After revoking Sarepta’s award in July and awarding one to Krystal last month, the FDA’s platform technology designation program appears to be back on track. These six biotechs could be on the regulator’s radar.
While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the “mixed” performance of a similar drug in a prior multiple sclerosis study.
After GSK subsidiary Tesaro filed a lawsuit Thursday claiming that AnaptysBio breached “certain requirements” under their 2014 license agreement involving GSK’s Jemperli, Anaptys responded Friday morning.
Amid an aggressive savings push, Moderna has cut three assets and taken on a loan to increase “flexibility.”
A new analysis from Jefferies shows that drugs receiving breakthrough designations sail through the regulatory process more quickly, on top of frequently winning approval.
Aspen is now also considering the possibility of an initial public offering next year in an effort to bring its cell therapy to the market.
FEATURED STORIES
While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay.
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.
J&J still holds the top deal of the year by value with its $14.6 billion buy of Intra-Cellular in January, but the next four biggest acquisitions came in the past four months.
The two most historically deal-conservative Big Pharmas have the most money to play with for a major M&A transaction, according to a recent Stifel analysis.
A new analysis from SRS Acquiom puts into perspective the headline values seen when a company announces a backloaded M&A deal. Biotechs have much on the line when they agree to deals with massive potential but little upfront.
Talks between pharma and successive U.K. governments have failed to deliver the market access terms that the industry wants, contributing to a pullback in investment.
LATEST PODCASTS
Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees and tying review times to drug prices; the regulator opens its trove of complete response letters in the name of transparency; and two companies receive rejections for rare disease therapies.
In this bonus episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel take a look at Q2 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
In this episode presented by Eclipsebio, BioSpace’s head of insights Lori Ellis discusses mRNA and srRNA with Andy Geall of Replicate Bioscience and Alliance for mRNA Medicines, and Pad Chivukula of Arcturus Therapeutics.
Job Trends
In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at Q4 job market performance and what we expect to see ahead.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away. -
The deal marks an end for CAR T company Cargo Therapeutics, which has been slashing its workforce and cutting programs since the January decision to halt its lead candidate for a certain type of aggressive large B cell lymphoma. -
After the FDA rejection of Zurzuvae in one type of depression and the triple failure of neuro asset dalzanemdor, Sage was searching for a path forward at the end of December 2024. Biogen CEO Chris Viehbacher spied a possible deal, but the smaller company wasn’t interested. -
Why did two private equity firms with more than $460 billion under management want a little old gene therapy biotech called bluebird bio? We wanted to know. -
Big Pharmas like Eli Lilly, Sanofi and Novartis headed back to the dealmakers table multiple times, with 32 total deals counted across the industry for the first half.
WEIGHT LOSS
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While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets. -
The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries. -
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news. -
Novo Nordisk’s Wegovy has been on a winning streak as of late, with a metabolic dysfunction-associated steatohepatitis approval last month and prime position in the oral obesity race. -
While Eli Lilly’s orforglipron is full speed ahead for a regulatory filing this year, the pharma is also pushing forward with one more Phase II study of naperiglipron, which uses the same scaffold as Pfizer’s failed obesity drugs danuglipron and lotiglipron.
POLICY
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Albert Bourla heralded the president’s COVID-19 leadership and Operation Warp Speed initiative as a Nobel Prize–worthy achievement and said that Pfizer stands by the integrity of the data already shared. -
In an opinion piece in the Wall Street Journal, Health Secretary Robert F. Kennedy Jr. said he will roll chronic disease programs into a new Administration for a Healthy America. -
Paul Offit, longtime member of the FDA’s vaccine advisory committee and an outspoken critic of Health Secretary Robert F. Kennedy Jr., was recently informed by the Department of Health and Human Services that his services are no longer required. -
While trade groups hail the executive order as a national health security opportunity, analysts warn that production costs could go up in the near term. -
During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
Looking for an automation engineer job? Check out these seven companies hiring life sciences professionals like you.
Learn five ways to answer difficult interview questions so you can leave the best impression possible on your potential employer.
Three executives whose combined careers include working at companies including Amgen, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Pfizer and Takeda share their career journeys.
This week, Carina discusses how to transition into a career in biotech when you don’t have lab experience. Plus, handling difficult interviews and getting a “dry” promotion.
A recent legal decision could signal the ultimate demise of the FTC’s final rule banning most noncompete clauses. A biotech talent expert discusses how that affects biopharma job searches.
For the second quarter of 2024, there were 25% fewer jobs posted live on BioSpace compared to the same quarter of 2023. The year-over-year job response rate rose from 14.6% to 15.3%.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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The recent announcement of RFK Jr.’s termination of mRNA vaccine contracts is the latest effort to undermine this promising technology at the federal level. Pharmaceutical companies and private investors must fill the gap and ensure that research into this critical resource continues. -
Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.” -
Strand Therapeutics’ lead asset is STX-001, an intra-tumor self-replicating mRNA therapy that carries a payload expressing the immunomodulatory protein IL-12. -
The small molecule drug, acquired by Jazz Pharmaceuticals in its $935 million Chimerix pick-up this spring, is intended for relapsed adult and pediatric patients with H3 K27M mutations. -
Terns, once a rising star in obesity and the MASH space, will refocus on cancer and partner out a handful of obesity assets.
NEUROSCIENCE
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Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
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LB Pharma will test the IPO market to seek funding for a Phase III-ready schizophrenia asset. -
The deal extends AbbVie’s commitment to the psychedelics space and depression, after emraclidine’s high-profile flop in schizophrenia last November. -
The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can be a goldmine for smaller companies. But it also has a unique set of challenges. -
The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid anyway.
CELL AND GENE THERAPY
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The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry. -
The pivotal Phase II trial is testing Allogene’s CAR T candidate cemacabtagene ansegedleucel for large B-cell lymphoma. ALLO-647 was being used as a preparative lymphodepletion therapy. -
The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome. -
As analysts parsed news of Vinay Prasad’s ouster, worries over drug approval delays, cell and gene therapy impacts and more were top of mind. -
The swift FDA action removes an overhang from Sarepta and allows Elevidys to return to the market without another safety study, as had been feared, Jefferies analysts said Monday.
