Deep Dive
Industry insights from our journalists
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‘The luckiest of the unlucky’: A Duchenne gene therapy brings hope to families — and tests the FDA
FDA advisers voted 8-6 in support of the agency approving a treatment that patient advocates and doctors believe to be a breakthrough for a deadly disease.
Ben Fidler and Shaun Lucas • May 7, 2023 -
Sarah Silbiger via Getty Images
FDA decision on preterm birth drug’s withdrawal nears, putting spotlight on patients, agency
A yearslong regulatory battle over the hormonal shot Makena is approaching its end, with consequences for both preterm birth prevention and the agency’s authority to withdraw drugs shown to be ineffective in follow-up testing.
Delilah Alvarado • March 6, 2023 -
Courtesy of AbbVie
Big pharma’s looming threat: a patent cliff of ‘tectonic magnitude’
Many top-selling products will lose patent protection by the end of the decade, putting pressure on companies to replace lost revenue with new medicines.
Jonathan Gardner • Feb. 21, 2023 -
Illustration: Xavier Lalanne-Tauzia for Industry Dive
A new generation of biotech leaders is emerging. Can they change how drug startups are built?
Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.
Gwendolyn Wu • Feb. 14, 2023 -
Kendall Davis/BioPharma Dive
10 clinical trials to watch in the first half of 2023
Highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s, while a pair of high-priced acquisitions could be put to the test.
BioPharma Dive staff • Jan. 3, 2023 -
Photo: Will Warasila for Industry Dive
For ALS patients, doctors, a new medicine reignites concerns about healthcare access
Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.
Jacob Bell and Shaun Lucas • Dec. 15, 2022 -
Kena Betancur via Getty Images
Health tech companies weigh funding options amid weak IPO market
Healthcare technology companies are delaying initial share sales and searching for new sources of cash. Experts don’t expect a quick recovery.
Sydney Halleman • Nov. 21, 2022 -
Photo: Amanda Greene for Industry Dive
‘I don’t feel safe.’ Abortion bans add new uncertainty to fertility treatment
BioPharma Dive’s Delilah Alvarado worked with reporters from Healthcare Dive to examine the impact of state laws banning abortion on people trying to conceive via in vitro fertilization.
Sydney Halleman, Delilah Alvarado, Shaun Lucas and Jasmine Ye Han • Oct. 24, 2022 -
Jeff J Mitchell via Getty Images
Can biosimilars, after years of limited impact, finally make a mark in the US?
Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.
Jonathan Gardner • Sept. 7, 2022 -
MadamLead via Getty Images
‘Flat is the new up’: After biotech correction, venture investors turn to safer bets
New companies are being built more carefully and platform technologies are less in vouge as the downturn's effects ripple through the private sector.
Ben Fidler • July 26, 2022 -
Kendall Davis/BioPharma Dive
10 clinical trials to watch in the second half of 2022
The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump endures.
Ben Fidler, Ned Pagliarulo and Jacob Bell • July 5, 2022 -
Permission granted by Akili Interactive
Can digital therapeutics be profitable?
Licensing deals with pharmaceutical companies were an early strategy for digital health companies, but not all of them have lasted.
Elise Reuter • April 11, 2022 -
Sarah Silbiger via Getty Images
How a long shot ALS drug came before the FDA
A negative vote from independent experts appears to lower the chances of Amylyx's medicine winning FDA approval. Still, FDA officials have cited flexibility and noted the difficulty of its forthcoming decision.
Jacob Bell • March 28, 2022 -
AbbVie
Two decades and $200 billion: AbbVie’s Humira monopoly nears its end
The first biosimilar copy of Humira is set to arrive in the U.S. next week, testing both AbbVie and the market potential for knockoff biologic drugs.
Jonathan Gardner • Updated Jan. 27, 2023 -
Spencer Platt via Getty Images
‘The music stopped’: Biotech rout leaves drug startups grounded as demand slumps for IPOs
For the first time in years, biotechs no longer had an easy path onto Wall Street, a market reversal that could change what the next generation of young drugmakers looks like.
Ben Fidler • Feb. 7, 2022 -
Kendall Davis/BioPharma Dive
10 clinical trials to watch in the first half of 2022
Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.
Ben Fidler • Updated Jan. 6, 2022 -
Permission granted by The ALS Association
On the hunt for new ALS drugs, researchers see progress, and a long road ahead
The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of biology will bring new options in the not-too-distant future
Jacob Bell • Dec. 13, 2021 -
Seth Babin/BioPharma Dive
Heart attacks struck Sek Kathiresan's family. He's devoted his life to stopping them.
After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.
Ben Fidler • Nov. 29, 2021 -
Permission granted by Ed Shipman for Mass Eye and Ear
Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy
Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.
Shoshana Dubnow • Nov. 15, 2021 -
Adeline Kon / BioPharma Dive/BioPharma Dive
A three-decade monopoly: how Amgen built a patent thicket around its top-selling drug
Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.
Jonathan Gardner • Nov. 1, 2021 -
Justin Sullivan via Getty Images
A play-by-play of the FDA's meeting on Pfizer's vaccine for kids
Experts on the agency's panel dug into questions on the vaccine's safety in younger children, as well as uncertainty over how widely it should be used. Catch up on the discussion here.
Ben Fidler, Shoshana Dubnow and Jonathan Gardner • Updated Oct. 26, 2021 -
Permission granted by Vertex Pharmaceuticals
'This is the time to double down': Top Vertex executives defend research plan as pressure builds
A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.
Ben Fidler • Sept. 22, 2021 -
Adeline Kon/BioPharma Dive
Biotech M&A is picking back up. Here are the latest deals.
Gurnet Point Capital’s deal for Paratek is the second recent biotech acquisition struck by the private equity firm, following its 2022 buyout of Radius Health.
Jacob Bell and Julia Himmel • Updated June 6, 2023 -
del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
Intellia, with first results, delivers a 'landmark' for CRISPR gene editing
Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research.
Ben Fidler • June 26, 2021 -
Kendall Davis/BioPharma Dive
8 key clinical trials to watch for the rest of 2021
The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19 and gene-targeted cancer therapy.
Ben Fidler • June 21, 2021
