2023, FDA, Leads and Side effects

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

Food and Drug Administration

Food and Drug Administration FDA Side effects Prospecting

Santhera seeks speedy FDA review of Duchenne drug vamorolone

pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA

FDA Side effects Biopharma Marketing

BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile.

Food and Drug Administration

Food and Drug Administration Side effects Safety Food

Mirati challenges Amgen with FDA okay for KRAS drug

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. Analysts have suggested, however, that the profile of the two drugs is very similar, leading to questions about how successful Mirati will be differentiating Krazati from its rival.

FDA

FDA Side effects Competition Patients

MHRA authorises alopecia treatment

European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

Food and Drug Administration

Food and Drug Administration Side effects Medicine Food

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

European Pharmaceutical Review

NOVEMBER 9, 2023

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.

Food and Drug Administration

Food and Drug Administration Side effects Pharmaceutical Leads

Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

NOVEMBER 14, 2022

Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure. Several other investigational therapies are expected to have material updates in 2023.

Side effects

Side effects Patients Manufacturing Safety

Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

European Pharmaceutical Review

AUGUST 3, 2023

The US Food and Drug Administration (FDA) recently converted the accelerated approval of the drug, granted in January 2023 , to a full authorisation on the back of data from pivotal clinical studies conducted by the marketing authorisation holder, Eisai 1. This conclusion was based on the same data submitted to the FDA.

Food and Drug Administration

Food and Drug Administration Medicine FDA Marketing

Three-dose vaccine prevents HIV patients getting hepatitis B

European Pharmaceutical Review

OCTOBER 21, 2022

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. The clinical trial is estimated to be completed in March 2023. Eight weeks after the second dose, 94.4

Patients

Patients Food and Drug Administration Side effects Food

Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

pharmaphorum

SEPTEMBER 16, 2022

Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen. Regarding both common cold and headache, they are as well among the side effects reported for similar drugs.

Management

Management Side effects Patients Safety

Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration

Food and Drug Administration Side effects Patients Leads

Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

Food and Drug Administration

Food and Drug Administration Side effects Patients Leads

Decline of novel drug approvals means less business for cutting-edge CMOs

Pharmaceutical Technology

JANUARY 30, 2023

The FDA approved fewer innovative drugs, New Molecular Entities (NMEs), in 2022 than it did in 2021: only 42 drugs compared to 59 drugs. In 2023, there will be opportunities for a wider range of CMOs that can offer services for less innovative drugs requiring reformulation or biosimilar production. months longer on the treatment.

Manufacturing

Manufacturing FDA Side effects Marketing

ANeuroTech shares plans for major depressive disorder pivotal programme

Pharmaceutical Technology

JUNE 16, 2023

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD).

Food and Drug Administration

Food and Drug Administration Side effects Safety Recruitment

The evolution of AAVs in cell and gene therapy

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting

Consulting Side effects Manufacturing Safety

The State of the Union in Cancer Innovation

PM360

JULY 13, 2023

Our lead indications are HER2-positive metastatic breast cancer (mBC) and metastatic castration-resistant prostate cancer (mCRPC). The FDA has granted Fast Track Designation for our HER2-targeted ADC, ARX788, and we are enrolling the signal-seeking ACE-Breast-03 Phase 2 clinical study in post-Enhertu mBC patients throughout 2H 2023.

Patients

Patients Engineering Side effects Leads

Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

OCTOBER 19, 2023

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. Can you share an update on the clinical trial for your lead candidate? Hoppin served as lead director of Noria as the two organisations were sold to Bayer Healthcare in June of 2021.

Food and Drug Administration

Food and Drug Administration Side effects Manufacturing Doctors

Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. 2023 AD/PD Conference. months for lecanemab and 5.5 months for donanemab.

Food and Drug Administration

Food and Drug Administration Safety Patients Leads

New Tech on the Rise: The Future of Cell and Gene Therapies Is Here

PM360

NOVEMBER 29, 2022

The patient populations of these diseases have long been without options, these advancements have inspired hope and the possibility of receiving an effective treatment. However, these immense efforts are in vain if they come with detrimental or life-threatening side effects or are simply unaffordable for the patients they intend to treat.

Patients

Patients Safety Marketing Side effects

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Medgadget

FEBRUARY 17, 2023

Thanks to kind support from Biomed Israel , the leading international Life Science and HealthTech conference in Israel (see more below), we met with Ronan Castro, the CEO of Human Xtensions at the company’s offices in Netanya, Israel.

Physicians

Physicians Engineering Side effects Leads

Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

DECEMBER 27, 2023

Lessons learned The process of establishing point-of-care CAR T manufacturing was a learning curve, not just in managing the toxicities and side effects, but also in understanding the important difference between emerging CAR T-cell adoptive immunotherapy and traditional stem cell transplantation. FDA; 2022 [cited 2023 Mar].

Manufacturing

Manufacturing Food and Drug Administration Patients Pharma

Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. More therapies to meet unmet needs GlobalData predicts that at least 35 US regulatory decisions on drugs for rare diseases are on the horizon for 2023. GlobalData is the parent company of Pharmaceutical Technology.

FDA

FDA Safety Pharmaceutical Patients

Pharma Rep Focus

FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Santhera seeks speedy FDA review of Duchenne drug vamorolone

Trending Sources

BMS strikes $14bn deal for Karuna Therapeutics

Mirati challenges Amgen with FDA okay for KRAS drug

MHRA authorises alopecia treatment

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

Early cell therapy successes start to turn the tide in lupus

Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

Three-dose vaccine prevents HIV patients getting hepatitis B

Almirall/Lilly lebrikizumab offers potential long-term management of atopic dermatitis

Developing a new treatment paradigm for chronic kidney disease

Developing a new treatment paradigm for IgAN

Decline of novel drug approvals means less business for cutting-edge CMOs

ANeuroTech shares plans for major depressive disorder pivotal programme

The evolution of AAVs in cell and gene therapy

The State of the Union in Cancer Innovation

Targeting tumours with novel radiopharmaceuticals

Paving the way for anti-Abeta active immunotherapy

New Tech on the Rise: The Future of Cell and Gene Therapies Is Here

Exclusive Look at HandX Robotic-Assisted Surgical Device from Human Xtensions

Developing point-of-care CAR T manufacturing

Can the FDA keep the momentum going for rare disease drug approvals?

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