Thursday, June 5, 2025
VISIT ROYALMOK
Agarwood Times
  • Home
  • Agarwood
  • Health
  • Diseases
  • Diet & Fitness
  • Nutrition
  • Sleep Info
  • Meditation
  • Shop
No Result
View All Result
  • Home
  • Agarwood
  • Health
  • Diseases
  • Diet & Fitness
  • Nutrition
  • Sleep Info
  • Meditation
  • Shop
No Result
View All Result
Agarwood Times
No Result
View All Result

Makary hearing, Hims, Nimbus, Ozempic

March 7, 2025
in Health
Reading Time: 4 mins read
0 0
A A
0
Home Health
Share on FacebookShare on Twitter



Need to keep on high of the science and politics driving biotech at present? Enroll to get our biotech publication in your inbox.

Hello there. Right now, we unpack Marty Makary’s Senate  affirmation listening to, see a brand new ruling towards GLP-1 compounders, study the consequences of the NIH patent freeze, and discover the tumultuous biotech job market.

The necessity-to-know this morning

Nimbus Therapeutics stated CEO Jeb Keiper is stepping down instantly as a part of a deliberate transition. The corporate named Abbas Kazimi, its chief enterprise officer since 2020, as Keiper’s successor.

Makary FDA listening to: Extra MAHA focus than regulatory coverage

Marty Makary’s Senate affirmation listening to to be FDA commissioner went relatively easily. He wasn’t pressed a lot on core regulatory points; 4 senators requested concerning the abortion drug mifepristone, and only one requested about accelerated approvals and uncommon illness medicine. There have been no questions on GLP-1 drug shortages, FDA’s regulation of AI, or lab-developed assessments — all key points for the company lately.

“We want extra humility within the medical institution,” Makary stated.

As a substitute the main target was on transparency, persistent illness, and company layoffs. Makary pledged to evaluate FDA staffing and effectivity, supported biosimilar and generic approvals to decrease prices, and promised stricter oversight on meals components and unlawful vapes. However he didn’t decide to restoring DEI tips or rescheduling vaccine advisory conferences.

Learn extra.

And hearken to the brand new episode of The Readout LOUD podcast on the affirmation listening to right here.

Decide guidelines towards compounding group; Hims’ shares fall

From STAT’s Elaine Chen: A federal decide this week dominated towards a compounding commerce group that needed to proceed making copies of Eli Lilly’s weight problems drug tirzepatide (offered underneath the model names Mounjaro and Zepbound).

For background: The FDA final 12 months took tirzepatide off its scarcity record, which meant compounding pharmacies might not legally make copies of the branded therapy. However the Outsourcing Facility Affiliation, a compounding commerce group, sued the FDA, arguing that the company’s transfer was arbitrary and illegal. The commerce group sought a preliminary injunction that might stop the FDA from taking actions towards its members making tirzepatide copies, however the decide has now denied the request. The decide’s order is sealed and couldn’t be considered by STAT.

In a press release, OFA chairman Lee Rosebush stated the group is contemplating all of its choices, together with an enchantment. He wouldn’t touch upon any explicit facet of the order till it’s unsealed by the court docket.

The ruling is a blow to compounders, which noticed a surge in demand from sufferers during the last two years as sufferers couldn’t entry the branded therapies as a consequence of shortages and their excessive prices. The identical commerce group has additionally filed a lawsuit towards the FDA for lately taking Novo Nordisk’s semaglutide (offered underneath the model names Ozempic and Wegovy) off its scarcity record.

Hims and Hers has been probably the most outstanding telehealth corporations connecting sufferers to compounded weight reduction medicine.

Although it was not providing compounded tirzepatide and lately stated it might cease making precise copies of semaglutide, the corporate stated it should nonetheless prescribe different types of compounded semaglutide “when there may be scientific necessity for that personalization.” Although the decide’s ruling doesn’t have a direct affect on Hims, it signifies the tough authorized atmosphere for corporations concerned with compounding. Hims’ shares dropped 16% yesterday.

The ruling, in the meantime, represents a win for Lilly and Novo, which have each been attempting to fight the rise of compounding. Each have began promoting their medicine direct-to-consumer at a lower cost, as a method to attract sufferers away from compounders. Simply yesterday, the telehealth firm Teladoc introduced a brand new partnership with Lilly’s DTC platform that enables Teladoc customers to get streamlined entry to tirzepatide.

NIH patent freeze stalls biomedical progress

The Trump administration’s clampdown on NIH exterior communications and new contracts has halted patent filings and licensing, disrupting biomedical innovation, STAT’s Megan Molteni writes. Since Jan. 29, NIH tech switch staff have been barred from negotiating agreements, delaying vaccine and drug growth.

A number of tech switch employees have been laid off, which is additional straining the company’s capability to guard and commercialize taxpayer-funded discoveries.

“Bench to bedside is such an advanced ladder — no firm or college and even the federal authorities has all of the experience wanted to get it from level A to level B,” one NIAID patent specialist instructed STAT. “It’s completely mind-boggling to remove so many rungs of that ladder and assume somebody will nonetheless have the ability to climb it.”

Learn extra.

Volatility is the norm for biotech careers now

The biotech business is getting increasingly more area of interest: Startups give attention to single property, aiming to be wolfed up by larger fish. Giant pharmas more and more desire bolt-on offers, whereas enterprise capital funding is extremely conditional, making job stability even tougher, opines Cambridge-based enterprise growth skilled Gairik Sachdeva.

“Biotech staff can put together for this new rollercoaster regular by selecting a distinct segment on this more and more specialised business after which fortifying their talent units to help milestones most related to corporations in that area of interest,” he writes in a brand new First Opinion piece.

Profession flux is the brand new norm, Sachdeva says — and those that repeatedly adapt and increase their experience are those that can thrive on this quickly evolving business.

Learn extra.

Extra reads

NIH places former Sexual & Gender Minority Analysis Workplace staff on administrative depart, STAT
Q&A: How ‘blast zone’ of gender politics is hurting analysis on girls’s well being, STAT
Novo Nordisk’s uncommon illness ‘firm inside an organization’ has an open purpose in sickle cell, Endpoints
J&J to cease late-stage examine of add-on despair drug, Reuters



Source link

Tags: HearingHimsMakaryNimbusOzempic
Previous Post

What’s new in pediatric concussion care?

Next Post

A Dietitian’s Review of Marley Spoon

Related Posts

Diabetes drug shows benefits for patients with liver disease
Health

Diabetes drug shows benefits for patients with liver disease

June 4, 2025
Household environments may affect the likelihood of children developing eczema
Health

Household environments may affect the likelihood of children developing eczema

June 4, 2025
Trump’s Cognitive ‘Decline’ Suggests He ‘Might Not Make It Through Four Years,’ Republican Strategist Says
Health

Trump’s Cognitive ‘Decline’ Suggests He ‘Might Not Make It Through Four Years,’ Republican Strategist Says

June 4, 2025
Monoclonal antibody halves hospitalizations of children younger than 6 months old
Health

Monoclonal antibody halves hospitalizations of children younger than 6 months old

June 3, 2025
Kura Oncology Drug’s Data at ASCO Support FDA Filing Now Under Priority Review for Leukemia
Health

Kura Oncology Drug’s Data at ASCO Support FDA Filing Now Under Priority Review for Leukemia

June 4, 2025
Guidance requiring hospitals to provide emergency abortions revoked
Health

Guidance requiring hospitals to provide emergency abortions revoked

June 4, 2025
Next Post
A Dietitian’s Review of Marley Spoon

A Dietitian’s Review of Marley Spoon

10 BEST FRAGRANCES IN The WORLD | And Their CHEAP ALTERNATIVE

10 BEST FRAGRANCES IN The WORLD | And Their CHEAP ALTERNATIVE

Quick takes: US food safety cuts, UK tracks Lassa contacts, malaria vaccine in Uganda

Quick takes: US food safety cuts, UK tracks Lassa contacts, malaria vaccine in Uganda

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

RECOMMENDED

Prior COVID vaccination produces immune response against new SARS-CoV-2 strains, study finds
Diseases

Prior COVID vaccination produces immune response against new SARS-CoV-2 strains, study finds

by admin
May 29, 2025
0

kovop58/iStock Receiving a previous COVID-19 vaccine didn't stop the immune system from producing protecting responses to both Delta or Omicron...

Colorado confirms 3 more infections in airport-linked measles outbreak

Colorado confirms 3 more infections in airport-linked measles outbreak

June 2, 2025
Norovirus vaccine produces mucosal immunity in phase 2b trial

Norovirus vaccine produces mucosal immunity in phase 2b trial

May 30, 2025
Diagnostic tool creates stronger, longer-lasting bioluminescence signals to detect viruses

Diagnostic tool creates stronger, longer-lasting bioluminescence signals to detect viruses

May 30, 2025
Celebrating Food, Culture, and AAPI Month with Remy Morimoto Park

Celebrating Food, Culture, and AAPI Month with Remy Morimoto Park

May 29, 2025
The new Covid variant NB.1.8.1 is driving infections in Australia. A virologist explains what you need to know | Lara Herrero for the Conversation

The new Covid variant NB.1.8.1 is driving infections in Australia. A virologist explains what you need to know | Lara Herrero for the Conversation

May 30, 2025
Facebook Twitter Instagram Youtube RSS
Agarwood Times

Stay informed with the latest news, articles, and insights on agarwood cultivation, history, sustainability, and more. Explore the timeless allure of agarwood and deepen your understanding of this extraordinary natural resource.

CATEGORIES

  • Agarwood
  • Diet & Fitness
  • Diseases
  • Health
  • Meditation
  • Nutrition
  • Sleep Info
  • Uncategorized
No Result
View All Result

SITEMAP

  • About us
  • Advertise With Us
  • Disclaimer
  • Privacy Policy
  • DMCA
  • Cookie Privacy Policy
  • Terms and Conditions
  • Contact us

Copyright © 2024 Agarwood Times.
Agarwood Times is not responsible for the content of external sites.

No Result
View All Result
  • Home
  • Agarwood
  • Health
  • Diseases
  • Diet & Fitness
  • Nutrition
  • Sleep Info
  • Meditation
  • Shop
VISIT ROYALMOK

Copyright © 2024 Agarwood Times.
Agarwood Times is not responsible for the content of external sites.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In