pharmaphorum

NOVEMBER 17, 2022

AstraZeneca has extended a contract to use a digital health device developed by ImpediMed that is being deployed in a trial of two of its drugs in chronic kidney disease (CKD). SOZO measures 256 data points over a spectrum of frequencies from 3 kHz to 1000 kHz, with results available immediately online to allow sharing.

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52

pharmaphorum

APRIL 14, 2022

ResApp’s technology was created to detect a wide range of respiratory conditions such as pneumonia, asthma, bronchiolitis and chronic obstructive pulmonary disease (COPD) using only the sound of a patient’s cough.

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PQA

AUGUST 11, 2023

Learn more about our commitment to standardized pharmacy measures below and how you can connect with us next week!We If you have news you'd like for us to spotlight in an upcoming Five For Friday, send us an email! The registration link is in the Member Resources Library. Learn more about this year's Leadership Summit.

Health and Personal Care Stores 52

Health and Personal Care Stores Community Pharmacies Immunization Vaccines 52

Pharmaceutical Technology

APRIL 13, 2023

ImaginAb will be responsible for licensing and supplying the clinical doses of 89Zr crefmirlimab berdoxam, its investigational CD8 ImmunoPET tracer, to Leucid Bio. Leucid Bio will use the CD8 ImmunoPET tracer along with LEU011 targeting NKG2DL, autologous CAR T-cells, in its basket study to treat solid tumours.

Labelling 52

Labelling Immunization 52

pharmaphorum

JULY 16, 2021

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront. . It is due to readout in the first half of next year.

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Hospital Pharmacy Europe

AUGUST 17, 2023

Cipaglucosidase alfa is a long-term enzyme replacement therapy (ERT) used in combination with the enzyme stabiliser miglustat for adults with late-onset Pompe disease. This rare, inherited lysosomal disorder is caused by deficiency of the enzyme acid alpha-glucosidase (GAA).

Hospitals 98

Hospitals 98

pharmaphorum

NOVEMBER 16, 2021

In the second of a two-part series, Leela Barham argues that whilst international comparisons of uptake are useful, there could be more to gain from looking at more medicines and their uptake in England rather than looking at a small set of medicines and their uptake internationally. Broaden the scope of work to more medicines.

Dosage 93

Dosage 93

European Pharmaceutical Review

NOVEMBER 3, 2022

EMA’s Committee for Medicinal Products for Human Use (CHMP) decides the product is of high importance for public health and therapeutic innovation. It combines GSK’s proprietary AS01E adjuvant, which contains QS-21 Stimulon adjuvant licensed from Antigenics Inc. Accelerated assessment?is is offered to MAAs if the?EMA’s

Vaccines 91

Vaccines 91

European Pharmaceutical Review

MARCH 1, 2023

Three-dimensional images using computed tomography (CT) provide a valuable, non‑invasive insight into the inner morphology of freeze-dried products. While traditional optical methods can only assess the surface, X-ray technology can be used to display the internal structure, and thus may detect defects and deviations in geometry.

Dosage 82

Dosage 82

European Pharmaceutical Review

NOVEMBER 2, 2023

Short-term measures to take control of current shortages in addition to longer-term, preventative actions have been part of the industry’s collective response. They could provide a temporary replacement for potentially unavailable, essential licensed medicines, the EDQM explained in its statement.

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pharmaphorum

JUNE 17, 2021

Tau is a protein that is found in cells of the central nervous system and is involved in the assembly and stabilisation of neuronal microtubules – channels used to transport substances to different parts of the nerve cell. In Alzheimer’s, the protein runs amok, forming tangles that have been linked to cell damage and neuronal death.

Immunization 98

Immunization 98

Impact Pharmaceutical Services

MAY 4, 2022

Abbreviations: BLA= Biologics License Application; IND= Investigational New Drug; NDA= New Drug Application; RMAT= Regenerative Medicine Advanced Therapy. *A A clinically significant or meaningful endpoint directly measures how a patient feels, functions, or survives and represents or characterizes the clinical outcome of interest.

FDA 52

FDA Documentation Communication 52

pharmaphorum

FEBRUARY 24, 2021

US biotech Day One has taken ownership of a cancer drug that has been languishing in Merck KGaA’s pipeline for years, in the hope of giving it a new lease of life. . The financial details of the Merck licensing deal haven’t been made public. The financial details of the Merck licensing deal haven’t been made public.

Chemotherapy 71

Chemotherapy Compounding FDA 71

The People's Pharmacy

JUNE 12, 2023

Several readers have written about using the sugar remedy in such cases. This old-fashioned approach may not work miracles, but many people praise its usefulness. If I ordered that mixture for a patient today, I’d lose my license. But I did use it on my mother and the decubiti cleared in a week. It worked.

Nursing Homes 78

Nursing Homes Hospitals 78

pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. The post Santhera seeks speedy FDA review of Duchenne drug vamorolone appeared first on.

FDA 98

FDA Immunization 98

Druggist

AUGUST 3, 2020

Otrivine Extra Dual Relief indicated use Otrivine Extra spray is used for the management of congestion and rhinorrhoea caused by colds. When used locally, for example, application inside the nose, ipratropium bromide stops secretions from the glands located in the lining of the nose (Bausch & Lomb, 2016).

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98

European Pharmaceutical Review

OCTOBER 12, 2023

Manfrin told EPR that a key challenge in developing the scheme was “ensuring a robust process for measuring the scheme’s success. Manfrin told EPR that a key challenge in developing the scheme was “ensuring a robust process for measuring the scheme’s success.

Communication 92

Communication 92

pharmaphorum

JUNE 6, 2022

months – a result that AZ said is “potentially redefining treatment for approximately half of all patients with breast cancer” It’s a spectacular result in a patient population with few effective treatment options and the first clear evidence that anti-HER2 therapy can be useful in a much broader range of patients than at present.

Chemotherapy 104

Chemotherapy 104

Pharmaceutical Technology

OCTOBER 14, 2022

The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients. Xcellbio said that the AVATAR AI technology uses the tight environmental control of the AVATAR product family.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

The FDA Law Blog

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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FDA Packaging 119

pharmaphorum

JANUARY 5, 2023

Addiction treatment specialist Spero Health has expanded an agreement to use Pear Therapeutics’ prescription digital therapeutics (DTx) in its network of US clinics. We believe having access to patient-reported data via Pear’s clinician dashboard gives us better insight into patient behaviours.”.

Labelling 52

Labelling FDA 52

pharmaphorum

MAY 24, 2022

Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts. There’s also a licensed antiviral drug for monkeypox.

Vaccines 92

Vaccines Labelling FDA 92

European Pharmaceutical Review

JANUARY 25, 2023

DEG and EG are toxic chemicals used as industrial solvents and antifreeze agent. Ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorised/licensed suppliers in the supply chain. Most are young children under the age of five.

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pharmaphorum

NOVEMBER 10, 2022

Annual checkups, cancer screenings, and vaccines are just some of the preventative measures that can help save lives, reducing the need for treatment and reliance on potentially costly medicines that are in short supply. Though often used interchangeably, there’s a key difference between the two terms. Preventive vs. diagnostic care.

Vaccines 96

Vaccines 96

Pharmaceutical Technology

JUNE 7, 2023

Rocuronium is a widely used intermediate-acting neuromuscular blocker. Baudax Bio also reported that additional data measured by electromyography (EMG) showed BX1000’s comparableness to rocuronium. All three agents are licensed from Cornell University, New York. mg/kg administered intravenously.

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52

Pharmaceutical Technology

APRIL 19, 2023

While the Clarksville, US-based company completed a Phase Ia study in healthy participants to eventually develop the drug for Alzheimer’s disease, it is likely that the company will now focus on Parkinson’s disease in its Phase II study first, said Kelleher-Andersson. Similarly, research collaborations are also a consideration.

Compounding 52

Compounding FDA 52

pharmaphorum

SEPTEMBER 20, 2021

The answer is probably, but to stop using them entirely would be short-sighted. Similar to how the advertising industry has shifted to using digital tools rather than older methods of mass marketing such as newspapers and tv commercials, personalisation is key to the future of pharma sampling. “An Personalisation is Key.

Communication 98

Communication 98

European Pharmaceutical Review

JULY 13, 2023

1,2 Yet the pace of adoption in Europe has notably lagged countries such as Canada, Australia and the US. 1 In many countries, medical cannabis is only utilised as a therapy when licensed medications have proven ineffective. The European Cannabis Report (7th Ed.). Expert Review of Clinical Pharmacology. 2023 Mar 4;16(3):257-66.

Compounding 84

Compounding Documentation Insurance Immunization 84

Pharmaceutical Technology

MARCH 9, 2023

According to GlobalData’s Technology Foresights, which uses over 756,000 patents to analyse innovation intensity for the pharmaceutical industry, there are 110 innovation areas that will shape the future of the industry. Immatics has established two proprietary cancer cell target and TCR discovery platforms, namely XPRESIDENT and XCEPTOR.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

DECEMBER 2, 2021

It will focus its efforts initially on neurological diseases like Alzheimer’s and Parkinson’s, using technologies that can measure how disease alters tissues, cells and proteins, with the aim of increasing the success rate of drug discovery and development. billion to the pot.

Vaccines 88

Vaccines 88

pharmaphorum

OCTOBER 19, 2021

Eli Lilly made a late entry into the checkpoint inhibitor market when it licensed ex-China rights to Innovent’s sintilimab last year, and a new trial in lung cancer will raise its hopes of getting a good return on its investment.

Chemotherapy 52

Chemotherapy Hospitals 52

The FDA Law Blog

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

FDA 64

FDA 64

pharmaphorum

NOVEMBER 30, 2021

Eisai has licensed rights to a cognition-checking algorithm developed by Australian digital health company Cogstate, which it uses in an app – called NouKNOW – that allows people to check their brain health. Phone users will be provided with BPI checks at no cost using the app up to four times a year.

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Pharmaceutical Technology

APRIL 13, 2023

Released on April 12, the report focuses on bluebird bio’s lovotibeglogene autotemcel and Vertex Pharmaceuticals and CRISPR Therapeutics’ exagamglogene autotemcel or exa-cel and their potential use in treating sickle cell disease. Bluebird already uses a lentiviral vector in its approved gene therapy for beta-thalassemia called Zynteglo.

FDA 59

FDA 59

pharmaphorum

MAY 30, 2022

RhoC overexpressed in cancer cells that are prone to spreading compared with healthy cells across multiple cancer types, raising the hope that RV001 could be a broadly useful, tumour agnostic treatment for cancer.

Vaccines 70

Vaccines 70

pharmaphorum

JULY 29, 2022

ESRD tend to have underlying conditions like diabetes, high blood pressure, atrial fibrillation, and cardiovascular disease that increase their risk of blood clots, and systemic anticoagulants are routinely used as a preventative measure. However, the high rates of haemorrhage make the treatment challenging.

FDA 70

FDA 70

European Pharmaceutical Review

DECEMBER 21, 2022

Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). This EU pathway is typically used when sponsors want to broaden a therapeutic’s indications, but regulators require more data.

Compounding 107

Compounding Controlled Substances FDA Patient Care 107