Despite steep budget and staffing cuts at the FDA in recent weeks and other headwinds, Gilead CEO Daniel O’Day assured investors that the pharma’s plans and preparations for lenacapavir’s launch remain on track.
Despite a dip in sales and a recent schizophrenia stumble, the company drew an optimistic outlook for sales for the rest of the year, even as the specter of pharmaceutical tariffs looms.
Merck, Bristol Myers Squibb, Sanofi and Roche had little clarity on the potential impact of President Donald Trump’s pharmaceutical tariffs but many companies are already preparing for what’s to come.
Granite will focus on two antibody therapies, both targeting crucial players in the inflammatory cascade to address autoimmune diseases.
In this episode presented by DIA, BioSpace’s head of insights Lori Ellis discusses how collaboration and investment shape the the future of women’s health with Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine.
With a new raise provided by Flagship Pioneering, the new company is aiming to find “the silent window” before disease symptoms set in.
FEATURED STORIES
The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.
Analysts expect the companies’ Vabysmo and Eylea HD to generate a combined $13.2 billion by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
With promising early results, cell and gene therapies are making headway against both rare and common ocular and auditory diseases.
With gene therapies by REGENXBIO and AbbVie, Adverum and others in mid- or late-stage trials, this therapeutic class could soon be an option for this common cause of blindness in the elderly.
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
This week on The Weekly we talk struggles with GLP-1 drug shortages and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD. Plus, Merck buys Caraway, Beigene’s deal with Ensem, ups and downs for Flagship.
CRISPR gene-editing has had its first ever approval in the UK. Will the FDA follow suit? What can patients expect the price tag to be?
This is part one of a discussion focused upon data bias, accuracy, access and the future of AI in drug development. Topics explored are ROI, human bias, data challenges, data management plans, and human expertise.
Job Trends
Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting
Pfizer Inc. highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology Annual Meeting, taking place May 31 to June 4 in Chicago.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
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.
DEALS
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Claiming that Karuna Therapeutics’ board of directors withheld crucial information, a shareholder has filed a lawsuit seeking to block the $14 billion merger with Bristol Myers Squibb. -
The neuroscience space saw a late push in merger and acquisition activity, while oncology start-ups reeled in the most venture capital funds. Industry leaders expect these trends to continue. -
Analysts say Novo Holdings made the right decision last week in scooping up the CDMO to increase manufacturing capacity for Novo Nordisk’s diabetes and weight-loss drugs. -
Gilead Sciences announced Monday it will purchase CymaBay Therapeutics and its investigational treatment seladelpar for primary biliary cholangitis, a type of liver disease that causes bile-duct damage. -
Shares of preclinical genetic medicines company Metagenomi tanked more than 30% on Friday afternoon in a disappointing debut for its initial public offering, bucking the trend of positive IPOs so far this year.
WEIGHT LOSS
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Zealand Pharma is looking to build on last week’s positive Phase Ib trial results by raising around $1 billion in a public offering, with the proceeds being used to advance its obesity candidates. -
Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina. -
Data showed that Eli Lilly’s Zepbound could resolve obstructive sleep apnea in at least 43% of patients, solidifying the pharma’s case for label expansion. -
Altimmune’s obesity candidate pemvidutide strongly preserved lean muscle mass, with fat accounting for more than 78% of weight lost by participants in a Phase II study. -
Novo Nordisk’s Wegovy elicited greater weight loss in women than in men with heart failure, according to data presented Sunday at the American Diabetes Association’s 2024 Scientific Sessions.
POLICY
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Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention. -
In a letter to FDA Commissioner Robert Califf, a House committee flagged several U.S. companies—including Eli Lilly and Pfizer—that have allegedly worked with the People’s Liberation Army on clinical trials in Xinjiang, raising ethical and intellectual property concerns. -
Last week, the Biden administration revealed the first drug prices negotiated under the Inflation Reduction Act; Lykos, Grail and others make substantial staffing cuts, and Pfizer/BioNTech see mixed results for their COVID/flu vaccine. -
As the pharma industry awaits congressional action on the bill, gaping holes in the domestic drug manufacturing ecosystem have never been clearer. -
The recent invalidation of an AAV gene therapy patent overlooks the complexity of innovation in biotechnology and could put a broad swath of intellectual property at risk.
A well-designed career development program provides the right guidance and training for workers to improve their professional careers.
Do you know that growing emotional intelligence at workplace can be beneficial for career growth? If not, have a look at the article and learn some tips.
Controlling interruptions when working from home can be challenging, but a little planning and some established rules can help.
Are you an introvert who is worried about your performance? Well, do you know that these unique skills can make you an excellent leader? Let’s find out those skills.
If you’re struggling to find your dream job or unsure of what your next career move should be, career assessments might be the next right step. Here’s how to do it.
Along with the growing trends of working from home and online, freelance careers are becoming a more popular career path. Here’s everything you need to know.
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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Bristol Myers Squibb presented the positive Phase III results on its already approved Opdivo-Yervoy combo at ESMO over the weekend, while separately announcing that it was returning Immatics’ bispecific T cell engager. -
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
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High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures. -
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions. -
Tecentriq Hybreza, which combines Roche’s Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology, is being touted as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy.
NEUROSCIENCE
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Approaches and targets for depression and other mental health illnesses have remained stagnant for decades. With several readouts for novel therapies on the horizon, that could be changing. -
Following a series of clinical failures, optimism builds for the first disease-modifying treatment. -
Disappointed with Phase I/II results for two Ionis-partnered programs, one for amyotrophic lateral sclerosis and another for Angelman syndrome, Biogen has opted to not proceed with their development. -
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients. -
With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.
CELL AND GENE THERAPY
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Roche’s Genentech subsidiary is terminating for undisclosed reasons its 2021 contract with Adaptimmune for the development of allogeneic T-cell therapeutics. -
Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection. -
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients. -
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints. -
Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year.
