European Pharmaceutical Review

APRIL 16, 2024

Novartis has released new data from the first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with the rare kidney disease IgA nephropathy (IgAN). Fabhalta was given a positive opinion from the CHMP of the EMA in March 2024, according to Novartis.

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Food and Drug Administration Food Safety Medicine 82

European Pharmaceutical Review

APRIL 17, 2024

Roche’s twice-yearly, 10-minute subcutaneous injection of OCREVUS ® (ocrelizumab) has shown significant promise for patients with either with relapsing or primary progressive multiple sclerosis (RMS or PPMS). percent had no relapse) in patients through 48 weeks of the treatment. No new safety signals were identified for OCREVUS SC.

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Food and Drug Administration Safety Medicine Food 70

European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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Food and Drug Administration Medicine Marketing Food 87

European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. The drug is also undergoing trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease.

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Food and Drug Administration Side effects Safety Food 96

Pharmaceutical Technology

JUNE 6, 2023

Findings from a two-year placebo-controlled, double-blind Phase II trial showed that Stargardt patients treated with gildeuretinol once a day as a pill experienced a statistically and clinically meaningful slowing of retinal damage over placebo. Alkeus Pharmaceuticals intends to submit a new drug application for gildeuretinol in 2024.

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Food and Drug Administration Food Pharmaceutical Medicine 111

European Pharmaceutical Review

APRIL 12, 2024

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. These agreements have amassed a total deal value of $21 billion.

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Food and Drug Administration Medicine Food Pharmaceutical 85

European Pharmaceutical Review

DECEMBER 1, 2023

AbbVie has agreed to acquire ImmunoGen and its first-in-class antibody-drug conjugate (ADC) ELAHERE ® (mirvetuximab soravtansine-gynx), for a total of approximately $10.1 The antibody-drug conjugate is the first to be approved for platinum-resistant ovarian cancer (PROC) and show meaningful survival benefit for this form of the disease.

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Food and Drug Administration FDA Marketing Food 108

Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.”

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Food and Drug Administration FDA Recruitment Physicians 52

European Pharmaceutical Review

NOVEMBER 2, 2023

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). He added that the approval of Wezlana “could have a meaningful impact for patients managing their disease.” US sales of Stelara totalled $6.4

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Food and Drug Administration FDA Side effects Safety 91

European Pharmaceutical Review

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. According to the FDA, this clinical trial evaluated 142 adult patients with progressing desmoid tumours not suitable to surgery.

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Food and Drug Administration Medicine FDA Food 86

European Pharmaceutical Review

FEBRUARY 8, 2024

Regulatory plans for the cystic fibrosis medicine By mid-2024, Vertex declared that it plans to submit a New Drug Application (NDA) to the US Food and Drug Administration and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in patients with cystic fibrosis aged six years and older.

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Food and Drug Administration Medicine Medical Consulting 91

European Pharmaceutical Review

DECEMBER 15, 2023

When the edited cells are transplanted back into the patients, BCL11A expression is reduced, increasing γ‑globin expression and production of foetal haemoglobin (HbF). This addresses absent haemoglobin A in patients with TDT and the aberrant haemoglobin S in patients with SCD, according to EMA.

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Medicine Food and Drug Administration Food Patients 93

European Pharmaceutical Review

MARCH 14, 2023

Together, Pfizer and Seagen seek to accelerate the next generation of cancer breakthroughs and bring new solutions to patients by combining Seagen’s antibody -drug conjugate (ADC) technology… with Pfizer’s capabilities and expertise,” shared Dr Albert Bourla, Pfizer Chairman and Chief Executive Officer. billion of revenue in 2023.

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Food and Drug Administration Medicine Engineering Food 110

European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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FDA Food and Drug Administration Manufacturing Medicine 78

European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Food and Drug Administration Medicine FDA 100

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). The major depressive disorder treatment is expected to be available for patients in early 2024.

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FDA Food and Drug Administration Medicine Food 94

Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has accepted Ipsen’s supplemental new drug application (sNDA) for the Onivyde regimen as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) patients.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older.

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Food and Drug Administration Medicine FDA Food 99

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. It will be offered to patients in prefilled syringe and autoinjector administration options.

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Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

MAY 23, 2023

The company expects that the proceeds obtained from the deal will extend its cash runway into the fourth quarter of 2024. In 2022, Avrobio’s investigational gene therapy, AVR-RD-04, received a rare paediatric disease designation from the US Food and Drug Administration.

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Food and Drug Administration Food Leads Pharmaceutical 103

Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). We are eager to confirm our preclinical data in the clinic and expect to begin enrolling patients in Phase I during the second quarter of 2024.”

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Food and Drug Administration FDA Food Safety 59

Pharmaceutical Technology

JUNE 15, 2023

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU. With a J-code from the Centers for Medicare & Medicaid Services, PEMRYDI RTU is expected to be launched in the first quarter of 2024.

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Food and Drug Administration FDA Food Pharmaceutical 52

Pharmaceutical Technology

APRIL 19, 2023

Neuronascent plans to start a potential Phase II trial of its neurorestorative agent NNI-362 in Parkinson’s disease in H1 2024, said CEO Judith Kelleher-Andersson in an interview with P harmaceutical Technology. The potential Phase II trial in Parkinson’s disease will recruit between 75 and 100 patients, said Kelleher-Andersson.

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European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. MHRA announced that it will publish its guidance in 2024.

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Medical Food and Drug Administration Manufacturing Safety 94

Pharmaceutical Technology

JUNE 8, 2023

Last month, Arexvy received approval from the US Food and Drug Administration (FDA ) for the same indication. overall efficacy against RSV-LRTD in adult patients. The vaccine will be available before the 2023/2024 RSV season, which begins later this year.

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Food and Drug Administration Marketing Manufacturing Medicine 59

Pharmaceutical Technology

APRIL 24, 2023

Validated through the access consortium work-sharing initiative, the marketing applications are currently under review, with approval decisions expected in the first half of 2024. In February 2023, Syfovre (pegcetacoplan injection) received the US Food and Drug Administration’s approval for the same indication.

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Marketing Food and Drug Administration Food Safety 52

Pharmaceutical Technology

APRIL 21, 2023

It will pay another $10m in instalments through to September 2024. Entadfi, a combination of finasteride and tadalafil, is administered as an oral, once-a-day drug to provide a safe and effective treatment option for benign prostatic hyperplasia (BPH), often referred to as enlarged prostate, in men.

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Pharmaceutical Technology

OCTOBER 12, 2022

Novo Nordisk has recently completed its six-part ONWARDS Phase III trial, as ONWARDS 5 reached its primary endpoint with Icodec demonstrating non-inferiority in reducing hemoglobin A1C (HbA1c) in patients with type 2 diabetes (T2D) at week 52 in comparison to once-daily basal insulin analogs. Patients had an overall baseline HbA1c of 8.9%

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Food and Drug Administration FDA Marketing Patients 72

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 Leads Patients 95

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 Leads Patients 95

European Pharmaceutical Review

FEBRUARY 21, 2023

SYFOVRE (pegcetacoplan injection) is the first and only treatment approved by the US Food and Drug Administration (FDA) for geographic atrophy (GA), a leading cause of blindness. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility via a dosing regimen of every 25 to 60 days.

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FDA Food and Drug Administration Food Leads 89

Legacy MEDSearch

SEPTEMBER 13, 2023

Food and Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024. The Company’s vision is to transform external breathing assistance for over 20 million patients each year that require ventilation and oxygenation via external mechanical ventilation machinery.

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FDA Food and Drug Administration Recruitment Medical 52

Legacy MEDSearch

OCTOBER 10, 2023

Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced today that it has received clearance from the Food and Drug Administration for its Hammerdesis Interphalangeal Fusion System. For further inquiries, interested parties may email contact@intelivationtech.com.

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Food and Drug Administration FDA Recruitment Marketing 52

Pharmaceutical Technology

JUNE 16, 2023

While the drug is marketed in other countries, it is not registered in the US. 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. The trial will also measure the patients’ cognition as an additional secondary endpoint.

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Food and Drug Administration Side effects Safety Recruitment 52

PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. Think about patients who need treatment multiple times per day versus you get an infusion and then you’re good to go for multiple years.” was approved by the U.S.

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European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. The FDA’s target action date is the second half of 2024.

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Food and Drug Administration Manufacturing Safety Medicine 92

European Pharmaceutical Review

MARCH 7, 2024

The Phase II clinical trial for Orano Med’s candidate AlphaMedix ( 212 Pb-DOTAMTATE) is still ongoing and top-line data are expected in mid-2024. percent for the gastroenteropancreatic neuroendocrine tumours (GEP-NET) patients who had never received radioligand therapy).

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