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.
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).
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.
Eli Lilly’s donanemab wins FDA approval for Alzheimer’s disease
Pharmaceutical Technology
JULY 2, 2024
Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.
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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.
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.
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.
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
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.
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.
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.
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.
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.
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
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.
Sobi starts rolling FDA filing for chronic gout drug
pharmaphorum
JULY 2, 2024
Sobi starts rolling application for refractory gout drug SEL-212 in the US, hoping to take on Amgen’s Krystexxa in the market.
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.
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.
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.
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.
The Power of Patience: Delaying Patents to Enhance Pharma Market Exclusivity
Drug Patent Watch
JULY 2, 2024
The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.
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
Viatris unit Mylan, former President Rajiv Malik cleared in DOJ price-fixing probe
Fierce Pharma
JULY 2, 2024
It's been nearly seven years since former Mylan President Rajiv Malik was first implicated in an industrywide generic drug price-fixing investigation. | Mylan and its former president Rajiv Malik are no longer considered to be "subjects of interest" in a federal generic industry antitrust probe, Viatris said in a release. Mylan has since merged with another company to form Viatris.
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).
Emergent BioSolutions bags $250M in contract modifications to help boost US supply of medical countermeasures
Fierce Pharma
JULY 2, 2024
With four contract modifications totaling more than $250 million, the government is leveling up its agreements with long-time medical countermeasures supplier Emergent BioSolutions. | The drugmaker will supply its anthrax vaccine Cyfendus, its smallpox vaccine and two other drugs to help bolster the U.S. government's medical countermeasures stockpile.
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.
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
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.
ALS treatment PrimeC slows disease progression by 36% phase 2b trial results show
Outsourcing Pharma
JULY 2, 2024
NeuroSense Therapeutics has announced positive phase 2b results for a drug combination designed to treat amyotrophic lateral sclerosis (ALS).
China-made injectable PD-L1 drug flunks pivotal trial, forcing US partner to seek strategic options
Fierce Pharma
JULY 2, 2024
The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. | The world’s first injectable immune checkpoint inhibitor likely won’t make it to the U.S. anytime soon, after the China-approved drug flunked a pivotal trial in a rare cancer, forcing its stateside developer Tracon to explore strategic alternatives.
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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