XTalks

DECEMBER 18, 2024

While manageable, the condition requires lifelong treatment and monitoring to prevent complications and ensure healthy development. In 2018, the company also received approval for Orilissa (elagolix), which it licenses to AbbVie, for the treatment of endometriosis. billion in revenue by 2024.

Genetics 116

Genetics Hormones Trials Drugs 116

Pharmaceutical Technology

OCTOBER 31, 2022

The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). The regulator has set 29 August 2023 as a Prescription Drug User Fee Act (PDUFA) goal date.

FDA Approval 147

FDA Approval Pharmacy Licensing Licensing 147

XTalks

MARCH 17, 2025

Roche, a global leader in biotechnology and diagnostics, has entered into an exclusive collaboration and licensing agreement with Zealand Pharma, a specialist in innovative therapeutics, to co-develop and co-commercialize petrelintide as a potential foundational therapy for people with overweight and obesity. billion $1.4 billion $1.4

Hormones 59

Hormones Drugs Sales Insulin 59

pharmaphorum

SEPTEMBER 29, 2021

The 10 startups – all from the US – will now embark on a four-week programme of assessment, training and development to ensure their technologies are ready for widespread deployment in the Amazon Web Services (AWS) cloud. The finalists are: AIVA , a startup that has developed a voice operating system for patient care.

FDA Approval 138

FDA Approval Pharmacy Development Containment 138

Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

Pharmacy 100

Pharmacy Production Development Clinical Trials 100

Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Danicamtiv overview Danicamtiv (MYK-491, DCM-1) is under development for the treatment of dilated cardiomyopathy (DCM), atrial fibrillation and systolic heart failure.

Drugs 100

Drugs Development Production Pharmacy 100

Druggist

SEPTEMBER 7, 2020

However, it has been documented that when used regularly, tolerance develops rapidly (Vande Griend, Anderson, 2003), within a few days of starting the treatment. All products containing diphenhydramine and promethazine are classified as pharmacy-only medicines (P). Nytol Original and One a Night is available only from pharmacies.

Containment 94

Containment Pharmacy Production Licensing 94

Pharmaceutical Technology

JUNE 9, 2023

The FDA accepted nirsevimab’s biologics license application (BLA) in January, with a PDUFA date penned for Q3 2023. The drug performed “extraordinarily well” in a variety of cohorts, said Nimish Patel, PharmD, professor of clinical pharmacy at University of California San Diego.

FDA Approval 147

FDA Approval Antibody Allergies Packaging 147

Pharma Mirror

MAY 7, 2022

a market leading global biotechnology company focused on developing next generation ImmunoPET imaging agents and therapeutic radiopharmaceuticals (RPT), is pleased to announce it has signed a new multi-year, non-exclusive supply agreement with Genmab A/S, an international biotechnology company. Los Angeles, CA, USA, ImaginAb, Inc.,

Clinical Trials 100

Clinical Trials Clinical Trials Licensing Licensing 100

XTalks

SEPTEMBER 13, 2024

Early this year, Elevance closed its acquisition of Paragon Healthcare, enhancing its specialty pharmacy and infusion services capabilities. In a large-scale collaborative real-world study , HCA helped develop an algorithm-driven tool, tested across 82 hospitals, that reduced hospital outbreak sizes by 64 percent before the pandemic.

Marketing 98

Marketing Pharmacy Gene Therapy Hormones 98

Druggist

APRIL 6, 2021

All eye ointments which are alternative to Lacri-Lube can be purchased from pharmacies and online. #. Most alternatives should be available from high street pharmacies or online. Some products are classified as pharmacy-only medicines, which means they can only be purchased from the pharmacy and online chemists.

Pharmacy 93

Pharmacy Containment Sales Production 93

FDA Law Blog

JUNE 3, 2021

A summary of these new state law developments is included below. Under the 2019 law, the price increase report had to contain, among other things, aggregate research and development costs, factors that led to the WAC increase, and the role of each factor’s impact on the cost.

Development 52

Development Drugs Manufacturing Pharmacy 52

Druggist

JULY 22, 2020

Promethazine is an antihistamine commonly available in the UK pharmacies. All products listed above are licensed as pharmacy only medicines – ‘P’ products. P products can only be purchased from a pharmacy, including online pharmacies. Promethazine cough syrup: where to get it?

Nurses 52

Nurses Pharmacy Containment Licensing 52

Druggist

JULY 29, 2020

The strongest over the counter steroid cream (OTC): legal classification Eumovate cream, which is available over the counter without a prescription, is classified as pharmacy-only ‘ P ‘ medication. ‘P’ medicines can only be sold in pharmacies, including online pharmacies with a pharmacist being present at the premises.

Pharmacy 72

Pharmacy Doctors Doctor Licensing 72

Druggist

SEPTEMBER 15, 2020

Zovirax cream for cold sores can be purchased over the counter from pharmacies and supermarkets. Zovirax cream for cold sores is licensed for the treatment of infections caused by Herpes simplex virus presented on lips or face in children and adults. It can be purchased from any retail outlets, including supermarkets and pharmacies.

Containment 98

Containment Pharmacy Sales Drugs 98

The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

Druggist

FEBRUARY 24, 2021

Certain factors may contribute to the development of haemorrhoids, including (NICE, 2016): . Maintaining a good diet (high in fibre) and drinking plenty of fluids is the main recommendations to minimise the episodes of constipation and possible development of piles. Causes and risk factors for haemorrhoids. Constipation . £5.72.

Containment 96

Containment Pharmacy Production Sales 96

Druggist

JANUARY 9, 2021

With approximate 190,000 migraine attacks experienced by people in the UK (NICE, 2012), pharmacies are among the first points of call to find over the counter migraine medication. This post will focus on the acute management of migraines with drugs, which can be purchased over the pharmacy counter. Price incl.

Containment 98

Containment Pharmacy Drugs Production 98

Druggist

SEPTEMBER 20, 2020

Parents have only one option for baby thrush treatment – over the counter antifungal oral gel (Daktarin Sugar-Free 2% Oral Gel), which be purchased from pharmacies only. The following restrictions exist on the availability and supply of Daktarin Oral Gel: Daktarin Oral Gel is a pharmacy-only medicine. References: eMC (2020).

Pharmacy 75

Pharmacy Doctor Doctors Licensing 75

Druggist

SEPTEMBER 1, 2020

Loperamide can be purchased over the counter in most supermarkets, pharmacies and online. When purchased outside the pharmacy counter, loperamide is limited in size to 6 capsules or tablets per pack. Larger packs / multiple-packs of loperamide can be bought from a pharmacy or online chemists, including Amazon’s 3rd party sellers.

Pharmacy 59

Pharmacy Containment Branding Production 59

XTalks

NOVEMBER 28, 2023

Featuring Ilsun Hong, VP and Product Evaluation Team Leader, and Thomas Newcomer, VP and Head of US Market Access at Samsung Bioepis, the discussion revolves around key developments, challenges and future trends in biosimilars. In this interview, Xtalks delves into the advancements from Samsung Bioepis, a leader in the biosimilar industry.

Production 98

Production Marketing Development Pharmacy 98

XTalks

FEBRUARY 8, 2021

As a subset of biosimilars, interchangeable biological products can be substituted for the reference product at the pharmacy level, without the input of the prescribing physician. Biosimilars developers may also be required to conduct PK/PD studies and assess the immunogenicity of their product prior to approval.

Production 78

Production Insulin Branding Generic Drugs 78

Drug Channels

OCTOBER 19, 2020

Channel Strategy for First Medical Product – A Look at Channel Considerations for Pharmacy vs. Medical Plus – Tailored Track Options Based on Company Size : Emerging/Small Companies – Infrastructure Set-Up, License Procurement and 3PL Contracting Mid-Large Companies – How Do I Think About My Portfolio Differently Based on Product Type?

Life Science 52

Life Science Pharmacy Gene Therapy Gene 52

The Pharma Data

NOVEMBER 8, 2020

At some hospitals, it can take up to 30 minutes to get a status epilepticus drug from the pharmacy to the point of care in the ER to treat a patient. Sedor Pharmaceuticals, LLC identifies, acquires and develops acute care pharmaceutical assets for commercial licensing. Both products were licensed from Ligand Pharmaceuticals.

FDA Approval 52

FDA Approval Licensing Licensing Production 52

XTalks

APRIL 24, 2023

To achieve this, Medpace works in multi-disciplinary teams of experts to jointly develop and execute advanced therapy protocols. For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Druggist

NOVEMBER 6, 2020

In today’s post, I will seek to find the best medicine for chesty cough by looking at over the counter and pharmacy-only products available in the UK. Products containing just guaifenesin are available for self-selection in supermarkets, pharmacies and online. Non-drowsy chesty cough syrups 1. . £4.39 delivery 5.

Medicine 69

Medicine Containment Production Pharmacy 69

Druggist

MARCH 8, 2021

In the UK, modafinil has narrow licensed use. The second licensed use of modafinil covers individuals who experience excessive sleepiness , defined as difficulty keeping wakefulness and an increased likelihood of falling asleep in inappropriate situations (eMC, 2020). A doctor or another qualified prescriber can only prescribe POMs.

Drugs 90

Drugs Licensing Licensing Doctors 90

The Pharma Data

SEPTEMBER 30, 2021

” To solve those problems, Varadarajan collaborated with Xinli Liu, professor of pharmaceutics at the UH College of Pharmacy, and an expert in nanoparticle delivery. a pioneering biotech company developing novel intranasal vaccines and therapies to assist patients defeat debilitating diseases, including COVID-19.

Vaccination 52

Vaccination Vaccine Immune Response Licensing 52

XTalks

MARCH 22, 2023

Our webinars have become a key vendor-selection tool for decision-makers across the drug development pipeline — from discovery to commercialization — which is why all ten of the top ten contract research organizations (CROs) have worked with Xtalks. Click on the infographic to explore the data.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

MARCH 26, 2021

The new data is a testament to the companies’ ongoing commitment to developing this vaccine further and collecting data in order to support broader and more flexible vaccine distribution and inoculation. The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

Vaccination 52

Vaccination Vaccine Doctors Doctor 52

The Pharma Data

NOVEMBER 1, 2020

It is a very exciting step for our Pharmaceutical Wholesale Division and a unique chance for us to further develop innovative services to manufacturers and pharmacists in Germany.”. Together, we look forward to delivering a successful model of operations to benefit the German healthcare ecosystem of patients, pharmacies and manufacturers.”.

Pharmacy 40

Pharmacy Manufacturing Medicine Licensing 40

Pharmacy Checkers

DECEMBER 12, 2019

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Perhaps most troubling is that when inspectors’ findings included the most severe designation, called Official Action Indicated, the FDA’s Center for Research and Development (CEDR) downgraded that determination to Voluntary Action Indicated.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Client Pharma

APRIL 9, 2020

Gary and Jonathan’s enthusiasm is infectious, and they have a clear vision on how they want the business to develop. I generally work behind the scenes developing processes and solutions to ensure that we get products to our clients on time and under the right specifications within the territorial regulatory guidelines.

Clinical Trials 52

Clinical Trials Clinical Trials Pharmacy Licensing 52

Client Pharma

APRIL 9, 2020

Gary and Jonathan’s enthusiasm is infectious, and they have a clear vision on how they want the business to develop. I generally work behind the scenes developing processes and solutions to ensure that we get products to our clients on time and under the right specifications within the territorial regulatory guidelines.

Clinical Trials 52

Clinical Trials Clinical Trials Pharmacy Licensing 52

The Pharma Data

JANUARY 18, 2021

BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to announce that Health Canada has confirmed that 2-bromo-LSD is not a controlled substance. VANCOUVER, Jan.

Containment 40

Containment Production Drug Delivery Regulation 40

Pfizer

DECEMBER 20, 2022

It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs 69

Drugs Licensing Licensing Containment 69

Druggist

AUGUST 19, 2020

A qualified prescriber needs to produce a prescription for quinine so that it can be supplied in the pharmacy. In the UK quinine is licensed for leg crams (nocturnal) and treatment of some forms of malaria. Crampex was the only over the counter medicine licensed for night muscle cramps. and other online websites and outlets.

Containment 69

Containment Production Pharmacy Doctor 69