Investors still aren’t sold on UniQure’s gene therapy for Huntington’s
Bio Pharma Dive
DECEMBER 19, 2023
The biotechnology company’s share price fell more than 10% Tuesday after the disclosure of more data from a small study.
Tue.Dec 19, 2023
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Pharma breakthroughs: 10 novel drug approvals that made headlines in 2023
Pharmaceutical Technology
DECEMBER 19, 2023
Pharmaceutical Technology outlines some of the biggest US Food and Drug Administration (FDA) drug approvals announced in 2023 that are set to make an impact in the coming years.
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Merck gets FDA decision date for new pneumococcal vaccine
Bio Pharma Dive
DECEMBER 19, 2023
The company’s shot targets 21 strains of pneumococcal bacteria and, if approved, would compete with Pfizer’s Prevnar 20.
Kronos Bio swivels focus towards multiple myeloma after AML failure
Pharmaceutical Technology
DECEMBER 19, 2023
Kronos Bio is prioritising its multiple myeloma therapy after reviewing negative Phase Ib AML data for lanraplenib.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
A Neuroscientist Explains How to Survive The Stress of The Holidays
AuroBlog - Aurous Healthcare Clinical Trials blog
DECEMBER 19, 2023
Just as the shift to shorter days and colder weather can bring with it mood swings and other emotional challenges, the holiday season can also bring about somewhat predictable changes in mood and behavior. Around this time of year, many of us experience more stress, anxiety and frustration than usual.
Sanofi licenses fourth NK cell engager from Innate Pharma
Pharmaceutical Technology
DECEMBER 19, 2023
Sanofi and Innate’s cancer collaboration agreement stretches back to 2016, with two of Sanofi’s NK cell engagers in clinical studies.
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Biogen holds onto Tecfidera market in Europe for a little longer
Bio Pharma Dive
DECEMBER 19, 2023
A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.
Magazine: What’s in a name
Pharmaceutical Technology
DECEMBER 19, 2023
In this issue: Fixing drug nomenclature to avoid confusing names, gene therapies for sickle cell disease, childproof packaging for drugs, and UK pharma manufacturing gears up for a shake up in 2024
FTC, DOJ finalize merger guidelines that could impede healthcare deals
Bio Pharma Dive
DECEMBER 19, 2023
The new guidelines may give regulators more ammunition to go after vertical and cross-market M&A that has historically been more difficult to challenge.
It’s a CRISPR-mas miracle: CRISPR approval marks early present for Vertex
Pharmaceutical Technology
DECEMBER 19, 2023
Last month, Vertex Pharmaceuticals and CRISPR Therapeutics made history, by gaining approval for the first clustered regularly interspaced short palindromic repeats (CRISPR)-based drug, exagamglogene autotemcel (Casgevy).
Amid BioNTech legal fight, CureVac takes a loss as German court invalidates patent
Fierce Pharma
DECEMBER 19, 2023
A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech. | A German court has dealt the first blow against CureVac amid the company's heated COVID-19 vaccine patent fight with fellow German mRNA specialist BioNTech.
INmune’s Alzheimer’s trial still on clinical hold, FDA requests more data
Pharmaceutical Technology
DECEMBER 19, 2023
The FDA has requested information on long-term potency after the Phase II trial was put on clinical hold due to manufacturing issues in 2022.
Heart vests to identify those at high risk of sudden cardiac death
Pharma Times
DECEMBER 19, 2023
In the UK, heart rhythms affect around two million people and can cause sudden death - News - PharmaTimes
POINT’s prostate cancer trial meets primary endpoint as Lilly’s offer looms
Pharmaceutical Technology
DECEMBER 19, 2023
The topline data announcement comes on the same day as Lilly further extends its tender offer for the acquisition of POINT.
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
Roche, Novartis move Xolair closer to FDA finish line for food allergies
Fierce Pharma
DECEMBER 19, 2023
On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. | On the market for two decades for asthma, Novartis and Roche’s Xolair is closing in on a new indication as a way for those with food allergies to avoid severe outcomes. The agency granted a priority review to Roche's filing and plans to make a decision during the first quarter of next year.
The risk of market contraction facing the IBD space
Pharmaceutical Technology
DECEMBER 19, 2023
For the IBD market to grow, it is critical for biologics to continue to show efficacy over current biological/small-molecule therapies.
BioMed X and Ono Pharmaceutical enter joint cancer research project
Pharma Times
DECEMBER 19, 2023
In 2020, there were over ten million deaths worldwide associated with cancer - News - PharmaTimes
Gaucher disease market expected to reach $1.3bn across 7MM by 2032
Pharmaceutical Technology
DECEMBER 19, 2023
The Gaucher disease market is expected to grow at a CAGR of 0.79%, reaching $1.3bn across 7MM by the end of this forecast period (2032).
Biogen notches another Tecfidera patent win in Europe as officials revoke generic approvals
Fierce Pharma
DECEMBER 19, 2023
Following a significant loss at the U.S. Supreme Court last October, Biogen’s Tecfidera patent odyssey continues to spin in the company’s favor overseas. | The European Commission has revoked marketing authorizations for generic versions of Biogen's multiple sclerosis med Tecfidera, also known as dimethyl fumarate, that are owned by Accord, Mylan, Neuraxpharm, Polpharma and Teva.
How COP28 raised the profile of ‘super pollutants’ like black carbon
Pharmaceutical Technology
DECEMBER 19, 2023
Super pollutants like black carbon found their way onto the agenda of COP28, which hosted the annual conference's first 'Health Day'
Why digital therapeutics (DTx) are effective and safe, but not being prescribed
pharmaphorum
DECEMBER 19, 2023
In a new episode of the pharmaphorum podcast, host Nicole Raleigh welcomes Joel Morse, CEO and co-founder of Curavit Clinical Research, and Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), for a discussion on why it is that digital therapeutics (DTx) are effective and safe, but not being prescribed.
Ionis and Otsuka sign agreement for hereditary angioedema therapy
Pharmaceutical Technology
DECEMBER 19, 2023
Ionis has signed a licence agreement under which Otsuka will gain sole rights to market donidalorsen for hereditary angioedema in Europe.
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.
Big pharma places big bets on antibody-drug conjugates
pharmaphorum
DECEMBER 19, 2023
Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.
Anagenex and Nimbus team up for small molecule drug discovery
Pharmaceutical Technology
DECEMBER 19, 2023
The companies will prioritise challenging drug targets across multiple therapy areas, leveraging Anagenex’s AI platform.
FDA says no to Checkpoint’s skin cancer drug cosibelimab
pharmaphorum
DECEMBER 19, 2023
Checkpoint Therapeutics’ PD-L1 inhibitor cosibelimab has been turned down by the FDA as a treatment for skin cancer cSCC
Regulatory changes in the US and UK to watch in 2024
Pharmaceutical Technology
DECEMBER 19, 2023
The life sciences sector is set to see a significant amount of change in 2024 with shake-ups expected in the US and UK.
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
Owkin and MSD join forces on AI-powered digital pathology
pharmaphorum
DECEMBER 19, 2023
Owkin and MSD join forces on AI-powered digital pathology Phil.
Organon and Lilly sign deal to supply two migraine drugs in Europe
Pharmaceutical Technology
DECEMBER 19, 2023
Organon has signed a commercialisation agreement with Eli Lilly and Company for two migraine medicines, Emgality and RAYVOW, in Europe.
After missing out on FDA voucher, bluebird quickly raises funds to support gene therapy launches
Fierce Pharma
DECEMBER 19, 2023
Despite bluebird bio winning a recent FDA nod for its muc | Bluebird's FDA approval for sickle cell disease gene therapy Lyfgenia left something to be desired because the agency rejected a request for a priority review voucher. Without that voucher, bluebird is moving fast to try to fund its launches.
EC approves Merck’s Keytruda combo for gastrointestinal cancers
Pharmaceutical Technology
DECEMBER 19, 2023
The EC has granted approval for Merck’s (MSD) anti-PD-1 therapy, Keytruda, plus chemotherapy for two indications in gastrointestinal cancers.
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.
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