Mon.Jun 26, 2023

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STAT+: Illumina to lay off 10% of research and development team in bid to cut costs by $100 million

STAT

SAN DIEGO — Months after announcing plans to cut costs by $100 million, DNA sequencing giant Illumina has begun to lay off 10% of its research and development team, according to internal emails obtained and reviewed by STAT. The layoffs, which began last Wednesday, impact research teams across the company’s California sites in San Diego and Foster City, as well as locations in Madison, Wisconsin; Singapore; and the United Kingdom.

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A unique study on COVID shows how machine learning can help personalize medicine

PharmaVoice

Based on real-world data from patients in China, researchers were able to pinpoint factors that led to recurring infections — and which drug combos helped.

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STAT+: STAT-Harris Poll: Nearly half of U.S. adults would spend $100 a month for Ozempic, other weight-loss drugs

STAT

Almost half of Americans would be willing to spend up to $100 a month for new weight-loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll. Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month.

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Your favourite nutraceuticals can be toxic: Discovered by Nutrify Genie

Express Pharma

Nutrify Genie combines information, speed, accuracy, and quality in the design of new products. However, it is crucial to consider potential concentrations of unwanted substances like pesticides and contaminants, including mycotoxins, during the extraction process The integration of plant-based nutraceuticals into a diverse diet has gained global attention due to their ability to promote health.

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Position Your Pharmacy for Expansion

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.

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‘I felt like I was dying’: How women with postpartum depression fall through the cracks of U.S. health care

STAT

Five and a half months after Kristina Dulaney had her second daughter, she developed postpartum psychosis. One day, she spontaneously quit her job as a nurse — which she doesn’t remember doing. Soon after, she began to quote scripture, grabbed her kids, and begged God to save them all. Then she passed out, and her husband called 911. Dulaney spent two nights in a behavioral health emergency room before being sent to a general inpatient unit that had both men and women in Greensboro

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5 FDA decisions to watch in the third quarter

BioPharma Dive

By the end of September, the FDA will hold two anticipated advisory meetings and issue important decisions on drugs for Alzheimer’s, depression and a type of vision loss.

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NASH drugs race to cross the finish line

Pharmaceutical Technology

After Intercept’s Ocaliva rejection, multiple companies are taking aim at becoming the first US-approved NASH therapy.

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Opinion: Health misinformation is rampant in youth baseball. Why isn’t MLB doing more to help?

STAT

“W e all know that we are in the middle of an epidemic with our youth throwers,” an orthopedic specialist opined in a March editorial. The sports medicine professionals and readers of the journal Arthroscopy may know this, but it is far from common knowledge among parents and coaches in youth baseball leagues. As scientists and sports fans, we are particularly interested in a scientific, evidence-based approach to injury prevention and sports medicine.

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More than 60 researchers ask Congress to support innovation

PhRMA

Earlier this month, 62 researchers from our member companies came to Washington, DC to meet with congressional offices during our annual fly-in event. This year included a record-breaking number of meetings — 145 over the course of the day.

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STAT+: Pharmalittle: Nearly half of U.S. adults would spend $100 a month for weight loss drugs; Pfizer scraps an obesity pill

STAT

Good morning, everyone. and welcome to another working week. We hope the weekend respite was restful and invigorating because now that familiar routine of online meetings, deadlines, and what-not has predictably returned. But what can you do when the world, such as it is, keeps spinning? As you might expect, we are coping by quaffing a few cups of welcome stimulation — our flavor today is Southern Pecan — and, as always, we invite you to join us.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Pharmacists defend anti-abuse signage at Tesco branch

The Pharmacist

Signs displayed in a supermarket pharmacy outlining a zero-tolerance policy to violence against staff and urging patients to ‘think’ before they speak, reflects a ‘decimation of morale’ among the pharmacy workforce, those in the sector have said. The signs, put up at a Tesco pharmacy in Oxfordshire, have been at the centre of an online […] The post Pharmacists defend anti-abuse signage at Tesco branch appeared first on The Pharmacist.

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STAT+: Shareholders elect director’s romantic partner to Biogen’s board

STAT

Biogen shareholders voted to add biotech executive Susan Langer, who is the romantic partner of departing director Alex Denner, to its board of directors on Monday, concluding a weeklong episode that led some investors to question the company’s leadership. Langer, 32, will join the eight-member board for a one-year term. Denner, who nominated her, did not stand for reelection.

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AstraZeneca’s Soliris given EU CHMP recommendation for marketing authorisation

Pharma Times

The authorisation would include certain patients with refractory generalised myasthenia gravis - News - PharmaTimes

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STAT+: U.K. agency declines to recommend Eli Lilly’s Mounjaro for type 2 diabetes

STAT

LONDON — A U.K. government agency on Tuesday said that it won’t recommend Eli Lilly’s Mounjaro — part of a new class of medications that help patients lose weight — for people with type 2 diabetes without additional evidence. Mounjaro, also known as tirzepatide, has U.S. approval for type 2 diabetes and is expected to win the regulatory green light for obesity later this year.

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FDA approves Pfizer's LITFULO™ (ritlecitinib) for adults and adolescents with severe alopecia areata

World Pharma News

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

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STAT+: UnitedHealth wins $3.3 billion takeover of home health giant Amedisys

STAT

Home health and hospice chain Amedisys has chosen a new corporate owner. Amedisys and UnitedHealth Group’s Optum agreed to a deal Monday in which UnitedHealth will pay $101 per share in cash for Amedisys, totaling $3.3 billion. UnitedHealth’s latest offer is $1 per share higher than what it proposed in its unsolicited buyout offer a few weeks ago.

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FDA publishes recommendations on psychedelic clinical trial design

European Pharmaceutical Review

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. The draft guidance is intended to advise researchers on aspects such as clinical study design as they develop medications that contain psychedelics. Dr Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research stated the regulatory body “hopes to outline the c

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STAT+: In setback, Pfizer abandons one weight-loss pill and bets on another

STAT

Pfizer said Monday that it had discontinued clinical trials of a once-daily weight-loss pill whose results were highly anticipated by investors because patients taking the drug had elevated levels of certain liver enzymes. Instead, the drug giant said that it would move forward with a twice-daily pill, danuglipron. Early results of danuglipron, which showed the drug appears to help control blood sugar and resulted in an average of 9.2 pounds of weight loss over 16 weeks, had led Pfizer’s

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MoS S&T launches GEMCOVAC-OM

Express Pharma

India’s first mRNA vaccine developed using the indigenous platform technology by Gennova, with funding support from DBT & BIRAC Union Minister of State (Independent Charge) for Science and Technology, MoS PMO, Department of Atomic Energy and Department of Space and MoS Personnel, Public Grievances and Pensions, Dr Jitendra Singh launched the GEMCOVAC-OM, an Omicron-specific mRNA-based Booster vaccine.

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CHMP gives positive opinion recommending authorisation to GSK’s CKD drug

Pharma Times

Chronic kidney disease affects roughly 700 million patients worldwide - News - PharmaTimes

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How can real-world evidence support regulatory decision making?

European Pharmaceutical Review

The European Medicines Agency (EMA) has published its report: Real-world evidence framework (RWE) to support EU regulatory decision-making. The review summarised what the organisation has learned from conducting real-world data (RWD) regulator-led studies from September 2021 to February 2023. There were 61 RWD research opportunities identified, 30 studies initiated and 27 completed in this period.

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Akums gets DCGI approval for Perampanel Oral Suspension

Express Pharma

Akums has received first-time approval of Perampanel Oral Suspension by the Drug Controller General of India (DCGI). This approval allows Perampanel Oral Suspension to serve as adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalised seizures, as well as primary generalised tonic-clonic (PGTC) seizures in patients with epilepsy aged 12 years and older in the country.

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Shionogi agrees $140m deal to buy antibiotic biotech Qpex

pharmaphorum

Shionogi agrees $140m deal to buy antibiotic biotech Qpex Phil.

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Planning to upgrade or setting up a new lab- Keep your purchasing options open!

Express Pharma

Your business depends on access to new, productive instrumentation, but the pace of evolving technology and regulatory requirements make equipment ownership risky, especially in the face of shrinking capital budgets. Flexible payment plans from Agilent can help you acquire your next instrument without the capital expenditure. Our Technical Knowledge and financial expertise enable us to equip you with customized financial solutions catered to your specific business requirement.

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Pfizer, citing safety concerns, scraps one of two obesity pill hopefuls

BioPharma Dive

Liver enzyme elevations in early- and mid-stage testing have led the drugmaker to discontinue development of lotiglipron and focus on another prospect that’s shown early promise.

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Zydus Lifesciences acquires 6.5 per cent stake in Mylab Discovery Solutions

Express Pharma

The acquisition represents collective vision to transform healthcare by combining therapeutic expertise in human formulations and diagnostic capabilities of the two companies Zydus Lifesciences through its wholly owned subsidiary Zydus Animal Health &Investments Limited (ZAHIL), has acquired 6.5 per cent stake in Mylab Discovery Solutions from Rising Sun Holdings Pvt Ltd, an investment company owned by Adar Poonawalla.

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Sarepta’s $3.2M Gene Therapy Receives FDA Approval

PharmExec

Drug expected to support children aged 4 and 5 with Duchenne muscular dystrophy.

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‘Hypoallergenic’ items sold at Superdrug and Boots fail allergy test

The Guardian - Pharmaceutical Industry

One in three products including shampoos, deodorants and wet wipes found to contain skin allergens More than a third of personal care products, such as shampoos and body washes, marketed as hypoallergenic at Boots and Superdrug have been found to contain common skin allergens, research shows. As a large proportion of the population have sensitive skin or allergies, products are increasingly using the term “hypoallergenic” to advertise goods.

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FDA sets out its thinking on psychedelic drug trials

pharmaphorum

FDA sets out its thinking on psychedelic drug trials Phil.

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Inflation Reduction Act Faces More Legal Challenges, including long-expected PhRMA lawsuit

FDA Law Blog: Biosimilars

By Faraz Siddiqui & Alan M. Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. federal district court on June 6 (see our post here ). Since then, complaints have been filed in federal court in Ohio by the U.S.

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NHS must ‘focus on’ preventative and personalised care

The Pharmacist

A new independent report has highlighted the importance of preventative and personalised care that is delivered closer to home. The document – published by an independent advisory group to the NHS called the NHS Assembly last week – said that this, alongside investment into general practice, would help deliver better outcomes for patients and save […] The post NHS must ‘focus on’ preventative and personalised care appeared first on The Pharmacist.

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Informa Connect’s Health Systems & Pharma Partnering Summit

Drug Channels

Informa Connect’s Health Systems & Pharma Partnering Summit August 14-16, 2023 in Boston, MA www.informaconnect.com/health-systems-partnering Drug Channels readers save 10% with code 23DRCH10 * View the agenda for Health Systems & Pharma Partnering 2023 to see the complete picture – the program, speakers, and more, and visit www.informaconnect.com/health-systems-partnering for further details and to register.

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DexCare raises $75m for digital patient booking system

pharmaphorum

DexCare raises $75m for digital patient booking system Phil.

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Biogen shareholders vote in favor of new board member

BioPharma Dive

Susan Langer, whose nomination stirred controversy due to her ties to an outgoing director, will now join seven other board members who successfully ran for re-election.

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Novo Nordisk, Lilly highlight oral obesity drugs at ADA

pharmaphorum

Novo Nordisk, Lilly highlight oral obesity drugs at ADA Phil.

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