Orbital rounds up biggest ’23 biotech fundraise yet

Today's Big News

Apr 26, 2023

Roche execs tightlipped on possible TIGIT fail, pledge more trials anyway


Roche, seeing MAGE magic wane, makes pair of solid tumor bispecifics disappear


GSK drops one of 2 maturation inhibitors in HIV pipeline


Orbital Therapeutics raises $270M series A for next-gen RNA meds, loops in 2 more execs


Novartis ups the ante in AstraZeneca blood disorder showdown with fresh data


Biopharma feels momentary relief as Supreme Court preserves abortion drug access—for now


Flagship-founded microbiome biotech shelves lead asset after another round of cohort data flops


Fierce Biotech Fundraising Tracker '23: Orbital rounds up $270M; Evommune bags $50M series B

 

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Roche execs tightlipped on possible TIGIT fail, pledge more trials anyway

Roche executives have insisted that they haven’t given up on anti-TIGIT checkpoint inhibitors, even as they dodged questions about whether their candidate has flunked yet another phase 3 trial.
 

Top Stories

Roche, seeing MAGE magic wane, makes pair of solid tumor bispecifics disappear

Roche no longer sees the magic in MAGE-A4. The Swiss drugmaker signaled a retreat from the TCR T-cell target in its first quarter results by putting a pair of phase 1 solid tumor programs out to pasture.

GSK drops one of 2 maturation inhibitors in HIV pipeline

GSK’s weighty HIV pipeline just got slightly lighter as the British Big Pharma decided not to progress a once-promising candidate into late-stage trials.

Orbital Therapeutics raises $270M series A for next-gen RNA meds, loops in 2 more execs

Orbital Therapeutics has raised an eye-popping $270 million for its collection of RNA tools and pursuit of next-gen medicines, while also looping in two new execs.

Novartis ups the ante in AstraZeneca blood disorder showdown with fresh data

Novartis’ pursuit of the crown jewels of AstraZeneca’s $39 billion Alexion buyout is gathering pace. The latest data show more than 90% of participants in a phase 3 trial experienced the hoped-for improvement after taking the oral factor B inhibitor, boosting the Swiss drugmaker’s prospects of creating a new standard of care.

Biopharma feels momentary relief as Supreme Court preserves abortion drug access—for now

The Supreme Court has for now preserved access to the abortion medication mifepristone—a win for the biopharma world that rallied to support the FDA’s authority to approve drugs. But the women behind the unprecedented letter campaign and amicus brief are not yet breathing a sigh of relief.

Flagship-founded microbiome biotech shelves lead asset after another round of cohort data flops

Flagship Pioneering-founded Evelo is moving on from its lead asset after additional dose cohort data in patients with atopic dermatitis mirrored past failures, with more job cuts on the way.

Fierce Biotech Fundraising Tracker '23: Orbital rounds up $270M; Evommune bags $50M series B

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

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time

The FDA has approved another Biogen drug for a neurological disorder. Unlike the controversial go-ahead for Aduhelm, the agency’s neuroscience division didn’t go against its external advisers’ advice this time.

AmerisourceBergen unveils hub to aid cell and gene therapy data exchange

AmerisourceBergen released its platform focused on cell and gene therapies to speed the exchange of real-time data with the goal of aiding development and ultimately getting novel treatments to patients.

Medtronic wraps up response to FDA warning letter over quality issues at diabetes HQ

Nearly a year-and-a-half after receiving a warning letter from the FDA detailing a list of quality control issues at the Los Angeles-area headquarters of its diabetes business, Medtronic said it has finally resolved all of the regulator’s concerns.

Roche nixes Tecentriq trial in early breast cancer, but it's 'still in the game' in key lung cancer use: exec

Roche’s plans for expanding Tecentriq in early-stage cancers have hit a snag. But the Swiss company’s newly minted pharma chief remains hopeful for an important trial in resectable lung cancer.

Post Dobbs fallout tracker—North Dakota's near-total abortion ban

Follow along with the latest news and insights from the Fierce Healthcare team on the fallout from the Supreme Court's Dobbs decision.
 
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'The Top Line': How Pfizer became the first in Big Pharma history to break $100B in sales, plus this week's headlines

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Resources

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eConsent: Flexible Consent Through Enabling Technologies

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Coming to America: Keys to Success for ex-US Digital Health Companies Entering the US Market

This paper outlines an approach that digital health / therapeutics companies can use when developing a go-to-market strategy for the complex US market.
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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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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.
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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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