brothel managers manage to advertise while evading authorities through the use of business cards that traffickers pass around the Langley Park community.
Manuel Quinteros, a former Langley Park resident and Sorto’s son, said he has seen brothels come and go in his former apartment building. He said he was once given a strange business card, which he suspected was a covert advertisement for sex.
“I got [handed] a card here in Langley Park and they said, ‘If you want a delivery, the girls will do it,’” said Quinteros. “This phone number appears as something false…it’s like a restaurant but it’s not. It is something else. It’s a cover.”
Quinteros said many pimps have stopped passing out business cards because authorities have caught on to this method. Others recounted how men knock on the windows of residences and offer sexual services from women.
Special Assistant U. S. Attorney LisaMarie Freitas said traffickers in Langley Park elude investigators by moving their operations frequently from apartment to apartment.
“These pimps don’t stay in the same locations with the girls,” she said. “They move around. If a repeat customer wants to come back to that girl, he has to search around.”
Getting the cooperation of victims is difficult, because many don’t speak English and some are in the United States illegally. When victims are willing to testify against their traffickers, extensive resources are needed to help guide them through the prosecution, said Donnell Turner, a deputy state’s attorney for Prince George’s County.
A Capital News Service investigation uncovers human trafficking abounds in Maryland, yet few are convicted. This six-part investigative series won several awards, including the Society of Professional Journalists' national Best in Show award in October 2016.
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