Pharma Pathway

FEBRUARY 28, 2023

PI Industries Ltd- Walk-In Interview for Production/ Instrumentation On 4th March 2023 Job Description PI Industries Limited (PI) is a fast growing agri-Sciences Company with a unique business model across the Agchem value chain from R&D.

Retail 52

Retail Safety Distribution Engineering 52

European Pharmaceutical Review

APRIL 5, 2024

For people with [propionic acidaemia], harmful amounts of toxic metabolites can build up in the body and lead to metabolic decompensation events and multisystemic complications. Study data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

Side effects 82

Side effects Safety Patients Leads 82

Pharma Pathway

JANUARY 7, 2023

PI Industries Ltd- Walk-In Interview for Supervisor/ Executive-Production On 12th Jan’ 2023. Known for our technological capabilities in Chemistry/ Engineering related services and on the other hand, have built leading brands over the last 75 years and connected with more than 70,000 retail points pan India. Job Description.

Retail 56

Retail Safety Distribution Engineering 56

Pharmaceutical Technology

JUNE 2, 2023

The original contract, signed in May 2021, required the EU to purchase 900 million doses from Pfizer/BioNTech, with an option for an additional 900 million, by the end of 2023. The European Commission (EC) and Pfizer/BioNTech have agreed to amend their current supply contract to deliver Covid-19 vaccines to the EU.

Leads 52

Leads Safety Distribution Marketing 52

Pharma Pathway

FEBRUARY 6, 2023

Freshers in Discovery Chemistry -R&D On 12th Feb’ 2023 Job Description Syngene International Ltd is an integrated research, development and manufacturing organisation providing scientific services – from early discovery to commercial supply. Freshers in Discovery Chemistry -R&D On 12th Feb’ 2023 We are hiring!

Specialization 81

Specialization Safety Manufacturing Medicine 81

PM360

DECEMBER 14, 2023

A New Online Destination for HCPs HealthCentral Corporation , operator of leading digital platforms that serve patients living with chronic illness, their care partners, and health professionals, has announced the newest addition to its suite of HCP support sites: MedCentral.

Physicians 52

Physicians Pharma Medical Patients 52

European Pharmaceutical Review

APRIL 17, 2024

billion in 2023 to $4.3 percent between 2023 and 2032. Factors supporting expansion of the rapid sterility testing market Concerns around the safety of biological medicinal products is rising and will contribute to expansion of the sterility testing sector in the subsequent years, according to the report. billion by 2032.

Marketing 78

Marketing Safety Pharmaceutical Medicine 78

pharmaphorum

DECEMBER 22, 2022

This will lead to more pre-protocol design discussions between sponsors and CROs and regulatory bodies seeking input on new and potentially acceptable approaches to, for example, measure digital endpoints. As this collective body of experience continues to proliferate, 2023 will see additional FDA guidance.

FDA 76

FDA Patients Electronics Medical 76

European Pharmaceutical Review

MARCH 26, 2024

Additionally, mRNA-1283 was found to have a similar safety profile to Moderna’s approved vaccines for COVID-19. Importantly, the next-generation design of the mRNA COVID-19 vaccine could lead to a combination vaccine as a treatment of for both influenza and COVID-19, the firm explained. Moderna’s Spikevax XBB.1.5-adapted

Safety 85

Safety Leads Patients Pharmaceutical 85

European Pharmaceutical Review

OCTOBER 20, 2023

This cytokine drives the type-2 inflammatory loop in the skin, which leads to skin barrier dysfunction, itch, skin thickening and infection. The first readout of two-year data from the ADjoin long-term extension study is being presented at the 2023 Annual Fall Clinical Dermatology Conference.

Safety 84

Safety Pharmaceutical Patients Medicine 84

European Pharmaceutical Review

OCTOBER 30, 2023

According to Atamyo Therapeutics, the condition is characterised by progressive muscular weakness, leading to loss of the ability to walk independently. Moreover, no unexpected safety signal for the gene therapy was identified in the LGMD2I/R9 study. Individuals with the disease are also prone to respiratory impairment.

Food and Drug Administration 82

Food and Drug Administration Safety Food FDA 82

European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 76

Healthcare Healthcare Electronics Safety 76

PM360

APRIL 7, 2023

Furthermore, many people underestimate their healthcare costs and do not save enough for annual expenditures, often leading to delays in treatment that can be detrimental to the patient. CMS factored in the efficacy of the device as well as its safety beyond the use of opioids.

Healthcare 52

Healthcare Healthcare Insurance Physicians 52

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 89

Food and Drug Administration Side effects Safety Food 89

Pharmaceutical Technology

APRIL 13, 2023

Lower DCT usage for Phase I studies may be accounted for due to the heavier focus on safety and efficacy, and increased monitoring of trial participants in-person. Metabolic disorders have remained the leading therapy area for DCT adoption for over five years, mainly due to the use of wearables, such as glucometers, and other smart devices.

Food and Drug Administration 52

Food and Drug Administration Electronics Healthcare Healthcare 52

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 72

Food and Drug Administration Manufacturing Safety Transportation 72

European Pharmaceutical Review

JANUARY 22, 2024

Between 2023 to 2030, this represents a CAGR of 15.13 Crititically, they also enable a lower cross-contamination risk, enhancing patient safety. North America was leading the E&L testing services market with a revenue share of 43.71 million by 2030, according to a report by ResearchAndMarkets. percent, the authors stated.

Marketing 52

Marketing Safety Medicine Pharmaceutical 52

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. As of October 2023, 62.93 cited Dec2023].

Safety 108

Safety Medicine Competition Networking 108

Pharmaceutical Technology

MARCH 20, 2023

Leading the race to commercialisation is Intercept Pharmaceuticals, which, in December 2022, resubmitted the new drug application (NDA) for its obeticholic acid (OCA), an FXR agonist, as a Class 2 resubmission (which has a six-month review period) for the treatment of patients with pre-cirrhotic liver fibrosis due to NASH.

Marketing 52

Marketing FDA Leads Safety 52

European Pharmaceutical Review

MARCH 4, 2024

Therefore, biologics identification and characterisation poses unparalleled challenges, as does their manufacturing processes and routes of administration while maintaining patient safety and clinical efficacy. 2023; 11(5):1434. 2023; 21(1). The state of cell and gene therapy in 2023. 2023; 13(11):2719–38.

Food and Drug Administration 83

Food and Drug Administration Transportation FDA Medical 83

Pharmaceutical Technology

MAY 18, 2023

This move shows the FDA’s determination to accept the NDA as a class 2 review that leads to a six-month evaluation period starting from the resubmission date. The regulator has set a user fee goal date of 17 October 2023. The PHREEDOM, BLOCK and AMPLIFY trials all met their primary and key secondary endpoints.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

Pharmaceutical Technology

JUNE 19, 2023

The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. Myelofibrosis is a rare bone marrow cancer that causes the dysfunctional production of blood cells, leading to extensive bone marrow scarring, causing severe anaemia.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Food 98

European Pharmaceutical Review

AUGUST 10, 2023

What Novo Nordisk will gain from the acquisition Through the acquisition agreement, the pharma company Novo Nordisk intends to investigate Inversago Pharma’s lead development asset, a potential first-in-class small molecule CB1 receptor (CB1r) blocker CB1 inverse agonist as a treatment for obesity and obesity-related complications.

Pharma 73

Pharma Safety Leads Medicine 73

European Pharmaceutical Review

FEBRUARY 2, 2024

However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise. Eisai is leading development of LEQEMBI and regulatory submissions globally.

Food and Drug Administration 70

Food and Drug Administration FDA Food Marketing 70

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

Food and Drug Administration 85

Food and Drug Administration Safety Medicine Patients 85

European Pharmaceutical Review

APRIL 17, 2023

percent during the forecast period 2023-2033. million in 2023, according to the data. Automated solutions, especially those aided by artificial intelligence (AI) , can enhance product safety, the report noted. The market’s overall world revenue value will exceed $1,855.0

Biopharma 84

Biopharma Manufacturing Pharmaceutical products Marketing 84

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Internet] Vera Therapeutics.

Food and Drug Administration 89

Food and Drug Administration Side effects Leads Patients 89

European Pharmaceutical Review

AUGUST 23, 2023

Retevmo’s potential in oncology The Phase III study LIBRETTO-531 enrolled 291 patients and is the first randomised trial to compare the safety and efficacy of a highly selective RET -kinase inhibitor with multikinase inhibitors in this patient population. Both biopharma companies have lead assets focusing on obesity and diabetes.

Biopharma 88

Biopharma Safety Medical Patients 88

European Pharmaceutical Review

MARCH 14, 2024

This leads to the formation of immune complexes that deposit in the glomerulus and result in haematuria, proteinuria, and decline in kidney function. The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Internet] Vera Therapeutics.

Food and Drug Administration 88

Food and Drug Administration Side effects Leads Patients 88

pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. Dengue fever is unusual in that a first infection is rarely serious, but a second can lead to much more serious disease.

FDA 117

FDA Marketing Leads Safety 117

European Pharmaceutical Review

AUGUST 22, 2023

In July 2023, the US government body approved the only monoclonal antibody for protection of infants in their first RSV season. The results of the MATISSE study were published in the NEMJ in April 2023. Two studies investigated the safety of the RSV vaccine Abrysvo. US FDA granted approval of Abrysvo to Pfizer Inc.

Food and Drug Administration 75

Food and Drug Administration FDA Government Food 75

European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. STADA is preparing to launch Ximluci ® in the UK during 2023. A biosimilar for biologic ophthalmic treatments.

Manufacturing 79

Manufacturing Marketing Medicine Safety 79

Pharmaceutical Technology

APRIL 6, 2023

Leading with Nefecon as our anchor product, we are building a pipeline of promising renal drug candidates to address huge unmet medical needs.” Everest’s NDA for Nefecon in mainland China is currently under priority review and is expected to receive clearance by the second half of 2023.

Food and Drug Administration 52

Food and Drug Administration Food Medicine Safety 52

Pharmaceutical Technology

MARCH 30, 2023

The FDA’s proposed FY2024 Budget tops $7bn, to be shared between drug, food, and cosmetics tasks and overheads such as buildings; this is $372m higher than in FY 2023, a 10% increase. Postmarket Safety Collaborative: +$10.1m to enhance the safety surveillance of adverse events. for a total of $36.8m ACT for ALS : +$2.5m

Manufacturing 59

Manufacturing FDA Safety Pharma 59

European Pharmaceutical Review

AUGUST 29, 2023

The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. More recently, on 24 July 2023, the EMA updated its guidance on nitrosamine impurities. Above acceptable levels of N-nitrosodimethylamine (NDMA) had been detected in ranitidine tablets and thus investigated. Cioc et al.

Medicine 82

Medicine Manufacturing Safety Healthcare 82

European Pharmaceutical Review

JUNE 13, 2023

In addition, atrasentan revealed a significant reduction in proteinuria versus baseline in a Phase II study, with good tolerability, including liver safety profile. For zigakibart (BION-1301), a Phase III trial in IgAN is expected to start in Q3 2023. IgA nephropathy IgAN is a progressive, rare kidney disease. The post £2.5b

Biopharma 52

Biopharma Safety Leads Pharmaceutical 52

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

Safety 52

Safety Leads Patients FDA 52