European Pharmaceutical Review

AUGUST 12, 2022

Key secondary endpoints include progression-free survival (PFS), duration of response (DoR) and safety. The safety profile of Tagrisso plus savolitinib was consistent with the known profiles of the combination and each treatment alone. No new safety signals were identified. The primary endpoint is ORR.

Safety 98

Safety Patients Prospecting Medical 98

European Pharmaceutical Review

MAY 28, 2024

Prospects of the ampoules packaging market On the other hand, advancements in ampoule packaging, as well as sustainability measures and manufacturing innovations such as automation and robotics, were highlighted as promising contributing factors for growth of the market.

Marketing 97

Marketing Transportation Distribution Pharmaceutical products 97

pharmaphorum

AUGUST 1, 2022

Sarepta reported updated clinical trial results with the one-shot therapy in July which bolstered the data for SRP-9001 (delandistrogene moxeparvovec) for efficacy and durability, but also raised a concern about its safety after a serious case of myocarditis was seen in one of 38 patients enrolled in its ENDEAVOR study.

FDA 105

FDA Safety Patients Doctors 105

European Pharmaceutical Review

JUNE 12, 2024

The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies. The study included 92 adult patients with confirmed CDI.

Safety 111

Safety Patients Side effects Management 111

PharmExec

AUGUST 23, 2022

Wed, Aug 24, 2022 7:00 AM EDT he DARWIN EU Coordination Centre will accelerate access to high-quality real-world evidence for the use, safety and effectiveness of drugs across the EU in support of the EMA’s regulatory decision-making.

Prospecting 52

Prospecting Networking Safety 52

European Pharmaceutical Review

JUNE 23, 2023

To expand the capabilities of cell therapy to new areas and improve safety, we engineered CAR T-cells with RNA and used them to treat patients with gMG,” Dr Miljković added. The RNA cell therapy study for myasthenia gravis There were 14 gMG patients enrolled in the study.

Engineering 98

Engineering Patients Prospecting Safety 98

pharmaphorum

JANUARY 27, 2023

It refiled in the US, but got a complete response from the FDA in December with a request for more clinical information that has delayed the programme even further, and the CHMP’s decision will further undermine confidence in the drug’s prospects.

FDA 98

FDA Marketing Medicine Prospecting 98

European Pharmaceutical Review

AUGUST 10, 2022

The prospective, open-label, single-arm, Phase II TUXEDO-1 study enrolled 14 women and one man with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy. Two patients (13.3

Patients 98

Patients Medicine Prospecting Safety 98

pharmaphorum

SEPTEMBER 30, 2022

The company says its filing is based on “positive preclinical, biomarker and clinical functional results” at various timepoints, including one, two and four years after treatment, in addition to a consistent safety profile. It is going for early approval based on the totality of the clinical data.

FDA 105

FDA Patients Prospecting Safety 105

pharmaphorum

NOVEMBER 16, 2022

Bleak prospects, indeed. The specifics of an exciting prospect. So, really,” he continued, “[there are] three major take-homes to talk about: first efficacy, then function, and then safety. It’s one of the most common causes of blindness across Europe and across the United States, and many developed countries around the world.

Safety 105

Safety Patients Prospecting Consulting 105

pharmaphorum

OCTOBER 27, 2022

There has been somewhat better news for GSK for another of its top pipeline prospects – renal anaemia drug daprodustat – although that also came with disappointment. GSK licensed otilimab from German biotech MorphoSys in 2013 in a deal valued at up to €423 million, including around €23 million upfront. Daprodustat backed.

Side effects 95

Side effects FDA Patients Sales 95

pharmaphorum

SEPTEMBER 28, 2022

However, it has become clear that if a treatment is likely to be the best available option for a child, doctors are often left with no choice but to use a product that has not been reviewed by the FDA for safety and efficacy in that age group.

FDA 59

FDA Ethics Prospecting Safety 59

Pharmaceutical Technology

JANUARY 22, 2023

Dr. Jerry Mendell, MD, professor of paediatrics and neurology at the Ohio State University College of Medicine, is optimistic for its approval and says the drug has a good safety profile. However, before the drug can receive an approval, Santhera will have to overcome doubts about vamorolone’s safety. compared to 38.5% on placebo.

FDA 126

FDA Safety Pharmaceutical Patients 126

Pharmaceutical Representative Training

OCTOBER 9, 2024

Introduction Every sales professional has experienced deals collapsing at the last minute due to objections from prospects. Handling objections begins with your prospects; According to Lincoln Murphy, “your ideal customer will be ready, willing, and able”. There are times when your prospect will have multiple objections at once.

Sales 52

Sales Pharma Pharmaceutical Sales Prospecting 52

The Brooks Group

MAY 27, 2020

Here are a few tips and considerations to prospecting with purpose: Risk Versus Reward: Though it may be tempting to resume face-to-face activity, the cost, right now, could outweigh the benefits. Your calls, therefore, should be more substantive in nature and deliver true value to customer.

Sales 75

Sales Prospecting Safety Marketing 75

Pharmaceutical Technology

JUNE 20, 2023

This comes after an independent data monitoring committee confirmed the safety and tolerability profile of ARGX-117 was consistent with results from an earlier Phase I study. In addition to assessing the safety and efficacy of ARGX-117, it will populate a PK/PD model to inform Phase III study dose selection.

Safety 98

Safety Patients Prospecting Marketing 98

Pharmaceutical Technology

APRIL 12, 2023

The expanded regulatory approval was based on the data obtained from an open-label, pivotal, non-controlled, prospective Phase III clinical trial conducted in 44 PI patients aged between two years and 16 years. Takeda noted that the findings from the interim data analysis indicated similar safety profiles to those of adults.

Food and Drug Administration 52

Food and Drug Administration FDA Prospecting Food 52

Infuse Medical

MAY 14, 2024

Regulatory Considerations Medical device marketing using VR must adhere to regulatory guidelines and standards to ensure patient safety and compliance. This includes considerations related to data privacy, content accuracy, and ethical implications.

Medical 130

Medical Marketing Training Sales 130

Pharmaceutical Technology

SEPTEMBER 13, 2022

An international team of scientific, regulatory, and safety and compliance (GxP) specialists, PharmaLex is based in Germany. This latest development will progress various AmerisourceBergen’s strategic imperatives and bolster its position to gain substantial growth prospects in the biopharma market.

Biopharma 52

Biopharma Manufacturing Pharmaceutical manufacturing Marketing 52

Pharmaceutical Technology

AUGUST 5, 2022

With respect to its safety profile, Cimerli had more than 3% fewer adverse events (AEs) than Lucentis; however, there were no clinically relevant differences for safety. Thus, the biosimilar presented a similar efficacy to the reference product. Cimerli’s biosimilar status is appealing to providers and patients alike in the US.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Marketing 52

Integrity Solutions

JANUARY 23, 2023

Technology’s job is to take the transactional, repetitive and otherwise inefficient tasks off the plates of your salespeople so they can be freed up to contribute at a higher level, providing clients and prospects with the kind of personal value that only humans can.

Sales 196

Sales Training Sales Management Management 196

Spotio

MAY 18, 2022

Sales canvassing is when you initiate contact with a prospect or lead that you don’t have an appointment set or meeting scheduled with. Sales canvassing is done both face-to-face or calling on the phone and involves qualifying prospects and pulling a list of target prospecting customers that would benefit from your service or solution.

Sales 52

Sales Prospecting Leads CRM 52

Pharmaceutical Technology

MAY 31, 2023

The Danish CRISPR biotech SNIPR BIOME has released the first glimpse at the safety profile for SNIPR001, a gene therapy intended to target antibiotic resistance. Interim clinical results from a Phase I trial have demonstrated SNIPR001’s safety in healthy volunteers. SNIPR001 consists of four CRISPR-edited phages targeting E.Coli.

Food and Drug Administration 98

Food and Drug Administration Safety Side effects FDA 98

Pharma Leaders

MAY 18, 2023

We are excited about the prospect of working collaboratively with the FDA to finalise this review over the next few months. “We The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

Healthcare Success

SEPTEMBER 20, 2022

Your business development team may also want to tour prospective businesses, which is a terrific opportunity to leave-behind marketing materials like business cards, brochures, or information about company-specific special promotions. to add value to your relationships with your target companies and attract more patients.

Patients 102

Patients Specialization Healthcare Healthcare 102

pharmaphorum

NOVEMBER 9, 2022

Likely baulking at the cost of starting a phase 3 study without the prospect of near-term revenues from cami, ADC is halting all investment in the drug for the time being.

FDA 59

FDA Prospecting Marketing Safety 59

Healthcare Success

AUGUST 19, 2024

SMS marketing, or text messaging, helps healthcare organizations communicate with patients and prospects one-on-one via text messages, leading to better outcomes, improved trust, better compliance, higher satisfaction, and more efficient healthcare delivery. Referral marketing to incentivize patients to refer friends and family.

Marketing 65

Marketing Healthcare Healthcare Patients 65

Pharmaceutical Technology

MAY 22, 2023

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour.

Medicine 59

Medicine FDA Prospecting Food 59

Spotio

JULY 5, 2023

Obvious value propositions include: “safety” and “peace of mind.” Because stories help sales reps like yourself build personal connections with their prospects. Once these personal connections are built, your prospects will trust you more. Ask your prospect a question to help engage them in conversation.

Sales 40

Sales Prospecting Sales pitches Leads 40

European Pharmaceutical Review

DECEMBER 28, 2023

Finally, Andreas looks at the prospects for antibodies that target the innate immune system in treating both haematological malignancies and solid tumours. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

Legacy MEDSearch

APRIL 21, 2023

.” Premarket approval was granted based on clinical evaluation of Lava LES in a prospective, multicenter, single-arm study (the “LAVA study” ) evaluating safety and efficacy in acute peripheral arterial hemorrhages.

FDA 52

FDA Safety Recruitment Prospecting 52

European Pharmaceutical Review

JULY 20, 2023

Dr Baghirzade continued, highlighting that since a particular defining moment for the industry in the late 90s, which resulted in an unfortunate patient fatality, “there is a lot more focus on safety” in gene therapy clinical trials today. For cell and gene therapy, a “big issue” she stated, was the complexity of manufacturing.

Consulting 74

Consulting Manufacturing Side effects Safety 74

pharmaphorum

JANUARY 18, 2023

The ROSE2 study found that obicetrapib was able to reduce LDL cholesterol (LDL-c) levels when added to high-intensity statin therapy, raising the prospect that it could help patients struggling to manage their cholesterol levels with current drug therapy.

Pharma 59

Pharma Prospecting Patients Safety 59

European Pharmaceutical Review

JULY 25, 2022

This means falsified medicines may contain the wrong ingredients or low levels of the active ingredient – a terrifying prospect for a global consumer base reliant on medical treatments. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacture. Supply-chain visibility.

Pharmaceutical 104

Pharmaceutical Medicine Manufacturing Pharmaceutical manufacturing 104

Healthcare Success

JULY 5, 2022

Here are two ways to define your doctor audience: Target your best prospects Enhance your database to target more precisely. Target Your Best Prospects. The best way to target your best prospects is to define the type of clients you want to acquire by assessing your existing customer base. More data is always better.

Doctors 59

Doctors Physicians Marketing Prospecting 59

Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. Veal explains that secondary endpoints become more important when optimizing dosage.

FDA 115

FDA Side effects Pharmacology Patients 115

Pharmaceutical Technology

AUGUST 3, 2022

The discovery of a new chemical entity (NCE) that could potentially lead the way to a ground-breaking therapeutic treatment is an exciting prospect for any chemist. Safety and risk management should also be top-of-mind during process development.

Safety 52

Safety Pharmaceutical manufacturing Pharmaceutical Manufacturing 52