Pharmaceutical Technology

FEBRUARY 23, 2023

InDex reported that cobitolimod has very limited systemic absorption and an excellent safety profile, in sharp contrast to many approved therapies such as Pfizer’s Xeljanz (tofacitinib). Pivotal data is expected around May next year with the maintenance trial expected to read out in June 2025.

Marketing 59

Marketing Safety Competition Pharmaceutical 59

Pharmaceutical Technology

MAY 25, 2023

According to the press release, the MHRA will be the first drug safety regulator in the world to pilot such a biobank. The first patients will have their genetic makeup sequenced in Spring 2024 and this data will be shared in 2025. While the pilot program will begin on 1 June, participant recruitment will start on 1 September.

Side effects 52

Side effects Medicine Recruitment Doctors 52

pharmaphorum

SEPTEMBER 21, 2022

Approval of the first-in-class TSLP inhibitor wasn’t considered a shoo-in, as Tezspire failed one of its two pivotal phase 3 trials, but the Commission and FDA have concluded that the totality of the data – which also included a positive phase 2b study – was enough to show efficacy and safety. billion or more.

Sales 110

Sales Biopharma Medicine Patients 110

European Pharmaceutical Review

FEBRUARY 17, 2023

The company believes this will be sufficient to fund its planned operations and expenses into the first quarter of 2025. Dr Sartor noted that there is increasing evidence that targeted alpha therapies for prostate cancer is effective even for “patients who progress on or after lutetium-based PSMA therapies.”

Patients 75

Patients Safety Pharmaceutical Medical 75

pharmaphorum

SEPTEMBER 20, 2022

The phase 1/3 ROSALIA study showed that the copycat denosumab matched Amgen’s brand on multiple pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity measures in postmenopausal women with osteoporosis, said Sandoz in a statement.

Medicine 52

Medicine Safety Marketing Biopharma 52

Contrarian Sales Techniques

FEBRUARY 24, 2023

RM1 billion will be allocated to strengthen domestic safety, including acquiring more than 2,100 units of body cameras for the Royal Malaysia Police. The Green Technology Financing Scheme (GTFS) is improved, with the guaranteed value increased to RM3 billion until 2025.

Government 52

Government Education Medical sales reps Food 52

Medgadget

SEPTEMBER 29, 2023

We aim to optimize the device’s design for enhanced safety, reliability, and patient comfort and are targeting FDA IND submission and approval in late 2024 to conduct a Phase I first-in-human study in 2025. The NeuroPASS device represents a significant leap forward in addressing the challenges posed by the blood-brain barrier.

Medicine 106

Medicine Distribution Specialization Medical 106

European Pharmaceutical Review

MARCH 14, 2024

The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 93

Food and Drug Administration Patients Leads Side effects 93

European Pharmaceutical Review

MARCH 14, 2024

The safety profile in the open-label extension was consistent with the randomised period and with the overall population of patients with IgAN. Topline data from Vera’s ORIGIN Phase III trial of atacicept is expected in the first half of 2025. 3 About the interviewee Dr Marshall Fordyce is CEO of Vera Therapeutics. cited 2024Mar].

Food and Drug Administration 92

Food and Drug Administration Patients Leads Side effects 92

pharmaphorum

AUGUST 19, 2022

If all goes well, the aim is to bring resiniferatoxin to market in 2025. It will recruit people with osteoarthritis who have exhausted other treatment options but are still experiencing moderate to severe pain. Along with knee osteoarthritis, Grünenthal also plans to test resiniferatoxin in other joints affected by the condition.

Side effects 52

Side effects Recruitment Patients Safety 52

pharmaphorum

DECEMBER 14, 2022

Tentative approval means Lumryz has satisfied all the FDA requirements for efficacy, safety, and quality standards, but it can’t be fully approved until a patent or other exclusivity expires. Two decades of exclusivity. The best-case scenario? Jazz and Avadel settle in court soon, giving people with narcolepsy another option for treatment.

Competition 109

Competition FDA Pharmaceutical Marketing 109

Pharmaceutical Technology

JUNE 1, 2023

In addition, the FDA previously rejected Intercept’s OCA NDA, with the federal agency issuing a complete response letter (CRL) requesting longer-term post-interim analysis efficacy and safety data from the ongoing pivotal Phase III REGENERATE trial (NCT02548351) in June 2020. risk reduction compared with placebo).

FDA 52

FDA Side effects Prescription Patients 52

pharmaphorum

SEPTEMBER 11, 2022

Analysts at Mizuho have suggested that competition from BMS’ drug could trim Otezla’s 2025 sales from $3 billion to $2 billion, although Amgen is attempting to defend its product by expanded the label of the drug to include mild psoriasis. Otezla was acquired by Amgen for $13.4

FDA 52

FDA Marketing Sales Patients 52

pharmaphorum

NOVEMBER 25, 2022

The Parma site, as yet only nine months into construction, is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. Going beyond the standards of care; improving drug safety and efficacy. But to make people safe requires a lot of research.

Pharmaceutical 98

Pharmaceutical Manufacturing Medicine Competition 98

Contrarian Sales Techniques

FEBRUARY 25, 2023

The pharmaceutical industry in India is growing rapidly and is expected to reach a value of US$100 billion by 2025, with a significant portion of that growth driven by domestic demand. However, there are still challenges, such as ensuring the quality and safety of generic drugs, as well as educating the public about their benefits.

Marketing 52

Marketing Distribution Medical Government 52

Pharmaceutical Technology

JANUARY 8, 2023

The Swiss pharma giant is running a Phase III trial (NCT05595642) with its anti-IL33 antibody astegolimab for patients with COPD, with an anticipated completion date in 2025, but a Phase II trial is expected to complete in 2024 (NCT05037929). Ongoing efforts. Have biologics for COPD arrived? Not yet, but soon, industry players hope.

Patients 119

Patients FDA Pharmaceutical Pharma 119

pharmaphorum

NOVEMBER 9, 2022

The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. In order to do this, an EU network is in the process of being established between national comprehensive cancer centres and anticipated to be properly in place by 2025. Her opener?

Insurance 98

Insurance Patients Healthcare Healthcare 98

Pharmaceutical Technology

JULY 29, 2022

On 25 June, Pfizer and BioNTech (Mainz, Germany) reported pivotal Phase II/III data demonstrating the safety, tolerability and immunogenicity of two Omicron-adapted vaccine candidates. Jubilant will double its injectable filling capacity in Spokane at a cost of $193m, to be completed by 2025. with BARDA (Washington DC).

Manufacturing 52

Manufacturing Food and Drug Administration FDA Marketing 52

Clarivate

OCTOBER 10, 2022

Fruquintinib was well-tolerated, with a safety profile consistent with that previously reported in other studies. The question of which KRAS inhibitor is most effective remains elusive, although being first to market in addition to strong efficacy and safety data could differentiate the more competitive agent. Market impact.

Marketing 52

Marketing Safety Patients Competition 52

European Pharmaceutical Review

DECEMBER 19, 2023

Injection Safety Fact Sheet. Since vaccines can now be reformulated to meet the relevant WHO guidelines, the route to a future of fridge-free vaccines is open. About the author Dr Bruce Roser MB BS, PhD founded Stablepharma in 2012, to bring to market his important work on vaccine stabilisation. Curr Med Chem. Nat Biotechnol. Internet] WHO.

Distribution 99

Distribution Manufacturing Food Specialization 99

Rep-Lite

JULY 27, 2023

billion by 2025. Navigating Regulatory Changes and Compliance The medical device industry operates under strict regulations to ensure patient safety. The demand for these life-saving technologies continues to surge, presenting an exciting opportunity for growth and success in medical device sales.

Sales 52

Sales Medical Medical sales Sales Strategy 52

European Pharmaceutical Review

AUGUST 30, 2023

The following new measures are set to be introduced on 1 January 2025. Implementing compliant medicine packaging and labelling With the new measures set to come into force at the start of 2025, joint EU/UK packs can no longer enter the supply chain.

Medicine 95

Medicine Marketing Government Safety 95

Clarify Health

JULY 13, 2020

By 2025, several new gene and cell therapies will be coming to market. Despite their efficacy and safety, the high cost and lifetime use made payers put up barriers to exclude the drug on formulary. This muddies the waters for launch teams, resulting in poor market performance.

Pharmaceutical 52

Pharmaceutical Pharma Patients Marketing 52

Clarivate

MAY 13, 2024

After staying relatively flat for several years, enrollment growth took off in 2021 after an expansion in federal subsidies for silver-level plans passed in the American Rescue Plan and was then renewed through 2025 in the Inflation Reduction Act.

Insurance 52

Insurance Marketing Healthcare Healthcare 52

European Pharmaceutical Review

APRIL 1, 2024

REGENXBIO’s Phase I/IIa trial investigated the safety and tolerability of a single dose of subretinal ABBV-RGX-314 for wet age-related macular degeneration (wet AMD). Regulatory submissions are expected in late 2025 through the first half of 2026, REGENXBIO confirmed.

Consulting 87

Consulting Safety Patients Management 87

PM360

AUGUST 9, 2022

billion in 2025. Needles cause patients pain, anxiety, pose safety risks, and for some people receiving injection therapy is a traumatic experience. from 2021 and reach $4.2 Furthermore, it is estimated to reach $6.5 billion in 2030 at a CAGR of 9.2%.

Prescription 105

Prescription Medical Side effects Patients 105

Referral MD

MAY 19, 2023

Blockchain will improve healthcare safety and transparency. Innovation and Security Implications of Blockchain in Health Care Innovation and Safety Blockchain’s impact on innovation and security depends on what it adds to a non-blockchain environment. Healthcare blockchain technology safety research should also be prioritized.

Healthcare 84

Healthcare Healthcare Distribution Medical 84

European Pharmaceutical Review

NOVEMBER 3, 2023

The new study, known as MATRIX-002 , researchers are assessing the acceptability, usability and safety of two prototype monthly vaginal films that contain no active drug. MATRIX would then expect to begin the first-in-human study of the monthly dapivirine film in 2025.

Safety 82

Safety Pharmaceutical 82

Pharmaceutical Technology

MARCH 9, 2023

SpyBiotech aims to have immunogenicity and safety data ready by the end of 2023 or the start of 2024, says Leuchtenberger. This round extended the company’s reserves until H2 2025, adds Leuchtenberger. Leuchtenberger likens SpyBiotech’s approach to a car chassis. The company previously raised $32.5

Safety 64

Safety Manufacturing Leads 64

European Pharmaceutical Review

FEBRUARY 7, 2023

From 31 January 2025, new and ongoing clinical trials in the EU must be conducted in compliance with the CTR. In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR. Authorisation of the clinical trial, may, however, be obtained later.

Government 93

Government Medical Medicine Marketing 93

pharmaphorum

JANUARY 4, 2023

The EC is hoping that, by the end of its current mandate on 31 October 2024, the legislative process will be completed, with the EHDS becoming operational in 2025. providing personalised healthcare consisting in assessing, maintaining, or restoring the state of health of individuals. When will it come into force?

Pharmaceutical 98

Pharmaceutical Electronics Healthcare Healthcare 98

Pharmaceutical Technology

DECEMBER 21, 2022

This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. According to GlobalData, global AI revenues in the pharmaceutical, medical, and healthcare sectors are expected to reach almost $21 billion by 2025.

Pharma 140

Pharma Medicine Pharmaceutical Government 140

Medico Reach

AUGUST 30, 2022

By 2025, the campaign hopes to impact the community of three billion people annually. Simultaneously, the institution began to post safety guides for children while subtly calling attention to its pediatric care facility. People immediately took to social media and other digital platforms to repost the content.

Healthcare 52

Healthcare Healthcare Marketing Medical 52

Pharmaceutical Technology

FEBRUARY 23, 2023

billion by 2025. However, the majority of biohacking communities, both on- and offline, are inherently resistant to regulation, critical evaluation, and guaranteed safety. Social media plays a massive role in all aspects of our lives with regular users expected to grow to approximately 4.4

Media 111

Media Ethics Healthcare Healthcare 111

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Prospecting 52

Pharmaceutical Technology

MAY 30, 2023

identifies hidden safety liabilities and efficacy gaps in drug candidates, and DenovAI focuses on the de novo design of antibodies with robust binding capabilities, specifically tailored to desired epitopes. This is the sixth call for applications that AION has launched. and DenovAI were launched last year.

Pharma 84

Pharma Government Prospecting Education 84

Pharmaceutical Technology

APRIL 25, 2023

A few months later, the board of the nonprofit Vaccine Alliance Gavi approved an initial investment of nearly $160 million, to be given between 2022 and 2025, to support the rollout of the malaria vaccine in GAVI-eligible countries. However, making sure the vaccine reaches everyone can be challenging due to the storage requirements.

Food and Drug Administration 69

Food and Drug Administration Government Prospecting Food 69