Sat.Aug 13, 2022 - Fri.Aug 19, 2022

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3 ways pharma can prep for Biden’s sweeping drug pricing policies

PharmaVoice

Now that Medicare will be able to negotiate drug prices under the Inflation Reduction Act, the industry can expect to see some changes. Here are some tips on how to navigate the changing tide.

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MHRA approves Pluvicto® and Locametz® for prostate cancer

European Pharmaceutical Review

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Pluvicto ® (lutetium [ 177 Lu] vipivotide tetraxetan), for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

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UK first to approve Moderna’s Omicron booster jab

pharmaphorum

The UK has become the first country in the world to authorise an updated COVID-19 booster vaccine directed at the Omicron variant, giving a green light to Moderna’s mRNA-1273.214 shot. The new vaccine is an updated version of Moderna’s widely-use Spikevax vaccine, which includes sequences from the original Wuhan strain of SARS-CoV-2, as well as from the Omicron BA.1 subvariant.

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Leading by Example

The Honest Apothecary

It is my conviction that managers really do make all the difference in the world. Great managers get great results and build great teams. Bad managers don’t. But it is also my conviction that managers generally mirror the leadership culture created by those they report to. There is, if you will, a “trickle down” effect in the style and priorities of your management.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Right under our noses: Could COVID-19 vaccines be better as nasal spray?

PharmaVoice

Nasal vaccines under development by Codagenix, Xanadu Bio and others have the potential to finally help reduce virus transmission and breakthrough infections.

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UK approves Moderna’s bivalent COVID-19 vaccine

European Pharmaceutical Review

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated version of Moderna’s COVID-19 vaccine, Spikevax, that targets two coronavirus variants as a booster. The regulator confirmed that the vaccine meets its standards of safety, quality and effectiveness. The decision was also endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after a careful review of the evidence.

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More Trending

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Auransa, Polaris harness AI, quantum computing to discover cancer drugs

Outsourcing Pharma

The AI and QC specialists have joined to use AI and QC in order to discover biological pathways relevant to the treatment of triple-negative breast cancer.

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Woman of the Week: Takeda Oncology’s Teresa Bitetti

PharmaVoice

Upon joining Takeda Pharmaceuticals as president of the global oncology unit, Teresa Bitetti had two important goals: to transform the business and create greater synergies between commercial and R&D operations.

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Copper coated surfaces found to reduce COVID-19 transmission

European Pharmaceutical Review

Research suggests copper (Cu) and silver (Ag) coated surfaces display significant differences in antiviral properties and that while copper is effective at reducing Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2; the cause of COVID-19) transmission, silver is not. As a result of corrosion, both copper and silver release positively charged ions into their environment, which can prevent bacterial growth or kill off the cells completely.

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GSK gets June 2023 FDA decision date for momelotinib

pharmaphorum

The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 billion acquisition of Sierra Oncology which completed last month. The US regulator is due to make a decision on momelotinib by 16 June, 2023, on the basis of phase 3 results reported in January, said GSK.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Scientists hope nasal vaccines will help halt Covid transmission

The Guardian - Pharmaceutical Industry

Unlike jabs, nasal vaccines target the respiratory tract, the body’s first line of defence against infection People who receive a Covid booster dose in the UK next month will be among the first in the world to receive Moderna’s dual-variant vaccine , which protects against two strains of the virus. But scientists say there is a misconception that this latest vaccine is an upgrade on what has come before.

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The CEO in the ophthalmologist’s coat

PharmaVoice

In balancing two roles — Lexitas CEO and practicing physician — George Magrath brings a patient-first perspective to developing and advancing eye treatments.

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Industry 1VQ Solutions: Change of Lot or Extension of Shelf-life of Reference Standard

PharmaTech

Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.

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Atomwise and Sanofi partner for drug discovery using AI

Pharmaceutical Technology

Atomwise and Sanofi have entered a strategic and exclusive research partnership to use the former’s artificial intelligence (AI)-driven AtomNet platform to discover and research up to five drug targets computationally. The approach of Atomwise makes the process of drug discovery more logical and efficient by moving away from serendipitous discovery and toward a search that is structure-based.

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New patent for Pharmacyclics Inc drug IMBRUVICA

Drug Patent Watch

Annual Drug Patent Expirations for IMBRUVICA Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty patents…. The post New patent for Pharmacyclics Inc drug IMBRUVICA appeared first on DrugPatentWatch - Make Better Decisions.

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Inventing the COVID vax pill: a matter of convenience and durability

PharmaVoice

Recent data from Vaxart’s phase 1 trial of its COVID-19 inoculation pill shows potential.

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Phase III trial shows tislelizumab improves outcomes for liver cancer patients

European Pharmaceutical Review

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . Hepatocellular carcinoma, or HCC, is the sixth most common type of cancer worldwide. HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. .

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IN FOCUS: Northgate Technologies

Pharmaceutical Technology

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The Verdict. Northgate Technologies Inc. (NTI) is a Illinois based producer of medical devices and technologies for the healthcare sector, with a particular focus on surgical environments. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories.

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Positive appraisal for Eisai’s Kisplyx in combination with MSD’s Keytruda

Pharma Times

NICE approval is for first-line treatment of intermediate and advanced renal cell carcinoma

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The FDA is mulling an OTC approval for a birth control. Will politics factor in?

PharmaVoice

Analysts are watching how cultural and political debates around reproductive rights may impact HRA Pharma's OTC birth control application.

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Frequently Asked Questions About CCRN Certification 

Board Vitals - Pharmacist

CCRN certification is a special certification granted by the American Association of Critical Care Nurses (AACN). CCRN certification is valuable for nurses, as it allows RNs to care for patients in acute care and/or critical care setting. We’ve compiled some of the most frequently asked questions about CCRN certification to help you prepare for the exam and maintain your licensure.

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What I Packed for a Miami Bachelorette

The Luxe Pharmacist

Hello friends, I cannot wait for my girlfriends bachelorette this weekend in Miami! (Currently publishing this from the airport). I’m expecting a lot of heat given that it’s mid August, so I figured I may as well bring the heat as well! I’m sharing everything I packed and more if you need some inspiration for an upcoming bachelorette trip, date night, girls night out or tropical vacay.

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IBNCC – Approach to CNS infection

EMCrit Project

This chapter explores some general aspects of neurological infectious diseases, including important historical features and high-risk groups. It also includes a more general discussion of lumbar puncture performance and interpretation. The IBCC chapter is located 👉 here. The podcast & comments are below. Follow us on iTunes. EMCrit Project by Josh Farkas.

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The 340B Program Climbed to $44 Billion in 2021—With Hospitals Grabbing Most of the Money

Drug Channels

Here’s a summer surprise for fans of the 340B Drug Pricing Program: Drug Channels has just obtained the 2021 figures from the Health Resources and Services Administration (HRSA)! Even better, my Freedom of Information Act (FOIA) request was able to pry out detailed purchases by covered entity type. The data tell a familiar story. For 2021, discounted purchases under the 340B program reached a record $43.9 billion —an astonishing $5.9 billion (+15.6%) higher than its 2020 counterpart.

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Pharma contract manufacturing market to grow to $130bn by 2026

European Pharmaceutical Review

Rising demand for therapeutics, especially in developing markets, is expected to expand the global pharmaceutical contract manufacturing market to $130.2 billion by 2026. The market was valued at approximately $100 billion in 2020. According to market research , factors promoting the 4.6 percent compound annual growth rate (CAGR) of the market include the increasing commercialisation of generics and emerging technologies and small biotechs with limited or no production capabilities driving devel

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From nasal vaccines to pills: the next defences against Covid

The Guardian - Pharmaceutical Industry

Analysis: a bivalent vaccine has been approved and research is being carried out into possible pan-coronavirus vaccines When the autumn booster programme begins next month, many people are likely to receive Moderna’s new bivalent vaccine , designed to protect against the original Covid strain and the more transmissible Omicron variant. As Covid continues to evolve, so will vaccination strategies.

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The Changing Landscape of Digital Trials

PharmExec

Richard Young, Vice President of Strategy, Vault CDMS and Tim Davis, Vice President of Strategy, MyVeeva for Patients, discuss the future of digital trials and their impact in the industry.

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Dr B raises $8m for telehealth service to deliver COVID antivirals

pharmaphorum

US startup Dr B – formed in 2021 to help match patients seeking a COVID-19 vaccine to suppliers with leftover stock – is branching out into antivirals with the help of an $8 million fundraising. The cash injection will be used to launch a telehealth service that promises to provide prescriptions and services to patients regardless of their ability to pay.

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Merck to support development of Orna’s circular RNA (oRNA) therapies

European Pharmaceutical Review

Merck (MSD outside of the US and Canada) has entered into a collaboration agreement with Orna Therapeutics to discover, develop and commercialise multiple programmes of engineered circular RNA (oRNA) therapies, including vaccines and therapeutics in the areas of infectious disease and oncology. Under the agreement, Merck will make an upfront payment to Orna of $150 million.

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New Year, New Services

PioneerRx

Forget the old fill-and-bill — 2022 is all about implementing clinical services that boost your bottom line. In the last year, independent pharmacists gained more.

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MHRA authorises Moderna’s omicron-containing bivalent booster

Pharma Times

Study results show the candidate has demonstrated significantly higher antibodies against Omicron

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Endo files for bankruptcy as it agrees opioid settlement

pharmaphorum

Endo International is the latest drugmaker to file for chapter 11 bankruptcy protection in connection with opioid litigation in the US, after agreeing a $6 billion deal with creditors that includes an offer to settle outstanding lawsuits. The Ireland-domiciled company is struggling under the weight of around $8 billion in debt, and has been hamstrung by costs associated with fighting thousands of suits that accuse it of wrongdoing in its marketing and promotion of painkiller Opana ER (oxymorphon

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Tackling the silent pandemic: AMR Industry Alliance sets the Standard

European Pharmaceutical Review

Antimicrobial resistance (AMR) is a growing concern worldwide. Recognised as one of the top 10 global health changes by the World Health Organization (WHO), 1 it was found to have played a role in 4.95 million deaths in 2019 and been the direct cause of 1.27 million of these, 2 meaning drug-resistant infections killed more people than HIV/AIDS (864,000 deaths) or malaria (643,000 deaths). 3 Just six resistant bacteria accounted for almost 80 percent of the direct deaths, with antibiotic-resistan

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UK MHRA grants authorisation for Moderna’s Covid-19 booster vaccine

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. The updated, Omicron-containing bivalent vaccine that acts on two coronavirus variants is indicated as a booster dose for active immunisation for the prevention of Covid-19 in people of this age group.

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Santen launches Ducressa for post-cataract surgery

Pharma Times

Treatment involves a combination of levofloxacin and dexamethasone for use after cataract surgery

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