Despite the regulatory setback, analysts appear optimistic, noting that Harmony’s long-term prospects remain bright given the development of its high-dose formulation of its sleep-regulating drug Wakix.
Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology.
The gene therapy world is in turmoil, but Arbor, armed with more than $1 billion in partnerships and raises, is going forward.
Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space.
AstraZeneca has recently been investing heavily in the cell therapy space, including two acquisitions for TeneoTwo and Gracell Biotechnologies.
The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
The company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease.
FEATURED STORIES
Some 90% of investigational drugs fail—and success rates are even more dire in the neuro space. Here, BioSpace looks at five clinical trial flops that stole headlines over the past 12 months.
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA.
IPO
Around 25 companies have gone public this year, most of them in the early months. Most have tumbled from their original offer price.
LATEST PODCASTS
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
In this episode of Denatured BioSpace’s head of insights Lori Ellis discusses the public health consequences of vaccine hesitancy and the critical distinction between skepticism and cynicism with Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
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SPECIAL EDITIONS
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
DEALS
  1. BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation discuss alternative financing strategies to consider for 2024. Listen now.
  2. Tome Biosciences has only been on the scene for a short time but on Tuesday notched an acquisition of CRISPR-based biotech Replace Therapeutics for $65 million upfront.
  3. All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
  4. The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.
  5. Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year, experts tell BioSpace.
WEIGHT LOSS
  1. Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?
  2. As competition with Eli Lilly heats up, Novo Nordisk has partnered with Flagship’s Metaphore Biotechnologies to take a biomimicry approach to GLP-1s.
  3. In an effort to improve diversity and accessibility in clinical trials, Boehringer Ingelheim is partnering with Walgreens to conduct a Phase III study in obesity and type 2 diabetes.
  4. It wasn’t calls from lawmakers but market competition with Eli Lilly’s Zepbound that prompted Novo Nordisk to lower the prices of its blockbuster weight-loss drug.
  5. Following strong Phase II data, Amgen is going all in on its next-generation obesity treatment MariTide, with plans to run a Phase III trial and a separate mid-stage study for diabetes.
POLICY
  1. FDA
    Verona Pharma on Wednesday secured the FDA’s approval for Ohtuvayre, which the company contends is the first inhaled chronic obstructive pulmonary disease medicine with a new mechanism of action in over 20 years.
  2. Teva Pharmaceuticals has settled years of tax litigation with the Israel Tax Authority for $750 million, which the company will pay in installments starting in 2024 to 2029.
  3. After back-to-back failures in 2021, Wave Life Sciences has finally aced a Phase Ib/IIa Huntington’s disease trial and is looking to a potential accelerated approval for its investigational antisense oligonucleotide.
  4. Pictured: Biopharma items with cyber accents
    Scrutiny of WuXi Raises Potential Opportunities for Indian CDMOs
    As congressional pressure increases on WuXi AppTec and other China-based companies over alleged ties to the Chinese government, India’s contract development and manufacturing organization sector could benefit.
  5. Citing issues with a third-party manufacturer, the FDA has issued another Complete Response Letter to AbbVie rejecting its New Drug Application for ABBV-951, a proposed treatment for motor fluctuations in adults with advanced Parkinson’s disease.
CAREER HUB
The idea is to have a conversation with someone holding a job like the one you’d like to have and perform informational interviews to ask all about what the job is like.
Establishing boundaries between your personal and professional lives is the key to maintaining fulfilling versions of each.
Is your job is slowly starting to make you feel unmotivated or unproductive? Are you unable to work properly? Use these motivation tips to rejuvenate yourself.
As we leave the winter of 2020-21 behind, let’s learn more about the strategies to help college graduates secure employment during COVID-19.
Let’s review the six tips for finding work during the coronavirus pandemic.
To help you kick off your yearly goal planning, we put together a series of prompts to get your brain mulling over achievable goals to set for 2021.
Use these ways to immediately make the a new co-worker feel at ease.
HOTBEDS
Where are the Best Places to Work in life sciences? BioSpace’s annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace - find out who made the list this year.
IN CASE YOU MISSED IT
Cobenfy’s late-stage flop is BMS’ second high-profile failure in as many weeks. The pharma announced last week that Camzyos was unable to improve disease burden in non-obstructive hypertrophic cardiomyopathy.
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
  1. Novartis continues its dealmaking spree with a bet on Dren Bio’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies in oncology.
  2. A longtime biopharma exec and Moderna shareholder argues in an anonymous email to the companies’ CFOs that they have a fiduciary responsibility to close the deal. Analysts say the proposal is interesting but “too simplistic.”
  3. AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
  4. Third Arc Bio, led by three former Johnson & Johnson executives, is advancing a portfolio of multifunctional antibodies for cancer and inflammatory and immune-mediated diseases.
  5. GSK is seeking to relaunch Blenrep after its market withdrawal in 2022. The pharma is eyeing a second-line niche for the antibody-drug conjugate in the treatment of relapsed or refractory multiple myeloma.
NEUROSCIENCE
  1. Acorda Therapeutics becomes the latest biotechnology company in 2024 to go bankrupt and shutter its business, following years of financial difficulty. Merz Therapeutics will acquire two commercial medicines from Acorda for $185 million.
  2. A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna.
  3. The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
  4. While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.
  5. Imagine testing a really good drug for HER2+ breast cancer in someone with liver cancer. Would it be any surprise when that drug fails?
CELL AND GENE THERAPY
  1. Investors drove up the price of Kyverna Therapeutics’ stock by 59% in its initial public offering on Thursday afternoon, the first day of trading, reaching a peak per-share price of $35.01.
  2. BioNTech will pay $50 million in cash and purchase $200 million of Autolus Therapeutics’ shares to progress the companies’ respective CAR-T candidates to commercialization.
  3. On Thursday, Kyverna Therapeutics is debuting on the Nasdaq with an upsized initial public offering which the biotech will use to support its pipeline of anti-CD19 CAR T therapy candidates.
  4. Under the FDA’s compassionate use program, an eyedrop formulation of Krystal Biotech’s Vyjuvek restored the vision of a teenager with the rare genetic disease dystrophic epidermolysis bullosa.
  5. Metagenomi could potentially raise over $100 million if the underwriters exercise their option to purchase additional shares in full, assuming an initial public offering price of $16 per share.