Sun.Jun 09, 2024

article thumbnail

STAT+: The inside story of how Lykos’ MDMA research went awry

STAT

At a heated advisory committee meeting convened by the Food and Drug Administration last week, regulators repeatedly expressed frustration that Lykos, a company seeking approval of MDMA-assisted therapy to treat PTSD , failed to follow instructions and track positive feelings such as “euphoria” that could be used to inform understanding of the drug’s addiction potential.

363
363
article thumbnail

US FDA expands approval to GSK’s Arexvy for adults aged 50-59, at increased risk

Express Pharma

GSK announced that the US FDA has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 to 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

Vaccines 109
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Urgent plea for type O blood after London cyberattack

pharmaphorum

NHS launches an urgent appeal for type O blood donors to come forward in the wake of the cyberattack which has hamstrung hospitals and GP services in London

Hospitals 113
article thumbnail

CDSCO cracks down on export licenses, antibiotic approvals

Express Pharma

India’s central drug regulator continues to strategically close the loopholes and rejig India’s drug regulatory protocols, focusing on state licensing authorities and their duties. For instance, in a letter dated April 30, the Drugs Controller General (India) directed that CDSCO Zonal offices, and not the state/UT licensing authorities (SLAs), would be responsible for granting manufacturing NOCs in these cases.

99
article thumbnail

Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

article thumbnail

Blame big pharma, not the NHS, for drug prices | Letters

The Guardian - Pharmaceutical Industry

The government must act to stop firms overcharging the NHS for cancer treatments, argues Tim Bierley I can’t imagine the distress of knowing that promising cancer treatments like Enhertu exist, yet being unable to access them because the price is too high for the NHS ( Women in England and Wales denied ‘exciting’ drug that can stop breast cancer spreading, 3 June ).

article thumbnail

Lab Logic: Decoding Analytical Testing for Optimal Product Development

PharmaTech

Because of the level of complexity required to develop and manufacture cell and gene therapies, resulting from the use of various raw materials, custom reagents, and tailored approaches for managing complex diseases, biopharmaceutical companies are increasingly partnering with CDMOs equipped with technologies and expertise to support analytical testing during process development.

59

More Trending

article thumbnail

Using Advanced Algorithms to Solve Formulation Challenges

PharmaTech

Artificial intelligence and machine learning can help overcome poor solubility and bioavailability.

80
article thumbnail

Bupropion Clinical Pearls – Top 5

Med Ed 101

Bupropion (Wellbutrin) is an antidepressant that is most commonly used as an alternative (or sometimes in combination) to SSRIs. In this post, I will share my most important bupropion clinical pearls as well as some things that may show up on your board exam! Seizure Risk One of the most highly testable bupropion clinical pearls […] The post Bupropion Clinical Pearls – Top 5 appeared first on Med Ed 101.

52
article thumbnail

Accelerate your mAb manufacturing workflow

PharmaTech

In this asset, you will discover how the Gibco Efficient-Pro system can revolutionize your mAb manufacturing workflow. It provides insights into optimizing CHO cell productivity, enhancing product titers and protein quality, streamlining process efficiency, and leveraging a reliable supply network.

52
article thumbnail

Third Person in US Tests Positive for H5N1 Bird Flu, CDC Emphasizes Risk Remains Low

Pharmacy Times

Compared to other cases, the most recent patient reported more flu-like symptoms, including cough, congestion, watery eyes, and sore throat.

55
article thumbnail

5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

article thumbnail

Gibco Efficient-Pro Medium and Feeds Evaluation Guide

PharmaTech

The Gibco Efficient-Pro Medium and Feeds Evaluation Guide provides insights into enhancing monoclonal antibody manufacturing workflows. Offering improved titers, viability, and protein quality in CHO cell lines, it introduces a comprehensive evaluation process for maximizing productivity.

52
article thumbnail

Solution dosed drug patent expirations by year

Drug Patent Watch

This chart shows the patent expirations for solution dosed drugs over the next decade. The term of drug patents varies.

59
article thumbnail

Navigate your Efficient-Pro journey with professional support

PharmaTech

This asset outlines the comprehensive support and guidance offered by the FAS team for optimizing monoclonal antibody (mAb) manufacturing processes using the Efficient-Pro medium and feeds.

52
article thumbnail

Episode 929: What is the incidence of torsades from low-dose ondansetron in peri-operative patients?

Pharmacy Joe

In this episode, I’ll discuss the incidence of torsades from low-dose ondansetron in peri-operative patients. Episode 929: What is the incidence of torsades from low-dose ondansetron in peri-operative patients? Subscribe on iTunes , Android , or Stitcher Ondansetron prescribing information has a warning that Electrocardiogram (ECG) changes including QT interval prolongation have been seen in patients receiving ondansetron.

article thumbnail

Efficient-Pro Medium and Feeds improve productivity in CHO-K1, CHO-S, and DG44 cells

PharmaTech

Learn about how Efficient-Pro Medium and Feeds elevate productivity in CHO-K1, CHO-S, and DG44 cells for bioproduction in this comprehensive content piece.

52
article thumbnail

Analytics and Assays Strive to Keep Pace with Innovative Modalities

PharmaTech

Webinar Date/Time: Thu, Jun 27, 2024 11:00 AM EDT

52