Tue.Sep 19, 2023

article thumbnail

Physicians say transgender sports bans are a health issue

STAT

Almost half of U.S. states have banned or restricted trans youths’ access to gender-affirming puberty blockers, hormones, and surgery — and many of the same states are also targeting trans youths’ participation in sports. Twenty-three states ban trans youths from participating in school sports consistent with their gender identity, with some laws focusing on students from kindergarten through 12th grade and others including, or exclusively applying to, students at the colleg

357
357
article thumbnail

The 2023 PharmaVoice 100

PharmaVoice

This year’s honorees are influential and devoted leaders lifting the pillars of the industry to new heights.

363
363
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Opinion: A popular breast cancer genomic test underestimates risks for Black women

STAT

When a woman first learns she has breast cancer, her mind immediately floods with “what now?” questions as she grapples with how this disease will impact her life. Unfortunately, Black women also have to ask themselves, “Will my racial heritage and ethnicity affect the care I receive and chances of survival?

347
347
article thumbnail

PBMs, PhRMA trade blame over drug costs in House hearing

PharmaVoice

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second PBM hearing on Tuesday.

130
130
article thumbnail

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.

article thumbnail

STAT+: Artificial wombs, after years in development, reach FDA review for human trials

STAT

The artificial womb, a device aiming to save infants born way too soon, is inching closer to being tested in humans. The technology is close enough to reality that the Food and Drug Administration has decided to convene a two-day panel starting Tuesday to discuss how to best evaluate safety and effectiveness, as well as the ethical quandaries in running clinical trials.

Hospitals 337
article thumbnail

Startup AIRNA emerges from stealth to bring RNA editing to a rare disease

BioPharma Dive

AIRNA is one of several biotechs to debut plans for target alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

120
120

More Trending

article thumbnail

Government should consider funding pharmacies in same way as GPs, report suggests

The Pharmacist

The current funding model for community pharmacy does not contain ‘the right incentives’ to deliver clinical services to patients, a new report outlining a long-term vision for the sector has suggested. A clinical future for the sector, helping to relieve the burden on general practice and other overstretched parts of the health system, formed a […] The post Government should consider funding pharmacies in same way as GPs, report suggests appeared first on The Pharmacist.

article thumbnail

STAT+: Biotech lab-space demand falls sharply as industry’s ‘sugar high’ turns into a ‘reset’

STAT

Demand for new lab space has plummeted by more than half since the end of 2021, and life science vacancy rates are the highest they’ve been in a decade amid the biotech industry’s ongoing downturn, according to a report released Tuesday by Jones Lang LaSalle, a commercial real estate services company Tenant demand, measured by the total amount of new space that companies are looking to lease, dropped from 25.3 million square feet at the end of 2021 to 10.1 million square feet by th

292
292
article thumbnail

PBMs, PhRMA trade blame over drug costs in House hearing

BioPharma Dive

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

109
109
article thumbnail

STAT+: FDA weighs animal data, ethical dilemmas at panel on artificial wombs

STAT

The Food and Drug Administration’s advisory panel of pediatric experts met on Tuesday to discuss advances in artificial womb technology, which aim to save the lives of premature babies. The goal of the meeting was to discuss measures for evaluating the safety and efficacy of an artificial womb. The group grappled with the limits of current animal data, as well as the ethical difficulties in running human trials.

291
291
article thumbnail

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.

article thumbnail

To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

By Sara W. Koblitz & Kurt R. Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.

article thumbnail

Rep. Adam Smith weighs in on the country’s mental health crisis with his own story

STAT

WASHINGTON — Rep. Adam Smith (D-Wash.) knew when he hit rock bottom. “I woke up one morning in early April of 2016 and seriously considered the possibility that I might never be able to get out of bed,” he opens his recent memoir, “Lost and Broken,” which details the six years in which “crippling anxiety” and chronic pain dominated his life even as he bounced back and forth from the Capitol to northern Seattle, the district he has represented for

287
287
article thumbnail

Evaxion validates its infectious disease AI vaccine platform

Pharma Times

The platform identifies antigens to fight against bacterial infectious disease - News - PharmaTimes

Vaccines 133
article thumbnail

STAT+: Pear’s shadow effect: Data from a Medicaid digital health experiment does the policy rounds

STAT

Pear Therapeutics may be gone, but one of its most important deals is still driving critical conversations about how medical apps can find a foothold in the slow-moving health care system. In recent months, representatives of the Massachusetts state Medicaid program, MassHealth, have been presenting data suggesting reSET and reSET-O, Pear’s prescription apps that treat substance use disorder and opioid use disorder, saved the state money over a one-year period from 2021 to 2022.

264
264
article thumbnail

Why Communication Is Important in Pharmacy Leadership

PioneerRx

Communication is key in the pharmacy industry. Whether you’re talking to patients, doctors, or wholesalers, communication is vital to your pharmacy’s success.

article thumbnail

STAT+: What happened to the House vote on health care price transparency?

STAT

You’re reading the web edition of D.C. Diagnosis.  Sign up here  to receive this newsletter in your inbox on Tuesdays and Thursdays. About last night… House leadership last night canceled a scheduled vote on a health care package that included transparency requirements for hospitals and insurers, reforms to some PBM practices, and a small site-neutral payment policy for administering drugs, Rachel writes.

Packaging 235
article thumbnail

BeiGene and Nona Biosciences expand collaboration for antibody discovery

Pharma Times

BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement - News - PharmaTimes

121
121
article thumbnail

STAT+: Pharmalittle: Cepheid agrees to sell a TB test at cost; Mallinckrodt weighs selling some or all businesses

STAT

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are happily snoozing in their respective corners after bounding about the grounds in search of creatures to annoy. As for us, we are as busy as ever hunting and gathering items of interest.

Vaccines 177
article thumbnail

Venus Remedies gets marketing approval for gemcitabine and docetaxel from Serbia

Express Pharma

Venus Remedies has secured marketing authorisation from Serbia for gemcitabine and docetaxel, widely used chemotherapy drugs. With this, the company has secured 511 marketing approvals for its oncology products across 66 countrles. Oncology drugs constitute the largest proportion of the Serbian pharma market (projected to reach $397.40 million in 2023), where Venus Remedies has secured five marketing approvals, all ln the oncology space.

article thumbnail

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

PharmaTech

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

98
article thumbnail

New community pharmacy vision ‘a powerful tool’ for negotiator

The Pharmacist

A new vision for community pharmacy which centres on a clinical future will help form the basis of the sector’s discussions with the government and policymakers going forward. Published today by independent experts the King’s Fund and Nuffield Trust, A Vision for Community Pharmacy sets out national and local services that community pharmacy could provide […] The post New community pharmacy vision ‘a powerful tool’ for negotiator appeared first on The Pharmacist.

article thumbnail

Kinnate Biopharma announces 70% layoffs and pipeline restructuring

Pharmaceutical Technology

The company will suspend the development of three assets, considering strategic alternatives for two clinical programmes.

111
111
article thumbnail

CAR T therapy exhibits encouraging proficiency in R/R LBCL

European Pharmaceutical Review

Kite’s Yescarta ® (axicabtagene ciloleucel) facilitated a high response rate in transplant ineligible relapsed/refractory (R/R) large B-cell lymphoma (LBCL), Phase II study results show. Patients with R/R LBCL who had received one prior line of therapy and were deemed ineligible for high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) were evaluated in the trial.

article thumbnail

Pelican and Primordial Genetics merge to form biotech company Primrose Bio

Pharmaceutical Technology

Pelican Technology has combined business with Primordial Genetics under a deal to create a private biotechnology company Primrose Bio.

105
105
article thumbnail

Dispensing ‘without a pharmacist on site’ recommended by think tanks

The Pharmacist

The government should change the law to ‘allow dispensing without a pharmacist on site’, a new report commissioned by the sector’s negotiator has recommended. The new blueprint, published today by the Nuffield Trust and the King’s Fund, added that pharmacy technicians should be trained to ‘have the skills and ability to provide much of the […] The post Dispensing ‘without a pharmacist on site’ recommended by think tanks appeared first on The Pharmacist.

article thumbnail

Do Plan Sponsors Understand How Their PBMs Make Money?

Drug Channels

Today, the House Committee on Oversight and Accountability will hold a hearing with a subtle and not-at-all pejorative title: The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What the Doctor Ordered. To help you prepare, I share fresh insights from a new survey of PBMs’ plan sponsor clients. As you will see, clients are somewhat more satisfied with the perceived transparency of smaller PBMs.

83
article thumbnail

A suit of armor for cancer-fighting cells

World Pharma News

In recent years, cancer researchers have hailed the arrival of chimeric antigen receptor T cell (CAR T) therapy, which has delivered promising results, transforming the fight against various forms of cancer. The process involves modifying patients' T-cells to target cancer cells, resulting in remarkable success rates for previously intractable forms of cancer.

88
article thumbnail

The fading generics industry and essential medicine supply

pharmaphorum

The fading generics industry and essential medicine supply Mike.

132
132
article thumbnail

Quanterix 'standarad blood draw' could reveal likelihood of Alzheimer's

Outsourcing Pharma

Qunaterix' LucentAD test could reveal whether a person is likely to have Alzheimer's Disease or not. In an interview with company CEO, Masoud Toloue, he explains the science and motivation behind the test.

74
article thumbnail

Leveraging technology for better women’s healthcare outcomes

pharmaphorum

Leveraging technology for better women’s healthcare outcomes Mike.

118
118
article thumbnail

FDA clearance given to Beacon Biosignals' AI-assisted sleep monitoring device

Outsourcing Pharma

An advanced wearable headband with integrated machine learning algorithms has achieved The US Food and Drug Administrationâs 510(k) clearance.

80
article thumbnail

EC approves Pfizer’s Litfulo for adolescents and adults with alopecia

Pharmafile

Pfizer has announced that the European Commission (EC) has granted marketing authorisation to Litfulo (ritlecitinib) to treat adult and adolescent patients over the age of 12 with sever alopecia areata. The once-daily oral capsule is the first drug to be approved by the EC for the treatment of patients as young as 12 with severe […] The post EC approves Pfizer’s Litfulo for adolescents and adults with alopecia appeared first on Pharmafile.

63
article thumbnail

Kinnate lays off 70% of staff, reorganizes pipeline

BioPharma Dive

The company is restructuring its workforce and discontinuing programs, including its monotherapy combination of its drug exarafenib with Pfizer’s Mektovi.

65
article thumbnail

Drug Patent Expirations for the Week of September 17, 2023

Drug Patent Watch

ACTOPLUS MET XR (metformin hydrochloride; pioglitazone hydrochloride) Takeda pharms usa Patent: 8,470,368 Expiration: Sep 19, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical… The post Drug Patent Expirations for the Week of September 17, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

59
article thumbnail

Pharma Award Finalists for CPHI Barcelona Have Been Announced

PharmaTech

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

59