STAT
OCTOBER 12, 2023
Family medicine physician Olusunmisola Oyesiku always thought she would practice in a big city, but after going through her family residency program at the University of Alabama in Selma, she ended up falling in love with rural medicine. The Selma program is one of a small, but growing, number of residencies in the country that places residents entirely in rural medical settings.
PharmaVoice
OCTOBER 12, 2023
Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.
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STAT
OCTOBER 12, 2023
The brain remains both the body’s most important organ and its least understood. But a draft atlas of the human brain published on Thursday gives scientists important insights into how it works and may pave the way for big advances in disease treatment and diagnosis. This brain map, pieced together by hundreds of researchers from San Diego to Seattle to Stockholm, is essentially a cellular “parts list” of the human brain and a guide to how those pieces are arranged and work
PharmaVoice
OCTOBER 12, 2023
Yvonne Greenstreet, CEO of RNAi specialist Alnylam, addressed the surprise move by regulators and the company’s new future plans.
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 12, 2023
Peter Marks wants drug developers to ask more stupid questions. It’s part of the top Food and Drug Administration official’s plan to reinvigorate gene therapy, a field that has struggled despite significant technological advances. Some companies are shelving programs or going out of business , even when they have promising data. The problems are numerous : The diseases are often exceptionally rare, limiting the potential market.
Pharma Times
OCTOBER 12, 2023
The financing will support the biotech’s clinical study of people with AD as a lead programme - News - PharmaTimes
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
World Pharma News
OCTOBER 12, 2023
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
STAT
OCTOBER 12, 2023
LONDON — European regulators on Thursday detailed their demands that Illumina divest the cancer diagnostics firm Grail, the latest fallout from the sequencing giant’s troubled 2021 acquisition. The move was just the most recent regulatory action against the deal. The European Commission in September 2022 ruled that the purchase violated antitrust rules, and Thursday’s order spelled out how the commission thought the deal’s unraveling should occur.
PharmExec
OCTOBER 12, 2023
A discussion of the impact the new FDA SaMD guidance, identifying the differences between companion apps and SaMD, and what to expect from this combination in the future.
STAT
OCTOBER 12, 2023
When is a billion-dollar deal a bad omen? Has Wall Street gone overboard on Ozempic? And how do you edit a chicken? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We discuss Bristol Myers Squibb’s multibillion-dollar acquisition of Mirati Therapeutics and what it means for a biotech sector still in a slump.
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Express Pharma
OCTOBER 12, 2023
Flawless Pharma announced that it has signed deals with a European contract development and manufacturing organisation (CDMO) and an African firm in Africa for the export and supply of the active ingredient of the anti-cancer and anti-viral drugs with a technology transfer agreement. Flawless Pharma’s product basket focuses on APIs and advanced intermediates in multiple therapy areas such as analgesic, antipyretic and cardiovascular diseases, oncology, neuroscience, ophthalmology, anti-infective
STAT
OCTOBER 12, 2023
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. Diabetes: Better shows data on app’s benefit with GLP-1s Better Therapeutics announced top-line data suggesting that its prescription app for diabetes treatment, AspyreRx, can boost the impact of GLP-1 diabetes treatments.
Pharma Times
OCTOBER 12, 2023
The service will benefit major research and industry projects across the UK - News - PharmaTimes
STAT
OCTOBER 12, 2023
Good morning, everyone, and welcome to another busy day. We are scrambling, in fact, to update our to-do list, schedule online calls, and sort out deadlines. To cope, we are quaffing several cups of stimulation, of course. Our choice today is maple bourbon. Meanwhile, here is the latest selection of interesting items for you to peruse. We hope your day is successful and productive.
European Pharmaceutical Review
OCTOBER 12, 2023
A new scheme from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to cut the approval time for the lowest-risk clinical trials in the UK by over half. The new Notification Scheme is based on that outlined in the MHRA’s clinical trials consultation, which was endorsed by 74 percent of those who responded. It forms a significant part of the regulator’s overhaul of the clinical trials regulation announced in March 2023, which aims to make the UK a prime location for con
Express Pharma
OCTOBER 12, 2023
In September 2023, the healthcare industry reported 53 deals worth $4.3 billion, compared to the last 12-month average (September 2022 to August 2023) of 82 deals worth $16.8 billion. Alfasigma SpA, a pharmaceutical company to acquire all issued and outstanding shares of Intercept Pharmaceuticals Inc, a biopharmaceutical company for $19 per share; Permira Advisers LLP to acquire Ergomed Plc, a provider of drug development and clinical research services for approximately $884.8 million; and Nirma
PharmaTech
OCTOBER 12, 2023
The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.
BioPharma Dive
OCTOBER 12, 2023
The company expects to deliver first results next year from the early-stage study of people with myotonic dystrophy type 1.
Express Pharma
OCTOBER 12, 2023
Sun Pharmaceutical Industries announced the presentation of Phase 4 data showing that CEQUA (cyclosporine ophthalmic solution) 0.09 per cent induces sustained improvement in the signs and symptoms of dry eye disease (DED). CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with kerato conjunctivitis sicca (dry eye).
European Pharmaceutical Review
OCTOBER 12, 2023
Strong demand for small molecules as treatment for non-small cell lung cancer (NSCLC) in the eight major markets means that the small molecule treatment market for the disease is expected to reach over $15 billion by 2029. This represents approximately 40 percent of the total NSCLC market, stated GlobalData. Sales for AstraZeneca’s Tagrisso are anticipated to exceed $7 billion and hold a 48 percent share of the market of small molecules in lung cancer treatment by 2029, according to data and ana
Pharmaceutical Technology
OCTOBER 12, 2023
IMIDomics has entered into a licence and partnership agreement with the University of Barcelona (UB) to advance treatments for IMIDs.
Drug Channels
OCTOBER 12, 2023
Today’s guest post comes from Sam Blake, Vice President of Launch Excellence at ConnectiveRx. Sam discusses the evolving landscape of copay adjustment programs. He explains how pharma brand teams and hub program managers can lessen the impact of accumulators and maximizers on patients’ access and adherence. To learn more, join Chris Dowd, Senior Vice President of Market Development at ConnectiveRx, for a free webinar on October 26th at 1:00 pm ET: The Battle Over Accumulators and Maximizers: Wha
PharmaTech
OCTOBER 12, 2023
The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.
PharmExec
OCTOBER 12, 2023
A look at the intersection of rigorous compliance and ethical behavior: independent, charitable patient assistance foundations.
Eye on FDA
OCTOBER 12, 2023
FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect. FDA stated in the agency’s press release that the committee’s subject matter jurisdiction will include helping the agency explore and assess is
Outsourcing Pharma
OCTOBER 12, 2023
Munther Baara has worked in the life sciences arena for more than 30 years. He has always been completely committed.
BioPharma Dive
OCTOBER 12, 2023
Earlier this year Pfizer removed thousands of participants from a study of its Lyme disease shot over concerns the group, Care Access, wasn't meeting clinical practice standards.
pharmaphorum
OCTOBER 12, 2023
Incyte’s oral vitiligo drug heading for phase 3 Phil.
Putting Patients First Blog
OCTOBER 12, 2023
How Generative Artificial Intelligence is Changing Patient Advocacy October 12, 2023 By: Elsa Racine, Intern, National Health Council, Washington, DC During my summer internship, I was privileged to work with the National Health Council (NHC), an organization that has one of the most important missions one can have: advocating to improve the lives of patients.
FDA Law Blog: Biosimilars
OCTOBER 12, 2023
By Sara W. Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition. Industry has been asking for Suitability Petition reform for years, either by FDA or mandated by Congress, but, other than a few rejected bills , such requests have ba
Drug Patent Watch
OCTOBER 12, 2023
Annual Drug Patent Expirations for XPOVIO Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Karyopharm Theraps drug XPOVIO appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
OCTOBER 12, 2023
MHRA pledges two-week review for low-risk clinical trials Phil.
Drug Patent Watch
OCTOBER 12, 2023
Annual Drug Patent Expirations for JESDUVROQ Jesduvroq is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent for Glaxosmithkline drug JESDUVROQ appeared first on DrugPatentWatch - Make Better Decisions.
BioPharma Dive
OCTOBER 12, 2023
The order includes an undisclosed timeline and potential additional fines. Illumina, which has been anticipating the decision, maintains the commission does not have jurisdiction over the completed merger.
Drug Patent Watch
OCTOBER 12, 2023
For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com The post New tentative approval for Mylan Gmbh drug trastuzumab-dkst appeared first on DrugPatentWatch - Make Better Decisions.
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