Fri.Jul 14, 2023

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J&J expands global access to TB drug as popular novelist joins advocacy campaign

STAT

Advocates have been fighting Johnson & Johnson for years over a patent on a lifesaving tuberculosis pill. On Thursday, they won a partial victory as the United Nations-affiliated group STOP TB announced an agreement to make cheaper generics available across dozens of low- and middle-income countries with high rates of disease. The deal had been in the works for months and was signed in June, according to STOP TB global drug facility chief Brenda Waning.

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Enhertu approved in China for patients with HER2-low metastatic breast cancer

LifeProNow

July 12, 2023: “AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

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Celiac study examines precisely how gluten triggers injury to intestine

STAT

For a person with celiac disease, eating a bagel goes something like this: chewing and savoring, the flavor of the high-gluten bread made ever more delicious by its forbidden nature, by knowing there will be hell to pay.  Then, the bagel is broken down, separated into the digestible and the not: Parts of gliadin, a protein found in gluten, stay in the gut.

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Bayer extends Partnership with Peking University to foster Pharmaceutical Innovation in China

LifeProNow

July 10, 2023 : “Bayer and Peking University (PKU) will collaborate to foster the translation of basic pharmaceutical research into drug discovery and development, while accelerating scientific research on cutting-edge technologies across the pharmaceutical value chain. The collaboration will focus on selected key areas of interests, such as oncology, cardiorenal, immunology, as well as cell and gene therapy.

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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+: Three women sue cancer diagnostic firm Grail alleging harassment, retaliation

STAT

Three sales executives, all of them women, have filed suit against Grail, a cancer diagnostics company, alleging that they were harassed, that the company failed to take corrective action, and that it retaliated by removing them from consideration for promotions. The suits, which were filed earlier this week, are complicated by the fact that Grail was purchased by Illumina , the largest DNA sequencing firm, for $8 billion in 2021 — yet Illumina has left Grail to operate as a separate comp

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Flagship, PhRMA prioritize experience in hot summer exec changes

PharmaVoice

With major projects brewing at both organizations, these new leaders will hit the ground running.

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More Trending

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UKHSA issues London measles outbreak warning

The Pharmacist

London could see a measles outbreak of tens of thousands of cases unless vaccination rates improve, the UK Health Security Agency has warned. In response, NHS England has launched a national campaign encouraging people to check their vaccination status, particularly targeted towards people living in the capital. So far this year, there has been 128 […] The post UKHSA issues London measles outbreak warning appeared first on The Pharmacist.

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STAT+: Big Health acquires Limbix, maker of mental health app for depression in adolescents

STAT

Big Health, one of the leading companies producing apps to help treat mental health conditions, on Thursday announced it acquired Limbix, developer of a prescription app for adolescent depression. The terms of the deal were not disclosed, but the acquisition comes at a time when many digital health companies are running into trouble raising money. Developers of prescription digital therapeutics , in particular, have been reeling.

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Positive data for Caribou Biosciences’ CB-010 candidate

Pharma Times

CAR-T cell therapy being researched among patients with relapsed or refractory B cell non-Hodgkin lymphoma - News - PharmaTimes

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STAT+: Demand spikes in seniors, behavioral health care challenge UnitedHealth’s provider arm

STAT

UnitedHealth Group’s Optum subsidiary saw a lower operating margin in the second quarter due to more seniors getting care, a spike in demand for behavioral health services, and an influx of members with higher health needs. “Those three elements, the senior trend piece, the behavioral piece, and then the effects of the strong growth is really what explains what’s going on,” UnitedHealth Group CEO Andrew Witty said on the company’s earnings call on Friday.

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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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Global study seeks pharmacists' views on self-care approaches and support

The Pharmacist

Community pharmacists are being asked to complete a new survey around their roles in supporting patients with self-care, as part of a global study launched by the International Pharmaceutical Federation (FIP). The anonymous survey explores pharmacist’s views on what self-care means and asks about the approaches, advice and solutions they offer to patients as part […] The post Global study seeks pharmacists' views on self-care approaches and support appeared first on The Pharmacist.

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STAT+: Pharmalittle: Key Senate panel has a plan for PBMs; Roivant eyes $7 billion sale of a stomach drug

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we expect to manicure the grounds, stroll with the official mascots, and maybe work in a listening party, where the rotation could include this , this, and this.

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Lasers for Thyroid Tissue Regeneration

The Thyroid Pharmacist

Is it possible to get off thyroid medications or regain thyroid function without taking medications when you have Hashimoto’s? Here’s an excerpt from my book, Hashimoto’s Protocol : Most physicians and endocrinologists will say that in Hashimoto’s, hypothyroidism is irreversible and ends with complete thyroid cell damage, leading to a lifelong requirement of thyroid hormone medications.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Lilly to buy Versanis, adding to obesity drug pipeline

BioPharma Dive

The pharma will pay up to $1.9 billion to acquire the private biotech and its experimental antibody, which Lilly plans to pair with its own weight loss medicines.

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STAT+: With momentum on Alzheimer’s therapies, Europe sees delivery challenges ahead, too

STAT

LONDON — Starting Sunday, Alzheimer’s specialists will gather for a major conference in Amsterdam, convening at a time when the field, depending on which expert you ask, has some rare momentum behind it, with new therapies starting to show benefits for patients. But despite the hard-won victories, the arrival of the new therapies presents a new set of challenges in Europe as countries plan for their possible rollouts, scientists and doctors told STAT.

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Lupin receives USFDA approval for Chlorpromazine Hydrochloride tablets

Express Pharma

This product will be manufactured at Lupin’s Somerset facility in the U.S. Lupin has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg, to market a generic equivalent to the reference listed drug (RLD), Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg of Upsher-Smith Laboratories, LLC.

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STAT+: Why hospitals are cutting ties with Moody’s rating agency

STAT

Not-for-profit hospitals have been cutting ties with Moody’s Investors Service in recent years, citing the high cost and time commitment required to maintain their relationships with the rating agency. With labor and supply costs inflated and margins thin following the Covid-19 pandemic, hospitals are eager to trim any expenses they can. Increasingly, that means cutting a bond rating.

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Atrial fibrillation market to decline during 2022-32: GlobalData

Express Pharma

GlobalData’s report, “Atrial Fibrillation: Eight Market Drug Forecast and Market Analysis,” reveals that five late-stage pipeline therapies are expected to enter the market during the forecast period, including four anticoagulants and one cardioversion agent The Atrial Fibrillation (AF) market is forecast to decline at a compound annual growth rate (CAGR) of 1.3 per cent from $14.53 billion in 2022 to $12.8 billion in 2032 across the eight major markets (8MM*), due to the patent expiration of th

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Cumulus Neuroscience in partnership with the Universities of Bath and Bristol

Pharma Times

Collaboration will focus on progressing test for early detection of Alzheimer’s dementia - News - PharmaTimes

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RNA editing specialist Korro to go public via reverse merger

BioPharma Dive

The deal with Frequency Therapeutics is the latest biotech reverse merger as private drugmakers still face challenges going public via an IPO.

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EMA accepts Intas Pharma’s MAA for DMB-3115

Express Pharma

herapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III Intas Pharma announced that the European Medicine Agency (EMA) confirms acceptance of the Marketing Authorisation Application (MAA) for DMB-3115, a biosimilar of Stelara (Ustekinumab). The MAA has been submitted by Accord Healthcare, a wholly owned subsidiary of Intas Pharma on June 23rd, and the EMA accepted the MAA submission on 14 th July.

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Roche agrees to develop oncology small molecule inhibitor

European Pharmaceutical Review

KSQ Therapeutics, Inc. has entered into a global license and collaboration agreement with Roche for the development and commercialisation of KSQ-4279. The drug candidate is a first-in-class, potent, and selective small molecule inhibitor of USP1. USP1 is a protein that regulates DNA damage response (DDR) using a unique approach, for example, when compared to PARP inhibitors.

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DCO(I) WA’s 1st annual congress concludes successfully

Express Pharma

The interactive sessions provided valuable insights and opportunities for skill development The Drugs Control Officers (I) Welfare Association (DCO(I) WA), a prominent organisation dedicated to the welfare, training, and professional development of drugs control officers across India, recently concluded its 1st Annual Congress cum Workshop in Delhi on 09 th july 2023.

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Changing Faces: Non-profit, professional organisation, and government hires from May & June 2023

pharmaphorum

Changing Faces: Non-profit, professional organisation, and government hires from May & June 2023 Mike.

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Nutrizoe raises Rs 3 Cr in bridge round

Express Pharma

The funds will be utiliaed for expanding the Lactobite portfolio after conducting clinical trials, exploring export opportunities and developing new product formulations Nutrizoe, a women’s nourishment brand raised Rs 3 Cr in a bridge round led by Inflection Point Ventures. The funds will be utilised for the expansion and enhancement of Nutrizoe’s Lactobite portfolio following the completion of clinical trials.

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Exclusive: UK pharmacy degree applications jump 28% in a year

The Pharmacist

The number of applications to study pharmacy across the UK has increased by more than a quarter within a year, The Pharmacist can reveal. Community Pharmacy England (CPE) said the spike in interest was ‘great to see’, especially amid latest commitments within the NHS Long Term Workforce Plan to expand pharmacy training in England. The […] The post Exclusive: UK pharmacy degree applications jump 28% in a year appeared first on The Pharmacist.

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10 ways to start (or continue) your patient engagement journey

pharmaphorum

10 ways to start (or continue) your patient engagement journey Mike.

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Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

Big Molecule Watch

Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its Complaint, Genentech asserts that Biogen is seeking FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).

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Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts

GMPSOP

Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts Pharmaceuticals quality assurance & validation procedures GMPSOP Equipment cleaning procedure in pharmaceutical, Do’s and Don’ts Last modified: July 15, 2023 Table of Contents “It looks clean, therefore it must be clean” This is not necessarily true for equipment cleaning in the pharmaceutical industry.

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Inhalers

RX Note

Introduction Poor inhaler technique has been reported among children and adults , including experienced inhalers. Incorrect technique → More symptoms →Worse adherence → More exacerbations → Higher environmental impact. Hence, correcting patients' inhaler technique can improve asthma and COPD control, quality of life and lung function. MDI Inspiratory Force In December 2018, U.S.

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New patent for Bausch drug DUOBRII

Drug Patent Watch

Annual Drug Patent Expirations for DUOBRII Duobrii is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are four patents protecting… The post New patent for Bausch drug DUOBRII appeared first on DrugPatentWatch - Make Better Decisions.

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Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case

Big Molecule Watch

Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. As we previously reported , the case was expedited, with trial occurring less than a year after Regeneron filed its complaint. The case was originally filed naming only Mylan as a defendant, but in March 2023, the parties stipulated to add Biocon as a defendant in view of Mylan’s transfer of its rights to the aflibercept biosi

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New patent for Novartis drug PIQRAY

Drug Patent Watch

Annual Drug Patent Expirations for PIQRAY Piqray is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent for Novartis drug PIQRAY appeared first on DrugPatentWatch - Make Better Decisions.

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Genentech Files BPCIA Complaint Against Biogen Regarding Tocilizumab

Big Molecule Watch

Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its Complaint, Genentech asserts that Biogen is seeking FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).