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. Mirati also says its drug penetrates the central nervous system more readily, making it a better option for patients whose disease has metastasised to the brain.

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European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

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Food and Drug Administration Side effects Safety Food 94

European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose. Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor.

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Food and Drug Administration Side effects Medicine Food 84

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

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Side effects Patients Manufacturing Safety 144

pharmaphorum

SEPTEMBER 16, 2022

Atopic dermatitis (AD) is a highly prevalent chronic dermatological disease, with symptoms which include itching, dry skin, severe pain, and inflammation – all of which create considerable stress in the daily lives of patients and often negatively affect their day-to-day and long-term well-being. However, side effects do happen.

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Management Side effects Patients Safety 78

pharmaphorum

JANUARY 13, 2023

And as I look out the window at that snow, my travel-addled brain can’t help but see it as a metaphor for pharma in 2023: a crisp white, wide canvas laden with possibilities, but also one that’s going to require a lot of immediate, hard work from me if I want to be a responsible homeowner. Ups and downs of government – FDA.

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FDA Side effects Pharma Manufacturing 97

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.

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Food and Drug Administration Side effects Pharmaceutical Leads 104

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.

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Food and Drug Administration Medicine FDA Marketing 52

Pharmaceutical Technology

JUNE 16, 2023

Since some of the patients with major clinical depression do not respond sufficiently to one or more antidepressants, there is a need for new treatments, said Buntinx. Due to this, adjunctive treatments are used as part of a patient’s treatment regimen. While the drug is marketed in other countries, it is not registered in the US.

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Food and Drug Administration Side effects Safety Recruitment 52

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 52

Manufacturing FDA Side effects Marketing 52

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 93

Food and Drug Administration Side effects Patients Leads 93

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).

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Food and Drug Administration Side effects Patients Leads 93

pharmaphorum

SEPTEMBER 12, 2022

The full data will be presented as a late-breaker later today, so may be subject to change, and for now shows a solid reduction in disease progression or death in patients with the KRAS inhibitor in KRAS G12C-mutated non-small cell lung cancer (NSCLC) compared to docetaxel, but no improvement in overall survival.

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Side effects FDA Patients Safety 52

Pharmaceutical Technology

APRIL 24, 2023

The British institute that oversees a therapy’s cost-effectiveness opted for the recommendation based on clinical data from the Phase II CAPTIVATE and the Phase III GLOW studies. The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance.

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Food and Drug Administration Side effects Sales Food 52

Pharmaceutical Technology

JULY 28, 2022

Cobitolimod, an agent being developed for patients with moderate to severely active UC, has both a novel MOA and a route of administration that is unique among marketed agents. The TLR9 agonist is currently being investigated in the Phase III CONCLUDE trial (NCT04985968), with an expected study completion date of August 2023.

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Food and Drug Administration Safety Side effects Marketing 98

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.

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Consulting Side effects Manufacturing Safety 58

PM360

AUGUST 9, 2022

How can we help ensure patients continue to take their medications as prescribed? The reasons why a patient may not take their medication are plentiful, and as a result so are the solutions now available to attempt to solve this issue. But it is not a simple answer. Furthermore, it is estimated to reach $6.5

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Prescription Medical Side effects Patients 105

PM360

JULY 13, 2023

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

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Patients Engineering Side effects Leads 98

Pharmaceutical Technology

FEBRUARY 26, 2023

While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. with placebo.

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Safety FDA Medicine Side effects 111

European Pharmaceutical Review

OCTOBER 19, 2023

Additionally, in June 2023, the world’s largest radionuclide production facility of lutetium-177 opened in Germany. These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management.

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Food and Drug Administration Side effects Manufacturing Doctors 88

European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

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Patients Food and Drug Administration Side effects Food 52

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. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

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Food and Drug Administration Safety Patients Leads 77

PM360

NOVEMBER 29, 2022

Many companies in the cell and gene therapy space are dedicated to bringing these novel therapies to the patients who need them. The patient populations of these diseases have long been without options, these advancements have inspired hope and the possibility of receiving an effective treatment.

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Patients Safety Marketing Side effects 111

Medgadget

FEBRUARY 17, 2023

All of these systems operate under the “master-slave” concept, which involves a surgeon sitting behind a console, away from the patient, who manipulates the mechanical arms of the robot via some kind of joystick-like device.

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Physicians Engineering Side effects Leads 80

European Pharmaceutical Review

DECEMBER 27, 2023

Due to shipping and manufacturing requirements, the time from a patient being included in the CAR T programme to receiving therapy can be several weeks. As a result, many patients waiting for the CAR T cells to be infused will need additional therapy (bridging therapy) against the malignance.

Manufacturing 83

Manufacturing Food and Drug Administration Patients Pharma 83

Pharmaceutical Technology

OCTOBER 10, 2022

The company is aiming to enrol the first patient in the ALETTA Phase III trial in Q1 or Q2 of 2023, says Dr. Jan van der Mooren, Freya’s chief medical officer (CMO). The company plans to submit a request for advice from the FDA at the end of this year or the start of 2023, he adds.

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Pharmacology Side effects FDA Safety 59

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.

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