Ben Fidler
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benthefidler.bsky.social
Ben Fidler
@benthefidler.bsky.social
330 followers 100 following 63 posts
Biotech journalist; Senior Editor, BioPharma Dive. Former Deputy Biotech Editor, Xconomy. #BioSky
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benthefidler.bsky.social
New: A #CRISPR gene editing drug custom-made for a critically ill baby in just a few months appeared to be safe and working as intended, according to results newly published in the New England Journal of Medicine. Details below:
#biotech #biosky #ASGCT2025
www.biopharmadive.com/news/crispr-...
A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases
A gene editing drug custom-made for a critically ill baby showed that, for some ultra-rare diseases, it’s possible to design and test a new CRISPR medicine in just a few months.
www.biopharmadive.com
May 15, 2025 at 5:24 PM
benthefidler.bsky.social
New: Shares in more than a dozen gene and cell therapy developers tumbled by double digits after Vinay Prasad, a vocal opponent of predecessor Peter Marks, was named head of the FDA office that regulates their products. #biotech #biosky #genetherapy

www.biopharmadive.com/news/prasad-...
Prasad’s FDA appointment pressures cell and gene therapy stocks
A vocal opponent of his predecessor Peter Marks, Vinay Prasad will now lead the office tasked with reviewing some genetic medicines, adding more uncertainty to an already struggling field of research.
www.biopharmadive.com
May 7, 2025 at 3:12 PM
benthefidler.bsky.social
New: market turmoil has made it harder for buyers and sellers to agree on price, slowing down #biotech M&A. More from Jacob Bell below:

www.biopharmadive.com/news/deals-p...
Facing ‘uncertainty on steroids,’ biotech dealmakers tread more cautiously
Experts say market turmoil has made it harder for buyers and sellers to agree on price, which can be an especially imposing obstacle to large acquisitions.
www.biopharmadive.com
May 6, 2025 at 4:26 PM
benthefidler.bsky.social
New: @gwendolynawu.bsky.social looks back at the first quarter in #biotech venture funding, which was again highlighted by financings of $100 million or more. Here's what's driving that trend, and the trade-offs investors are making as a result. #biosky

www.biopharmadive.com/news/venture...
Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs
More than three-quarters of private biotech investment tracked by BioPharma Dive between January and March was distributed via rounds worth at least $100 million, which experts believe reflects a stra...
www.biopharmadive.com
April 3, 2025 at 2:41 PM
Reposted by Ben Fidler
gwendolynawu.bsky.social
lots happening in the chaos with CDC, FDA, HHS firings this week - but one #biosky takeaway many are still reeling from is the departure of Peter Marks, a long-time champion for cell and gene therapy. from @benthefidler.bsky.social for @biopharmadive.com www.biopharmadive.com/news/peter-m...
Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.
www.biopharmadive.com
April 1, 2025 at 6:20 PM
benthefidler.bsky.social
“The loss of many support and review functions across OND that are critical to the work we do is going to have a deep impact on our efficiency and our capabilities,” departing office of new drugs director Peter Stein told @nedpagliarulo.bsky.social: #biosky

www.biopharmadive.com/news/hhs-lay...
HHS begins layoffs in chaotic fashion
Reduction-in-force notices went out Tuesday morning to employees across HHS. At FDA, OND director Peter Stein is departing as cuts hit CDER.
www.biopharmadive.com
April 1, 2025 at 4:03 PM
benthefidler.bsky.social
New: The resignation of Peter Marks leaves the cell and gene therapy field without a regulator many view as “integral” to its progress over the last decade. #biosky #biotech #genetherapy

www.biopharmadive.com/news/peter-m...
Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks
Marks’ resignation leaves the field without a regulator many view as “integral” to its progress over the last decade.
www.biopharmadive.com
March 31, 2025 at 8:57 PM
benthefidler.bsky.social
New, from @nedpagliarulo.bsky.social: Peter Marks, the FDA's top vaccine official, has resigned following disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.” #biosky

www.biopharmadive.com/news/peter-m...
Peter Marks, FDA’s top vaccine official, resigns
In his resignation letter, Marks cited disagreement with HHS Secretary Robert F. Kennedy Jr., who he said pushed “misinformation and lies.”
www.biopharmadive.com
March 29, 2025 at 5:30 PM
Reposted by Ben Fidler
gwendolynawu.bsky.social
Alnylam's new heart drug Amvuttra is nearly twice the price of its pharmaceutical rivals'. Here's why, from @benthefidler.bsky.social www.biopharmadive.com/news/alnylam...
Alnylam prices heart drug at premium to rivals
Initially, Amvuttra’s annual list price will be nearly double the yearly cost of rival medicines from Pfizer and BridgeBio. But executives argue its “compelling and highly differentiated value” justif...
www.biopharmadive.com
March 21, 2025 at 6:54 PM
Reposted by Ben Fidler
nedpagliarulo.bsky.social
Alnylam gets expanded FDA approval for Amvuttra, which is now cleared to treat transthyretin amyloidosis with cardiomyopathy.

The new indication is seen as vital for Alnylam's growth, as @benthefidler.bsky.social reports:

www.biopharmadive.com/news/alnylam...
Alnylam drug gets long-awaited FDA approval in deadly heart disease
Amvuttra’s clearance in a rare form of cardiomyopathy could help Alnylam turn a regular profit — if it can wrest control of a competitive and fast-changing market.
www.biopharmadive.com
March 20, 2025 at 10:05 PM
benthefidler.bsky.social
New: A young man treated with Sarepta's #Duchenne gene therapy Elevidys, which has long faced questions about its benefits, died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future:

#biosky #genetherapy

www.biopharmadive.com/news/sarepta...
Duchenne patient dies after receiving Sarepta gene therapy
A young man treated with Elevidys died of acute liver failure. The case may give doctors pause before prescribing the treatment in the future, some analysts wrote.
www.biopharmadive.com
March 18, 2025 at 2:33 PM
Reposted by Ben Fidler
nedpagliarulo.bsky.social
Vertex’s new pain drug gains interim coverage from UnitedHealth's Optum:

www.biopharmadive.com/news/vertex-...
Vertex’s new pain drug gets first coverage nod from major insurer
Optum, the pharmacy benefit manager owned by UnitedHealth Group, placed Journavx on some of its commercial formularies in an interim decision while a formal review continues.
www.biopharmadive.com
March 6, 2025 at 11:11 PM
benthefidler.bsky.social
New: an in-depth look at the fast-growing effort to determine whether an emerging class of multi-pronged, PD-1 x VEGF-targeting drugs can build upon Keytruda and other cancer immunotherapies like it. #biosky #biotech

www.biopharmadive.com/news/pd1-veg...
Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda
Striking study results last year indicated a new type of medicine may improve on Merck’s dominant immunotherapy, spurring a wave of research practically overnight.
www.biopharmadive.com
March 4, 2025 at 11:43 AM
Reposted by Ben Fidler
gwendolynawu.bsky.social
“How are you going to get the next generation of therapies? There’s no biotech without venture, but there’s also no biotech without academic discovery.” I wrote about the proposed NIH funding cuts for @biopharmadive.bsky.social & how it'd affect #biosky #medsky www.biopharmadive.com/news/biotech...
‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts
The Trump administration’s plans to reduce NIH grant funding could have long-term consequences for the U.S. drug industry, investors said.
www.biopharmadive.com
February 25, 2025 at 6:16 PM
benthefidler.bsky.social
New: @gwendolynawu.bsky.social looks at the long-term implications, for U.S. #biotech #startups, of a prolonged pullback in NIH grant funding. #biosky

www.biopharmadive.com/news/biotech...
‘Fear and uncertainty’: Biotech investors warn of impact from NIH research cuts
The Trump administration’s plans to reduce National Institutes of Health grant funding could have long-term consequences for the U.S. drug industry, investors said.
www.biopharmadive.com
February 25, 2025 at 2:02 PM
benthefidler.bsky.social
New, from @nedpagliarulo.bsky.social: Pfizer has decided to stop selling a treatment called Beqvez in the latest sign of sparse patient interest in gene therapies for hemophilia. #biosky

www.biopharmadive.com/news/pfizer-...
Pfizer stops selling hemophilia gene therapy, citing weak demand
Pfizer’s decision to halt further marketing of Beqvez is further sign of the sparse patient interest in gene therapies for the bleeding condition.
www.biopharmadive.com
February 21, 2025 at 4:12 PM
benthefidler.bsky.social
New: Bluebird Bio is being acquired in a deal that marks an ending of sorts for a company long at the forefront of gene therapy research and whose scientific achievements — and struggles — have been emblematic of the field’s ups and downs. More below: #biosky

www.biopharmadive.com/news/bluebir...
Bluebird, at risk of default, agrees to take-private deal
The pioneering gene therapy developer will be acquired by investment firms Carlyle Group and SK Capital for a fraction of what it was once worth years ago.
www.biopharmadive.com
February 21, 2025 at 3:30 PM
Reposted by Ben Fidler
joshtpm.bsky.social
Termination notices going out this afternoon to more than 300 employees of the National Cancer Institute. Access likely ends today. Four weeks paid leave and that’s it.

Strong power move for Team Cancer.
February 14, 2025 at 7:01 PM
benthefidler.bsky.social
New: an inside look from Jacob Bell at the painstaking preparations a #biotech has to make to lay the foundation for a successful #IPO. #biosky

www.biopharmadive.com/news/biotech...
‘It’s not for the faint of heart.’ How 3 CEOs took their biotechs public
Speaking this week at BIO CEO, the heads of Septerna, Upstream Bio and Actuate Therapeutics shared lessons from going public in a challenging market for biotech stocks.
www.biopharmadive.com
February 14, 2025 at 6:51 PM
benthefidler.bsky.social
Might popular weight loss drugs, already proven to have myriad other health benefits, also be helpful treating alcohol use disorder? Early study findings are pointing in that direction. More here from @byjongardner.bsky.social: #biosky

www.biopharmadive.com/news/ozempic...
New study offers hints of GLP-1 drugs’ potential in curbing alcohol cravings
A small semaglutide trial suggests the medicine's suppression of appetite may extend to alcohol, but larger tests are needed to establish a conclusive benefit.
www.biopharmadive.com
February 12, 2025 at 6:59 PM
Reposted by Ben Fidler
dereklowe.bsky.social
Biopharma companies and CEOs are keeping their heads down at their own peril. They should speak up about what’s happening to the NIH and other science agencies before it’s too late.

Silence gives consent. And no one should consent to this.
Stand Up And Be Counted
www.science.org
February 12, 2025 at 4:45 PM
benthefidler.bsky.social
New: Novartis on Tuesday acquired a startup it joined with Blackstone Life Sciences to form six years ago and, along with it, a blood thinner that originated from its own labs. More below: $NVS $REGN #biosky #biotech

www.biopharmadive.com/news/novarti...
Novartis pays $925M to reel in a startup it helped launch
The acquisition of Anthos Therapeutics could be worth up to $3.1 billion and returns to Novartis a blood thinner it licensed to the Blackstone-backed startup six years ago.
www.biopharmadive.com
February 11, 2025 at 3:57 PM
Reposted by Ben Fidler
carlbergstrom.com
1. Today the NIH director issued a new directive slashing overhead rates to 15%.

I want to provide some context on what that means and why it matters.

grants.nih.gov/grants/guide...
NOT-OD-25-068: Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates
NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates NOT-OD-25-068. OD
grants.nih.gov
February 8, 2025 at 12:18 AM
Reposted by Ben Fidler
adamfeuerstein.bsky.social
VACCINES DO NOT CAUSE AUTISM.
(Yes, I'm typing in my loud voice.)

@matthewherper.bsky.social lays out the facts.

www.statnews.com/2025/02/03/v...
Here is how we know that vaccines do not cause autism
Vaccines do not cause autism. You’ve almost certainly read that before — but often without a full explanation of how we know it to be true. Here's how we know.
www.statnews.com
February 3, 2025 at 9:20 PM
benthefidler.bsky.social
www.biopharmadive.com/news/rfk-ken...
RFK Jr. clears key hurdle on path to become HHS secretary
Louisiana Sen. Bill Cassidy joined his Republican colleagues in voting to advance Kennedy's nomination to a vote by the full Senate.
www.biopharmadive.com
February 4, 2025 at 3:53 PM