Regulatory

The industry is facing challenges from the new administration that could have serious impacts on everything from market access, pricing, and supply chains.

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria compared to the original Spikevax as a vaccine for COVID-19.

The biopharmaceutical sector is underpinned by a unique ecosystem that combines public funding for basic research, university-led translational science, technology transfers, venture capital funding, partnerships with larger companies, and a relatively transparent and responsive regulatory system.

Approval of Nucala marks the first biologic approved for chronic obstructive pulmonary disease patients with blood eosinophil counts as low as ≥150 cells/μL.

Approval of Susvimo marks the first continuous delivery therapy indicated for diabetic retinopathy.

Clearance of ASC50 paves the way for a Phase I trial in patients with mild-to-moderate plaque psoriasis.

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Positive feedback was based on Phase III AQUILA trial results, which showed a significant clinical benefit with Darzalex Faspro in patients with high-risk smoldering multiple myeloma.

Previously granted Emergency Use Authorization, Nuvaxovid is now available for individuals over 12 years of age.

Zynyz is the first and only FDA-approved first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Welireg marks the first FDA-approved non-surgical treatment option for locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma in patients over 12 years of age.

Emrelis is the first FDA-approved treatment for previously treated patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression.

The organization believes that the proposed cuts will be harmful to Americans suffering from mental illnesses.

The decision follows ongoing investigations into serious adverse events primarily reported in elderly individuals who received the Ixchiq chikungunya vaccine.

Groups like PhRMA and the HDA issued statements explaining their stance of the drug-pricing policy.

The order pushes drug companies to reduce drug prices in the United States to fall in line with other countries around the world.

The President plans to sign an executive order on Monday morning to enforce the trade clause.

Proposed cuts to Medicaid could cause serious issues in rural areas of the United States.

Navigating technology and regulatory shifts in pharma revenue management.

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

Commissioner Markary announced the plans alongside the results of a generative AI pilot for scientific reviewers.

Pharma companies have opportunities to grow, but they also must plan for a complicated future.

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

In the face of potential tariffs, the pharmaceutical industry must find alternative ways to reduce costs.

Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.