Acting FDA device chief on creating healthcare hubs at home

Today’s Big News

Oct 17, 2024

Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic


Sage lays off half of R&D team, shakes up C-suite again


CDRH’s Michelle Tarver lays out vision for leadership and bringing healthcare into the home


3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev


Aura’s virus-based drug regimen eradicates tumors in 4 out of 5 low-grade bladder cancer patients


Johnson & Johnson sets 'new standard in inclusive marketing' with diverse Tremfya psoriasis ad


Terray assembles $120M series B to push AI-powered small molecules into clinic

 

Featured

Novartis falls short in legal effort to undo FDA approval of MSN's Entresto generic

In a court decision filed in Washington, D.C., U.S. District Judge Dabney Friedrich rejected Novartis’ position that the FDA’s approval of MSN’s Entresto generic was unlawful. In issuing the decision, the judge upheld the green light that MSN won in July. Novartis has pledged to appeal the outcome.
 

Top Stories

Sage lays off half of R&D team, shakes up C-suite again

Sage Therapeutics’ latest attempt to shrink its pipeline and workforce will see a third of the biotech’s employees heading for the exits along with a swath of the company’s leadership.

CDRH's Michelle Tarver lays out vision for leadership and bringing healthcare into the home

At a town hall featuring FDA leadership at the AdvaMed MedTech Conference in Toronto, Michelle Tarver took the time to introduce—or reintroduce—herself to members of the industry, this time as the acting director of the agency’s Center for Devices and Radiological Health.

3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev

The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.

Aura's virus-based drug regimen eradicates tumors in 4 out of 5 low-grade bladder cancer patients

With its lead candidate in a phase 3 trial for a rare eye cancer, Aura Biosciences is looking to expand the drug into a more common disease: bladder cancer.

Johnson & Johnson sets 'new standard in inclusive marketing' with diverse Tremfya psoriasis ad

Though psoriasis affects people of all skin tones, that diversity isn’t always represented in portrayals of the condition in clinical studies, commercials, textbooks and beyond.

Terray assembles $120M series B to push AI-powered small molecules into clinic

Terray Therapeutics has raked in $120 million for a series B fundraise as the AI-focused biotech aims to transform small molecule drug development.

Viatris makes good on CEO's dealmaking promise with $25M licensing pact for Lexicon's heart med Inpefa

Viatris is ponying up $25 million upfront to obtain the rights to sell Lexicon Pharmaceuticals’ SGLT1/SGLT2 heart med sotagliflozin, known commercially as Inpefa, in all global markets beyond the U.S. and Europe.

Tarsus taps actor Betsy Sodaro to embody a ‘mitey problem’ in 1st Xdemvy DTC TV ad

As the first treatment cleared by the FDA for Demodex blepharitis, an eye disease estimated to affect 25 million people in the U.S. alone, Tarsus Pharmaceuticals’ Xdemvy is pitting its might against the skin-infesting mites that cause the disease.

NIH study shows Bavarian Nordic's mpox shot elicits immune response in teens

With the clade 1 outbreak of mpox raging through parts of Africa, interim results of an NIH trial of Bavarian Nordic's Jynneos indicate that it is safe and elicits an immune response in adolescents.

Eli Lilly shows how public restroom rarity affects ulcerative colitis patients

Eli Lilly has thrown its weight behind a cause beyond the traditional remit of pharma companies. As the sponsor of an app for finding public restrooms, the Big Pharma is shining a light on just how common a problem finding the facilities is for people with ulcerative colitis.

Novartis pays China's Baiyu $70M upfront, with $1.1B chaser, for small molecule cancer candidate

Novartis is paying Chengdu Baiyu Pharmaceutical $70 million to add to its crop of cancer candidates. The deal, which features $1.1 billion in milestones, covers the global rights to a small molecule discovered by a Chinese biotech that has built a business around botanical drugs.

ABPI finds familiarity breeds trust, supporting push for industry-healthcare collaborations

The more healthcare professionals know the pharma industry, the more they trust the pharma industry. That is the claim of U.K. pharma industry group ABPI, which reported another small uptick in how many HCPs trust drugmakers in its latest survey.
 
Fierce podcasts

Don’t miss an episode

A revival in neuro therapeutics

This week on "The Top Line," Fierce Pharma's Fraiser Kansteiner chats with industry leaders about the surge in neuroscience investment, breakthroughs and future targets in neuropharmaceuticals.
 

Resources

eBook

Decoding the data

Need the superpowers to select the right lab equipment?
Whitepaper

Strategies to Optimize Expression Challenges of Multi-chain and Bispecific Antibodies

Take a brief journey through some of the efforts that Lonza has made to optimize the manufacturability of bsAbs and other formats, and take a glance towards future directions with an emphasis on the upstream aspects.
Whitepaper

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.
Whitepaper

Accelerating Timelines to Clinic with GPEx® Lightning

Unlock the Future of Biotherapeutics with Catalent Biologics!
Whitepaper

Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

Upcoming Fierce Events

18-19
Nov
Free Virtual Event
20
Nov
Free Virtual Event
4
Dec
Free Virtual Event
5
Dec
The Lighthouse at Pier 61 in New York City
14-15
Jan
San Francisco, CA

View all events