STAT
SEPTEMBER 25, 2024
Recent headlines about a potent new immunotherapy have mostly focused on the U.S. company helping to develop it. Less attention has been paid to Akeso, a Chinese biotech that had kept a low profile until its drug bested Merck’s mega-blockbuster Keytruda in a late-stage lung cancer trial. Now, Akeso’s leaders want you to know that its recent success isn’t a one-off.
ALiEM - Pharm Pearls
SEPTEMBER 25, 2024
A 24-year-old male with a history of microscopic hematuria presented to the emergency department (ED) with left lower quadrant abdominal pain. His pain started about two weeks ago and has been intermittent. He describes the pain as stabbing. He decided to come to the ED today because of the persistent nature of the pain. He denies chest pain, cough, shortness of breath, fevers, nausea, vomiting, diarrhea, constipation, rectal bleeding, dysuria, and increased urinary frequency.
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STAT
SEPTEMBER 25, 2024
Pfizer said Wednesday that it was removing Oxbryta, a pill for the treatment of sickle cell disease, from all markets globally due to high risks of severe safety events, including deaths. The decision is a stunning blow for a drug that was approved in 2019 , heralded as a new way to treat the inherited blood disorder. Pfizer acquired the maker of Oxbryta, a biotech company called Global Blood Therapeutics, in 2022 for $5.4 billion.
PharmaVoice
SEPTEMBER 25, 2024
The announced job cuts are the latest in a series of steps Bluebird has taken to preserve cash and break even financially amid slow uptake of its marketed gene therapies.
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STAT
SEPTEMBER 25, 2024
Prostate cancer presents a tricky screening challenge. Catching it early could mean dodging a painful journey with advanced cancer. Yet a sizable majority of prostate cancers are “indolent” — slow growing tumors that most likely would never metastasize during the patient’s lifetime, and whose treatment would do more harm than good.
PharmaVoice
SEPTEMBER 25, 2024
4D Molecular Therapeutics reported positive interim analysis in the high-potential wet AMD indication last week.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 25, 2024
Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.
STAT
SEPTEMBER 25, 2024
People taking semaglutide medications like Ozempic for diabetes may be at reduced risk of drug overdose, according to new research. Prescriptions for semaglutide, which includes Ozempic and Rybelsus, were linked to lower overdose rates among patients with type 2 diabetes who were also diagnosed with opioid use disorder, according to a paper published Wednesday.
pharmaphorum
SEPTEMBER 25, 2024
Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company.
STAT
SEPTEMBER 25, 2024
WASHINGTON — The trade association for generic drugs and biosimilars has chosen a new leader: John Murphy. Four sources familiar with the decision said Murphy will be named as the new head of the Association for Accessible Medicines. AAM declined to comment on the CEO selection, but a spokesperson for the group said it will make an announcement later Wednesday.
Speaker: Joe Sharpe and James Carlson
Running a small business is no small feat. Payroll management, in particular, can be one of the most time-consuming and complex parts of that equation. Yet, businesses that crack the code on streamlining these processes often discover not just savings, but new avenues for growth. Our expert speakers will share actionable insights and real-world examples of how businesses have reduced overhead and improved payroll efficiency.
Express Pharma
SEPTEMBER 25, 2024
Dr Reddy’s Laboratories has been fined by the Mexican health authority, Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS), for failing to comply with import guidelines. The penalty amounts to MXN 651,420 (approximately INR 28 lakh). According to a notice received on 25th September 2024, the violation relates to the company’s late filing of an import reference standard for one of its active pharmaceutical ingredients (API).
STAT
SEPTEMBER 25, 2024
Over the three decades that I have worked in animal health, I have borne witness to the mounting effects of antimicrobial resistance (AMR) in animals. Just like in people, while bacterial infections in animals were once predictably treatable with routine antimicrobials, we now face resistant infections that make it harder to treat animals. Then we end up on a slippery slope of needing to use newer antimicrobials, helping to treat the infection but adding risks for development of even more resist
BioPharma Dive
SEPTEMBER 25, 2024
The financing will support a technology designed to make delivery of lentiviral gene therapies, which are typically administered through a complex process, more convenient.
STAT
SEPTEMBER 25, 2024
Celldex Therapeutics reported Wednesday that its experimental medicine for a condition that causes chronic hives reduced hive activity in patients, completely clearing it in some. However, there was a high rate of patient discontinuations in the trial, due in part to side effects including changes in hair color. Those concerns sent Celldex shares down more than 20% following the company’s announcement.
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Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.
pharmaphorum
SEPTEMBER 25, 2024
Flagship Pioneering-backed artificial intelligence startup Generate:Biomedicines has attracted another big pharma partnership, this time with Novartis.The wide-ranging deal, worth up to $1 billion, covers multiple targets and disease areas and focuses on the discovery and development of protein-based therapeutics using Generate's generative AI (genAI) platform.
STAT
SEPTEMBER 25, 2024
Moderna was scolded by a U.K. trade group over a WhatsApp message that offered children a hefty $2,000 for participating in a clinical trial of its Covid-19 booster vaccine. The trial, which was called NextCOVE, recruited adults and children age 12 and older in a number of locations last year around the U.K., the U.S. and Canada. A pediatrician, who worked at an unnamed hospital in the U.K., posted the message in hopes of soliciting participants, mentioned the amount of money involved, and close
Drug Patent Watch
SEPTEMBER 25, 2024
Generic drug manufacturers face significant challenges when attempting to navigate around REMS (Risk Evaluation and Mitigation Strategies) imposed by brand-name drug companies. These strategies, intended to ensure drug safety, are sometimes misused to delay generic competition.
STAT
SEPTEMBER 25, 2024
On July 1st, 1995, the world’s spotlight shone upon Yale’s football stadium in New Haven, Connecticut. It was the latest Special Olympics World Games, and the organizers had lined up big-name musicians like Hootie & the Blowfish and Boyz II Men for the opening ceremony. United States President Bill Clinton and First Lady Hillary Clinton even made an appearance.
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.
The Pharmacist
SEPTEMBER 25, 2024
Pharmacists from across the UK are celebrating World Pharmacists Day by highlighting the profession's 'vital role' within healthcare systems and in meeting health needs. FIP celebrates pharmacists' role in medicines, patient care and public health The International Pharmaceutical Federation (FIP), which organises the day, celebrated pharmacists' 'first and foremost' role in ensuring access to and […] The post World Pharmacists Day celebrates 'vital' role of profession appeared fi
STAT
SEPTEMBER 25, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. Which CEO drank out of my colleague Matt Herper’s glass of water? Read on today to find out!
BioPharma Dive
SEPTEMBER 25, 2024
The offering, which was upsized twice, will support development of a drug the company believes can boost the effects of popular weight loss medicines like Eli Lilly’s Zepbound.
STAT
SEPTEMBER 25, 2024
Hello, everyone, and how are you today? We are doing just fine, thank you, and given that the middle of the week is here, we are determined to hang on for another couple of days. And why not? The alternatives — at least those we can identify — are not so appetizing. And what better way to make the time fly than to keep busy. So we are digging about the pantry and firing up our coffee kettle to get things started.
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Express Pharma
SEPTEMBER 25, 2024
Biocon Biologics , a subsidiary of Biocon announced new dermatology data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress in Amsterdam. The results from two separate pivotal Phase 3 clinical studies supported interchangeability between adalimumab and adalimumab-fkjp as well as underscoring biosimilarity of bUstekinumab.
The Guardian - Pharmaceutical Industry
SEPTEMBER 25, 2024
Closure of hundreds of outlets hitting rural areas, older people and deprived communities hardest, according to Healthwatch England High street pharmacies are closing at such an alarming rate that it threatens the drive to use them instead of GPs to care for millions of people, the NHS’s patient champion warns today. A total of 436 community pharmacies in England shut permanently last year and there were also 13,863 temporary closures, which stopped patients from obtaining health advice and medi
pharmaphorum
SEPTEMBER 25, 2024
Pfizer is voluntarily withdrawing its sickle cell drug Oxbryta after a review revealed an imbalance of deaths in clinical trials
BioPharma Dive
SEPTEMBER 25, 2024
The biotech expects that stopping enrollment for KarMMa-9, a trial evaluating early use of the multiple myeloma cell therapy Abecma, should save it $80 million in the near term.
pharmaphorum
SEPTEMBER 25, 2024
Eli Lilly has opened up a second market for its new Alzheimer's disease therapy Kisunla, after Japan followed the US in approving the drug
BioPharma Dive
SEPTEMBER 25, 2024
Medicines the company is developing for eczema and myasthenia gravis met their objectives in Phase 3 trials. But analysts weren’t convinced they can compete with available alternatives.
The Pharmacist
SEPTEMBER 25, 2024
The General Pharmaceutical Council (GPhC) has not met the healthcare super-regulator's standards relating to timeliness of fitness to practise (FtP) investigations for the sixth year in a row. The Professional Standards Authority for Health and Social Care (PSA) found that the GPhC met 17 out of 18 of its Standards of Good Regulation during 2023/24. […] The post GPhC failing on FtP timeliness for sixth year running appeared first on The Pharmacist.
Express Pharma
SEPTEMBER 25, 2024
U.S. drugmaker Pfizer, said on Wednesday it is withdrawing its sickle cell disease treatment Oxbryta from all markets where it is approved, citing risks of a painful complication and deaths. Pfizer bought Oxbryta, also known as voxelotor, as part of its $5.4 billion buyout of Global Blood Therapeutics in 2022. It reported $328 million in revenues from the therapy for the full year 2023.
FDA Law Blog: Biosimilars
SEPTEMBER 25, 2024
By Kurt R. Karst — In the Hatch-Waxman Community there are certain folks who are viewed as “the Founders” or pioneers of the law. There are, of course, the names Representative Henry Waxman and Senator Orrin Hatch, but there were several other Founders. One of them—and about whom some have said was the honorary Member of Congress leading up to the September 24, 1984 enactment of the Hatch-Waxman Amendments—is Alfred B.
PharmaTech
SEPTEMBER 25, 2024
Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.
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