STAT
JULY 2, 2024
As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people. In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time.
PharmaVoice
JULY 2, 2024
BeiGene’s Brukinsa is the first in a hematology franchise that the company hopes will rival top-sellers and introduce a new lineup of medicines for patients.
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STAT
JULY 2, 2024
Why do Americans pay so much more for common medications than people in other countries? Why does an inhaler that costs $7 in France cost almost $500 in the United States? These are just a few of the questions the Senate Judiciary Committee looked to answer in a recent hearing. The common answer? Dominant corporations use a variety of patent-related strategies to protect their power, maximize their profits, and squash their competition.
BioPharma 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.
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
JULY 2, 2024
The unilateral decision by Peter Marks, a top official at the Food and Drug Administration, to approve the gene therapy Elevidys , a treatment for Duchenne muscular dystrophy, despite the misgivings of his staff, looks even more surprising on a close examination. Marks’ decision to overrule three different review teams appears unprecedented in recent FDA history.
BioPharma 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.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Express Pharma
JULY 2, 2024
Techinvention Lifecare has been appointed as a consultant by Botswana Vaccine Institute (BVI) to monitor setting up of the new cGMP compliant, vaccine manufacturing unit in its existing facility at Gaborone, Botswana. According to the statement, the scope encompasses comprehensive project management role for the state-owned Botswana Vaccine Institute (BVI), that has been manufacturing and supplying critical veterinary vaccines since the 1970s, in the region and beyond.
STAT
JULY 2, 2024
Moderna has been awarded $176 million by the Biomedical Advanced Research and Development Authority to accelerate development of messenger RNA-based pandemic influenza vaccines, the company announced in a statement Tuesday. BARDA, a strategic preparedness arm of the Department of Health and Human Services, has said for weeks that it has been in talks with mRNA vaccine manufacturers with an aim to diversify the government’s pandemic flu vaccine response capacity.
Express Pharma
JULY 2, 2024
Körber, a leading company for Manufacturing Execution Systems (MES) in pharma manufacturing, announces a strengthened partnership with Nymi, a biometric wearable company, to deliver secure and contactless user authentication solutions in pharmaceutical production. Building on a foundation of successful collaboration in the past, Nymi now joins the Körber Ecosystem as part of the “PAS-X K.ME-IN” partner certification program on the “Ready” level.
STAT
JULY 2, 2024
The Food and Drug Administration’s rare pediatric disease priority review voucher program , which has been providing incentives for lifesaving innovations since 2012, is doomed to disappear unless Congress reauthorizes it before the end of September. Some lawmakers have downplayed its impressive track record based on unfounded allegations. I have data showing it works.
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pharmaphorum
JULY 2, 2024
Apellis Pharma has said it will seek a re-evaluation of its marketing application for Syfovre for eye disease geographic atrophy (GA) after the EMA’s human medicines committee turned it down for a second time.The CHMP said at its late June meeting that it was issuing a negative opinion for Syfovre (pegcetacoplan) for the treatment of GA secondary to age-related macular degeneration (AMD), a progressive disease leading to sight loss.
STAT
JULY 2, 2024
A looming anti-China biotechnology bill has spooked U.S. life sciences companies, according to a new report. The report by the China-based L.E.K. Consulting quantifies what until now has been mostly a vibe check. At this year’s Biotechnology Innovation Organization’s international conference, multiple biotech companies told STAT they plan to switch from striking deals with Chinese companies to U.S.
Express Pharma
JULY 2, 2024
The U.S. Food and Drug Administration has approved Eli Lilly’s Kisunla (donanemab-azbt) injection, a new treatment for Alzheimer’s disease. Targeted at adults in the mild cognitive impairment or mild dementia stage, Kisunla has shown significant promise in slowing clinical decline, offering a new beacon of hope for patients and their families.
STAT
JULY 2, 2024
The U.S. has slid backward on control of high blood pressure, despite ready access to medicines and other tools to moderate its risks. Dan Jones, former president of the American Heart Association, thinks the nation can learn from China. Researchers there recently detailed the success of community health workers — well trained people but not M.D.s — helping thousands of people living with high blood pressure in rural regions.
BioPharma 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.
STAT
JULY 2, 2024
WASHINGTON — The Supreme Court took up an e-cigarette case Tuesday, weighing Food and Drug Administration decisions blocking the marketing of sweet flavored products amid a surge in vaping by young people. The FDA is appealing a lower court ruling siding with vape companies who argue the FDA unfairly denied more than a million applications to market fruit or candy flavored versions of nicotine-laced liquid that’s heated by the e-cigarette to create an inhalable aerosol.
Express Pharma
JULY 2, 2024
Glenmark Pharma (Glenmark), has joined forces with The Indian Association of Dermatologists, Venereologists, and Leprologists (IADVL), to unveil postcards and calendars aimed at raising awareness, showing empathy and support for individuals living with vitiligo, a skin disorder that affects pigmentation. In an effort to combat misinformation and promote acceptance, Glenmark and IADVL recently conducted a painting competition named “Empathy in Every Stroke” on World Vitiligo Day, June 25, 2024.
STAT
JULY 2, 2024
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third quarter: Late last month, Alnylam Pharmaceuticals reported positive, top-line results from its HELIOS-B clinical trial testing vutrisiran in an increasingly common heart disease called ATTR-CM. Detailed study results are being presented at the annual meeting of the European Society of Cardiology in late August.
Pharmaceutical Technology
JULY 2, 2024
The EMA has accepted AstraZeneca's MAA for sipavibart as Covid-19 pre-exposure prophylaxis (prevention) in immunocompromised patients.
STAT
JULY 2, 2024
Peter Slavin, who ran Massachusetts General Hospital in Boston for nearly two decades before stepping down in 2021 , has taken a new job heading up Cedars-Sinai Medical Center in Los Angeles. Slavin, 66, starts Oct. 1 as president and chief executive of Cedars-Sinai, an institution dubbed the “hospital for Hollywood stars.” He’ll also lead parent Cedars-Sinai Health System, which includes several other owned and affiliated hospitals and a network of outpatient clinics.
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
STAT
JULY 2, 2024
Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of maple bourbon for the occasion. Spring has sprung, after all.
pharmaphorum
JULY 2, 2024
Explore the latest hires in pharma and biotech, including executive moves at Seaport Therapeutics, Anthos Therapeutics, Pfizer, and Novartis, from April 2024. Stay updated with the industry's top talent movements.
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).
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 Pharmacist
JULY 2, 2024
There has been a sharp increase in the use of high-strength nicotine amongst vape smokers in England, a study has revealed. Researchers at University College London (UCL) found that the proportion of adults using high-strength e-liquids has increased to 32.5%, compared to an average of 3.8% between July 2016 and June 2021. The increase is […] The post Sharp increase in use of high-strength nicotine vapes appeared first on The Pharmacist.
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 Pharmacist
JULY 2, 2024
The British Medical Association (BMA) has defended its decision to advise GPs in England to turn off the Update Record functionality that allows pharmacies to share clinical updates from Pharmacy First consultations. In a statement shared with The Pharmacist, Dr David Wrigley, deputy chair and digital lead of BMA's GP Committee, said the BMA was […] The post GPs defend decision to turn off Pharmacy First updates appeared first on The Pharmacist.
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).
Drug Patent Watch
JULY 2, 2024
The pharmaceutical industry is a high-stakes arena where innovation, investment, and intellectual property (IP) protection intersect.
Pharma Times
JULY 2, 2024
According to WHO, around 15% of pregnant women will develop an obstetric complication
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.
Pharmaceutical Technology
JULY 2, 2024
Leqembi will now face a challenger as donanemab enters the market under the brand name Kisunla.
European Pharmaceutical Review
JULY 2, 2024
Researchers have developed a technique to optimise drug delivery using nanoparticles. They applied computer simulations based on blood flow dynamics, to investigate the effects of blood flow on the adhesion and retention of nanoparticle drug carriers. Studies investigating drug delivery via the bloodstream to diseased tissues “have been effective” when “using mouse models and in vitro tissue models”, yet these have used nanoparticles designed “mostly by trial and error”, the researchers emphasis
Outsourcing Pharma
JULY 2, 2024
NeuroSense Therapeutics has announced positive phase 2b results for a drug combination designed to treat amyotrophic lateral sclerosis (ALS).
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