2024 - Pharmacy Technician Pulse

STAT+: Equity, technology, and costs top of mind for life science’s leaders

STAT

APRIL 24, 2024

Physicians, researchers, CEOs, reporters, and more gathered in downtown Boston Wednesday night to celebrate STAT’s 2024 STATUS List , which features 50 leaders in the life sciences. and the rest of the world.

Medical Schools

Medical Schools Hospitals

GSK pill works in uncomplicated gonorrhea

STAT

FEBRUARY 27, 2024

Today we’re excited to unveil the 2024 STATUS List , a rundown of the 50 most influential people shaping the future of health and life sciences across biotech, medicine, health care, policy, and health tech. Want to stay on top of the science and politics driving biotech today? It’s Meghana.

FDA

STAT+: Profiting from ‘legal’ insider trading isn’t always easy

STAT

APRIL 25, 2024

Last night, we held our 2024 STATUS List dinner, honoring 50 influential people shaping the future of health, medicine and life sciences. This is the online edition of Adam’s Biotech Scorecard, a new subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered every Thursday to their inbox.

2023 IS the Year for OTC Naloxone!

The FDA Law Blog

MARCH 29, 2023

Both harm reduction experts and FDA have long agreed that the prescription status for naloxone posed a barrier to wider access to this safe and life-saving drug. NNS (N208411) is the reference listed drug (RLD) which applicants have relied on for approval of generic versions of naloxone nasal spray. launch would be in early 2024.

Insurance

Insurance FDA Labelling

RPS seeks pharmacist feedback on ‘green guide‘ ahead of hospital pharmacy toolkit launch

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. Pharmacies will be able to upload evidence and write reflections, resulting in a ‘green achievement level’ badge of bronze, silver or gold.

Hospitals

Hospitals Community Pharmacies Documentation Communication

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

The FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. The initial notification may include a list of all affected covered finished products or API.

FDA

FDA Communication

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Pharmaceutical Technology

JULY 29, 2022

5 compared with the currently authorised Moderna booster, regardless of prior infection status or age. The expansion will be operational in 2024. The booster dose elicited a significantly higher neutralising antibody response against Omicron subvariants BA.4 Regulators are well-disposed to these boosters.

Vaccines

Vaccines Packaging Immunization FDA

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

The FDA Law Blog

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. That did not happen.

FDA

FDA Documentation

The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

The FDA Law Blog

APRIL 16, 2024

In 2020, CMS issued a final rule providing a broad definition of “new formulation” as “any change to the drug, provided that the new formulation contains at least one active ingredient in common with the initial brand name listed drug.” Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

Dosage

Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

The FDA Law Blog

FEBRUARY 5, 2024

In keeping with the goal of standardization, the Draft Guidance is issued by a long list of agency level offices (including the Offices of the Commissioner, Minority Health and Health Equity, and Women’s Health, among others) and all three human medical product centers (CDER, CBER and CDRH), as well as the Oncology Center of Excellence.

FDA

FDA Medical Records

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

PharmaShots

JUNE 1, 2023

The study flowchart is divided into two parts after pre-screening: an active phase (screening, treatment phase and safety period up to 4 weeks after the last injection) and a long-term follow-up period (up to 2 years after the end-of-treatment visit) during which information about clinical status and disease assessment will be collected.

Immunization

Immunization Vaccines Health and Personal Care Stores Labelling

Money moves: How the biotech market is weathering inflationary storms

Pharmaceutical Technology

JANUARY 25, 2023

Instead, reverse mergers, like privately-held Elicio Therapeutics’s plans to merge with the NASDAQ-listed company Angion Biomedica, might be a sign of things to come. While there will be some exceptions, fundraising and initial public offerings (IPOs) will be difficult for most. range in December 2022.

Communication

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

The FDA Law Blog

FEBRUARY 11, 2024

Houck — With apologies to David Letterman, who introduced the first Top Ten List on Late Night with David Letterman on September 18, 1985, we present “Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not.”* January 29, 2024). By Larry K. Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

Controlled Substances

Controlled Substances Chemotherapy Compounding FDA

Pharmacy Technician Pulse

STAT+: Equity, technology, and costs top of mind for life science’s leaders

GSK pill works in uncomplicated gonorrhea

Trending Sources

STAT+: Profiting from ‘legal’ insider trading isn’t always easy

2023 IS the Year for OTC Naloxone!

RPS seeks pharmacist feedback on ‘green guide‘ ahead of hospital pharmacy toolkit launch

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01

Money moves: How the biotech market is weathering inflationary storms

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

Stay Connected

STAT+: Equity, technology, and costs top of mind for life science’s leaders

GSK pill works in uncomplicated gonorrhea

Trending Sources

STAT+: Profiting from ‘legal’ insider trading isn’t always easy

2023 IS the Year for OTC Naloxone!

RPS seeks pharmacist feedback on ‘green guide‘ ahead of hospital pharmacy toolkit launch

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

Covid-19 Omicron boosters will reinvigorate injectables manufacturing

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 2)

The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation”

Guidance on Standardizing Terminology and Collection: Another Step in FDA’s Path to Increasing Diversity and Inclusion in Clinical Trials

Eric Halioua, President & CEO at PDC*line Pharma Shares Insights on the Results from P-I/II Trial with PDC*lung01

Money moves: How the biotech market is weathering inflationary storms

Marijuana: Top Ten Reasons for Descheduling, Rescheduling or Not

Stay Connected

Eric Halioua, President & CEO at PDCline Pharma Shares Insights on the Results from P-I/II Trial with PDClung01