Markets & Regulations

The National Institute for Health and Care Excellence is weighing the viability of PD Neurotechnologyâs PDMonitor system for Parkinsonâs disease patients.

After scientists and reporters raised red flags about a study, Cassava Sciences is being accused of falsifying data in pursuit of an Alzheimerâs treatment.

Biopharmaceutical company Global Blood Therapeutics specializes in conditions that often disproportionately impact underrepresented communities, such as SCD.

This monthâs announcements of appointments, partnerships, expansions, and mergers include Curia, Thread, TFF Pharmaceuticals, and other notable companies.

With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.

Bridging the Gap for Clinical Trials is a free competition designed to employ artistic expression to dispel misinformation start positive conversations.

This monthâs announcements of launches, appointments, and partnerships includes Saama, COTA, Yourway, Eversana, Kindeva, and other notable industry companies.

The past two years have been full of shifts and shakes in the drug development field, but the change at Outsourcing-Pharma is easy and one […]

The 32nd iteration of the companyâs Beyond Borders report offers an in-depth look at the state of the current market landscape, and whatâs on the […]

The Biotechnology Innovation Organization elected the fresh slate of leaders during the BIO International Convention, taking place in San Diego this week.

Unveiled at the 2022 BIO International Convention, the group’s third annual diversity, equity, and inclusion report spotlights improvements both made and needed.

During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.

A leader from the site management organization, which already has expanded since opening in 2019, is planning on adding sites and talent to its roster.

A leader from the site management organization, which already has expanded since opening in 2019, is planning on adding sites and talent to its roster.

This yearâs DIA Global Annual Meeting (taking place June 19-23 in Chicago) reunites professionals for face-to-face learning and networking opportunities.

Coming back to the real world June 13-16, the industry event will offer face-to-face learning, networking opportunities, and fun, star-studded opportunities.

Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.

This monthâs announcements of awards, investments, executive appointment, and expansions include Javara, Thread, uMotif, Lonza, and other notable companies.

Michelle Keefe, formerly the president of medical affairs and commercial solutions, joined the company in 2017; she also had spent 20 years working for Pfizer

The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.

With Veeva Link for Key People, LEO Pharma is looking to deepen its efforts to engage with knowledgeable medical professionals in the dermatology community.

The two companies are forming a European Medical Advisory Committee to better connect patients and physicians, inviting other trial professionals to join in.

The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.

This monthâs news on partnerships, appointments, expansions, and investment includes Javara, ACG, Phastar, Elligo Health Research, and other notable companies.

According to the 2022 EY CEO survey, life science executives are seeking to build resilience into their supply chains and dive into M&A opportunities.

A leader from the organizer of the pharmaceutical event discusses whatâs in store for the upcoming conference, and for the drug development industry itself.

Introduced by two Republican Congressmen, the American Made Medicine Act is intended to boost domestic drug manufacturing and create jobs in the sector.

The agency has approved an expanded indication for Quelbree extended-release capsules to treat attention deficit hyperactivity disorder in younger patients.

The US agency has expanded its approval of Veklury to include use in pediatric patients 28 days and older who have tested positive for the […]

The US Food and Drug Administration has approved a move to make the oral lead-in period for ViiV Healthcareâs once-every-other-month drug Cabenuva optional.

The CDMO has been awarded funding from the US government to work on treatments for sarin and other substances used frequently employed in chemical attacks.

The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

This monthâs news includes hiring, promotions, expansions, and acquisitions at H Clinical, Charles River, DHL Supply Chain, X-Chem, and other key companies.

The US Department of Health and Human Serviceâs Office of Research Integrity has uncovered evidence that Toni Brand committed fraud in a number of reports.

An executive from RephineConsulting.com discusses how pharmaceutical companies dealing with supply chain challenges could draw lessons from the food industry.

Working with numerous partners, DiMe has introduced the 3Ps of Digital Endpoint Value to help inclusion of digital endpoints in drug reimbursement decisions.

A renowned university researcher explains the path that laid the foundation and what the novel diagnostic and treatment means for prostate cancer patients.

A leader from the healthcare technology company discusses the conflictâs impact on the region and beyond and the need to better guard against interruptions.

The agency’s requested funding for FY 2023, nearly 34% higher than for FY 2022, calls for investments in public health modernization and pandemic preparation.

The drug has received the agencyâs seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.

The agency has approved Lynparza for use in the US as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

The latest news on software, manufacturing solutions, partnerships, and more includes IQVIA, TFF Pharmaceuticals, Quotient Sciences and other key companies.

According to findings from Press Ganey, physicians and pharmaceutical company sites are the top resources patients turn to for information about medicines.

The business tech companyâs Pharmaceutical Supply Chain Vision Study gauges pharma and patient perceptions, including key concerns and areas for improvement.

This monthâs announcements include hiring, expansion, and acquisition news from companies like DFE Pharma, ClinOne, Novartis, LEGO, Benchling, and more.

Returning to an in-person format March 21-24, the industry event is bringing a range of networking, educational, and social programming to New York City.

A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

This monthâs announcements include new hires, promotions, acquisitions, and other events from Saama, Javara, Firma, GlaxoSmithKline, and other companies.

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.

According to the companyâs 12th Annual Pharmaceutical Innovation Report, pharmaceutical R&D return on investment has climbed to its highest peak since 2014.

In a report outlining predictions for the coming year, the organization advises industry professionals to brace themselves for supply chain challenges.

A forward-looking report from company experts includes a breakdown of the top trends to watch for in pharmaceutical development and in healthcare overall.

It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are […]

OSPâs list of the yearâs most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.

This monthâs collaborations, tech partnerships, new facilities, and other happenings includes news from Flywheel, Medable, Veeva, and other organizations.

Professionals from various corners of the life-sciences field share views on significant challenges of 2021, bright spots, and what to look for in 2022.

A leader from the company discusses how advanced analytical tools can be put to work to help tackle adverse event case processing and compliance issues.

The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.

The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.

This monthâs announcements of awards, expansions, name changes, hires, and other news includes items from CPhI, Almac Group, ICON, and other organizations.

A leader from the IT consulting company makes the case for digitization and explains the potenial benefits of bringing an operation into the 21st century.

The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.

This monthâs launches, expanded facilities, partnerships, and other news includes items from Veeva, Hovione, Florence, Medidata, and other notable firms.

Johnson & Johnson has announced its intent to separate its Consumer Health business into a new publicly traded company: allowing J&J to put a sharpened […]

Polyfoil MMB mono-material tubes, designed to be recyclable, landed top honors in the Excellence in Sustainability at the recent Pharmapack Awards program.

According to the market intelligence firm, automation appeals to drug packaging and manufacturing firms, thanks to their productivity-boosting potential.

Wasdell, a UK-based packaging and manufacturing provider in the UK, has opened a quality control laboratory in Dundalk to analyze products for its pharmaceutical clientele.

At the open of the global pharmaceutical industry gathering, a survey of executives from around the globe indicates a rosy mood among professionals in the […]

Under the terms of the strategic arrangement, Pfizer would handle commercialization for Biohavenâs rimegepant in markets outside the bounds of the US.

This monthâs announcements of programs, names, appointments, hires, and other happenings includes items from Emmes, Science 37, Cerner and other companies.

A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.

The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical […]

This monthâs list of partnerships, manufacturing facilities, new technologies and other items includes AstraZeneca, Charles River, Veeva, and other firms.

A study from Climedo Health aims at revealing the growing influence the decentralized format is enjoying across the industry and what might lie ahead.

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

The HIV treatment specialist has sent an application to the agency for tolutegravir, a single-tablet treatment indicated for children living with the virus.

This monthâs news on appointments, expansions, acquisitions and other events includes Nanoform, Elligo Health Research, Curavit, and other organizations.

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

This monthâs roundup of new technology, equipment, and industry partnerships includes news from IBM, IQVIA, Mediata, Labcorp, and other notable companies.

A survey commissioned by Bristol Myers Squibb reveals healthcare providers are confident that immunotherapy can positively impact earlier-stage cancers.

The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.

This monthâs news on new hires, board launches, acquisitions, and other important news includes items on Pfizer, Javara, Clinical Ink, and other companies.

FarmaTrust is helping assemble a collective of public and private firms working on solutions for smart manufacturing and creating medicines of the future.

According to the study, the countryâs overreliance on pharmaceutical ingredients manufactured in overseas factories threatens national security and health.

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians […]

The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.

This monthâs news on hires, promotions, acquisitions, expansions, and funding includes items about Syneos Health, ProSciento, Phastar, CPhI, Immunai, and other key industry players.

Producers of CPhI North America 2021 offer a glimpse at programming, including sessions on COVID-19 challenges, supply chain issues, and more key topics.

An industry study from the producer of CPhI North America shows the pandemic and other factors are contributing to a very dynamic pharmaceutical market.

A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.

The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.

The US Food and Drug Administration has stayed on top of developments around the pandemic, including research into potential vaccines and treatments.

This monthâs roundup of new excipients, manufacturing sites, partnerships, and other items includes news from DFE Pharma, Vetter, and other notable firms.

US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.

The global contract research organization has announced it will be purchased by Goldman Sachs Asset Management and EQT Private Equity.

This monthâs news on hires, promotions, acquisitions, and expansions includes items about Javara, Elligo, Lonza, Yourway, Medable, and other notable firms.

As the industry begins coming out of the COVID-19 pandemic, experts advise keeping an eye on growth and partnership opportunities in the US pharma market.

The agency has been busy with actions related to the virus behind the pandemic, keeping an eye on vaccinations, emerging variants, and other concerns.

The annual event (scheduled July 12-16 online) will feature educational sessions, presentations, and networking opportunities for drug manufacturing pros.

This monthâs roundup of new equipment, materials, tech partnerships and other news includes items from Ajinomoto, Evonik, Quanticate, Pharmasol, and more.

The current COO will assume leadership of the neuro-focused pharma firm while the company board investigates questions on Leen Kawasâs doctoral research.

The US federal agency has released a document designed to help clinical trial teams obtain effective, efficient data from patients in their cancer research.

A leader with the association discusses the value in attending events like the DIA 2021 Annual Meeting gather to tackle COVID-19 and other challenges.

The US agencyâs latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.

The pharmacy company’s Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.

The trial services firm has entered an acquisition agreement with Thoma Bravo, a private equity company centered on software and technology services.

According to the clinical research solutions firm, disruptions due to the pandemic did not stop the industry from fueling R&D at unprecedented levels.

Acting FDA commissioner Janet Woodcock explains how government, researchers, doctors and patients can contribute to improving the clinical research system.

The medical device tech firm is poised to assist manufacturers in navigating the new European Medical Device Regulation, which goes into effect this week.

This monthâs roundup of new equipment, technology partnerships, and other news includes items from Ajinomoto, Elligo, Syneos, ACD/Labs and other companies.

In this third part of a series on the state of clinical research, the acting FDA commissioner talks about possible pathways to improving the infrastructure.

The company reportedly will utilize the investment funding to expand its research platform, and to advance six of its preclinical therapeutic programs.

The newly formed company (valued at $1.05b USD) will center on funding the firmâs decentralized trial technology platform and exploring new opportunities,

This monthâs roundup of new hires, investment funding, partnerships, and other industry news includes key firms such as Clinical Ink, Medable, CPhI, and Sterling Pharma.

In the face of increasing demand for decentralized clinical trials and remote technology, the company has received funding to enable its further expansion.

The US agency continues to keep a watchful eye over the nationâs pandemic response, issuing advice to professionals and taking action where appropriate.

According to a recent survey of executives conducted by CPhI, COVID-19âs impact is driving manufacturing and CDMOs are fueling industry growth.

The combination of companies brings together ERTâs clinical endpoint data capabilities and Bioclinicaâs imaging, eClinical and drug-safety solutions.

The chairman, president and CEO of Thermo Fisher says the acquisition stands to benefit clinical trial and drug development clients in a long list of […]

ImmunoScape plans to use the investor funds to grow its Asia presence, expand into the US, and to further develop its Deep Immunomics platform technology.

This monthâs roundup of new equipment, materials, digital solutions and other news includes items from Lonza, Waters, Eversana, Clinical Ink, and more.

The science service and technologies firm plans to bring the CRO under its Laboratory Products and Services Segment umbrella after the deal is completed.

An expert from FourKites shares impacts of the February storm that hit Texas and other parts of North America, and lessons can be learned from […]

The clinical research tech specialists, which had held 60% of Q2 Diagnostics, will now wholly own the comprehensive clinical laboratory services company.

This monthâs hires, promotions, acquisitions and other notable news includes Ajinomoto, Medable, Charles River, Immunai, AstraZeneca and other top firms.

According to a Veeva Systems survey, contract research organizations are working to ensure clinical trials keep going during the COVID-19 era and beyond.

A survey by the Pistoia Alliance indicates most professionals believe the tech can accelerate R&D, but companies are stymied by a skills gap and data […]

A new report from the organization forecasts a wave of pharma innovation over the next four years could lead to 75 FDA drug approvals annually […]

As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering […]

As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering […]

The company is recalling 10 mg/mL vials of phenylephrine hydrochloride due to potential lack of sterility assurance in several lots of the product.

The companies announcing acquisitions, new hires, promotions and other news this month include Syneos, Elligo, PCI Pharma Services, I Holland and more.

The deal consolidates two significant players in the contract research organization arena, in a deal reportedly worth approximately $12b USD.

Immunai has secured a total of $80m in funding to develop and promote its efforts to harness machine learning to fuel advancement of novel immunotherapies.

This monthâs announcements about industry hires, promotions, alliances and other important events includes Merck, Lonza, Medable and other key firms.

As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to […]

While the change signifies the life-sciences solutions firmâs commitment to help customers and patients, day-to-day functions will remain much the same.

The agency has given the thumbs up to ViiVâs once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.

Formerly Parexel Informatics, the renamed clinical research technology company has broken off and will operate as an independent company going forward.

A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China.

The companyâs Forensic Chemistry Group comprises a collection of technical professionals using their respective talents to detect and thwart counterfeiting.

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.

Industry professionals and consumers alike continue to look to the US agency for action, advice and news related to the global COVID-19 response.

A Miami physician has owned up to falsifying research data and patient participation figures for a pediatric asthma trial conducted from 2013 to 2016.

Industry organizations with hires, promotions, acquisitions and other news to share this month include Parexel, Novartis, WCG, Idifarma and more top firms.

A new survey from the supply-chain analysis company revals inefficiencies, inaccurate data and other flaws can be costly in terms of revenue, reputation and patient […]

William Carson says while the past year was full of challenges, embracing AI and other advanced technology led to impressive progress and opportunity.

The companyâs cancer drug, devimistat, has received orphan status from the agency for treating clear-cell sarcoma, pancreatic cancer, and other diseases.

The agency continues to offer advice, resources and oversight during the pandemic to help develop tests, treatments and other solutions for the virus.

The industry analysis dives into likely developments in supply chain, impact of the new White House occupant, CDMO growth and other key areas.

CureDuchenne is investing in and collaborating with Mesentech, a company with a prodrug platform designed to selectively deliver therapeutics to bone.

The Series C funding will be used to help accelerate the research industryâs adoption of decentralized and digital clinical trial technology.

As the pandemic continues to impact the globe, the agency has kept busy issuing EUAs for potential treatments, and cited sellers of unapproved treatments.

This monthâs news about industry hires, promotions, acquisitions and other events includes Signant, PRA, Lonza, Bora Pharmaceuticals and other top firms.

The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.

The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.

The companyâs annual survey of pharmaceutical and biotechnology leaders reveals their needs, plans and concerns for the immediate and long-term future.

As the pandemic maintains a grip on the globe, the federal agency continues to offer advice and take action to guide life-sciences professionals.

The institutional review board services provider has acquired the AAHRPP-accredited central IRB, which specializes in early-phase research.

President-elect Joe Biden has launched a Transition COVID-19 Advisory Board to support the USâ COVID-19 response.

The most recent news on pharmaceutical industry hires, promotions, acquisitions and other events includes Lonza, Medidata, Vetter, and Almac Group.

The latest coming from the agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

A leader from the company advises planning ahead when filing investigational new drug applications to avoid wasting time, work and money later.

The federal government continues to offer life-sciences professionals advice and resources as they pursue treatments to help fight the COVID-19 virus.

Under the terms of the contract, Gilead will supply the EC with up to half a million treatment courses of Veklury to treat COVID-19 patients.

Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report

The popular pharma industry conferences plan to combine live and digital elements when assembling its calendar of international events next year.

As the pandemic maintains its hold, the US agency continues to issue advice and take action related to testing, treatment and information on the virus.

The survey, unveiled ahead of next week’s CPhI Festival of Pharma, reveals perspectives, concerns and future plans of more than 500 industry executives.

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

The pharmaceutical technology investment fund is partnering with and financing Atomwise, a company that provides AI solutions for drug discovery

The US federal agency continues to keep busy offering resources, issuing EUAs and taking action related to the COVID-19 pandemic.

The agency continues to provide resources for the life-sciences industry, approve tests, and take action against companies offering false treatments

The bipartisan bill calls for an assessment of the countryâs pharma supply chain, including potential vulnerabilities and impact of foreign manufacturing.

The US agency continues to put out informational resources, issue EUAs for tests and treatments, and monitor industry activity related to the virus.

The US agency continues releasing resources, offering advice and taking actions related to the pandemic, and how life-sciences professionals respond.

As the virus behind the pandemic continues to impact the globe, the federal agency continues to offer advice and take action in response to the […]

The agency continues to offer advice to pharma industry professionals during the global public health crisis, and offer advice on developing solutions.