Industry News
Pharmaceutical Industry News
As biopharma and healthcare…
As biopharma and healthcare companies face a rapidly shifting regulatory environment, marketing and advisory firm Avalere Health is bolstering its abilities to help its clients navigate the changes.
With COVID sales falling and…
With COVID sales falling and patent protections expiring, Pfizer is forecasting its 2026 revenue to be in the range of $59.5 billion to $62.5 billion. The midpoint of the projection ($61 billion) would be a
Novo Nordisk, which has stumbled…
Novo Nordisk, which has stumbled through a bit of a manufacturing hangover at a former Catalent production site it picked up last year, was hit with a warning letter from the FDA.
Why Does Rosacea Get Worse As You Age?
Scientists aren’t entirely sure what causes rosacea, or why it intensifies as you get older, but they have some theories.
With the investigational product,…
With the investigational product, Gilead is targeting certain segments of the HIV market who are underserved by current options. Analysts with Citi are modeling 2030 sales of $630 million for the novel combo.
As both Novo Nordisk and Eli Lilly…
As both Novo Nordisk and Eli Lilly race to develop their long-anticipated oral GLP-1 obesity meds, a new report shows one taking a clear lead among potential prescribers.
The FDA has approved Enhertu…
The FDA has approved Enhertu combined with Roche’s Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer. The combo was shown to reduce disease progression or death risk by 44% compared to
A new survey from SiriusXM Media…
A new survey from SiriusXM Media details the issues that many people have with the current state of TV drug ads—and highlights an opportunity for greater investment in audio ads instead.
The FDA has “proactively”…
The FDA has “proactively” granted Johnson & Johnson a coveted Commissioner’s National Priority Voucher (CNPV), the agency said Monday.
Akeega, a dual-action tablet made…
Akeega, a dual-action tablet made up of J&J's Zytiga and GSK's PARP inhibitor Zejula, is the first precision medicine combo approved to treat patients with BRCA2-mutated metastatic castration-sensitive prostate cancer.
LIB Therapeutics has scored an FDA…
LIB Therapeutics has scored an FDA approval for its cholesterol-lowering third-generation PCSK9 inhibitor, Lerochol, which offers a convenience edge over its predecessors.
While argenx has been able to…
While argenx has been able to demonstrate the merit of its FcRn drug Vyvgart in multiple autoimmune indications, not every shot in the clinic is destined to land. Now, facing that fact in thyroid eye
The FDA has signed off on…
The FDA has signed off on Milestone Pharmaceuticals’ Cardamyst, a self-administered nasal spray to quell symptomatic episodes from paroxysmal supraventricular tachycardia, which is a type of abnormal heart rhythm. It is the first approval for
F.D.A. Approves Two New Drugs to Treat Gonorrhea
The sexually transmitted disease has become increasingly resistant to existing antibiotics.
After three decades of no new…
After three decades of no new antibiotics for the treatment of gonorrhea, the FDA has signed off on two first-in-class oral treatments for the sexually transmitted infection. The U.S. regulator has green lit Innoviva’s Nuzolvence
The CDC findings were released as…
The CDC findings were released as the FDA considers placing a black box safety warning on COVID vaccines, according to a CNN report.
GSK’s depemokimab, a long-acting…
GSK’s depemokimab, a long-acting biologic that’s key to the British pharma’s growth plan, has won an endorsement from European regulators for approval in asthma and chronic rhinosinusitis with nasal polyps.
As it shifts strategic direction…
As it shifts strategic direction to prioritize its recently acquired ENvue feeding tube placement system, NanoVibronix is changing its name to reflect the new focus.
Thursday, the FDA greenlighted…
Thursday, the FDA greenlighted Uplizna to treat generalized myasthenia gravis in adults who are anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody positive. After two loading doses, Uplizna for gMG is administered just twice a
With an increase in the…
With an increase in the antimicrobial resistance to therapies for gonorrhea, doctors have been left with fewer options to treat the sexually transmitted infection. Thursday, the FDA addressed the shortfall with a label expansion for