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Combining Trodelvy with Keytruda and pushing it into the frontline setting could “potentially double” the ADC’s market in metastatic triple-negative breast cancer, according to analysts at Truist Securities.
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Jay Ferro, EVP, CIO, CPO & CTO at Clario discusses safety, trust and what keeps him up at night.
Just a few months after Vir Biotechnology lost an emergency authorization for its COVID-19 antibody, Marianne de Backer stepped in as CEO to answer a critical question: What’s next?
As the Q4 2024 pharma earnings period rolls on through the first month of President Donald Trump’s second term, executives find themselves faced with policy questions ranging from the Inflation Reduction Act to RFK Jr.
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Genentech, a member of the Roche Group, announced that the FDA has granted Breakthrough Therapy Designation for inavolisib, an investigational oral therapy, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
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Read our takes on the biggest stories happening in the industry.
In a recent BioSpace LinkedIn poll, nearly half of respondents predicted the job market won’t turn around until 2027 or later. It’s easy to see why people are skeptical, especially when you consider recent hiring activity and layoffs.
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Merck continues to build the case for the pulmonary arterial hypertension drug that won FDA approval in 2024.
AIRNA’s lead candidate AIR-001 works by correcting the most common pathologic mutation driving the rare disease alpha-1 antitrypsin deficiency.
Analysts at financial firm Cantor Fitzgerald are urging President Donald Trump to rethink his appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services.
The layoffs will take place throughout 2025 and will mostly affect Tenaya’s research and manufacturing operations. The company is continuing to test its hypertrophic cardiomyopathy gene therapy.
Despite a $400 million impairment charge, analysts say the removal of a drug-device combo from its portfolio is not a huge loss for Vertex given that the company has a more advanced type 1 diabetes candidate in zimislecel.
The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”
Unlike other hemophilia therapies, Qfitlia is indicated for both hemophilia A and B, and can be given in patients regardless of the presence of neutralizing antibodies against clotting factor VIII or IX.
BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in development to date” in the competitive Lp(a) space, where drugs are designed to lower the risk of cardiovascular events such as heart attack and stroke.
Ayrmid’s offer is 50% higher than bluebird’s previously announced deal with Carlyle and SK Capital Partners.
According to BMO Capital Markets, Rybelsus’ outcomes in SOUL were “inconsistent,” failing to significantly lower cardiovascular death and nonfatal stroke.