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Remodeling REMS: FDA kicks off guidance series with draft on new framework

In the first of what’s expected to be a series of REMS-related advice for the industry, the FDA on Monday unveiled new draft guidance on how to improve the safety programs often attached to higher-risk...

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ADC Therapeutics reveals topline Zynlonta data, $105M stock offering

ADC Therapeutics announced a $105 million offering after sharing what it called positive topline data from a Phase 2 trial of its cancer drug Zynlonta. The Swiss biotech is selling off 13.4 million...

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Industry groups critique new guidance for Medicare drug price negotiations in...

The Centers for Medicare & Medicaid Services proposed a number of changes to its Medicare negotiation guidance on Friday, some of which would affect how the next round of drug prices is negotiated...

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Sen. Cassidy calls on Biden to do better at sharing H5N1 bird flu information

Senate HELP Committee ranking member Bill Cassidy (R-LA) is calling on the Biden administration to do a better job of communicating its findings on the recent outbreak of avian flu among cattle that...

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UPenn and Stanford analysis finds no secondary cancer cases directly due to...

The University of Pennsylvania’s pioneering cell therapy physician Carl June shared new data Monday that showed the risk of secondary cancers following CAR-T therapy was very low. In over 1,500...

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Illumina takes a step toward spinning off Grail, though keeps option open for...

Illumina prefers to spin off Grail into an independent business rather than sell the cancer diagnostics company, according to a financial document released Monday that describes the Illumina board’s...

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Vertex touts Casgevy sickle cell launch as bluebird makes progress with rival...

Vertex said it’s making strong progress bringing its CRISPR Therapeutics-partnered gene therapy to patients after a landmark approval for sickle cell disease in December. Chief operating officer Stuart...

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Memo Therapeutics completes $49M Series C to develop kidney transplant...

Swiss biotech Memo Therapeutics raised $22 million (CHF 20 million) in a Series C extension to develop an antibody treatment for BK polyomavirus (BKV) infection in kidney transplant recipients, a...

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Flagship commits $50M to new startup that scours viral proteins for new drugs

In the midst of the Covid-19 pandemic, while most scientists were busy plotting new ways to combat viruses, one startup quietly began a counterintuitive campaign: getting viruses to work for us,...

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Zenas BioPharma closes $200M round to broaden autoimmune potential for lead drug

Lonnie Moulder’s latest biotech has secured some new cash to expand its work in autoimmune diseases. The startup, Zenas BioPharma, closed a $200 million Series C and will use the money to fund clinical...

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Arbor acquires Feng Zhang startup for next-gen gene editing enzymes

In the bid to lock up patent rights to a growing suite of gene editing technologies, Arbor Biotechnologies has acquired a small startup founded by MIT scientist and CRISPR pioneer Feng Zhang, the...

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As digital health unicorns are pressured to do more with less, Transcarent...

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.)  Transcarent’s $126 million Series D round, which in May bumped its valuation to $2.2 billion, stands...

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LabCentral helped create 6,300 jobs and 19 IPOs. Amid a slump, demand for lab...

When LabCentral celebrated its 10th anniversary last year, it was a bittersweet moment. The incubator has helped hundreds of biotechs launch and gain their footing. But startups, especially those with...

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Lilly gets June adcomm for Alzheimer's drug donanemab, following earlier delay

Eli Lilly will face questions from a panel of Alzheimer’s experts on June 10, setting up an approval decision for donanemab after a surprise delay by the FDA in early March. The drug will go before the...

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Lykos’ MDMA therapy to go before FDA committee; GSK expands work with BioVersys

Plus, news about Eledon and Travere Therapeutics: Lykos Therapeutics’ MDMA therapy gets an adcomm date: An FDA advisory committee is scheduled to meet June 4 to weigh the benefits and risks of the...

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From the editor: Our final edition of Endpoints MarketingRx

To our MarketingRx readers — Last week, we made the decision to shut down Endpoints MarketingRx. Over the last year, Endpoints News has put more resources into our core biopharma and healthcare...

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How insurance upstart Alignment kept medical costs in check while Medicare...

(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) High medical costs ate away at the profits of big Medicare Advantage insurers CVS Health and Humana in...

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Antitrust, AI and Alzheimer’s: Join us in New York next week

On May 16 in New York, Endpoints News and the Financial Times are teaming up to host the US Pharma and Biotech Summit. I’ve been deeply involved in planning our interviews and panels, and we have a...

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Exclusive: Engineered B cell therapy startup Walking Fish shuts down

Walking Fish Therapeutics, a biotech startup that attempted to create engineered B cell therapies, has shuttered, founder Rusty Williams confirmed to Endpoints News. The South San Francisco biotech...

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House Oversight chair presses FDA on China amid growing tensions

House Oversight Committee Chair James Comer (R-KY) is pressing the FDA to share more information on its presence in China amid growing concerns on Capitol Hill about Chinese involvement in biotech and...

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