Thu.Jun 29, 2023

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Medical leaders decry Supreme Court decision on affirmative action

STAT

Medical leaders on Thursday reacted swiftly to the Supreme Court’s decision to severely restrict the use of race in college admissions, saying the ruling could reverse decades of progress toward diversifying the nation’s physician workforce — something seen as key to helping end the country’s widespread and deeply entrenched health disparities.

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Transgender patients are rarely included in clinical trials. Can pharma fix it?

PharmaVoice

Transgender and nonbinary patients suffer more adverse health outcomes than the general population, yet are often underrepresented in clinical research. Now, there’s momentum to change the status quo.

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Supreme Court strikes down use of affirmative action, a blow to efforts to diversify medical schools

STAT

Overturning decades of precedent, the U.S. Supreme Court on Thursday struck down the use of affirmative action, ruling that it is unconstitutional for colleges, universities — and professional schools for law, medicine, and nursing — to consider race as one factor in deciding who they will admit. The decision comes as a blow to many in the field of medicine, which has been unable to appreciably increase the numbers of Black, Hispanic, and Indigenous doctors in recent decades.

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Major clinical trial trends transforming life sciences research

PharmaVoice

From AI to diversity and decentralized trials, here’s how clinical trial operations are evolving.

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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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Opinion: The love my daughter and I found in the PICU

STAT

The ventilator alarm woke me at 3 a.m. It was the fourth alarm in the past two hours. My 5-year-old daughter Molly had been there eight days, intubated and heavily sedated so she wouldn’t feel her skin blistering off her body, the terrible effect of a severe drug reaction. I looked over and saw her nurse, Kelli, holding Molly’s hand with her right hand and trying to chart with her left.

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BioMarin finally secures FDA approval of hemophilia gene therapy

BioPharma Dive

After a prolonged journey, the medicine, known as Roctavian, is now cleared for certain patients with hemophilia A, the more common form of the rare bleeding disorder.

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Lilly takes over partner working on cell therapies for diabetes

BioPharma Dive

Sigilon Therapeutics, a biotech that’s been collaborating with Lilly since 2018, has agreed to be bought for up to $310 million in the pharma’s second announced buyout this month.

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STAT+: BioMarin wins approval for gene therapy to treat hemophilia A

STAT

The Food and Drug Administration on Thursday approved a gene therapy to treat people with hemophilia A, an inherited and rare bleeding disorder. The treatment, called Roctavian, is made by BioMarin Pharmaceutical. It was first approved in Europe in August 2022. Roctavian is a one-time therapy that, in clinical trials, dramatically reduced bleeding episodes and helped patients live without the blood transfusions used to treat the disease.

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Wine drinking linked to lower risk of cardiovascular disease

The Pharmacist

Wine drinking is linked to a lower risk of death from cardiovascular disease (CVD) but also reduces the risk of developing both CVD and coronary heart disease (CHD), according to the findings of a recent meta-analysis. Previous studies have hinted that the polyphenolic content of wine confers a cardio-protective effect whereas consumption of spirits, increases the risk of […] The post Wine drinking linked to lower risk of cardiovascular disease appeared first on The Pharmacist.

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We have a cure for hepatitis C — so why aren’t more people getting treatment?

STAT

In 2005, Nick Voyles was diagnosed with hepatitis C after being released from five years of incarceration. A nurse told him he had only six months to live. He was prescribed a drug cocktail, a combination of interferon and ribavirin, that proved ineffective and gave him severe side effects. “It ripped me apart — the entire treatment was killing me,” Voyles, who lives in Bloomington, Ind., recalled.

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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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First cell therapy approved for Type 1 diabetes

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Lantidra, the first cell therapy for certain adults with Type 1 diabetes. The allogeneic pancreatic islet therapy is made from deceased donor pancreatic cells and is indicated for Type 1 diabetes patients who are unable to approach target glycated haemoglobin due to current repeated severe hypoglycaemia episodes even with intensive diabetes management and education.

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STAT+: Drug wholesaler owner indicted for alleged role in diverting Gilead and J&J HIV medicines

STAT

The owner of a pharmaceutical wholesaler has been indicted for his alleged role in distributing misbranded HIV pills, a sign that U.S. authorities are now targeting an extensive scheme that pumped the medicines into the pharmaceutical supply chain. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y., was indicted for participating in a conspiracy in which at least $150 million worth of HIV medicines were purchased at “steeply discounted” prices from patients and then

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Momentum for Poolbeg and CytoReason’s AI collaboration

Pharma Times

Partnership establishes several influenza therapy targets using artificial intelligence - News - PharmaTimes

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STAT+: Alkermes shareholders re-elect directors, rebuffing effort by hedge fund Sarissa

STAT

Alkermes shareholders voted Thursday to re-elect all of the drugmaker’s current directors, ending an acrimonious proxy fight with hedge fund Sarissa Capital Management, which had sought to seat three directors on the board. At the company’s annual meeting, shareholders voted in favor of Alkermes’ proposal to retain all seven of the director nominees to the 11-person board.

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Optimizing Patient Care Services with Rare Disease Limited Distribution Drugs

Orsini Pharmacy

The complexities of managing the care of a rare disease patient are tremendous. Several models of care are efficient when optimizing patient care services with rare disease limited distribution drugs; however, the most promising is the concierge model. This model is where all communications would filter through the health plan. The health plan has a line of sight to precisely what that patient needs and where to get their drug.

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Listen: Novavax’s CEO promises a turnaround & how Lilly roiled the obesity market

STAT

Can Novavax finally get it right? What’s a “triple-G” drug? And is Novo Nordisk losing ground? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. Our colleague Elaine Chen joins us to explain how the era of Wegovy could be short-lived in light of powerful new weight-loss medicines from Eli Lilly.

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Ambulatory BP monitoring: 'We're hoping to get a second monitor'

The Pharmacist

Lisa Olins, pharmacist manager at Crown Pharmacy in Shenley, Hertfordshire, talks to Saša Janković about a tie-up between ambulatory blood pressure monitoring (ABPM) and NMS services Service type: Ambulatory blood pressure monitoring and New Medicine Service Name and location of pharmacy: Crown Pharmacy, Shenley Name of pharmacist: Lisa Olins Why did you start offering this service?

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STAT+: Pharmalittle: Drug-wholesaler owner indicted for alleged role in diverting HIV medicines; Catalent linked to Regeneron drug rejection

STAT

Top of the morning to you. A delicious cool breeze and shiny sun are hovering over the Pharmalot campus, where birds are singing, mascots are barking, and another cup of stimulation is brewing (our choice today is roasted coconut). A fine start to the day, yes? Hopefully, things will continue on this trajectory, despite the smoky skies heading our way from Canada.

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CORONA acquires Myoril brand from Sanofi Healthcare

Express Pharma

The acquisition of the Myoril brand for the Indian market is effective from June 28, 2023 CORONA Remedies has announced the acquisition of the Myoril brand from the global pharma giant Sanofi. The acquisition, valued at Rs 234 crore (including taxes), marks CORONA’s largest acquisition to date. With the Myoril brand becoming a part of its portfolio, CORONA gains its first offering in the muscle relaxant category, strengthening its existing lineup of more than 80 brands.

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Superdrug deal for Thriva at-home and in-store testing

The Pharmacist

A company which provides online health testing kits has partnered with Superdrug under a two-year deal to help people ‘make informed decisions about their health and lifestyle’. Thriva will be offering its health tests through the high-street pharmacy chain for heart disease and diabetes risk, liver function, fertility, white blood cell count, vitamin D levels, iron […] The post Superdrug deal for Thriva at-home and in-store testing appeared first on The Pharmacist.

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Eli Lily ulcerative colitis antibody drug doubles remission rates

European Pharmaceutical Review

New drug mirikizumab doubled remission rates up to 50 percent in certain patient groups in two ulcerative colitis (UC) Phase III trials. Results from the studies were recently published in the New England Journal of Medicine. Researchers identified Interleukin-23 as an important protein in triggering and maintaining gut inflammation. This is relevant in Crohn’s disease, ulcerative colitis and chronic skin disease psoriasis.

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Genprex’s Reqorsa gene therapy secures another FDA fast-track designation

Pharmaceutical Technology

Genprex has announced that the FDA has granted fast-track designation for Reqorsa, its small cell lung cancer (SCLC) therapy.

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Reflecting on five years of quality control for nitrosamine impurities

European Pharmaceutical Review

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. However, it is difficult to predict exactly how processes could behave and how materials could react under each process conditions.

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Lilly to acquire cancer antibody drug startup Emergence

BioPharma Dive

The yet-to-be-announced deal for the German biotech is the latest move by Lilly to bulk up its oncology business, adding a drug in early development for solid tumors.

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Lantidra wins FDA approval as first-ever type 1 diabetes cell therapy

Pharmaceutical Technology

The FDA has announced that Lantidra, a cellular therapy for type 1 diabetes, has become the first treatment of its kind to be approved.

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Anebulo Pharmaceuticals: providing an effective antidote for cannabis intoxication

Outsourcing Pharma

Anebulo Pharmaceuticals is currently developing a new, first-of-its-kind drug, ANEB-001, intended to rapidly reverse the negative effects of ACI within one hour of administration. The treatment is a cannabinoid receptor antagonist, which blocks THC, the substance which gives cannabis its psychotropic effects, from binding in a personâs CB1 receptor.

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Q&A: How can the US maintain access to essential drugs?

Pharmaceutical Technology

Carrie Harney, the vice president of government and regulatory Affairs at US Pharmacopeia (USP) explains US drug shortages.

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Enzene Biosciences launches Bevacizumab

Express Pharma

Manufactured using Enzene Biosciences’ patented Continuous Manufacturing Process, Bevacizumab is a biosimilar to Avastin and will be available through a non-exclusive partnership for pharmaceutical firms in India Pune-based Enzene Biosciences has now announced the India launch of Bevacizumab, a biosimilar of Avastin that is used for the treatment of metastatic colorectal cancer.

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CRISPR gene editing on human embryos may have dangerous consequences, says new study

Pharmaceutical Technology

Experts warn caution around CRISPR gene editing technology on human embryos as it may have dangerous consequences.

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uMotif 'off to the races' with patient first platform after announcing partnership with Syneos Health

Outsourcing Pharma

uMotif is starting to reap the rewards of its patient first technology â that really does what it says on the tin, says the companyâs CEO, Steve Rosenberg.

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University of Oxford and PrecisionLife reach data agreement

Pharma Times

PrecisionLife to analyse OXEGENE data to improve mechanistic understanding of endometriosis - News - PharmaTimes

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FDA approves first cell therapy for type 1 diabetes

pharmaphorum

FDA approves first cell therapy for type 1 diabetes Phil.

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Boots closures will ‘consolidate’ stores and workforce

The Pharmacist

Pharmacy multiple Boots has announced the closure of 300 UK stores over the next twelve months, citing the need to concentrate its team members ‘where they are needed’. Community Pharmacy England chief executive Janet Morrison said that the move was ‘not surprising’ and reflective of the pressures currently experienced by community pharmacy. The pharmacy chain […] The post Boots closures will ‘consolidate’ stores and workforce appeared first on The Pharmacist.

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England turns to digital health checks to cut GP pressure

pharmaphorum

England turns to digital health checks to cut GP pressure Phil.

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Alvotech to raise cash after third FDA rejection for Humira biosimilar

BioPharma Dive

The latest regulatory setback, tied to continuing manufacturing issues, ensures Alvotech and partner Teva won’t be able to launch their drug alongside a wave of emerging Humira copycats.