Remove FDA Remove Food and Drug Administration Remove Manufacturing Remove Side effects
article thumbnail

Clinical trials authorised for 3D-printed ulcerative colitis drug

European Pharmaceutical Review

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

article thumbnail

Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

First treatment approval for advanced ASPS

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has given the first approval of a treatment for advanced alveolar soft part sarcoma (ASPS) to atezolizumab (Tecentriq), for adults and children two years and older with ASPS that has spread to other parts of the body or cannot be removed by surgery.

article thumbnail

Three-dose vaccine prevents HIV patients getting hepatitis B

European Pharmaceutical Review

The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. It will also evaluate ENGERIX-B, a GSK-manufactured three-dose hepatitis B vaccine series.

article thumbnail

Prescribing shift for Pfizer’s Paxlovid expands access but draws questions

Pharmaceutical Technology

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

article thumbnail

Commercialization of novel gene-editing technology in beta-thalassemia

pharmaphorum

Several manufacturers are developing novel treatments for the disease, including Vertex, which has partnered with CRISPR Therapeutics to develop a gene-editing treatment for beta-thalassemia and sickle cell. Beta-thalassemia is a rare blood disorder caused by a genetic defect in hemoglobin. Novartis also recently inked an up-to $1.5

article thumbnail

Interview: Dr Alan S Louie – US Food and Drug Administration Delays

Pharmaceutical Technology

Nicola Boyes: The FDA has come under criticism recently for extreme delays in approving new drugs for the market, is the criticism valid and if so how are the delays impacting on the US pharmaceutical industry at present? This higher threshold, although not explicit, would also be expected to slow drug approvals.