Blujepa, which treats UTIs in female patients aged 12 and up with common and uncomplicated infections, will hit the market in the second half of this year.
Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency.
President Donald Trump continues to warn of tariffs on the pharmaceutical industry; Susan Monarez replaces Dave Weldon as CDC director nominee; Novo Nordisk joins the triple-G race; Alnylam wins approval for Amvuttra in ATTR-CM; and Cassava Sciences ends development of simufilam in Alzheimer’s.
After years of controversy and allegations of doctored data, Cassava is moving on from Alzheimer’s.
As part of cost-cutting efforts, Alector is letting go of about 25 people as it focuses on advancing its preclinical and research pipeline. Alector is also continuing clinical-stage work on programs for frontotemporal dementia and Alzheimer’s disease.
The British pharmaceutical giant is working with the U.K. Dementia Research Institute to exploit a “natural randomization” experiment to determine whether 65- and 66-year-olds who received GSK’s shingles vaccine Shingrix have reduced dementia risk.
FEATURED STORIES
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
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
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the importance of target product profiles, particularly when navigating funding challenges, with Ian Fisher, head of development analytics.
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.
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.
Job Trends
Takeda Pharmaceutical Company Limited, Astellas Pharma Inc., and Sumitomo Mitsui Banking Corporation announced that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company.
Subscribe to Genepool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
SPECIAL EDITIONS
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.
Year-over-year BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the first quarter of 2025.
DEALS
-
All assets of the regenerative medicine and cell therapy company are being divested to its research partner to the tune of $2 million in the form of a credit bid. -
Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio. -
From the rising trend of royalty financing to other adaptive funding strategies, firms think outside the box in responding to unprecedented challenges. -
Harpoon has several antibodies in its pipeline that are engineered to redirect a patient’s T cells to recognize and kill cancer cells. -
The pharmaceutical giant will pay $28 a share to acquire Ambrx’s pipeline of ADCs, particularly its lead candidate for prostate cancer.
WEIGHT LOSS
-
SixPeaks Bio emerged from stealth Wednesday with up to $110 million, a deal with AstraZeneca and plans to take weight-loss candidates designed to preserve muscle mass toward the clinic. -
While Eli Lilly and Novo Nordisk currently dominate the GLP-1 receptor agonist space, there are more than 50 candidates in clinical development for obesity and type 2 diabetes, according to analytics firm GlobalData. -
A Senate health committee report published Wednesday forecasts spending on prescription drugs to hit $1 trillion a year in 2031, unless the prices of GLP-1 medicines such as Novo Nordisk’s Wegovy are cut. -
Roche’s $2.7 billion acquisition of Carmot Therapeutics in December 2023 appears to be paying off as its investigational GLP-1/GIP receptor agonist induced strong weight loss in a Phase Ib study. -
The weight-loss drug bonanza continued in the first quarter of 2024 for Novo Nordisk and Eli Lilly, as Amgen also posted strong results, while Biogen and BMS struggled early in the financial year.
POLICY
-
President Joe Biden and Sen. Bernie Sanders in a Tuesday op-ed in USA Today called on Novo Nordisk and Eli Lilly to “stop ripping off Americans” with “unconscionably high prices” for their GLP-1 medicines. -
Despite an uncertain legislative path to becoming law, the BIOSECURE Act has already impacted the biopharma industry’s confidence in Chinese service providers and prompted efforts to diversify manufacturing partners. -
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. -
This week on Denatured, Head of Insights Lori Ellis and guests discuss the implications of not addressing the DE&I data gaps for the future. -
The Department of Justice and Securities and Exchange Commission are investigating two senior employees of Cassava Sciences in connection with allegations of data manipulation for its Alzheimer’s disease candidate simufilam.
Reasons for investing in leadership development program in the biotech industry are divided into need and opportunity. Read the proper opportunity divisions here.
No matter in which industry you are, clear communication is very important. Follow these tips for clear communications to be prepared to fit in the work environment.
Virtual meetings might have enhanced the ways we connect with each other but it can be really hard to communicate with someone who doesn’t know the basic Zoom meeting etiquette.
Learn these important leadership qualities. The first five on the list are emotional and attitudinal. The other five concern intellectual abilities and learned skills.
Here are four questions to think about when considering a career change during the pandemic.
A career in regulatory affairs combines knowledge of law, science, economics and more. Those who follow this biotech career path aren’t necessarily scientists, but they do need to understand the science behind the products that they need to regulate.
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
-
Approved under the regulator’s accelerated pathway, Tecelra is also the first new synovial sarcoma therapy in more than a decade, according to Adaptimmune Therapeutics. -
In pursuit of Merck’s blockbuster Keytruda, GSK’s Jemperli scored its own broad FDA label expansion, allowing its use in first-line endometrial cancer regardless of biomarker status. -
As part of a major reorganization, Vir Biotechnology has discontinued the bulk of its virology work and pivoted to cancer in an exclusive licensing deal with Sanofi. -
Incyte announced Tuesday it is realigning its research and development priorities to focus on dermatology and inflammatory assets obtained from the $750 million acquisition of Escient Pharmaceuticals. -
BioNTech and Regeneron will face off against Merck and Moderna, which are advancing their investigational cancer vaccine mRNA-4157/V940 in combination with Keytruda, in advanced melanoma.
NEUROSCIENCE
-
Following cases of convulsions in rabbits in a preclinical study, the FDA has placed a clinical hold on Neumora Therapeutics’ Phase I schizophrenia drug candidate NMRA-266. -
Experts are hopeful that objective biomarker measures for amyotrophic lateral sclerosis, such as the ones being developed by EverythingALS, will lead to more targeted, effective treatments. -
For the second time in as many years, the FDA has hit Supernus Pharmaceuticals with a Complete Response Letter, citing undisclosed quality and master filing issues for the drug-device combination. -
Fresh off of its $14 billion acquisition of Karuna Therapeutics, Bristol Myers Squibb on Saturday reported promising late-stage data for Karuna’s antipsychotic KarXT, which elicited significant symptomatic improvement in schizophrenia symptoms. -
Following disappointing late-stage data, Amylyx on Thursday said it is withdrawing the company’s amyotrophic lateral sclerosis drug Relyvrio from the U.S. and Canadian markets and cutting its workforce by approximately 70%.
CELL AND GENE THERAPY
-
Sarepta Therapeutics on Wednesday called the launch of the gene therapy for Duchenne muscular dystrophy “exceptional” but the company does not expect to see significant growth in the first half of 2024 due to its currently limited patient pool. -
Cell and gene therapy professionals gathered in Miami last month to discuss new manufacturing approaches for these up-and-coming treatments. -
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting. -
After treatment with a CD19 CAR-T therapy, patients with systemic lupus erythematosus, idiopathic inflammatory myositis or systemic sclerosis achieved long-lasting remission, according to results published in the NEJM. -
The regulator has granted a priority review of the efficacy supplement for Sarepta Therapeutics’ gene therapy Elevidys with a target decision date of June 21, 2024.
