Ascendis wins hard-fought HRT nod

Today’s Big News

Aug 12, 2024

In a one-two punch for Lykos, three articles on MDMA treatment retracted due to unethical conduct


Lykos will ask FDA to reconsider its decision following rejection of MDMA therapy for post-traumatic stress disorder


Daxxify maker Revance agrees to $924M buyout by private skincare company Crown Laboratories


Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath


Stryker continues shopping spree with acquisition of smart hospital developer care.ai


AbbVie’s Skyrizi, Rinvoq retake the top TV drug ad spenders’ crown as top climber Rexulti continues strong run

 

Featured

In a one-two punch for Lykos, 3 articles on MDMA treatment retracted due to unethical conduct

The journal Psychopharmacology has pulled three articles about several midstage clinical trials assessing Lykos Therapeutics’ investigational MDMA candidate for treating post-traumatic stress disorder. The journal cited “unethical conduct” at a research site as the reason for the retraction.
 

Top Stories

Lykos will ask FDA to reconsider its decision following rejection of MDMA therapy for post-traumatic stress disorder

On Friday, the FDA declined to approve Lykos’ midomafetamine (MDMA) therapy in patients with PTSD. Lykos had been seeking approval of its MDMA capsule along with psychological intervention, also known as MDMA-assisted therapy.

Daxxify maker Revance agrees to $924M buyout by private skin care company Crown Laboratories

Revance and Crown Laboratories—a privately held skin care company with multiple marketed products of its own—are merging, the companies said in a release Monday. Under the deal, which has won the unanimous blessing of Revance’s board of directors, Crown will enter a tender offer to acquire all outstanding Revance stock for $6.66 per share in cash, for a total deal value of $924 million.

Ascendis scores hard-fought FDA nod for hormone replacement therapy Yorvipath

After two delays, the FDA has finally signed off on Ascendis Pharma's hormone replacement therapy Yorvipath, also known as TransCon PTH, which is the first approved product for hypoparathyroidism in adults in the U.S.

Stryker continues shopping spree with acquisition of smart hospital developer care.ai

Last month, CEO Kevin Lobo said Stryker planned to pursue multiple M&A deals this year. It hasn’t taken long to start making good on that promise.

AbbVie’s Skyrizi, Rinvoq retake the top TV drug ad spenders’ crown as top climber Rexulti continues strong run

As we hit the middle of the year, AbbVie is comfortably back in the top TV drug ad spenders’ driving seat taking the top two spots in July with its immunology blockbuster duo Skyrizi and Rinvoq, respectively, according to real-time TV trackers at iSpot.TV.

Halda raises $126M to advance 'hold and kill' solid tumor drugs into the clinic

The initial stages of oncology R&D aren’t short of intriguing new modalities, and Halda Therapeutics is planning to join them by using $126 million in fresh funding to run its RIPTAC program into the clinic.

Ajinomoto will lay off 71 staffers in CA to streamline CDMO business following $620M Forge Biologics buy

Following last year’s acquisition of viral vector and plasmid specialist Forge Biologics, Japan’s Ajinomoto Bio-Pharma Services is streamlining its business in San Diego. As a result, 71 California-based staffers—or 13% of the company’s overall workforce—are set to lose their jobs, Ajinomoto said in a memo shared with Fierce Pharma.

The largest known protein has been discovered in algae—and it’s a machine that makes poison

The muscle protein titin has long been the titan of the molecular world. Built of more than 34,000 amino acids and weighing in at a hefty 3.7 megadaltons, titin has long been considered the largest protein in the world—until now.

Pfizer, looking to expand RSV vaccine's reach, touts its benefits in immunocompromised adults

Locked in a closely watched RSV vaccine competition, Pfizer aims to expand the reach of its offering Abrysvo. Monday, Pfizer said Abrysvo elicited a strong response in adults with compromised immune systems.

Analysts dig into details of Avidity's DMD win, revealing nuances in strong data

Avidity Biosciences impressed investors with phase 1/2 data in Duchenne muscular dystrophy Friday, extending its winning streak in the clinic. But closer examinations of the data revealed details that analysts said present a much more nuanced picture than what the headline result implies.

Paige and Microsoft roll out updated image-based AI models for cancer diagnosis

Nearly a year after it announced a collaboration with Microsoft, digital pathology player Paige unveiled the second generation of an image-based AI model to help detect cancer.

After icodec rejection, Novo Nordisk plots 2024 FDA filing for once-weekly insulin and semaglutide combo

Despite hitting a roadblock on the path to approval for its once-weekly insulin icodec in the United States, Novo Nordisk is continuing to move full speed ahead with a combo treatment pairing the drug with its unstoppable GLP-1 semaglutide.

Analysts tip Madrigal to target digestive scientific meetings to kick-start MASH growth

GlobalData analysts have assessed the actions Madrigal Pharmaceuticals is taking to drive growth of its metabolic dysfunction-associated steatohepatitis (MASH) drug Rezdiffra, highlighting upcoming industry events as opportunities to boost awareness and adoption.
 
Fierce podcasts

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A closer look at Fierce Biotech's Fierce 15

In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report.
 

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