European Pharmaceutical Review

JANUARY 9, 2024

Revolutionising quality control In the backdrop of stringent quality standards and regulatory demands inherent to pharmaceutical manufacturing, the addition of AI technologies introduce a paradigm shift. AI and future perspectives: a glimpse into tomorrow Figure 2: adapted from Saha, G.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

European Pharmaceutical Review

JANUARY 16, 2023

A Mutual Recognition Agreement (MRA) relating to pharmaceutical Good Manufacturing Practice (GMP) has been signed between Switzerland and the US. Good Manufacturing Practice for pharmaceutical drugs. The post Switzerland and US sign drug inspection agreement appeared first on European Pharmaceutical Review.

Food and Drug Administration 111

Food and Drug Administration FDA Manufacturing Food 111

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.

Pharmaceutical 99

Pharmaceutical Food and Drug Administration Medicine FDA 99

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

Food and Drug Administration 105

Food and Drug Administration Pharmaceutical FDA Food 105

European Pharmaceutical Review

JUNE 21, 2023

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital.

Food and Drug Administration 121

Food and Drug Administration Medicine FDA Food 121

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

European Pharmaceutical Review

MARCH 27, 2024

Drivers of the pyrogen testing market Increased R&D activities within the pharmaceutical and biopharmaceutical sector and a focus on biologics, were reported to hold significant growth opportunities for the pyrogen testing market. The market is predicted to grow at a CAGR of 8.2 percent from 2023 to 2032, according to the research.

Safety 72

Safety Marketing Food and Drug Administration Pharmaceutical 72

European Pharmaceutical Review

SEPTEMBER 12, 2023

Initial data from the CPHI Annual Report 2023, which provides insight from 250 global pharmaceutical companies, reveals that AI (artificial intelligence) is expected to transform every area of the industry, from drug discovery through to drug development , within the next 24-months.

Food and Drug Administration 99

Food and Drug Administration Manufacturing FDA Pharmaceutical 99

Pharmaceutical Technology

APRIL 19, 2024

The US Food and Drug Administration (FDA) has granted approval for Takeda’s ENTYVIO subcutaneous (SC) administration as a maintenance therapy to treat adults with moderately to severely active Crohn's disease (CD).

Food and Drug Administration 59

Food and Drug Administration FDA Food 59

European Pharmaceutical Review

FEBRUARY 5, 2024

Incentivising small molecule drug innovation According to the Biotechnology Innovation Organization (BIO), the bipartisan Ensuring Pathways to Innovative Cures ( EPIC Act ) passed last week in the US, is a “critical” step for incentivising small molecule drug innovation.

Food and Drug Administration 79

Food and Drug Administration Medicine Food Pharmaceutical 79

European Pharmaceutical Review

JANUARY 17, 2024

The small molecule heart failure drug acoramidis has potential in slowing or stopping the progression of transthyretin amyloid cardiomyopathy (ATTR-CM), according to study data published in the New England Journal of Medicine. The drug was also shown to lower cardiac congestion.

Food and Drug Administration 82

Food and Drug Administration FDA Food Competition 82

Pharmaceutical Technology

APRIL 23, 2024

The US Food and Drug Administration (FDA) has granted approval for ImmunityBio's ANKTIVA, plus Bacillus Calmette-Guérin (BCG), for treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

Food and Drug Administration 52

Food and Drug Administration FDA Food Patients 52

European Pharmaceutical Review

NOVEMBER 18, 2022

Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). Tzield clinical trials that supported the US Food and Drug Administration approval.

Food and Drug Administration 95

Food and Drug Administration FDA Side effects Food 95

Pharmaceutical Technology

JUNE 19, 2023

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

Pharmaceutical Technology

MAY 16, 2023

Juno Pharmaceuticals Canada has purchased Omega Laboratories, a specialist injectable pharmaceutical manufacturer in Canada, for an undisclosed sum. The deal allows Juno to provide medical practitioners and patients with new critical pharmaceutical products.

Pharmaceutical 52

Pharmaceutical Food and Drug Administration Pharmaceutical manufacturing Manufacturing 52

Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation for Arcturus Therapeutics’ ARCT-032 for cystic fibrosis.

Food and Drug Administration 52

Food and Drug Administration FDA Food 52

Pharmaceutical Technology

NOVEMBER 28, 2023

The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.

Food and Drug Administration 105

Food and Drug Administration Medical FDA Food 105

Pharmaceutical Technology

JUNE 12, 2023

The US Food and Drug Administration (FDA) has granted approval for Milla Pharmaceuticals’ generic version of Precedex, dexmedetomidine hydrochloride injection 4mcg/ml in 50mL and 100mL. Milla Pharmaceuticals stated that Precedex is now on the US FDA’s drug shortages list.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical FDA Food 52

Pharmaceutical Technology

JUNE 8, 2023

The US Food Drug Administration (FDA) has granted orphan drug designation to DTx Pharma’s investigational DTx-1252 for the treatment of Charcot-Marie-Tooth disease Type 1A (CMT1A). Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Food and Drug Administration 98

Food and Drug Administration FDA Food Manufacturing 98

Pharmaceutical Technology

OCTOBER 18, 2023

Sage Therapeutics’ SAGE-718 has been awarded the orphan drug designation from the US Food and Drug Administration (FDA) for the treatment of Huntington’s Disease.

Food and Drug Administration 52

Food and Drug Administration Food FDA 52

Pharmaceutical Technology

JANUARY 17, 2024

Takeda has gained approval from the US Food and Drug Administration for HYQVIA to treat chronic inflammatory demyelinating polyneuropathy.

Food and Drug Administration 98

Food and Drug Administration Food FDA 98

Pharmaceutical Technology

MARCH 13, 2023

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Acadia Pharmaceuticals CEO Steve Davis said: “Today marks an important milestone for the Rett community and Acadia.

Food and Drug Administration 72

Food and Drug Administration Pharmaceutical FDA Side effects 72

Pharmaceutical Technology

SEPTEMBER 6, 2022

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Food 98

European Pharmaceutical Review

NOVEMBER 22, 2022

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.

Food and Drug Administration 106

Food and Drug Administration Side effects FDA Medicine 106

European Pharmaceutical Review

MARCH 1, 2024

API method development and testing at Polpharma API As a key player in the Polish pharmaceutical market and a prominent drug manufacturer in Central and Eastern Europe, Polpharma API exports medicinal products to 35 markets and active pharmaceutical ingredients (APIs) to over 60 countries.

Food and Drug Administration 59

Food and Drug Administration Manufacturing Pharmaceutical products Food 59

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Food and Drug Administration 97

Food and Drug Administration FDA Pharma Food 97

European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. Supporting clinical development in the pharmaceutical industry NIH funding for clinical trials represented <3.5 million per approved drug. This was ~10 percent of reported industry spending.

Food and Drug Administration 86

Food and Drug Administration Training Pharmaceutical Food 86

Pharmaceutical Technology

SEPTEMBER 13, 2023

The US Food and Drug Administration has sent letters to eight companies for unauthorised manufacturing or marketing of unapproved eye drugs.

Food and Drug Administration 52

Food and Drug Administration Food Manufacturing FDA 52

Pharmaceutical Technology

APRIL 7, 2023

The US Food and Drug Administration (FDA) has rescinded its approval for Swiss drug maker Covis Pharma’s (Covis) Makena drug and its generic versions , the only approved treatments aimed at reducing the risk of premature birth.

Food and Drug Administration 95

Food and Drug Administration FDA Pharma Food 95

Pharmaceutical Technology

MARCH 8, 2023

The US Food and Drug Administration (FDA) has granted approval for Shorla Oncology’s Nelarabine Injection, an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The company develops innovative oncology drugs with a focus on paediatric and orphan cancers.

Food and Drug Administration 98

Food and Drug Administration FDA Food Patients 98

Pharmaceutical Technology

AUGUST 18, 2023

Nuvectis Pharma has received US Food and Drug Administration (FDA) orphan drug designation for NXP800 to treat cholangiocarcinoma.

Food and Drug Administration 52

Food and Drug Administration Food FDA Pharma 52

European Pharmaceutical Review

NOVEMBER 25, 2022

The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 The post Promising schizophrenia drug faces tough competition appeared first on European Pharmaceutical Review.

Competition 99

Competition Food and Drug Administration Pharma Food 99

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

Food and Drug Administration 90

Food and Drug Administration FDA Food Medicine 90

Pharmaceutical Technology

MAY 12, 2023

Speciality pharmaceutical company SERB Pharmaceuticals has acquired exclusive US rights for bentracimab from SFJ Pharmaceuticals. SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab.

Food and Drug Administration 52

Food and Drug Administration Pharmaceutical FDA Specialization 52

Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The company stated that its findings support the potential for a safe, flexible, effective and convenient oral treatment option for PKU.

Food and Drug Administration 104

Food and Drug Administration FDA Engineering Medicine 104

Pharmaceutical Technology

APRIL 12, 2023

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir). It targets Covid-19 patients who were asymptomatic or only had mild symptoms.

Food and Drug Administration 59

Food and Drug Administration Food FDA Patients 59

Pharmaceutical Technology

DECEMBER 4, 2023

The US Food and Drug Administration (FDA) has granted approval for Ambio’s generic version of Forteo for the treatment of osteoporosis.

Food and Drug Administration 98

Food and Drug Administration FDA Food 98