Tue.Dec 05, 2023

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STAT+: Pfizer plans to depart BIO

STAT

WASHINGTON — Pfizer has decided to leave the Biotechnology Innovation Organization, according to two sources familiar with the decision. The departure is a blow to BIO, which represents members ranging from small biotech startups to massive pharmaceutical companies. The group on Tuesday announced its new CEO, rare disease advocate and biotech executive John Crowley.

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BIO names longtime Amicus head John Crowley as new CEO

PharmaVoice

Crowley, a rare disease advocate who led Amicus for nearly two decades, will take the reins as the industry group seeks to challenge Medicare’s new drug pricing powers.

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Is the flu shot market a slam dunk for mRNA vaccines? Experts aren’t so sure

STAT

Here are two things that are true. The world needs more effective flu vaccines. And pharmaceutical companies that learned of the vaccine-making power of the messenger RNA platform during the Covid-19 pandemic need new markets for their technology.

Vaccines 355
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The digital therapeutics revolution is here. Will payers play ball?

PharmaVoice

Apps, VR and more could play an increasingly vital role in the wider goals of creating value-based treatments — if the industry can get payers to sign on.

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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+: CVS’s new drug payment plan won’t lower patients’ prices, experts warn

STAT

CVS Health is promising to simplify how its pharmacies get paid for drugs. But that doesn’t mean the drugs will get cheaper. The country’s biggest pharmacy chain said it’s switching to a system where pharmacy benefit managers, employers, and other insurers pay for drugs based on the cost of the drug plus a set markup and dispensing fee.

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FDA Grants Breakthrough Designation to Johnson & Johnson’s Novel Treatment for HR-NMIBC

PharmExec

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery.

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More Trending

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Creating a future where the healthcare ecosystem works for everyone

pharmaphorum

In a new episode of the pharmaphorum podcast, web editor Nicole Raleigh speaks with Ari Tulla, CEO and co-founder of Elo Health, about his ‘big vision’ to transform food – changing it from a leading cause of disease to the medicine it can be.

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Opinion: New abortion restrictions pose a serious threat to fetal surgery

STAT

The concept of fetal surgery captures the imagination when, from time to time, it makes the headlines. Few pregnant mothers will need the assistance of fetal medicine specialists; fewer still will need a fetal surgeon to save their children. But it can offer parents-to-be a sense of hope: In the appropriate circumstances, doctors may be able to help before the child is even born.

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KCL molecular communication system to revolutionise drug delivery

Pharma Times

The platform safely and effectively replicates the electric signalling process compounds - News - PharmaTimes

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STAT+: BIO selects rare disease advocate, biotech executive John Crowley as new CEO

STAT

WASHINGTON — The Biotechnology Innovation Organization has chosen longtime biotech executive and rare disease advocate John Crowley as its new CEO, the organization announced Tuesday. Crowley came to biotech when his children were diagnosed with a rare genetic neuromuscular disease. He started working at Bristol-Myers Squibb, and started Novazyme, which was eventually successful in creating an enzyme replacement therapy for Pompe disease.

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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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Fresh call for greater sector support from political health leaders

The Pharmacist

Community Pharmacy England (CPE) is reaching out on both sides of the political divide to call for greater support for the pharmacy sector. CPE has written to both the health secretary, Victoria Atkins, and her Labour shadow, Wes Streeting, urging political leaders to work with the sector, patient bodies and charities to ‘realise the potential’ […] The post Fresh call for greater sector support from political health leaders appeared first on The Pharmacist.

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STAT+: New CAR-T company, Brainchild Bio, will focus first on brain tumors in children

STAT

About a decade ago, Mike Jensen, a pediatric oncologist at Seattle Children’s hospital, licensed to a startup his designs for a powerful new type of therapy, called CAR-T, that would re-engineer a child’s own immune cells to target cancer. The deal proved be a mixed blessing. The therapy eventually reached market as Breyanzi, one of three CAR-Ts approved for adult leukemia.

Immunity 275
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Pfizer, after delay, completes enrollment in Lyme vaccine trial

BioPharma Dive

The announcement ends a lengthy setback that began when the company and partner Valneva accused a clinical trial site operator of study misconduct.

Vaccines 109
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STAT+: RNA startup ReNAgade cuts staff seven months after raising $300 million

STAT

Biotech startup ReNAgade Therapeutics is cutting staff just seven months after raising the largest Series A round in the industry this year. ReNAgade launched in May with hopes of becoming a one-stop shop for medicines targeting RNA, the genetic blueprints that cells use to make proteins instrumental in numerous diseases. These types of medicines are in high demand following the advent of mRNA vaccines for Covid and RNA-silencing therapies made by companies like Alnylam Pharmaceuticals.

Vaccines 264
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Phase III data for novel telomerase inhibitor released

European Pharmaceutical Review

Results from Geron’s Phase III IMerge trial evaluating its first-in-class investigational telomerase inhibitor imetelstat, have shown long-term and durable response in participants with a rare haematologic malignancy. Efficacy of the treatment was compared to placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

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STAT+: $100 billion estimate for Ozempic-style weight loss drugs gets wary eye from analysts

STAT

NEW YORK — Will the world actually soon spend $100 billion a year on the new obesity medicines? Plenty of people in pharma and at the banks that invest in it seem to think so. Goldman Sachs, Barclays, BMO Capital Markets and Pfizer have all arrived at the glossy, cut-for-headline number for spending by around 2030. Yet Jared Holz, a healthcare strategist at Mizuho, is skeptical.

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NIHR invests £55m to tackle health inequalities and outcomes

Pharma Times

Millions of people in the UK are set to benefit from the second wave of funding - News - PharmaTimes

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STAT+: Senate panel considers Medicare policy fixes to drug shortages

STAT

WASHINGTON — Members of the Senate Finance Committee took their first steps today toward using Medicare payment policy to fix drug shortages. Drug shortages are particularly vexing because they’re mostly caused by policies within the control of the government, as opposed to outside shocks such as natural disasters. Instead, it’s economic factors — the complicated way Medicare pays hospitals or the dominance of group purchasing organizations that buy hospital drugs &#x

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UK’s entrance into Horizon Europe finalised

European Pharmaceutical Review

With the UK set to become an associated country to Horizon Europe on 1 January 2024, the political agreement on UK’s association to Horizon Europe has been adopted. Now, this final step in the process has been implemented by the EU-UK Specialised Committee on Participation in Union Programmes (SCPUP), the European Commission (EC) has announced. The programme is the EU’s key funding initiative for research and innovation with a budget of €95.5 billion for 2021-27.

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ChatGPT doesn’t know much about drugs, Hims & Hers enters weight-loss market

STAT

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.

Hospitals 209
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Q&A: Tackling the rise of fake anti-obesity drugs on the market

Pharmaceutical Technology

Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.

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Carmot’s chance of beating the odds in the biotech market just ended

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Damian here with a special thanks to everyone who joined us for STAT’s live event in New York City last night. Today we have a sober look at the future of mRNA, a plot to bring CAR-T back to its founding ideals, and the downside of a billion-dollar buyout.

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Roche to advance novel obesity and diabetes treatments

European Pharmaceutical Review

Roche has agreed to acquire biotech Carmot Therapeutics for an upfront purchase price of $2.7 billion, enabling the Swiss pharma company to add a range of incretin treatments for obesity and diabetes to its portfolio. Incretins are “gut hormones that are secreted after food intake and play a role in modulating blood glucose by stimulating insulin secretion and suppressing appetite,” Roche highlighted.

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STAT Morning Rounds: The health news you need to read today

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter here. Buongiorno, Nalis here! A question for you to consider: Is it fair to let the Sacklers off the hook from facing future justice, if that is the best guarantee of compensation to victims of the opioid epidemic? Don’t worry if you’re not sure; the Supreme Court doesn’t seem to know either.

Vaccines 188
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Pass rate for pharmacist registration exam up 10% in a year

The Pharmacist

The overall pass rate from November 2023’s registration assessment for pharmacists was 66%, the General Pharmaceutical Council (GPhC) and Pharmaceutical Society of Northern Ireland (PSNI) have revealed. The figure represents a significant 10% rise on the previous year’s overall pass rate. A total of 1,067 candidates across the four UK countries sat the assessment on […] The post Pass rate for pharmacist registration exam up 10% in a year appeared first on The Pharmacist.

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Pharma accuses UK of ‘mixed messages’ on rebate schemes

pharmaphorum

The pharma industry and the UK government may have reached an accord on the voluntary scheme of rebates used to limit rises in medicines spending in the UK, but the alternative statutory scheme remains a prickly subject.

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CVS overhauls how its retail pharmacies charge for prescription drugs

BioPharma Dive

Under the new model, CVS’ pharmacy network will price drugs based on the amount the company paid for them, plus a defined markup and additional pharmacist fee.

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Why Adial is developing a pill for alcohol addiciton: 'Abstinence is not the only road to recovery’

Outsourcing Pharma

We sat down with Cary Claiborne, CEO and president of Adial Pharma, to discuss the challenges of treating alcohol abuse and company's solution â a serotonin-3 receptor antagonist that could affect neurotransmitters like dopamine and modulate the behavioural effects of alcohol.

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Oxford Biomedica agrees to acquire ABL Europe

Pharmaceutical Technology

Oxford Biomedica has signed an agreement to acquire CDMO ABL Europe from Institut Mérieux subsidiary TSGH SAS in a deal worth €15m ($16.27m).

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Sentynl completes asset transfer of CUTX-101 Copper Histidinate product candidate for treatment of Menkes Disease from Cyprium

Express Pharma

Sentynl Therapeutics, a US-based biopharma company wholly-owned by Zydus Lifesciences announced the execution of an assignment and assumption agreement with Cyprium Therapeutics, a Fortress Biotech subsidiary company. Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and US FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.

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Merck signs $70 million deal to commercialize Abbisko’s new cancer drug in China

Outsourcing Pharma

Merck has entered into a $70 million licensing agreement with Abbisko Therapeutics for pimicotinib, which is currently being evaluated in a phase 3 study for the treatment of tenosynovial giant cell tumor (TGCT).

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Drug Wholesalers and Brand-Name Drug Prices: Understanding CVS Health/McKesson and Why Pharmacies Lose Money on GLP-1s

Drug Channels

Consider two apparently unrelated drug channel anomalies: In McKesson’s 2023 fiscal year, CVS bought $75 billion in pharmaceuticals from McKesson’s wholesale business—a jump of more than 35% compared with the previous year. Despite skyrocketing sales for anti-obesity GLP-1 drugs, many retail pharmacies are losing money on every prescription. The common factor behind these two disparate situations: Pharmaceutical wholesalers’ unusual pricing for brand-name drugs sold to pharmacies, hospitals, and

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Lupin gets US FDA approval for Varenicline Tablets

Express Pharma

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. The product will be manufactured at Lupin’s Pithampur facility in India. Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.

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BIO names longtime Amicus head John Crowley as its new CEO

BioPharma Dive

Crowley, a rare disease advocate who led Amicus for nearly two decades, will take the reins as the industry group seeks to challenge Medicare’s new drug pricing powers.

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Reinvigorating the Cancer Moonshot with empowered patients

pharmaphorum

Reinvigorating the Cancer Moonshot with empowered patients Mike.

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