The White House has denied reports that the government could soon ban COVID-19 vaccines, noting that in the absence of an official announcement, “any discussion about HHS policy should be dismissed as baseless speculation.”
Appia Bio’s shutdown continues an unfortunate trend this year that has seen biotech closures nearly every month.
Closely watched data from Eli Lilly and Viking Therapeutics this month have reignited the discussion around oral weight-loss drugs—and their ultimate place within the anti-obesity medication market.
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.
Arnatar is developing ART4, an antisense oligonucleotide that ups the expression of its target protein to treat a rare disease called Alagille syndrome.
FEATURED STORIES
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.
A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.
Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
LATEST PODCASTS
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more.
In this third episode of Denatured’s series on AI in drug discovery, we discuss patient behavior and its influence on clinical trials and AI models with guests from GSK, IQVIA, Exelixis and DataHow.
Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
Job Trends
AbbVie (NYSE: ABBV) will announce its first-quarter 2024 financial results on Friday, April 26, 2024, before the market opens.
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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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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings. -
Companies inked 204 deals in the fourth quarter of 2023 with venture capital funding slipping to $6.3 billion from $7.8 billion in the third quarter last year, according to market data firm Pitchbook. -
After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year. -
Antibody-drug conjugates are a breakthrough in targeted cancer therapy and will continue to attract big pharma investment over the next few years, finds a new report from market intelligence firm Evaluate. -
After a slow start to 2023 in an uncertain economic climate, biopharma mergers and acquisitions are on the rise.
WEIGHT LOSS
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Eli Lilly comfortably cleared analyst estimates in the second quarter after improving supply of its blockbuster tirzepatide brands Mounjaro and Zepbound, which together generated more than $4 billion in sales. -
Novo Nordisk’s semaglutide brands Ozempic and Wegovy fell short of analyst expectations in the second quarter, mainly held back by supply headwinds. The company’s shares dropped more than 7% in Wednesday morning trading. -
A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages. -
The company is projecting that future growth will be driven by geographic and label expansions for its rare disease assets, as well as potential approvals in obesity. -
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.
POLICY
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Robert F. Kennedy, Jr.’s recent disclosures have revealed several potential conflicts of interest, including investments in two biopharma companies. -
The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself. -
At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry. -
Biopharma executives shared their thoughts on the potential impacts of the new administration; Annalee Armstrong recaps JPM and her talks with Biogen, Gilead, Novavax and more; Wegovy’s higher dose induces more weight loss; AstraZeneca and Daiichi Sankyo’s Dato-DXd scores its first FDA approval. -
Drugmakers will have until the end of February to decide whether they want to participate in the second round of Medicare negotiations or not. CMS has until June 1 to send an initial offer for the adjusted prices.
CAREER HUB
In this graceless age where people look at their phones when you are talking to them, only communicate via text or email, scroll head down on their phone while a speaker is presenting, post inappropriate pictures and commentary on Facebook, it’s no wonder many people do not send thank you notes.
If you’re struggling to figure out how, exactly, to back up your accomplishments with facts, think about your impact, and then ask yourself some of these questions.
If you’ve never worked from home or had a flexible schedule, how do you portray to a recruiter or hiring manager that you have what it takes to be productive outside of the traditional office?
While you don’t want to be the person that survived mass layoffs only to turn around and ask for a salary bump for reasons you can probably guess, you also don’t want to be severely underpaid or underappreciated.
What factors do you think affect burnout? Do you think some industries are more prone to burnout than others?
Many people stepping into middle age feel that they’re too old to make a career change, but we live in times when an average person changes up to 12 jobs in a lifetime.
If you’ve been furloughed, it’s normal to feel some apprehension, fear and/or doubt about your employment. These are four ways to stay productive if you’ve been furloughed.
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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Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion. -
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease. -
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials. -
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment. -
With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.
NEUROSCIENCE
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As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company. -
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II. -
Despite recent concerns about suicidality and other neuropsychiatric issues, a recent study has found that Novo Nordisk’s Ozempic (semaglutide) is associated with lower risks of dementia, cognitive deficit and nicotine misuse. -
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
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Halia Therapeutics, NodThera and Gain Therapeutics target neuroinflammatory processes in hopes of modifying the course of Parkinson’s progression.
CELL AND GENE THERAPY
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Regeneron Pharmaceuticals on Wednesday revealed that its investigational gene therapy DB-OTO restored hearing in two young children, according to an oral presentation at the American Society of Gene & Cell Therapy annual meeting. -
Pfizer’s investigational Duchenne muscular dystrophy gene therapy fordadistrogene movaparvovec has been hit with another patient death, forcing the pharma to pause dosing in its Phase III study. -
As Sarepta Therapeutics moves closer to full approval and an expanded label for its gene therapy, some experts push back on clinical efficacy and cost while others note the hope it provides patients with Duchenne muscular dystrophy. -
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production. -
AAVs and accelerated approval are just two of the topics being discussed at ASGCT. Meanwhile, the race between Vertex and bluebird bio’s gene therapies Casgevy and Lyfgenia is heating up.
