This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Food Safety Side effects 
World of DTC Marketing
FEBRUARY 4, 2021
The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.
180 
World of DTC Marketing
APRIL 15, 2021
The major concerns for hesitancy included worries over side effects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness. The government allowed the drugmakers to mass-produce the vaccine while still conducting clinical trials.
Pharmaceutical Technology
MAY 16, 2023
The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. The trial has confirmed its safety and efficacy for the treatment of pain and fever in the targeted patients. All but one patient in the trial received a single dose of Caldolor.
Pharmaceutical Technology
APRIL 11, 2023
Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies. Together, Cerner Enviza and John Snow Labs have all the right expertise, data and technology to make it happen.”
59 
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.
European Pharmaceutical Review
OCTOBER 10, 2022
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline Biologicals’ Boostrix vaccine for use in pregnant woman in their third trimester, to prevent against whooping cough (pertussis) in infants up to two months of age.
105 
European Pharmaceutical Review
NOVEMBER 2, 2023
The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Like Stelara, the most serious known side effect of Wezlana is infection.
European Pharmaceutical Review
OCTOBER 7, 2024
New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials.
European Pharmaceutical Review
DECEMBER 18, 2023
Treatment-related side effects included nausea and headache but were generally mild. “As In terms of safety, they noted that being a part of the group calmed their fears and increased their sense of preparedness to engage in therapy. Participants described generally positive experiences.
Pharmaceutical Technology
NOVEMBER 23, 2022
The US Food and Drug Administration (FDA) has granted approval for CSL Behring’s adeno-associated virus vector-based gene therapy, Hemgenix (etranacogene dezaparvovec), to treat haemophilia B (congenital Factor IX deficiency) in adult patients. The trial is designed to analyse the safety and efficacy of Hemgenix.
European Pharmaceutical Review
DECEMBER 22, 2023
KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.
European Pharmaceutical Review
DECEMBER 7, 2022
The common, expected side effects were within expectations for a vaccine in this age group. The Commission on Human Medicines (CHM), which endorsed the authorisation, advises ministers on the safety, efficacy and quality of medicinal products. Data that facilitated the line extension of Comirnaty ® for Covid-19.
European Pharmaceutical Review
FEBRUARY 9, 2023
To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. Side effects seen in the trial included headache, dizziness, constipation, and increased urine output occurred with difelikefalin. The reduction from baseline in the worst itch score at week eight was 4.0
Pharmaceutical Technology
DECEMBER 7, 2022
On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.
64 
Pharma Marketing Network
MAY 3, 2023
Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs. References: 1.
52 
European Pharmaceutical Review
OCTOBER 21, 2022
At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B.
96 
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. The trial was designed to assess the safety and efficacy of trofinetide against placebo in 187 Rett syndrome female patients aged five to 20 years.
Pharmaceutical Technology
JULY 28, 2022
While data from the Phase III trial is not yet available, the Phase IIb CONDUCT trial (NCT03178669) assessed the efficacy and safety of cobitolimod in patients with moderately to severely active UC and demonstrated promising results and a strong safety profile.
European Pharmaceutical Review
OCTOBER 17, 2024
Additionally, EURneffy could alleviate the risk of accidental needle-related side effects (such as injection into the blood vessel and hand) 3 and it has the attributes of being smaller in size, has better temperature sensitivity, and is less complex to use compared to needle-based injectors. Motohiro E, Kento T, Kyohei T , et al.
PM360
NOVEMBER 29, 2022
Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.
Pharmaceutical Technology
JANUARY 24, 2023
The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Developed with the University of Edinburgh, the EXACT self-contained technology enables MeCP2 protein therapeutic levels while avoiding overexpression-related toxicities.
83 
European Pharmaceutical Review
JULY 5, 2022
Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.
104 
Pharmaceutical Technology
MAY 26, 2023
After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). In response to the approval news, some pointed concerns about long-term safety.
Pharma Leaders
JUNE 14, 2023
Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. It offers dual advantage of providing a longer duration of pain relief, with less systemic side effects, stated the company. According to the U.S.
Pharma Leaders
APRIL 19, 2023
Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). Diarrhea was the most common side effect using Xphozah in clinical trials. The Phase III trials were designed to assess the efficacy and safety of Xphozah.
European Pharmaceutical Review
NOVEMBER 9, 2023
Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.” The sarcopenia study met both of its primary endpoints.
pharmaphorum
AUGUST 11, 2022
Next, pharmacists review the participant’s genetic results – along with health data such as drug, lifestyle, and food interactions – to customize a “Medication Action Plan” that members’ physicians can access to determine which drugs should be prescribed to increase safety and efficacy.
81 
Pharma Leaders
MAY 18, 2023
The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.
Pharmaceutical Technology
JUNE 16, 2023
This includes the company’s upcoming Phase IIIb trial, but also another Phase III study and a long-term safety trial, said ANeuroTech CEO Eric Buntinx in an interview with Pharmaceutical Technology. Earlier this month, the US Food and Drug Administration (FDA) approved the drug’s investigational new drug application (IND) to start this trial.
European Pharmaceutical Review
MARCH 14, 2024
For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
European Pharmaceutical Review
MARCH 14, 2024
For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan). Internet] Vera Therapeutics. cited 2024Mar].
PM360
AUGUST 9, 2022
Accordingly, multiple reasons for subpar patient adherence are gaining attention, including fear of side effects, lack of medical understanding, or even financial limitations. Housing, access to food and transportation, as well as the ability to pay for healthcare and medicine are just a few economic barriers to medical adherence.
105 
Pharmaceutical Technology
JUNE 15, 2023
But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Food and Drug Administration approval. Pharma companies need tools like AI that can reliably improve this percentage without jeopardizing safety.
European Pharmaceutical Review
SEPTEMBER 22, 2023
Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.
European Pharmaceutical Review
DECEMBER 27, 2023
4 Manufacturing of CAR T-cell therapies: an overview In addition, multi-disciplinary teams must be established for in-house CAR T-cell therapy programmes to ensure maximum success and safety. US Food and Drug Administration. After this incident CAR-related toxicity scales and guidelines were established to prevent adverse reactions.
104 
European Pharmaceutical Review
JULY 18, 2024
1 As they can be highly targeted in their action, they could become the treatment of choice for clinicians and patients due to the reduced risk of side effects. Because ADCs offer a good way to specifically deliver an effective treatment to tumour systems, this could be an improvement on the systemic impact of chemotherapy.
Pharmaceutical Representative Training
JUNE 22, 2024
They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales. Communication Skills: Effective communication is essential when interacting with HCPs in order to build relationships in sales.
52 
Pharma Marketing Network
OCTOBER 3, 2024
A strong brand message conveys the unique value proposition of the pharmaceutical product, highlighting its benefits, efficacy, and safety. An effective brand message not only differentiates the product from competitors but also establishes credibility and trust with the target audience.
52 
Pharma Marketing Network
OCTOBER 1, 2024
One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. Advertisements must clearly communicate potential side effects and contraindications, ensuring that consumers and healthcare professionals can make informed decisions.
52 
Pharmaceutical Technology
AUGUST 17, 2008
Yes there has been some slowing in the approval of drugs from the FDA, in part due to legitimate concerns in relation to drug safety. In terms of concerns over safety, it has meant that the FDA has been essentially very cautious in moving forward. Some of that funding is going towards other efforts, including food safety.
European Pharmaceutical Review
DECEMBER 1, 2022
Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA). Further clinical study data for Rebyota.
World of DTC Marketing
SEPTEMBER 28, 2020
As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.
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.
Pharmaceutical Technology
FEBRUARY 23, 2023
In a previous FIH Phase I study, BOS172767 had shown poor and variable exposure with a large food effect, which had resulted in clinical progression being halted. This results in sponsors exiting FIH with not only safety, tolerability, and PK data, but also having performed formulation selection.
Expert insights. Personalized for you.
We have resent the email to
Are you sure you want to cancel your subscriptions?
Let's personalize your content