Bicycle inks 2nd $1.7B deal

Today's Big News

May 10, 2023

FDA's nagging doubts about Sarepta's DMD gene therapy won't quit as advisory meeting looms


Boehringer posts slim slice of phase 2 obesity data on Lilly, Novo rival, reporting 15% weight loss


Bicycle rides to 2nd $1.7B Big Pharma deal in 2 months, this time with Bayer


All the rumors are true: Syneos Health inks $7.1B acquisition with investment firm trio


Reata, Kyowa Kirin's bardoxolone faces the music after ph. 3 flop, ending 13-year saga


Gossamer cuts loose 25% of its staff, ties future to phase 3 trial of tarnished Merck rival


FibroGen snags sole ADC asset from small biotech for $280M in biobucks


Fierce Biotech Fundraising Tracker '23: Cullgen raises $35M; DiogenX snags $30M

 

Featured

FDA's nagging doubts about Sarepta's DMD gene therapy won't quit as advisory meeting looms

An FDA committee will consider whether evidence supports the benefits and risks of Sarepta's DMD gene therapy on Friday. The agency seems unconvinced.
 

Top Stories

Boehringer posts slim slice of phase 2 obesity data on Lilly, Novo rival, reporting 15% weight loss

Boehringer Ingelheim has teased the obesity data that emboldened it to start gearing up for phase 3. Recipients of the Zealand Pharma-partnered prospect lost up to 14.9% of their weight after 46 weeks, but the data released so far make it hard to say how Boehringer compares to Eli Lilly and Novo Nordisk.

Bicycle rides to 2nd $1.7B Big Pharma deal in 2 months, this time with Bayer

Bayer has taken its radiopharmaceutical pipeline up a gear, paying out $45 million upfront to Bicycle Therapeutics on a collaboration spanning multiple oncology targets.

Risk Management Processes for Cell and Gene Therapies

Cell and gene therapies hold great promise but can also carry serious risks. Applying a risk-based approach during development and manufacturing increases patient safety and product quality. Read more.

All the rumors are true: Syneos Health inks $7.1B acquisition with investment firm trio

All the rumors are true. After months of sale speculation, Syneos Health has officially been snapped up by three private investment firm affiliates for the eye-watering sum of $7.1 billion.

Precision's President Sofia Baig on Change, Adaptation & The Future of Clinical Research from a CRO’s Perspective

Discover Sofia Baig's vision for clinical research, data-driven insights & patient centricity at Precision for Medicine!

Reata, Kyowa Kirin's bardoxolone faces the music after ph. 3 flop, ending 13-year saga

Reata and Kyowa Kirin are taking the cleaver the bardoxolone ending development of the kidney disease treatment after more than 13 years of work. The decision was simultaneous to new phase 3 data showing the med did not improve the time to end-stage renal disease compared to placebo.

Gossamer cuts loose 25% of its staff, ties future to phase 3 trial of tarnished Merck rival

Gossamer Bio is going all in on seralutinib, laying off 25% of its staff and stopping work on all other candidates to free up money for a phase 3 trial of its pulmonary arterial hypertension prospect.

FibroGen snags sole ADC asset from small biotech for $280M in biobucks

FibroGen is taking on Fortis Therapeutics' sole asset, an antibody-drug conjugate for prostate cancer and multiple myeloma, to fortify a pipeline that has to date been mainly siloed toward anemia and fibrotic diseases.

Fierce Biotech Fundraising Tracker '23: Cullgen raises $35M; DiogenX snags $30M

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Thermo Fisher, Pfizer team up on global access to cancer DNA testing

Genomic sequencing can help match cancer patients to the most effective treatments based on their specific genetic makeup—but only if they have access to the necessary testing. Thermo Fisher Scientific and Pfizer, which have joined forces to expand the global reach of next-generation sequencing technologies.

All change: Patient groups name Horizon as US' most reputable pharma, push ViiV, Pfizer out of top 3

The U.S. has a new most reputable pharma company: Horizon Therapeutics. In a survey (PDF) of U.S. patient groups, Horizon was the only company to keep its position in the top three, with Roche and Servier rising to displace ViiV Healthcare and Pfizer from the other two spots on the leaderboard.

Siemens Healthineers profits plummet 81% amid exit from cardiology robotics, slowed COVID test sales

Only a few years after Siemens Healthineers put down $1.1 billion to pick up Corindus and its robotic-assisted endovascular surgery system, the medtech giant is tightening the technology’s scope.

Defense Department backs new study of Idorsia's Quviviq as a treatment for PTSD

Idorsia’s insomnia treatment Quviviq will be tested in post-traumatic stress disorder patients in a DOD-sponsored phase 2 study. The trial will also measure the effectiveness of two antidepressant drugs as remedies for the disorder.
 
Fierce podcasts

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'Podnosis': The rise of digital therapeutics, and ways to fix the PBM industry

This week on "Podnosis," we discuss the rise of digital therapeutics and remaining barriers to implementation. We also talk about what it takes to fix the PBM industry.
 

Resources

Whitepaper

ChatGPT in Drug Discovery: Rise of Large Language Models

ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations.
eBook

Decentralized Clinical Trials: The Complete Guide for 2023

Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success.
Research

How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.

Whitepaper

Medical Affairs Metamorphosis VI: The Changing Face of Stakeholder Engagement

This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing.
Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
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eConsent: Flexible Consent Through Enabling Technologies

How can eConsent provide a more flexible approach to informed consent?

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Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

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Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
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Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

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Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
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Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
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Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
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Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
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Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
 

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