Regulatory affairs

Intelligent eCOA use enhances trials, amplifies patient voice: Medable

28-Jun-2022 By Jenni Spinner

An expert from the decentralized trial solutions company shares how eCOA and ePRO can be useful tools that improve the collection and quality of such data.

Janssen invests $5m in Stand Up To Cancer’s health equity effort

27-Jun-2022 By Jenni Spinner

The sponsorship from Janssen Pharmaceutical Companies will be used by the cancer support network to boost diversity in Phase I and Phase 2 clinical trials.

HistoSonics hits enrollment target en route to FDA filing for liver cancer therapy

22-Jun-2022 By Nick Taylor

The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.

BIO research outlines risks in changing accelerated approval pathway

21-Jun-2022 By Rachel Arthur

If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.

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Pandemic highlights need for supply chain visibility, partnerships

14-Jun-2022 By Jenni Spinner

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

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BIO panel takes on patient recruitment, retention challenges

09-Jun-2022 By Jenni Spinner

Representatives from Clincierge, Rare Patient Voice, Insight and Measurement, and Ultragenyx Pharmaceutical will lead the lively panel discussion on June 13.

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DIA offers tracks to deliver focused educational experience

08-Jun-2022 By Jenni Spinner

Offering 13 topic tracks to choose from, the DIA Global Annual Meeting (scheduled June 19-23) lets attendees chose the path that fits their unique interests.

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Can the industry elevate the success rate of cancer trials?

07-Jun-2022 By Jenni Spinner

During the upcoming BIO International Convention, experts from CerFlux, the MD Anderson Cancer Center, and Aga Khan University will weigh in with insights.

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BIO International 2022 to bring insights, athletes to San Diego

06-Jun-2022 By Jenni Spinner

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.

Sanofi hemophilia A drug lands breakthrough therapy designation

06-Jun-2022 By Jenni Spinner

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

Danish National Genome Center, Lifebit form personalized medicine partnership

01-Jun-2022 By Jenni Spinner

The Lifebit CloudOS will be employed to create a Federate Trusted Research Environment within the center’s supercomputing cluster to handle data management.

How Lithuania aims to become a leading European biotech hub

01-Jun-2022 By Ben Hargreaves

Lithuania’s life sciences industry is growing at one of the fastest rates in Europe. Ahead of BIO, Innovation Agency Lithuania explains what the country’s plans are for future growth in the area and how this is built upon students heading into STEM studies.

Digital health initiative offers resources to increase inclusivity

25-May-2022 By Jenni Spinner

The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.

Virtual care tech firm Biofourmis lands $300m vote of confidence

24-May-2022 By Jenni Spinner

The digital medicine solutions developer has received $300m in a Series D investment round, which will be used to help scale up its virtual care offerings.

Regeneron and Sanofi’s Dupixent FDA-approved for eosinophilic esophagitis

23-May-2022 By Jenni Spinner

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.

NIH awards $577m to antiviral drug developers

20-May-2022 By Rachel Arthur

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

Lilly deploys AI-powered tech to expedite drug approval process

18-May-2022 By Jenni Spinner

The pharmaceutical company is partnering with Yseop to install the software company’s Augmented Analyst, designed to elevate and accelerate data analysis.

FDA lifts clinical hold on Gilead’s investigational HIV treatment

17-May-2022 By Jenni Spinner

The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.

Collaboration, communication can benefit patient advocacy groups: IQVIA

12-May-2022 By Jenni Spinner

Leaders from the biotech company share advice on how such organizations can make the most of often limited resources via smart strategy and collaboration.

AstraZeneca metastatic breast cancer treatment secures FDA approval

10-May-2022 By Jenni Spinner

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

FDA outlines benefit-risk approach to drug or biologic product quality assessment

10-May-2022 By Jane Byrne

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.

Takeda joins with Xavier University to increase equity in healthcare

09-May-2022 By Jenni Spinner

The pharmaceutical firm and university have launched T-REX, a multi-year partnership focused on increasing health outcomes for underrepresented populations.

TFF: Phase I study of inhalable COVID-19 drug shows promise

09-May-2022 By Jenni Spinner

The thin-film freezing specialist reports positive safety and pharmacokinetic data coming out of the Phase I trial of its niclosamide inhalation powder.

Survey: industry leaders looking to shore up pharma supply chain

05-May-2022 By Jenni Spinner

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.

CPHI North America

Future drugs will need novel excipients: IPEC

04-May-2022 By Jenni Spinner

An expert from the organization discusses ahead of his CPhI North America presentation how tomorrow’s drugs can’t all be formulated with yesterday’s excipients.

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Continuous manufacturing adoption continues to rise: Pharmatech

04-May-2022 By Jenni Spinner

An expert from Pharmatech Associates offers a glimpse into the evolution of CM and previews a lively discussion during the upcoming CPhI North America event.

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Pharma growth, partnerships focus of 2022 CPhI North America

04-May-2022 By Jenni Spinner

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

Proposed bill aims to encourage US pharmaceutical manufacturing

03-May-2022 By Jenni Spinner

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

FDA approves expanded indication for ADHD treatment from Supernus

02-May-2022 By Jenni Spinner

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

FDA approves Gilead's COVID-19 treatment for young children

26-Apr-2022 By Jenni Spinner

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 COVID-19 virus.

Impel Pharmaceuticals upper-nasal delivery offers hope for migraine patients

26-Apr-2022 By Jenni Spinner

The company’s Precision Olfactory Delivery technology, currently combined with its Trudhesa migraine treatment, reportedly facilitates high absorption rates.

HPAPI Summit hones in on pharmaceutical manufacturing risk

25-Apr-2022 By Jenni Spinner

The 2022 edition of the Highly Potent Active Pharmaceutical Ingredients Summit (June 28 to 30 in Boston) will take on a range of topics, including safety.

FDA approves label update to ViiV’s long-acting HIV treatment

25-Apr-2022 By Jenni Spinner

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

Advanced analytic tools can improve safety reporting: IQVIA

20-Apr-2022 By Jenni Spinner

An expert from the health tech company explains how AI, natural language processing, and other tools can improve pharmaceutical product safety reporting.

CMC lands funding to develop treatment for nerve agent poisoning

19-Apr-2022 By Jenni Spinner

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.

Cryoport buys French biostorage and logistics specialist

19-Apr-2022 By Jane Byrne

Cryoport Inc has acquired Cell&Co BioServices, continuing its EMEA expansion efforts.

FDA draft guidance outlines path to increased trial inclusivity

14-Apr-2022 By Jenni Spinner

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

RWE can boost trial acceleration, cost efficiency, and inclusivity

13-Apr-2022 By Jenni Spinner

An expert from trial tech specialist Komodo Health talks about how real-world evidence use could elevate study design, conserve costs, and improve recruitment.

UK-based collaborators to create world’s largest cancer database

12-Apr-2022 By Jenni Spinner

The partnership among three research and data specialists is aimed at creating a global database to support faster development of novel cancer treatments.

Cancer researcher nabbed for falsifying data in PHS-funded grants

07-Apr-2022 By Jenni Spinner

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

Big pharma experts join forces to drive automation of data workflow

05-Apr-2022 By Nick Taylor

Leaders from some of the industry’s most notable companies are working together to streamline and automate IDMP workflow and come up with various standards.

Noxopharm cancer drug secures Orphan Drug Designation from FDA

05-Apr-2022 By Jenni Spinner

The Australian biotechnology company has been granted ODD status from the agency for Veyonda, a therapy intended for the treatment of soft-tissue sarcoma.

Pharma supply chain could learn from the food industry: Rephine

04-Apr-2022 By Jenni Spinner

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

Digital Medicine Society launches digital endpoint toolkit

04-Apr-2022 By Jenni Spinner

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

Embracing clinical tech can benefit all stakeholders: IQVIA

31-Mar-2022 By Jenni Spinner

An expert from the clinical technology solutions provider discusses some of the top challenges associated with technology adoption, and how to tackle them.

Innovative Purdue research leads to FDA-approved prostate cancer treatment

31-Mar-2022 By Jenni Spinner

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

Ukraine war offers hard lessons for clinical research industry: H1

29-Mar-2022 By Jenni Spinner

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

FDA requests total of $8.4b for fiscal year 2023 budget

29-Mar-2022 By Jenni Spinner

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.

UCB’s Fintepla oral seizure treatment receives FDA approval

28-Mar-2022 By Jenni Spinner

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

Ukraine war dramatically impacting global clinical development: Phesi

24-Mar-2022 By Jenni Spinner

The company’s analysis of clinical research activity in the region shows the conflict will have long-lasting effects that reach beyond the country’s borders.