Roche relinquishes hemophilia A med

Today's Big News

Jul 27, 2023

FDA CBER Chief Marks overrules staff drug reviewers 'with trepidation'


Eli Lilly's tirzepatide aces 2 more late-stage obesity trials as FDA decision nears


Roche loses spark for gene therapy, axing hemophilia A candidate from pipeline


Boston Scientific ups 2023 forecast after sales jump 11% in Q2


Despite big Q2 declines for Humira and Imbruvica, AbbVie still boosts earnings guidance

 

Featured

FDA CBER Chief Marks overrules staff drug reviewers 'with trepidation'

Peter Marks, M.D., Ph.D., says he trusts staff reviewers at the FDA, who do “incredibly great work”—but sometimes decisions about efficacy require a broader view.
11-14
Sep
Philadelphia, PA
 

Top Stories

Eli Lilly's tirzepatide aces 2 more late-stage obesity trials as FDA decision nears

Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday.

Roche loses spark for gene therapy, axing hemophilia A candidate from pipeline

Roche’s gene therapy ambitions have taken another blow. Shortly after writing down the value of one of Spark Therapeutics’ hemophilia A candidates, the Swiss drugmaker has removed a second therapy aimed at the disease from its midphase pipeline.

Boston Scientific ups 2023 forecast after sales jump 11% in Q2

Boston Scientific said it expects this year to shake out to between 10.5% and 11.5% sales growth.

Despite big Q2 declines for Humira and Imbruvica, AbbVie still boosts earnings guidance

As Humira biosimilars continue to swarm the market, AbbVie says the situation is playing out as it had expected—or even slightly better. Still, the company is weathering hefty sales declines.

Further blow for Biohaven as FDA refuses to consider failed rare disease drug for approval

Biohaven’s attempts to redefine itself as a post-migraine company are continuing to encounter headaches, with the company expressing “deep disappointment” at the FDA’s refusal to review the brain disorder drug troriluzole.

Takeda hypes up dengue vaccine launch progress as Vyvanse generics loom

While it’s still early days for Qdenga’s launch, Takeda is “encouraged by the positive momentum” it’s seen in markets where the product is now available, the company’s CEO, Christophe Weber, said on a conference call Thursday. He added that the company is “already seeing early signs of higher-than-expected demand.”

Know Labs narrows accuracy gap between its noninvasive glucose sensor and current CGMs

Know Labs is rapidly whittling down the difference between its noninvasive diabetes sensor and traditional continuous glucose monitors.

Facing potential $10B trial loss, Teva seeks appeal of recent ruling in kickbacks case

Teva has worked hard to wrap up its wide-ranging opioid litigation. But a separate lawsuit from the U.S. government related to alleged kickbacks on Copaxone could prove to be "enterprise-threatening," its lawyers recently wrote.

Merck’s next-gen pneumococcal vaccine strides forward after two phase 3 wins

Merck & Co.’s next-generation pneumococcal vaccine has secured success in a pair of phase 3 trials, bringing the Big Pharma within touching distance of getting the first pneumococcal conjugate shot specifically designed for adults to market.

After CRO spinoff, Labcorp sets second-half focus on ‘robust’ M&A and partnership pipelines

Labcorp closed out the first half of the year with the spinoff of its clinical development business, which left the nest on June 30 as a standalone, publicly traded CRO dubbed Fortrea.

Merck, insurers advance fight over cyberattack-related coverage to New Jersey Supreme Court

That didn't take long. About a month and a half after Merck & Co. scored a legal win in the insurance case tied to the 2017 "NotPetya" cyberattack, the case is in appeals—again.
 
Fierce podcasts

Don't miss an episode

'The Top Line': Digital phenotyping, plus this week's headlines

This week on "The Top Line," we discuss the state of digital phenotyping, plus the vaccine patent lawsuits, the smallest insulin pump, and the rest of the week's headlines.

 

Resources

Webinar

Novel Antibodies for the Characterization of CAR-T Cells

Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more.
Whitepaper

Improving the Patient Experience Through Research-Driven Design

Learn more about the current challenges and issues that eClinical technology providers are facing.
Research

Develop a cost-effective cGMP chemical sourcing strategy

The right sourcing strategy can help save of millions of dollars—learn about developing a strategy for sourcing the cGMP chemicals critical to your processes.
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
eBook

Medical Affairs Metamorphosis

This eBook identifies the trends driving major change in the Medical Affairs (MA) function. It also outlines the strategic and tactical implications for MA leaders and team members.
eBook

6 Tools Trial Sponsors Need to Take Action Earlier in Enrollment

Take a look at the reporting tools sponsors need to access insights earlier in the clinical trial enrollment funnel, so you can take informed actions.
Whitepaper

Enhance the cost-effectiveness of your GMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows.
 

Industry Events

 

Upcoming Fierce Events

11-14
Sep
Philadelphia, PA
13
Sep
Philadelphia, PA
19-21
Sep
Virtual Event
26-28
Sep
Philadelphia, PA
5-6
Oct
San Diego, CA

View all events