Pharma Pathway

FEBRUARY 19, 2023

Co – Operative Industrial Estate, Bachupally, Miyapur, Hyderabad SMS Pharmaceuticals Ltd- Walk-Ins for Freshers & Experienced in Production/ Quality Control/ Stores/ ETP/ Safety On 24th & 25th Feb’ 2023 24 & 24B, 36 & 37, S.V.

Safety 52

Safety Pharmaceutical Pharmaceutical manufacturing Manufacturing 52

European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. In December 2023, the FDA granted OCU400 Regenerative Medicine Advanced Therapy (RMAT) designation. Unlike conventional methods…modifier gene therapy…emphasises the importance of the broader biological system, potentially leading to more effective treatments.”

Manufacturing 145

Manufacturing Food and Drug Administration Engineering Safety 145

European Pharmaceutical Review

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. When production at the 17,200-ft 2 site begins, currently anticipated for the end of Q3 2023, the facility will further enhance bioproduction capabilities and contribute to the growth of the sector in France and Europe.

Pharmaceutical manufacturing 104

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharma 104

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 97

FDA Patients Electronics Medical 97

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 98

Side effects Safety Patients Leads 98

European Pharmaceutical Review

NOVEMBER 13, 2023

Data revealed at the AHA 2023 Scientific Sessions showed that participants who received lepodisiran had lipoprotein(a) levels reduced by the top dose as much as 96 percent within two weeks. No safety issues were observed in the trial. These levels were maintained more than 94 percent below baseline for 48 weeks.

Leads 111

Leads Safety Manufacturing Medical 111

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 105

Safety Pharmaceutical Patients Medicine 105

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 110

Safety Leads Patients Pharmaceutical 110

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 62

Specialization Safety Manufacturing Medicine 62

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 98

Healthcare Healthcare Safety Electronics 98

European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. With the data having been collected in a real-world (RW) setting during the 2022-2023 RSV season, it was “gathered at a time when RSV was recovering from the dip in case numbers during COVID lockdown” Professor Openshaw added.

Safety 104

Safety Leads Manufacturing Medicine 104

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 98

Marketing Safety Pharmaceutical Medicine 98

European Pharmaceutical Review

OCTOBER 24, 2023

While meningococcal disease is uncommon, serious illness can lead to a fatal outcome within 24 hours, a Pediatrics paper highlighted. PENBRAYA is administered as a two-dose series given six months apart, Pfizer stated.

Food and Drug Administration 105

Food and Drug Administration Safety Food FDA 105

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

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 98

Food and Drug Administration Safety Food FDA 98

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 98

Food and Drug Administration Side effects Safety Food 98

European Pharmaceutical Review

DECEMBER 26, 2023

The increasing adoption of technologies promoting safety, efficacy and reduced production costs has been a persistent trend that will continue to benefit the industry and help to treat a broader patient population. million for Hemgenix [AAV5-hFIX-Padua]). This enhances the commercial viability of USP.

Manufacturing 98

Manufacturing Safety Patients Competition 98

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 122

FDA Marketing Leads Safety 122

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

OCTOBER 22, 2024

Introduction of this framework was originally announced by the MHRA in January 2023. It follows a consultation with stakeholders in 2021, which resulted in great support for proposals for a framework focused on point of care and modular manufacturing.

Medicine 89

Medicine Manufacturing Safety Consulting 89

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 97

Food and Drug Administration Manufacturing Safety Transportation 97

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 104

Manufacturing Marketing Medicine Leads 104

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].

Medicine 116

Medicine Safety Competition Medical 116

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 97

Pharma Leads Safety Medicine 97

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 98

Biopharma Manufacturing Pharmaceutical products Marketing 98

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 98

Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

JUNE 5, 2024

The company confirmed that Jemperli (dostarlimab-gxly)’s safety and tolerability was “generally consistent” with the agent’s existing profile. GSK highlighted that the first 24 patients demonstrated “a sustained clinical complete response, with a median follow-up of 26.3 months was observed”.

Safety 98

Safety Patients Manufacturing Medicine 98

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 97

Food and Drug Administration FDA Food Marketing 97

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

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 98

Food and Drug Administration FDA Government Food 98

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

Pharmaceutical Technology

NOVEMBER 7, 2022

A lead product candidate of the company, SNK01 is presently being analysed as a single agent and along with other agents, including checkpoint inhibitors and cell engagers, in trials to treat advanced refractory solid tumours. . “We

Food and Drug Administration 98

Food and Drug Administration Food Networking Safety 98

European Pharmaceutical Review

JANUARY 18, 2023

She shared: “Respiratory diseases are a major public health priority given they… are a leading cause of hospitalisation.” The trial showed the mRNA vaccine was well tolerated with no safety concerns identified. Safety and tolerability will continue to be followed in this ongoing study.

Safety 105

Safety Leads Pharmaceutical 105

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 98

Food and Drug Administration Transportation FDA Medical 98

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. The safety profile of SYFOVRE is well-demonstrated following ~12,000 injections. SYFOVRE is expected to be available by the beginning of March 2023.

FDA 98

FDA Food and Drug Administration Food Leads 98

European Pharmaceutical Review

FEBRUARY 7, 2023

Ultimately, this leads to heart failure and can be fatal for male patients. The Phase I trial for Danon disease The RMAT designation was granted based on positive safety and efficacy data from the Phase I RP-A501 clinical trial. A Phase II trial is on track for the second quarter of 2023.

Food and Drug Administration 105

Food and Drug Administration FDA Medicine Food 105

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 98

Biopharma Safety Medical Patients 98