STAT
SEPTEMBER 6, 2022
WASHINGTON — Researchers studying next-generation vaccines to fight an evolving Covid-19 threat are running into problems getting existing vaccines to use in their research. Because Pfizer and Moderna hold the patents for the current vaccines, researchers would likely have to get the companies’ permission to use them for research into products like nasal or pan-coronavirus vaccines.
PharmaVoice
SEPTEMBER 6, 2022
From standout executives to R&D pioneers — this year’s class of honorees is defining the next era of leadership.
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pharmaphorum
SEPTEMBER 5, 2022
Sam Crowther, founder and CEO of cybersecurity company Kasada, tells us about a recent discovery his company made that revealed tens of thousands of accounts with prescription drug attachments in major online pharmacies had been compromised. While performing analysis for a client of online accounts for sale, Kasada uncovered a new and illegal way bots are being used – to steal pharmacy customers’ accounts and resell prescriptions on a secondary market for in-demand substances, such as Oxyc
Pharmaceutical Technology
SEPTEMBER 5, 2022
Following AstraZeneca’s success in vaccine development during the Covid-19 pandemic , the pharmaceutical giant is now looking to expand its scope through acquisitions across a range of indications, says CEO Pascal Soriot. “We want to be a sustainably growing company. Until 2025, we have strong growth ahead of us, but we also believe we can continue to grow very strongly post-2025 and it’s all about innovation in the pipeline.”.
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.
STAT
SEPTEMBER 8, 2022
At the end of an unusual and dramatic meeting on Wednesday, an independent panel of advisers to the Food and Drug Administration recommended the approval of a new drug to treat people with ALS developed by Amylyx Pharmaceuticals. The vote was 7-2, a substantial margin of support for the Amylyx drug called AMX0035 and a reversal of the same group’s vote against the drug last March.
PharmaVoice
SEPTEMBER 6, 2022
Real-world data (RWD) from clinical drug registries can and should be used throughout the drug development lifecycle. At all stages, registries ensure that assumptions about the current standard of care are accurate and evidence-based.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 8, 2022
Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 programme of Good Therapeutics.
STAT
SEPTEMBER 8, 2022
Nothing has made the nation’s addiction epidemic more deadly than fentanyl’s infiltration of the drug supply. Yet in more than a dozen states, tools used to detect the ultra-potent synthetic opioid are still classified as drug paraphernalia — making it a crime to possess or distribute them. The practice of “drug-checking” — essentially, testing illicit drugs to see if they contain unknown toxins — has remained controversial even as the crisis of f
PharmaVoice
SEPTEMBER 8, 2022
Supply chain challenges, labor shortages and increased FDA inspections are boosting recall risks — but careful planning can keep companies in the clear.
pharmaphorum
SEPTEMBER 6, 2022
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an agreement on price with the drugmaker. The health technology assessment (HTA) authority said that the PARP inhibitor “is not cost-effective at its current price” as a treatment for BRCA-positive prostate cancer that has spread to other parts of the body and relapsed after prior hormonal therapy.
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Pharmaceutical Technology
SEPTEMBER 5, 2022
Bayer has agreed to make a payment of $40m for settling claims over the alleged violations of the False Claims Act linked to three drugs, Trasylol, Avelox and Baycol, the US Department of Justice said in a press statement. The settlement comes after a former Bayer employee, Laurie Simpson, filed two 'whistleblower' lawsuits against the company. These litigations were filed under the qui tam or whistleblower provisions of the False Claims Act, which facilitate private citizens to file lawsuits ag
STAT
SEPTEMBER 5, 2022
By this time next year, if the medical forecasts are correct, I will probably be dead, another casualty of a fatal illness that most people have never heard of: idiopathic pulmonary fibrosis (IPF). This condition has been described by Michael J. Stephen in his 2021 book “Breath Taking” as the “most frustrating and disheartening of all the diseases in pulmonary medicine.
PharmaVoice
SEPTEMBER 6, 2022
With his unique platform, the has built a bridge between patients, physicians and researchers around the world.
pharmaphorum
SEPTEMBER 8, 2022
Asking patients with chronic conditions to regularly inject themselves can be challenging, causing needle anxiety and worry that they may not carry out the procedure correctly, which can reduce compliance. Now, a partnership between Ypsomed and Sidekick Heath aims to tackle that problem. Ypsomed is a top developer of injection and infusion systems, so knows a lot about the difficulties that patients can face when getting to grips with these medical devices, particularly when they are just starti
Pharmaceutical Technology
SEPTEMBER 7, 2022
Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.
STAT
SEPTEMBER 8, 2022
Gilead Sciences said Wednesday that its cancer drug Trodelvy prolonged the survival of women with the most common form of breast cancer by just under 30% — a clinical trial result that could lead to a better treatment option for patients with advanced disease and strengthen the drug’s commercial outlook. In the study, called TROPICS-02, Trodelvy showed a median overall survival of 14.4 months compared to 11.2 months for comparator chemotherapy.
PharmaVoice
SEPTEMBER 6, 2022
The CMO at Kura Oncology, a clinical-stage biopharma company, is charting a new course to deliver on the promise of precision medicine in oncology.
Pharma Times
SEPTEMBER 7, 2022
Link up will utilise Brainomix’s AI software for the assessment of idiopathic pulmonary fibrosis
European Pharmaceutical Review
SEPTEMBER 8, 2022
Comparing the use of common antiretroviral therapy (ART) regimens in pregnancy suggests that dolutegravir-based regimens have a higher probability of human immunodeficiency virus type 1 (HIV-1) viral suppression at delivery. In a study published in the New England Journal of Medicine , researchers compared the effectiveness and safety of dolutegravir-based ART to five ART regimens recommended for use in pregnancy in the US and Europe: atazanavir–ritonavir, darunavir–ritonavir, oral rilpivirine,
STAT
SEPTEMBER 8, 2022
A daily dose of Relay Therapeutics’ experimental drug for cholangiocarcinoma, a rare cancer of the bile ducts, led to tumor shrinkage of a third or more in 15 of 17 patients with metastatic disease, the company said Wednesday. The results were released in an abstract at the annual meeting of the European Society of Molecular Oncology, where they will be presented in full on Sunday.
PharmaVoice
SEPTEMBER 7, 2022
The longtime marketing pro details her fascinating career journey and how she’s positioning early stage health companies to thrive.
PharmExec
SEPTEMBER 9, 2022
Tracking the pandemic’s influence on brand awareness and prescribing efforts in light of decline in physician visits and fewer diagnoses—and what these dynamics, still unsettled post-pandemic, might mean for future launches.
Pharmaceutical Technology
SEPTEMBER 6, 2022
The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. Updated using the pre|CISION technology, AVA6000 is a kind of generic chemotherapy doxorubicin. This approach aids the therapy to be activated mainly in the tumour, sparing healthy tissue from exposure.
STAT
SEPTEMBER 7, 2022
For Illumina, the leading maker of DNA sequencing equipment, there was bad news and worse news Tuesday. The bad news: The European Commission said it was blocking Illumina’s $8 billion acquisition of Grail, a firm focused on the early detection of cancer. The worse news? In its press release on the ruling, Illumina acknowledged that, although it will appeal, that may not prevent the European Commission from forcing it to divest Grail, which it purchased before regulatory approvals were in
PharmaVoice
SEPTEMBER 6, 2022
As a patient advocate, The Spark Global’s owner is transforming how pharma companies approach patient centricity.
Outsourcing Pharma
SEPTEMBER 6, 2022
Bioprocessing 4.0 and digitalization is all about embracing new technologies to enable faster, smoother and more efficient biomanufacturing. And that also requires embracing a new mindset.
Pharmaceutical Technology
SEPTEMBER 9, 2022
US-based biotech company Gatehouse Bio is extending its collaboration with AstraZeneca for developing RNA therapeutics to treat heart failure with preserved ejection fraction (HFpEF). Initially, the companies partnered to identify new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s artificial intelligence (AI)-powered platform in December 2019.
STAT
SEPTEMBER 9, 2022
“I really believe this is why God gave us two arms — one for the flu shot and the other one for the Covid shot.” — Ashish Jha, White House Covid coordinator, Sept. 6, 2022. As the promotional push to get people vaccinated with one of the updated, bivalent Covid vaccines heats up, federal health authorities are urging Americans to consider getting their Covid shot and their flu shot at the same time.
PharmaVoice
SEPTEMBER 6, 2022
GSK’s medical oncology head is paving the way for patient-driven drug development and more equitable care.
pharmaphorum
SEPTEMBER 5, 2022
Greater use of telehealth services forced by COVID-19 seems to have benefitted people with opioid use disorder (OUD), leading to longer times on treatment and reduced risk of overdose, according to a new study. The researchers examined data from two groups of Medicare patients, one treated for OUD before the pandemic, and another who were treated after COVID-19 took hold, with greater use of telehealth support to complement in-person care.
European Pharmaceutical Review
SEPTEMBER 7, 2022
The 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU ( ACT EU ) has been published by the European Commission (EC), Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA). Launched in January, ACT EU aims to transform how clinical trials are initiated, designed and run, building off of the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) which became applicable in the same month.
STAT
SEPTEMBER 7, 2022
In May, Sarah Fama had to get blood work done before refilling a prescription for an autoimmune disorder. Because her condition put her at high risk for Covid-19, and she lives with her parents, both in their 80s, she checked the lab’s website, which stated that masks were required inside. When she arrived, she was reassured by a sign on the door that said the same thing.
Pharma Times
SEPTEMBER 6, 2022
PhoreMost will use Siteseeker platform to identify novel targets for Roche’s discovery programmes
pharmaphorum
SEPTEMBER 8, 2022
Ben Hargreaves examines what advantages radiopharmaceuticals offer in the treatment of cancer and why there has been interest from big pharma in developing these types of therapies. The article also outlines some of the challenges remaining to be tackled. Radiotherapy dates back more than a hundred years, yet it still remains a core part of cancer treatment today.
PioneerRx
SEPTEMBER 6, 2022
There are so many things that go into an independent pharmacy’s success: the quality of patient care, the range (or lack) of clinical services you provide, the.
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