STAT

MAY 11, 2023

In April 2020, the Food and Drug Administration announced a pandemic enforcement policy allowing mental health app developers to release certain treatment products without seeking authorization from the agency. With the end of the official public health emergency, companies that did so will now need to submit the products for FDA clearance and have them pass an early stage of review by early November — or remove the products from the market.

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PharmaVoice

MAY 11, 2023

Whether you’re looking to build a new site or expand lab space, here are the biggest trends impacting life sciences real estate.

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STAT

MAY 11, 2023

It “rots” flesh. It “tears” bone. It will turn you into a “zombie.” According to Senate Majority Leader Chuck Schumer and his colleagues, these are some of the  reasons we should fear  and  criminalize  xylazine, a veterinary sedative and painkiller that is  increasingly  found in drugs purchased on the U.S. illicit market.

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Pharmaceutical Technology

MAY 11, 2023

Results published in Nature for a personalised pancreatic cancer vaccine that uses neoantigens from patients’ tumours have lent further support to early positive signals. The vaccine, developed by BioNTech, led to half of the patients with pancreatic cancer in the Phase I trial remaining cancer-free 18 months later. In the study, 16 patients were treated with a vaccine called autogene cevumeran that contained a maximum of 20 neoantigens, alongside Roche’s anti-PD-L1 immunotherapy Tecentriq (atez

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Vaccines Immunity Immunization 138

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.

STAT

MAY 11, 2023

WASHINGTON – The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it. Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of he

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Drug Pricing Packaging 240

The Pharmacist

MAY 11, 2023

Community pharmacies have had to turn patients away who thought that new pharmacy services announced this week were already available, leaders in the sector have told. On Tuesday, NHS England announced that a nationally funded Pharmacy First service will be launched in England before the end of 2023, subject to consultation. National newspaper headlines heralded […] The post Reports patients trying to access Pharmacy First early appeared first on The Pharmacist.

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Community Pharmacies 132

World Pharma News

MAY 11, 2023

Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.

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STAT

MAY 11, 2023

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Putting Patients First Blog

MAY 11, 2023

Registration Is Now Open for the NHC’s Inaugural International Patient Forum May 11, 2023 By: Jennifer Schleman, SVP Communications & Governance Registration is open for the National Health Council’s (NHC) virtual International Patient Forum on Wednesday, May 31 from 1-3 p.m. ET. At this members-only event, the NHC will explore the international nature of health care advocacy, even for patient groups that operate primarily in the United States.

Communication 97

Communication 97

STAT

MAY 11, 2023

WASHINGTON – Tobacco giant R.J. Reynolds is suing the state of California in an effort to keep a controversial new line of cigarettes on shelves, the company announced Thursday in a press release. R.J. Reynolds launched the products in question shortly after California voters endorsed a statewide ban on menthol cigarettes. It’s advertising these cigarettes, marketed under Reynolds’ popular menthol brands, Camel Crush and Newport, as being “crisp” and producing

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Pharmacy Management

BioPharma Dive

MAY 11, 2023

Revenue from the biotech’s ALS therapy Relyvrio totaled $71.4 million in the first quarter, well above analyst estimates and helping the company turn a profit only months into the drug’s launch.

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STAT

MAY 11, 2023

The World Health Organization ended the global health emergency for mpox  on Thursday, saying that while the virus continues to spread internationally, steady progress has been made in controlling the outbreak. The decision, announced by WHO Director-General Tedros Adhanom Ghebreyesus, came less than a week after the U.N. health agency announced the termination of the global health emergency for Covid-19.

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Express Pharma

MAY 11, 2023

Glenmark Foundation, in collaboration with Idobro Impact Solutions, announced the successful conclusion of the fifth season of the “Meri Poushtik Rasoi” cooking contest. As a pan-India initiative, it aimed at addressing the issue of malnutrition through the promotion of nutrition-rich native recipes, which could be used to tackle this issue at local, grassroots levels, both in urban and rural areas of the country.

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Hospitals 96

STAT

MAY 11, 2023

Thanks to changes in tax law six years ago, several of the largest pharmaceutical companies saw their tax rates fall substantially, but they also reported that most of their profits were shifted offshore in an effort to avoid paying U.S. taxes, according to a memo by a U.S. Senate Committee. Specifically, the average effective tax rate for seven of the biggest drug makers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016.

Pharmaceutical Companies 217

Pharmaceutical Companies Pharmaceutical Companies 217

Express Pharma

MAY 11, 2023

TechInvention Lifecare India, has partnered with Eubiologics Co, South Korea, to launch Euvichol-Plus, a oral cholera vaccine (OCV), in a low-density polyethylene (LDPE) unidose pack in India. TechInvention recently received approval by the CDSCO for the launch of Euvichol-Plus following the completion of a phase III clinical study. A phase III, open-label, multicenter, parallel-group, randomised clinical study to compare the immunogenicity and safety of Euvichol-Plus with Shancho

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Vaccines Labelling 94

STAT

MAY 11, 2023

AbbVie has filed a lawsuit against a behind-the-scenes company that helps health plan sponsors take advantage of the assistance programs created by drug companies to provide specialty medicines to patients for free. At issue is a maneuver called alternative funding, which a growing number of drug makers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help uninsured and underinsured patients obtain

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Pharma Times

MAY 11, 2023

Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma

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STAT

MAY 11, 2023

Hello, everyone, and how are you today? We are doing just fine, thank you, as we gaze at birds on the nearby telephone wire and the official mascot curls up for a much-needed nap. Meanwhile, we are perusing our ever-growing to-do list and firing up the trusty coffee kettle to brew yet another cup of stimulation. As always, you are invited to join us.

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Pharma Times

MAY 11, 2023

The companies will use proprietary technology to enable the discovery of peptide-radioisotope conjugates

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Immunity Immunization 106

STAT

MAY 11, 2023

Is there a Bermuda Triangle of drug prices? Do FDA advisers matter? And when should biotech companies throw in the towel? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We discuss a Senate hearing that put major pharma CEOs in the same room with the middlemen they love to blame for rising drug prices, with mixed results.

Drug Pricing 164

Drug Pricing 164

PhRMA

MAY 11, 2023

America is currently facing a mental health crisis — one that is impacting families and individuals in every community, with the COVID-19 pandemic only exacerbating these trends. Mental Health Awareness Month, which is held each year in May, presents an opportunity to discuss ways to address the growing burden of, and stigma surrounding, mental illness.

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European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion. The questions in Section B aim to initiate a discussion with stakeholders and solicit feedback on three key areas in the context of AI/ML in drug development.

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Drug Development Pharmaceutical Manufacturing Communication 85

Express Pharma

MAY 11, 2023

The Income Tax department searched the premises of Mankind Pharma over allegations of tax evasion, informed official sources. The department is searching the company premises in Delhi and nearby locations, documents are being checked and people are being questioned, they said. The company made its debut on the stock exchanges this week. It also launched its IPO this year.

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Documentation 79

European Pharmaceutical Review

MAY 11, 2023

Born from two words, ‘revolutionise’ (rev) and ‘vita’ (vit) meaning “life” in Latin, Revvity, Inc. officially launches as a science-based solutions company that leverages innovation across life sciences. Delivering end-to-end expertise and solutions from research discovery to development, and diagnosis to cure, Revvity provides reagents, consumables, assays, instruments and software to customers in markets ranging from pharma and biotech , diagnostic labs, academia and go

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FDA Law Blog: Biosimilars

MAY 11, 2023

By Sara W. Koblitz — Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of the U.S. government in the now-infamous (at least in FDA circles) Teva v.

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Labelling Documentation Communication 72

Integra X Files

MAY 11, 2023

Pharmacy automation is an exciting and innovative tool that can help pharmacies manage growth and demand in the industry. Miriam Cho, PharmD, President/CPO of MAC Rx , joined our podcast and shared her positive experiences with implementing automation in three different pharmacy locations. From her valuable insights, we’ve compiled a list of five crucial factors to help you effectively execute pharmacy automation.

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Pharmacy Automation Pharmacy Management Communication 70

The Pharmacist

MAY 11, 2023

New plans for community pharmacy to free up GP access by taking on the treatment of seven common conditions should be seen as an appropriate partnership between community pharmacists and GPs, the chief executive of the Association of Independent Multiple Pharmacies (AIMp) has said. A new national Pharmacy First service, backed by a £645m investment […] The post GPs should see pharmacists ‘as a solution, not a threat’ appeared first on The Pharmacist.

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Community Pharmacies 69

PharmExec

MAY 11, 2023

How the pivot to corporate development became a natural fit for once-destined scientist.

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Pharmaceutical Technology

MAY 11, 2023

Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. The collaboration will see Bicycle use its phage platform to discover and develop bicyclic peptides while Bayer will fully fund and manage further preclinical and clinical development, manufacturing and commercialisation aspects.

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Express Pharma

MAY 11, 2023

DKSH has partnered with CRY, an Indian NGO, to provide six community schools in the local regions of Pune and Wardha, Maharashtra in India with new labs for Science, Technology, Engineering, and Mathematics (STEM) subjects. DKSH India has started the collaboration with CRY to ensure children get hands-on learning experiences through STEM labs. The partnership aims to develop the aptitude of children studying in grades six to nine toward science, eradicate the fear of learning, and set them up fo

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pharmaphorum

MAY 11, 2023

Eight components of effective brand planning tools Mike.

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PharmExec

MAY 11, 2023

Torrey Cope, partner, food, drug, and medical device practice, Sidley Austin LLP, reveals current regulatory challenges in the U.S. for drug approvals, how a one-sized-fits-all approach to marketing and global launches no longer works, and when a global launch may be advantageous.

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Pharmaceutical Technology

MAY 11, 2023

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease. Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US.

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pharmaphorum

MAY 11, 2023

FDA clears Rexulti as first drug for Alzheimer’s agitation Phil.

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Pharma Marketing Network

MAY 11, 2023

Pharmaceutical companies have made major strides in developing new treatments for Alzheimer’s disease, offering hope for the millions of people affected by this debilitating condition. Alzheimer’s is a progressive brain disorder that destroys memory and cognitive abilities, and currently there is no cure. However, recent advancements in research have resulted in new drugs that show promising results in slowing the progression of the disease.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Vaccines Drug Development 52