The company is pursuing a Phase III trial for its topical stem cell-rejuvenating molecule that aims to reactivate hair growth.
2025 has been a busy year for Boehringer Ingelheim, which has so far inked at least five hefty partnerships—including its latest one with South Korea’s AimedBio for an antibody-drug conjugate therapy for cancer.
Bristol Myers Squibb and insitro first partnered in 2020 to develop induced pluripotent stem cell models of amyotrophic lateral sclerosis and frontotemporal dementia. Last December, BMS exercised its option for an ALS target.
The acquisition will give BioCryst an investigational injectable drug for hereditary angioedema, potentially complementing its FDA-approved oral drug Orladeyo.
After the FDA revoked Sarepta Therapeutics’ platform designation in July, Krystal Biotech is “poised to be the first major beneficiary” of this program, according to analysts at William Blair.
Johnson & Johnson has yet to make a drug pricing deal with Trump; Novo makes more moves under new CEO; more than 1,000 laid off from CDC, though many immediately hired back; the BIOSECURE Act is back and more.
FEATURED STORIES
The primary focus in scaling up production should first be the adoption of lean manufacturing principles used in virtually every other industry.
After decades of limited progress—owing to the difficulty of treating the disease and resultant market risk—glioblastoma research is entering a new phase spurred by smarter trials, targeted funding and renewed interest from companies like Merck and Jazz Pharmaceuticals.
Sarepta and Capricor learned of key regulatory decisions from the media and investors, and Duchenne muscular dystrophy families have turned to the news for answers. Meanwhile, the FDA insists it remains committed to notifying companies of any regulatory action before sharing information with the media or public.
Against steep odds and well-established paradigms, these four companies have successfully been commercializing their products on their own.
Though nerves abound for funders and founders in the industry, money continues to flow into startups, sometimes in eye-popping numbers. BioSpace rounds up the biggest raises so far this year.
Acknowledging the limits of disease-modifying drugs like Leqembi and Kisunla, companies like Bristol Myers Squibb, Acadia, Otsuka and Lundbeck are renewing a decades-old search for symptomatic treatments, including in high-profile drugs like Cobenfy.
FROM BIOSPACE INSIGHTS
As with any new year, 2024 presents new possibilities; though new and existing challenges are also poised to shape its trajectory. BioSpace reflects on the recent JP Morgan Healthcare Conference and future outlook with key opinion leaders who share their thoughts on the economic climate.
LATEST PODCASTS
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses the underrepresentation of women in clinical trials with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
A consumer-driven weight loss market could put pharma at greater risk if a recession hits; the continued turmoil at FDA and other HHS agencies magnifies the uncertainty facing the industry; Lilly files a lawsuit against a med spa selling its drugs; and more.
Biopharma leaders react to the forced resignation of CBER Head Peter Marks as RFK Jr.’s promised job cuts begin at the FDA; Novo Nordisk presents mixed results from oral semaglutide in cardiovascular disease; the EU’s Committee for Medicinal Products for Human Use declines to recommend Eli Lilly’s Alzheimer’s drug; and pharma R&D returns grew in 2024.
Job Trends
AN2 is discontinuing a study that evaluated epetraborole for treatment-refractory MAC lung disease and plans to shift focus to its boron chemistry platform.
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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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M&A and IPOs got off to a quick start in 2025 only to crash into a wall of policy challenges. Upfront payment for licensing transactions, however, grew as pharmas looked for less-risky deals. -
The Alchemab deal will further strengthen Lilly’s early-stage pipeline for amyotrophic lateral sclerosis, coming less than a year after the pharma licensed QurAlis’ antisense oligonucleotide to correct a specific protein alteration in ALS. -
After multiple rounds of layoffs that cut Kronos down to just 10 people, the small molecule biotech has accepted a buyout offer from Kevin Tang’s Concentra Biosciences. -
Announcing first-quarter results, Biogen CEO Chris Viehbacher admitted that tariffs are “a new topic for us,” but said he does not expect major impacts—at least for 2025. -
Many companies have foreshadowed deals to come during earnings calls in recent days. The return of M&A would be a welcome sign for the biopharma ecosystem, which has been battered by macro headwinds such as tariffs and the possibility of new drug pricing pressures.
WEIGHT LOSS
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The overturning of the FDA’s lab-developed tests rule is just the tip of the iceberg. With the loss of Chevron deference, power has shifted from federal agencies to the courts, with potential implications for everything from the FDA shortage list to CMS drug price negotiations. -
HHS Secretary RFK Jr. removes the COVID-19 vaccine recommendation for healthy kids and pregnant women—the latest in a string of changes to vaccine policies; judge issues an order to halt HHS’ reorganization and mass layoff plans; Rocket Pharmaceuticals’ pivotal Danon disease trial is on hold after a patient death; and President Trump has named Mehmet Oz to spearhead his Most Favored Nation drug pricing policy. -
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care. -
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
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Currently trailing Eli Lilly and Structure Therapeutics in the oral weight loss space, Novo Nordisk strikes a deal with Septerna to put new discovery-stage programs into play.
POLICY
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In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’ -
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure. -
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. -
Monarez is the first CDC director to be confirmed by the Senate under a new 2023 law and will be the first person without a medical degree to assume leadership of the agency in more than 70 years. -
Under the Inflation Reduction Act, medications with the same active ingredient will be treated as the same drug for price negotiation purposes—even if approved by the FDA under a separate application—disincentivizing companies from investing time and money in gaining approval for new formulations and indications.
Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.
Plus, tips on applying to multiple jobs at the same company, making new work friends, and how to ask for more time at the offer stage.
Presentations are standard requirements in the hiring process for some biopharma positions. Here’s how to approach them.
Depending on their needs, candidates can choose among tools such as AI-powered resume generators, professional coaches and university career services to hone their applications.
Companies are relying on artificial intelligence–powered applicant tracking systems to keep up the evolving recruitment demands. Here is how.
Artificial intelligence and a flood of data in the pharmaceutical industry will likely change some of the current functions of its data scientists, experts say, but the ability to learn and adapt to new technologies will remain key in this role.
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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Sanofi and BMS paid big money for rare disease and cancer assets, while Regeneron got in the obesity game; AstraZeneca, Gilead and Amgen shone at ASCO; RFK Jr. and the CDC appeared to disagree over COVID-19 vaccine recommendations and several news outlets are questioning the validity of the White House’s Make America Healthy Again report.
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Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about one-quarter of patients. -
The cancer conference overwhelms the senses and shows off the might of the pharmaceutical industry. -
Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca. -
Bristol Myers Squibb is dropping at least $3.5 billion to jointly develop the bispecific antibody, which will race with Summit Therapeutics, Merck and Pfizer in the crowded PD-1/PD-L1xVEGF space.
NEUROSCIENCE
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Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative. -
Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on target for a Q1 2026 submission for its one-time gene therapy for Huntington’s disease—but patients have been here before. -
Disappointing results for iluzanebart come shortly after Vigil Neuroscience struck a buy-out deal with Sanofi, but analysts say the outcome is unsurprising and shouldn’t affect the deal. -
Nearly two years in with Zurzuvae, Biogen tackles an ‘all of the above market’ to find patients and battle stigma in postpartum depression. -
In addition to a $140 million series D, GRIN Therapeutics has signed a global licensing deal for the epilepsy disorder drug radiprodil worth $50 million upfront.
CELL AND GENE THERAPY
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Interim results from a small group of children in a Phase I/II trial are essentially in line with that of Elevidys, according to BMO Capital Markets analysts. -
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases. -
J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy. -
While an adverse event reported in Intellia’s gene therapy trial was a “non-concern” for analysts, it follows a handful of patient deaths in other trials for the modality and sent the company’s stock tumbling in pre-market trading. -
Acute systemic infection caused the patient to develop fatal capillary leak syndrome, highlighting the unpredictability of gene therapies and potentially challenging investment in the space, analysts say.
