Mon.Jul 01, 2024

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Opinion: Psychiatrists aren’t fulfilling the social contract that subsidized their training

STAT

There has been much handwringing about how difficult it is for Americans with mental health issues to see a psychiatrist. Failures in the health insurance market are often blamed for the problem. As a new class of psychiatry residents begins work in hospitals across the country this week, I see an additional cause: the lack of commitment to honor the subsidies that made it possible for psychiatrists to enter the profession.

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The IRA will lower U.S. drug spending, CMS finds — but not for awhile

PharmaVoice

As the first 10 drugs undergo price negotiations with the U.S. government, the latest spending projections reveal soon-to-be-implemented price caps will have an impact by 2027.

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Bird flu snapshot: A pathologist sees familiar echoes in U.S. response to the outbreak

STAT

Bird flu snapshot: This is the latest installment in a series of regular updates on H5N1 avian flu that STAT is publishing on Monday mornings. To read future updates you can also subscribe to STAT’s Morning Rounds newsletter. When pathologist Thijs Kuiken looks at what’s happening in the U.S. response to the H5N1 bird flu outbreak in dairy cows, he’s reminded of a difficult period in the Netherlands, where he lives, back in the late aughts.

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Protein power: a biotech mining viruses to fight disease

PharmaVoice

Flagship Pioneering-backed Prologue Medicine is harnessing the evolutionary tactics of viral proteins to systematically find new drugs.

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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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STAT+: Ascension is racing to unload hospitals as execs work to stem losses

STAT

For 15 years, a formidable CEO-CFO duo often called “the two Tonys” ushered their St. Louis-based health system through a period of explosive growth, adding hospital after hospital until it became one of the country’s biggest health systems. The year after former CEO Anthony Tersigni and former finance chief Anthony Speranzo stepped down, their sprawling empire of roughly 140 hospitals underwent the ultimate stress test: the Covid-19 pandemic.

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AstraZeneca files rival to Pemgarda for COVID PrEP

pharmaphorum

AstraZeneca may have exited the COVID-19 vaccine market, but it is still hoping to protect vulnerable patients with its antibody sipavibart for pre-exposure prophylaxis (PrEP).The drugmaker said this morning that an application for sipavibart (AZD3152) has been accepted for review by the EMA as PrEP for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

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How can pharmaceutical marketing evolve with generic entry? The example of Lipitor

Drug Patent Watch

Lipitor’s marketing strategy underwent a significant evolution as generic competition emerged, employing aggressive tactics to retain market share and brand […] Source

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Microbiome composition varies based on sampling time, mouse study finds

STAT

The microbiome has immense power to shape health outcomes. The bacteria that take up residence in the human body, including the gut, have been shown to impact health and disease, including neurodegenerative disorders. Medical research is invested in finding ways to reconstruct healthy microbiomes to help cure some of those ills.  But like many fields in science , microbiome research is suffering from a reproducibility crisis.

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Eisai and Bristol Myers cancel cancer ADC deal

BioPharma Dive

The Japan-based drugmaker said its U.S. partner’s “portfolio prioritization efforts” led to the termination. It will refund part of an upfront payment.

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STAT+: After months of warnings, FTC opens investigation into Teva over ‘improper’ patents

STAT

The Federal Trade Commission is formally investigating Teva Pharmaceuticals after the company refused to remove approximately two dozen patents for asthma and COPD inhalers from a key federal registry. The agency sent a civil investigative demand requiring Teva to provide information related to the patents listed in the so-called Orange Book, which is maintained by the Food and Drug Administration.

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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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OPPI urges government to boost R&D and innovation in pharma sector ahead of Union Budget

Express Pharma

In anticipation of the upcoming Union budget, the Organisation of Pharmaceutical Producers of India (OPPI) has voiced its expectations and recommendations for the healthcare and pharma sector. Anil Matai, Director General of OPPI, expressed optimism about the government’s ongoing efforts to enhance quality healthcare and the continuous reforms aimed at bolstering innovation and streamlining regulatory processes.

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Opinion: Medicare should wait on approving coverage for new obesity drugs

STAT

My dad, Randy, a 72-year-old retired sales manager, started to gain weight after grad school, and it didn’t let up until he was middle-aged. He’s now living with high blood pressure and high cholesterol. His cardiologist has told him, “You know, if you lost 15 pounds, you could get off your blood pressure medicine.

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Why informed patient consent is vital for successful clinical trials

pharmaphorum

Informed patient consent is crucial for the success of clinical trials. Learn about the importance of consent in clinical trials and how it impacts the outcomes.

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STAT+: Pharmalittle: We’re reading about indicted drug wholesalers, a gene therapy rejection, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because the familiar routine of online meetings, calls, and deadlines has predictably returned. But you know, the world — such as it is — continues to spin. So what can you do but try to give it a nudge in a better direction.

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Lilly builds in radiopharma with $140m Radionetics deal

pharmaphorum

Eli Lilly has lined up another deal in the radiopharmaceutical sector, paying $140 million to partner drugs developed by Radionetics Oncology and taking an option on buying the company outright for $1 billion.Radionetics is working on small-molecule drugs that target G protein-coupled receptors (GPCRs), a fertile source of drug targets for the pharma industry and the target of around a third of all marketed drugs but according to the company is a “largely unexplored” class for radiopharma.

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STAT+: Steward Health Care spent millions on surveillance of its critics — even amid financial crisis

STAT

This story was reported by Hanna Krueger, Jessica Bartlett, Mark Arsenault, and Elizabeth Koh. It was written by Krueger and edited by Brendan McCarthy. One night last year, a surveillance team camped outside a financial analyst’s English country home and videotaped him as he watched television with his partner. The team — contracted through a British private intelligence agency — put a tracker on the analyst’s car, watched his daughter go to

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France agrees to fund experimental glioblastoma therapy

pharmaphorum

France's HAS agrees to fund treatment with Carthera's ultrasound device for French subjects enrolled in a glioblastoma trial.

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Eli Lilly inks another radiopharma deal, gaining option to buy startup

BioPharma Dive

Under an arrangement with Radionetics, Lilly will have rights to acquire the San Diego biotechnology company for $1 billion.

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Amylyx looks to cover financial gap left by Relyvrio with avexitide deal, says GlobalData

Express Pharma

In June, Amylyx Pharmaceuticals acquired the rights to Eiger Biopharmaceuticals’ experimental glucagon-like peptide-1 (GLP-1) receptor antagonist, avexitide, for $35.1 million. Avexitide was previously developed for post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). The acquisition is a notable strategic action by Amylyx following the failure of its lead amyotrophic lateral sclerosis (ALS) therapy, Relyvrio (sodium phenylbutyrate and taurursodiol), formerly known as AMX0035,

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University of Liverpool launches new biotech spin-out company Galytx

Pharma Times

The biotech company will develop novel therapeutic drugs for the treatment of fatal diseases

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10 clinical trials to watch in the second half of 2024

BioPharma Dive

Study results are expected for a pair of closely watched obesity drugs, while key tests await for a high-priced AbbVie acquisition and one of 2023’s largest IPOs.

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Navigating investment trends in dietary supplement markets

Express Pharma

Season 2 of the Express Pharma – Nutrify Today Boardroom series presents key dialogues from the Nutrify C Suite Sumflex 2024, held over June 6-7, 2024. Transitioning from a latent player a decade ago to a leading market for nutraceutical ingredients and finished products, India is now attracting significant attention from innovators and investors worldwide.

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NeuroSense says ALS drug extends survival

pharmaphorum

NeuroSense Tx reports 12-month data with its amyotrophic lateral sclerosis therapy PrimeC, including a 43% improvement in survival

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AstraZeneca’s COVID prevention drug application gets EU fast-track assessment

Express Pharma

AstraZeneca stated on July, 1 2024, that the European Union drug regulator has accepted a market authorisation application for its investigational COVID-19 prevention drug, sipavibart, for an accelerated assessment. The submission was based on positive data from a late-stage trial that showed the drug reduced the risk of infection in patients with weaker immunity. “The EMA’s (European Medicines Agency) Committee for Medicinal Products for Human Use(CHMP) granted sipavibart accelerate

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ICL granted £150,000 to explore link between breast cancer and breastfeeding

Pharma Times

Breast cancer is the most common cancer in the UK, accounting for 15% of all cancers

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Navigating investment trends in dietary supplement markets

Express Pharma

Season 2 of the Express Pharma – Nutrify Today Boardroom series presents key dialogues from the Nutrify C Suite Sumflex 2024, held over June 6-7, 2024. Transitioning from a latent player a decade ago to a leading market for nutraceutical ingredients and finished products, India is now attracting significant attention from innovators and investors worldwide.

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CHMP meeting highlights – June 2024

European Pharmaceutical Review

At its recent June meeting, the EMA’s human medicines committee (CHMP) recommended 10 medicines for approval. Recommendations for regulatory approval The committee saw a need to give a marketing authorisation to Balversa (erdafitinib) as a treatment for adults with unresectable or metastatic urothelial carcinoma. In its meeting, the CHMP gave a positive opinion for the first nasally administered emergency treatment for allergic reactions.

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Signet Therapeutics announces IND approval by the FDA for world’s first targeted therapy for DGC

Express Pharma

Signet Therapeutics, a biotech company using organoid disease models and AI to advance targeted cancer therapy, today announced that the FDA has granted its IND application for sigx1094 as a potential treatment for diffuse gastric cancer (DGC). According to the statement, sigx1094 is reportedly the first targeted drug candidate for DGC, a disease currently lacking effective treatments.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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How AI is impacting ideation to commercialization in nutraceuticals

Express Pharma

Season 2 of the Express Pharma – Nutrify Today Boardroom series presents key dialogues from the Nutrify C Suite Sumflex 2024, held over June 6-7, 2024. The two day Nutrify Today C Suite Sumflex 2024, where over 360 decision-makers from around the globe gathered to explore and discuss the burgeoning opportunities within the Indian market, mirrored the World Economic Forum on a micro-scale, tailored specifically for the nutraceutical industry.

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With new IPO pitch, Artiva touts ‘natural killer’ cell therapy for autoimmune disease

BioPharma Dive

Like many of its cell therapy peers, Artiva, which originally sought an IPO in 2021, has shifted its strategy in hopes of riding a recent wave of investor interest in autoimmune disease research.

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Risk adjusted net present value: What is the current valuation of Pfizer’s Atirmociclib?

Pharmaceutical Technology

Atirmociclib is a small molecule commercialized by Pfizer, with a leading Phase III program in Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer).

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Alembic Pharma announces USFDA Tentative Approval for Bosutinib Tablets, 100 mg and 500 mg

Express Pharma

Alembic Pharmaceuticals (Alembic) announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V.

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UK’s antibiotic subscription funding model – a route to market sustainability?

Pharmaceutical Technology

On 8 May, the UK was the world's first government to formally implement a new model for the funding and support of novel antibiotic commercialisation.

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Sanofi shares results from phase 2 trial for frexalimab in MS treatment

Pharmafile

Sanofi has announced new phase 2 trial data for its CD40L monoclonal antibody, frexalimab, for the treatment of patients with relapsing multiple sclerosis (MS). The results showed a significant reduction in plasma levels of neurofilament light chain (NfL) after one year of treatment, which is a biomarker of nerve cell damage, typically raised in patients […] The post Sanofi shares results from phase 2 trial for frexalimab in MS treatment appeared first on Pharmafile.

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