Lilly drug for Alzheimer’s approved by FDA
Bio Pharma Dive
JULY 2, 2024
The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.
Tue.Jul 02, 2024
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EMA fast-tracks review of AstraZeneca’s sipavibart to stop Covid
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
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Cartesian data add to progress, questions for CAR-T in autoimmune disease
Bio Pharma Dive
JULY 2, 2024
The company claimed Phase 2 study results prove the therapy’s promise treating myasthenia gravis. But shares lost more than a quarter of their value amid questions about the data.
EAN 2024: anti-CGRPs more effective than onabotulinumtoxinA in chronic migraine prevention in real world
Pharmaceutical Technology
JULY 2, 2024
On 30 June 2024, at the tenth Congress of the European Academy of Neurology (EAN) 2024, during an e-presentation session on the topic of 'Headaches', Danilo Antonio Montisano, MD, presented real-world evidence findings from a retrospective, observational multicentre cohort study (RAMO) comparing the effectiveness of monoclonal antibodies against calcitonin gene-related proteins (anti-CGRP mAbs) to onabotulinumtoxinA (BoNT-A) for chronic migraine prevention.
Moderna gets US funding for bird flu vaccine development
Bio Pharma Dive
JULY 2, 2024
BARDA will provide Moderna with $176 million to advance late-stage testing of an H5 influenza shot, as health officials monitor animal outbreaks.
The pathway to preventative health: How pharma can support the NHS Long Term Plan
Pharmaceutical Technology
JULY 2, 2024
Utilising innovative digital tools and access to real-time data, the pharmaceutical industry could offer invaluable support to the NHS’s preventative care mission.
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FTC investigates Teva over contested product patents
Pharmaceutical Technology
JULY 2, 2024
Teva’s asthma and COPD patents listed in the FDA’s Orange Book are under scrutiny and the company has until 24 July to adhere to the demands.
Esteve invests €100 million in Spanish API manufacturing muscle
Outsourcing Pharma
JULY 2, 2024
The Spanish company Esteve Pharmaceuticals is building a manufacturing unit in its Girona plant with the aim to expand its production of active pharmaceutical ingredients (APIs).
Eisai and Bristol Myers Squibb terminate ADC development deal
Pharmaceutical Technology
JULY 2, 2024
Eisai has announced the termination of a deal with Bristol Myers Squibb to jointly develop and commercialise farletuzumab ecteribulin (FZEC).
FTC launches probe of Teva over ‘improper’ patents; report
pharmaphorum
JULY 2, 2024
The FTC is reported to have opened an investigation into Teva focusing on improperly listed patents in the FDA’s Orange Book
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
FDA grants priority review for Neurocrine’s crinecerfont NDAs
Pharmaceutical Technology
JULY 2, 2024
The US FDA has accepted Neurocrine Biosciences’ NDAs for crinecerfont to treat congenital adrenal hyperplasia, and granted priority review.
Researchers find whole genome sequencing improves care for paediatric cancer
Pharma Times
JULY 2, 2024
Affecting around 3,755 young people in the UK every year, leukaemia is the most commonly diagnosed cancer in children
Samsung Bioepis’ PYZCHIVA gains FDA approval as Stelara biosimilar
Pharmaceutical Technology
JULY 2, 2024
Samsung Bioepis has received US FDA approval for PYZCHIVA (ustekinumab-ttwe / SB17) as a biosimilar to Stelara for various indications.
Game on: Lilly's Alzheimer's drug Kisunla, a challenger to Biogen and Eisai's Leqembi, gains full FDA nod
Fierce Pharma
JULY 2, 2024
After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Bioge | After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy, a competitor to Eisai and Biogen’s Leqembi, a full approval.
Tracon mulls strategic options after sarcoma drug fails Phase II trial
Pharmaceutical Technology
JULY 2, 2024
The company scrapped the envafolimab trial, after an independent review found the study was unlikely to meet its primary endpoint.
Biden joins Sanders' campaign targeting Novo Nordisk, Eli Lilly's diabetes and obesity drug prices
Fierce Pharma
JULY 2, 2024
In recent months, frequent pharma critic Sen. | As the November U.S. elections near, it's clear that drug pricing will remain an important topic for voters and politicians. In a Tuesday op-ed, President Joe Biden and Sen. Bernie Sanders placed a spotlight on Novo Nordisk and Eli Lilly's drug pricing.
Aerovate slashes workforce after failed Phase IIb trial
Pharmaceutical Technology
JULY 2, 2024
The company has announced plans to lay off 39 employees, with most of the workforce cuts expected in coming months.
The power and potential of regenerative medicine
pharmaphorum
JULY 2, 2024
The field of muscle stem cell research has been tangibly developing over the decades and in today’s pharmaphorum podcast wed editor Nicole Raleigh speaks with Dr Michael Rudnicki, co-founder and CSO of Satellos Biosciences, a company dedicated to developing novel therapeutics based on this science for those who live with Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases.
The New Age of Decentralized Clinical Trials
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Eli Lilly continues radiopharma push with $140m Radionetics partnership
Pharmaceutical Technology
JULY 2, 2024
The deal also gives Eli Lilly exclusive rights to acquire Radionetics for $1bn after the exercise period is over.
CHMP okays first therapy targeting FGFR3 alterations in bladder cancer
Drug Discovery World
JULY 2, 2024
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Janssen-Cilag’s Balversa (erdafitinib). It is recommended as a monotherapy to treat adult patients with unresectable or metastatic urothelial carcinoma, harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.
Changing Faces: Pharma and biotech hires from April 2024
pharmaphorum
JULY 2, 2024
Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.
Trial to test monoclonal antibody for virus of growing concern
Drug Discovery World
JULY 2, 2024
The National Institutes of Health (NIH) is sponsoring a clinical trial to evaluate the safety of an investigational monoclonal antibody to treat enterovirus D68 (EV-D68), which can cause severe respiratory and neurological diseases such as acute flaccid myelitis (AFM). AFM has emerged in the United States with spikes in cases every other year, primarily in the late-summer months over the last decade.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
J&J, Legend's Carvykti shows CAR-T can extend lives in multiple myeloma
Fierce Pharma
JULY 2, 2024
In a major win for Johnson & Johnson and Legend Biotech, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma. | In a major win for J&J and Legend, their star CAR-T therapy Carvykti showed it can prolong the lives of patients with previously treated multiple myeloma.
Changing the gut microbiome improves outcomes in kidney cancer
Drug Discovery World
JULY 2, 2024
In a Phase I trial, patients with metastatic kidney cancer who took a live biotherapeutic product alongside immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes. City of Hope, US, researchers are now in discussions with the global SWOG Cancer Research Network to design a Phase II/III trial to assess the novel use of CBM588 and microbiome modulation in people with advanced cancer.
US FTC ramps up patent crusade with investigation into Teva's inhaler IP: report
Fierce Pharma
JULY 2, 2024
While certain other drugmakers have relented in the face of the U.S. | The FTC has launched an investigation into Teva over the Israeli-American drug giant's refusal to remove roughly two dozen patents for its asthma and chronic obstructive pulmonary disease inhalers, The Washington Post first reported, citing confidential agency documents.
Drug discovery hotspots: What is the secret to Switzerland’s success? (p1)
Drug Discovery World
JULY 2, 2024
DDW’s Diana Spencer takes a closer look into why Switzerland is such a life sciences powerhouse and how Swiss researchers are advancing new technology and tackling modern health challenges. OECD data places Switzerland second in the world for biotechnology R&D intensity 1 , and in 2021, the country had the seventh largest share of the global biotech market 2.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Female cancer survivors at low risk of developing obstetric complications
Pharma Times
JULY 2, 2024
According to WHO, around 15% of pregnant women will develop an obstetric complication
BIOSECURE Act hurts US biopharma industry's confidence in Chinese partners: survey
Fierce Pharma
JULY 2, 2024
Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. | Even as the BIOSECURE Act works its way through the legislative process, the draft bill has already caused a slide in U.S. life sciences companies' confidence in Chinese partners, a new survey has found.
Advancing sleep health: Wearable technologies revolutionize clinical trials and patient care
Outsourcing Pharma
JULY 2, 2024
Christine Guo, chief scientific officer at ActiGraph, discusses the pivotal role of wearable health technologies in revolutionizing sleep health measurement within clinical trials.
High-flying Samsung Biologics inks $1B production pact with unnamed US pharma
Fierce Pharma
JULY 2, 2024
As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap. | As Korean CDMO giant Samsung Biologics continues to ink production pacts around the globe, the company has added another billion-dollar feather to its cap.
Roles and Responsibilities of Specialized Clinical Supply Experts
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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