STAT
OCTOBER 3, 2023
The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option. Though the FDA’s green light came three weeks after the approvals for the updated Moderna and Pfizer-BioNTech shots, it contained some welcome news for the Gaithersburg, Md.
PharmaVoice
OCTOBER 3, 2023
Not every unicorn company lives up to its $1 billion promise. Here are four worth watching.
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STAT
OCTOBER 3, 2023
WASHINGTON — It started with a tweet: A year-old, 43-second clip of Kevin Wang talking about how parents and teachers can help affirm and support a child’s gender identity, encouraging children to explore. The vitriolic tweets were swift, and they snowballed. Right-wing influencers accused Wang, an unassuming Seattle physician, of “mutilating” and “destroying” children, though he did not discuss surgery in the clip.
Pharma Times
OCTOBER 3, 2023
The Cancer Hub aims to create a world-leading ecosystem for cancer research - News - PharmaTimes
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
OCTOBER 3, 2023
In the latest battle over access to medicines, Colombian authorities have decided to issue a compulsory license for a needed HIV treatment, a step that underscores ongoing friction between the pharmaceutical industry and cash-strapped governments around the world. By issuing such a license, the Colombian government hopes to obtain lower-cost generic versions of an HIV medicine called dolutegravir, which is made by ViiV Healthcare, a company that specializes in HIV treatments and is largely contr
pharmaphorum
OCTOBER 3, 2023
How the rise of medical device use in pharma R&D is driving wearable technology in healthcare and revolutionising the medical industry Mike.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
BioPharma Dive
OCTOBER 3, 2023
The deal will hand Lilly a pipeline of experimental radioligand therapies, including a potential rival to Novartis’ Pluvicto, as well as a valuable manufacturing plant.
STAT
OCTOBER 3, 2023
As theorists from Samuel Coleridge to Kenneth Burke have noted, language often does our thinking for us. In health care, all too often, that leads to problems. In a particularly worrisome example of this, recent headlines about the new monoclonal antibody injection nirsevimab (trade named Beyfortus) designed to protect infants against the third culprit in last year’s tripledemic — respiratory syncytial virus (RSV) — contain language that may cloud parents’ d
Express Pharma
OCTOBER 3, 2023
Strides Pharma Science on September 23, 2023 announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the United States Food & Drug Administration (USFDA). The product complements Strides’ range of approved soft gelatin capsules. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin.
STAT
OCTOBER 3, 2023
A couple billion here, a couple billion there, and pretty soon Eli Lilly hopes it will be talking about real money. Eli Lilly agreed to purchase Point Therapeutics Tuesday morning for $1.4 billion , a 90% premium, adding to its pipeline of cancer drugs. Point is developing cancer drugs that deliver a focused dose of radiation to tumor cells. Data for its lead medicine, for prostate cancer, are expected in the fourth quarter.
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BioPharma Dive
OCTOBER 3, 2023
The longtime partners believe that, by combining their technologies, they can create “in vivo” genetic medicines for nervous system and muscular disorders.
STAT
OCTOBER 3, 2023
A follow-up study of a first-of-its-kind cancer treatment may reflect systemic biases, the Food and Drug Administration said ahead of an advisory committee meeting Thursday to determine whether the drug should remain on the market. The treatment, Lumakras, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS.
European Pharmaceutical Review
OCTOBER 3, 2023
A paper published in Regulatory Toxicology and Pharmacology has proposed a consistent, health protective read-across methodology for extractables and leachables (E&Ls). The Extractables Leachables Safety Information Exchange (ELSIE) ’s safety team developed the methodology for generating permitted daily exposures (PDEs) for E&Ls. Current challenges in extractables and leachable studies According to the paper, a challenge for E&L read-across is that most toxicology data is from the or
STAT
OCTOBER 3, 2023
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, everyone. Damian here. Yesterday’s Nobel wins for Katalin Karikó and Drew Weissman called to mind the humble beginnings of mRNA research — and the fact that Karikó’s scientific career nearly ended before their key discovery, as she explained back in 2020.
Outsourcing Pharma
OCTOBER 3, 2023
The U.K. startup Automata Technologies has bagged $40 million in a funding round to expand its workforce and the geographic reach of its life sciences lab automation technology.
Drug Channels
OCTOBER 3, 2023
This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Since I published the article below in July 2023 , there have been three notable market develpoments: IQVIA has reported that as as of mid-2023, there was almost no adoption of Amgen's Amjevita, the first Humira biosimilar.
Express Pharma
OCTOBER 3, 2023
The Central Drugs Standard Control Organisation (CDSCO), in association with the Indian Drug Manufacturers’ Association (IDMA), organised a workshop on “Revision of Schedule-M” on September 30, 2023 in Mumbai. Dr S Eswara Reddy, Joint Drugs Controller of India, was the Chief Guest and keynote speaker. The event witnessed in-person attendance of more than 300 participants and 6,000+ viewers online.
Pharmaceutical Technology
OCTOBER 3, 2023
Drug manufacturer Viatris has announced the divestment of a number of businesses owned by the company in a $.37bn deal.
Express Pharma
OCTOBER 3, 2023
Indore Pharma Summit 2023: Forging and Fostering Progress Click to download: October 2023 Digital Magazine The post Express Pharma October 2023 appeared first on Express Pharma.
pharmaphorum
OCTOBER 3, 2023
Digital therapeutics at a turning point: What we heard at DTx East Mike.
PharmExec
OCTOBER 3, 2023
Chandler discusses how life sciences companies are navigating the current climate.
Express Pharma
OCTOBER 3, 2023
Marksans Pharma has received final approval from US Food & Drugs Administration for its Abbreviated New’ Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC). This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals LP.
Pharma Times
OCTOBER 3, 2023
NIHR awards £97.
pharmaphorum
OCTOBER 3, 2023
Finding a long-term fix to UK’s growing patient waiting list Mike.
BioPharma Dive
OCTOBER 3, 2023
Only two of the eight biotech companies that priced offerings since July 1 trade at or above their debut share price, according to data from BioPharma Dive.
Outsourcing Pharma
OCTOBER 3, 2023
Syndax Pharmaceuticals says it is âthrilledâ to report positive top line results for its treatment for acute leukemia.
pharmaphorum
OCTOBER 3, 2023
Takeda pulls Exkivity in US after failed confirmatory trial Phil.
Outsourcing Pharma
OCTOBER 3, 2023
The Nobel Prize in medicine has been awarded to two scientists who developed the technology which led to the mRNA vaccines against COVID-19.
pharmaphorum
OCTOBER 3, 2023
AZ pays $425m to settle claims heartburn drugs caused harm Phil.
Drug Patent Watch
OCTOBER 3, 2023
Annual Drug Patent Expirations for NUMBRINO Numbrino is a drug marketed by Cody Labs Inc and is included in one NDA. It is available from one supplier. The generic ingredient… The post New patent for Cody Labs drug NUMBRINO appeared first on DrugPatentWatch - Make Better Decisions.
Fuld & Company Blog
OCTOBER 3, 2023
It looks like Shell is considering 1 selling battery management and utility company sonnen, which it acquired in 2019. Although the news has not yet been confirmed, it would not be a surprise if Shell is putting the company up for sale given the recent shift in the company’s portfolio strategy. Earlier this year, Shell faced a significant shakeup when Thomas Brostrom, the Senior Vice President responsible for the company’s transition to renewable energy, and the executives overseeing offshore wi
assurecare
OCTOBER 3, 2023
Is your pharmacy doing everything it can to diversify revenue, improve patient outcomes, and stay relevant? DIR reform and its pharmacy reimbursement challenges are around the corner in 2024. It's the latest curveball thrown at independent community pharmacy in recent times. Is your pharmacy fully capitalizing on all revenue options, improving patient outcomes, and keeping pace with the latest developments?
Pharmafile
OCTOBER 3, 2023
The World Health Organization (WHO) has announced that it has recommended a new vaccine, R21/Matrix-M, for the prevention of malaria in children. This recommendation follows advice from WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) and the Malaria Policy Advisory Group (MPAG), as well as being endorsed by WHO’s director-general during its regular biannual […] The post WHO recommends new vaccine for prevention of malaria in children appeared first on Pharmafile.
World Pharma News
OCTOBER 3, 2023
Messenger RNA (mRNA) technology has become popular in the last few years due to its use in COVID-19 vaccines. This technology has been so groundbreaking that it recently won the 2023 Nobel Prize in medicine "for discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19." This isn't new technology, however - modified mRNAs have been studied for decades and show significant potential for therapeutic applications.
Pharmafile
OCTOBER 3, 2023
Acurx Pharmaceuticals has announced that it has discontinued its phase 2b clinical trial of its lead antibiotic candidate, ibezapolstat, for the treatment of patients with Clostridioides difficile infection (CDI) following positive results. The company has decided to end the trial following consultation with its medical and scientific advisors and statisticians based on data and other […] The post Acurx Pharmaceuticals announces positive data from phase 2b trial for C. difficile infection
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