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Tag: featured


FDA, Regulations

AbbVie’s IL-23 inhibitor Skyrizi approved by FDA to treat ulcerative colitis in adults

June 19, 2024

Via: PMLiVE

Affecting more than one million people in the US, UC is a type of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of […]


FDA, Regulations

FDA Approves Immunoglobulin Therapeutic to Treat Primary Immunodeficiencies

June 18, 2024

Via: Biopharm International

Global healthcare company, Grifols, announced on June 17, 2024 that its subsidiary Biotest has garnered its first FDA approval with the intravenous immunoglobulin (Ig) therapeutic, Yimmugo, which Grifols hopes to launch commercially in the United States in the second half […]


FDA, Regulations

FDA clears Roche digital pathology platform for diagnosis

June 18, 2024

Via: Pharmaphorum

The clearance covers Roche’s Ventana DP 200 slide scanner, digital pathology workflow software, and a display that can be used to review and interpret digital images of scanned pathology slides. Proponents of digital pathology technologies say that having this image data in […]


News

Study finds low secondary cancer risk with CAR-Ts

June 17, 2024

Via: Pharmaphorum

Last November, the FDA issued a warning about a risk of secondary cancers – particularly T-cell cancers – and earlier this year it requested a change to safety labelling to include a ‘black box’ warning on all six of the […]


FDA, Regulations

Amgen’s Blincyto approved by FDA for new acute lymphoblastic leukaemia indication

June 17, 2024

Via: PMLiVE

The therapy has been authorised for use in patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status. With more than 6,500 new cases diagnosed in the US […]


Clinical Trials, Research and Development

EMA announces launch of two advice pilots to improve clinical trials in Europe

June 12, 2024

Via: PMLiVE

The pilots aim to improve the quality of applications for clinical trials and lay the foundation for the development of safe and effective medicines in Europe. First launched in January 2022, the ACT EU initiative seeks to transform how clinical […]


FDA, Regulations

FDA Advisors Support New Alzheimer’s Drug, Donanemab

June 11, 2024

Via: Drugs.com

A U.S. Food and Drug Administration advisory panel voted unanimously on Monday to recommend that the benefits of a new drug for Alzheimer’s outweigh its harms, which can include brain swelling and bleeding. Eli Lilly’s donanemab did slow declines in thinking skills […]


News

Drug Shortage Reports Emphasize Continuing Problems

June 11, 2024

Via: Biopharm International

In early June 2024, FDA and the US Pharmacopeial Convention (USP) both published reports on drug shortages as of the end of 2023. The Center for Drug Evaluation and Research at FDA published its 11th annual report to Congress on […]


FDA, Industry, Regulations, Vaccines

FDA Gives Nod to RSV Vaccine for People in Their 50s

June 10, 2024

Via: Drugs.com

The U.S. Food and Drug Administration on Friday has for the first time approved the use of a respiratory syncytial virus (RSV) vaccine for people in their 50s who are at increased risk for the illness. Drugmaker GSK’s Arexvy vaccine, […]


FDA, Regulations

FDA OKs wider use of Almirall’s actinic keratosis drug

June 10, 2024

Via: Pharmaphorum

First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can […]


FDA, Regulations

FDA Panel Says No to MDMA as Treatment for PTSD

June 5, 2024

Via: Drugs.com

A U.S. Food and Drug Administration advisory panel on Tuesday voted against recommending the psychedelic MDMA for the treatment of post-traumatic stress disorder (PTSD). In a 10-1 vote, the panel determined the evidence amassed so far fails to show the […]


Cell and Gene Therapy, Industry

Gene Therapy in Both Ears Restores Hearing to Babies Born Deaf

June 5, 2024

Via: Drugs.com

Chlidren born deaf have had their hearing restored in both ears as a result of gene therapy, a new study reports. All five children showed hearing recovery in both ears, with dramatic improvements in speech perception and the ability to […]


News

Abbott’s OTC glucose monitor ‘will grow the market’

June 4, 2024

Via: Pharmaphorum

Abbott hasn’t issued a public statement on the 510k approval, which has just been published on the FDA’s website, but the wearable device has a similar indication to Stelo and can be used in both non-insulin-dependent type 2 diabetics as […]


Industry, Vaccines

U.S. Will Make Millions of Bird Flu Vaccines This Summer

June 3, 2024

Via: Drugs.com

As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans. Since the outbreak in livestock began this spring, bird […]


FDA, Regulations

Bristol Myers Squibb’s Breyanzi receives FDA approval for mantle cell lymphoma

June 3, 2024

Via: PMLiVE

Representing around 3% of all non-Hodgkin lymphoma (NHL) cases, MCL is a rare form of NHL that originates from cells in the mantle zone of the lymph node. For most patients, relapse after initial treatment is common and the disease […]


News

Lilly’s Retevmo cleared for RET-positive child cancers

May 30, 2024

Via: Pharmaphorum

Retevmo (selpercatinib) can now be used to treat RET-positive thyroid cancers and other solid tumours with the mutation, regardless of their type. Specifically, the new indication covers advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, advanced or […]


Industry, Vaccines

Vaccines Will Be Best Defense Against Bird Flu, Experts Say

May 29, 2024

Via: Drugs.com

Humanity’s best protection against bird flu will be the development of effective vaccines, a new study says. The H5N1 avian flu has been raging through cattle and poultry in the United States, increasing fears that the virus will make the […]


Clinical Trials, Research and Development

Trial readout sets up filings for Insmed bronchiectasis drug

May 29, 2024

Via: Pharmaphorum

The phase 3 trial achieved a statistically significant reduction in the frequency of exacerbations in patients with bronchiectasis, a serious, chronic lung disease with no approved treatment that affects around a million people across the US, Europe, and Japan. In […]


FDA, Regulations

FDA sets date for Sarclisa in first-line multiple myeloma

May 28, 2024

Via: Pharmaphorum

The French pharma group has filed anti-CD38 antibody Sarclisa (isatuximab) for use in combination with Takeda’s Velcade (bortezomib), lenalidomide, and dexamethasone – known as the VRd regimen – in previously untreated multiple myeloma patients who are not eligible for or […]


Mergers and Acquisitions

Asahi Kasei makes $1.1bn bid to buy Calliditas

May 28, 2024

Via: Pharmaphorum

The Japanese group’s tender offer is a premium of around 83% on Calliditas’ closing share price yesterday and has been recommended by the biotech’s board, which says a takeover would enhance its ability to develop and commercialise its products. Calliditas […]