Pharmaceutical Technology

JULY 7, 2025

J&J gained prostate cancer rights for Zejula from Tesaro in 2016, the latter company was acquired by GSK. Akeega combines the active ingredients in GSK’s PARP inhibitor Zejula (niraparib) and J&J’s androgen blocker Zytiga (abiraterone).

Labelling

pharmaphorum

JULY 7, 2025

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Pharmaceutical Companies

pharmaphorum

JULY 2, 2025

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Pharmaceutical Companies

pharmaphorum

JULY 7, 2025

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Pharmaceutical Companies

pharmaphorum

JUNE 30, 2025

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Vaccines

Pharmaceutical Technology

MARCH 29, 2024

Vemlidy was first approved to treat adults with HBV in 2016. Its label was expanded in 2022 for use in patients 12 years and older.

Labelling

IDStewardship

MARCH 12, 2023

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. ” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication.

Medication Guidelines

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Documentation

pharmaphorum

JULY 1, 2021

neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device as an implant to lower blood pressure, among other applications. The Merck collaboration will concentrate on using the device alongside anti-inflammatory drug therapies.

Labelling

pharmaphorum

AUGUST 23, 2022

The phase 1/2 trial will be an open-label, dose-escalation study that will test various doses of BV-101 in between 12 and 18 subjects. In 2019, Bayer bought cell therapy company BlueRock Therapeutics, which was created in 2016 via a joint venture between Bayer and Versant Ventures.

Labelling

pharmaphorum

NOVEMBER 15, 2021

Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial. . billion in 2016 before the product was linked to an increased risk of lower limb amputation.

Labelling

European Pharmaceutical Review

DECEMBER 1, 2022

Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. About the Phase II/III study. 208 patients were recruited at 10 hospitals in the Democratic Republic of the Congo (DRC) and Guinea.

Labelling

pharmaphorum

JUNE 6, 2022

Xalkori is billed as an ALK inhibitor and has been approved to treat ROS1-positive NSCLC since 2016, with sales of $22 million in the first quarter, but is also used to treat ALK-mutated NSCLC and lymphoma. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

Chemotherapy

The Checkup by Singlecare

NOVEMBER 29, 2023

” MiraLAX—which is also used off-label for bowel preparation before a colonoscopy —is formulated to offer gentle, gradual relief. Always follow the instructions on the label for correct dosing. “This in turn increases the volume and water content of the stool, making it softer and more pliable. appeared first on The Checkup.

Pharmacy Program Director

The Checkup by Singlecare

FEBRUARY 2, 2024

According to a study published in 2016 in the journal Environmental Toxicology and Pharmacology , chlorophyllin showed some promise in targeting non-small cell lung cancer cells in mice. Another study published in 2016 also found that chlorophyll may be helpful for people with anemia. Pharmacopeia , UL Solutions , and Consumer Lab.

Compounding

pharmaphorum

AUGUST 11, 2022

These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4

Dosage

The Checkup by Singlecare

AUGUST 8, 2024

She also explains that “Zyrtec’s use for dogs is ‘ off-label.'” Check the drug’s packaging and label carefully before giving it to your pet. One 2016 study concluded that it performed about the same as a placebo in treating the condition, and an older study showed it reduced eczema symptoms in only 18% of dogs.

Dosage

Druggist

SEPTEMBER 15, 2020

Zovirax cream is available in two different pack types, each containing 2g of the cream: Aluminium tube Pump pack Zovirax Cold Sore Cream Aciclovir Tube 2 g Zovirax contains aciclovir, an anti-viral treatment; always read the label Fights the cold sore virus Works at the tingle and blister £6.98 Buy on Amazon Price incl.

Labelling

The FDA Law Blog

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

FDA

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

FDA

The Checkup by Singlecare

JANUARY 4, 2024

In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day. Read all medication labels and consult a healthcare provider for medical advice before consuming alcohol while taking medications for cough and cold symptoms.

Immunization

The FDA Law Blog

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD). Loose Ends IDEs.

FDA

The Checkup by Singlecare

MAY 1, 2024

The Centers for Disease Control and Prevention (CDC) estimated in 2016 that one in every 20 American children was on stimulant medication for ADHD. The manufacturer lists cocaine dependence as an off-label use. It can negatively affect children’s academic performance, behavior, and social skills.

Dosage

The FDA Law Blog

APRIL 21, 2024

Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. Thus, regardless of the technicality of an initial notification letter stating approval on September 30, 2022, Taiho was prohibited under the FDCA from marketing LYTGOBI with false labeling, 21 U.S.C.

Labelling

The Checkup by Singlecare

FEBRUARY 8, 2024

Clopidogrel and omega-3 fatty acids Omega-3 fatty acids are a popular dietary supplement, often labeled as fish oil capsules. Before you get too upset about this, check with your healthcare provider to see if any change in your coffee consumption is actually advised. Little known to most people, omega-3 fatty acids inhibit platelet activity.

Labelling

pharmaphorum

FEBRUARY 23, 2022

The drug was originally rejected for schizophrenia and bipolar by the FDA back in 2013 with a request for more clinical data, finally getting a green light two years later, and it then failed a phase 3 study in depression in 2016. Vraylar is now one of AbbVie’s fastest-growing products with sales expected to reach around $2.2

Labelling

Hospital Pharmacy Europe

SEPTEMBER 29, 2022

T-VEC was also approved by the EMA in 2016. In the phase 1 open-label trial discussed at the congress, PR2 was used as either mono-therapy and combined with nivolumab in a cohort of 30 patients with nivolumab given at a dose of 240 mg twice weekly for 4 months from the second RP2 dose, then 480 mg every four weeks for 20 months. .’

Immunization

The Checkup by Singlecare

MAY 24, 2024

It can also be used off-label for weight loss. OTC metformin substitutes for weight loss In certain situations, healthcare providers may prescribe metformin off-label for weight loss. Healthcare providers typically prescribe metformin along with a healthy diet and regular exercise routine.

FDA

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. 2016; 46: 479–93. The study included 92 adult patients with confirmed CDI. Intern Med J. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. Song JH, Kim YS.

Documentation

The FDA Law Blog

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.

Documentation

pharmaphorum

JULY 12, 2021

Merck’s chief science and technology officer Laura Matz said that Innerva’s platform could become “a true enabler for digital personalised treatment of patients suffering from severe and chronic diseases such as inflammatory disorders” An open-label, proof-of-concept study looking at a vagus nerve-stimulating implant as a therapy (..)

Labelling

pharmaphorum

OCTOBER 27, 2020

The PolarisDMD study failed across the board, leaving Catabasis with no choice but to abandon the drug, including an ongoing open-label extension study from an earlier failed trial in the muscle-wasting disease. We are deeply saddened and disappointed by the results of our Phase 3 PolarisDMD trial,” said Jill Milne, Catabasis’ CEO. “I

Labelling

The Checkup by Singlecare

JULY 20, 2024

However, healthcare professionals sometimes prescribe phentermine for off-label uses, such as for the treatment of ADHD. A 2016 article published in Frontiers in Pharmacology noted that phentermine has similarities with the CNS stimulant dexamphetamine, which is found in ADHD medications like Dexedrine, ProCentra, and Zenzedi.

Adverse Reactions

The FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).

FDA

The Checkup by Singlecare

DECEMBER 29, 2023

For this reason, some OTC cetirizine product labels recommend that seniors get medical advice from a doctor before taking it, but Zyrtec does not include this recommendation on its packaging. Read the package label or drug insert before taking Zyrtec. This is why it causes side effects like dry mouth. Take Zyrtec as instructed.

Packaging

pharmaphorum

JUNE 20, 2022

The serotonin (5-HT2A) receptor-selective inverse agonist has been approved for Parkinson’s psychosis since 2016, and brought in $481 million from that indication last year, but remains Acadia’s only commercial product. At one point it had been tipped as a future blockbuster.

FDA

pharmaphorum

AUGUST 5, 2020

In a recent analysis of data from 2016 at the Queen Elizabeth Hospital Birmingham, 75% of unplanned admissions, which account for almost 30,000 admissions per year, were for older adults. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. The hallmarks of aging. EBioMedicine.

Hospitals