STAT

JANUARY 19, 2024

Scientists at Dana-Farber Cancer Institute, one of the nation’s leading cancer research and treatment centers, are “moving to” retract one paper and correct others amid an expanding investigation of data manipulation, officials told STAT. The investigation includes scores of papers authored by four top scientists and institute leaders, including CEO Laurie Glimcher and COO William Hahn.

Hospitals 359

Hospitals 359

LifeProNow

JANUARY 19, 2024

January 08, 2024: “The U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

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Labelling 130

STAT

JANUARY 19, 2024

WASHINGTON — Theranos founder and ex-CEO Elizabeth Holmes is banned from federal health programs for nine decades, the health department announced Friday. Holmes was sentenced in November 2022 to 11 years in prison following a trial that determined she knew her blood-testing startup, which was founded in 2003 and which claimed to be able to test for a range of diseases and risks with one finger prick, produced inaccurate and faulty results.

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PharmaVoice

JANUARY 19, 2024

Amid criticisms of Takeda’s megamerger, the company’s CSO said it has built a pipeline that will deliver.

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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

JANUARY 19, 2024

Hospitals aren’t usually in the business of selling technology tools. But that’s changing thanks to a collision of financial pressures and an explosion of new technology that could both improve patients’ health and ease the burden of administrative tasks on limited staff. At the J.P. Morgan Healthcare conference, an exclusive, invitation-only event for investors, several influential health systems like Mayo Clinic and Mass General Brigham doubled down on new revenue streams

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Hospitals Mayo Clinic 283

The Pharmacist

JANUARY 19, 2024

Around 3,000 pharmacies in England have now signed up to provide the NHS Pharmacy Contraception Service, the government has confirmed. This comes as health secretary Victoria Atkins said that problem periods, menopause and maternity care would be top priorities under the government’s women’s health strategy in 2024. And it follows the expansion of the Pharmacy […] The post Around 3,000 pharmacies sign up to contraception service appeared first on The Pharmacist.

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BioPharma Dive

JANUARY 19, 2024

Phase 3 trial results showed Lutathera cut the risk of disease progression or death by 72% as initial treatment for gastroenteropancreatic neuroendocrine tumors, or GEP-NETs.

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STAT

JANUARY 19, 2024

What a week — this year’s might have been the busiest JPM I’ve ever had. I’m not saying that to brag, it’s a statement about the industry. There was even one tweet from STAT’s Adam Feuerstein calling the meeting mood “jubilant.” As a partner at an executive search firm, I’d concur. My time was packed with the usual mix of requests from potential, current, and former clients as well as investors to discuss search projects, and of cour

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pharmaphorum

JANUARY 19, 2024

Learn more about Graham Heap, Takeda VP and the lead of TAK-279, in this exclusive live interview at JP Morgan in 2024. Gain insights into Heap's role, achievements, and the future of TAK-279.

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STAT

JANUARY 19, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. We’re seeing some rays of hope that this ghastly biotech job market may loosen up a bit. Also, Bernie Sanders wants to subpoena some pharma CEOs, and as always, we’ve got a rad podcast for you today.

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Drug Pricing Drug Development 194

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Pharmacy Management

Express Pharma

JANUARY 19, 2024

Zydus Lifesciences’ wholly owned subsidiary, Zydus Worldwide DMCC, has entered into an exclusive licensing and supply agreement with Synthon BV for Palbociclib Tablets (a generic version of IBRANCE) for the US market. Under the terms of this agreement, Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets, and thereafter, for the manufacturing and supply of the product.

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STAT

JANUARY 19, 2024

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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pharmaphorum

JANUARY 19, 2024

Basel, Switzerland, is becoming an innovative biotech hub at the forefront of the digital revolution, proving fertile ground for a variety of start-ups in the healthcare space.

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The Pharmacist

JANUARY 19, 2024

The government has been urged to ‘get a grip’ on the cost of prescriptions in England amid concerns around patients struggling to access the medicines they need and a low awareness of prescription pre-payment certificates. Speaking at the Health and Social Care Committee (HSCC’s) pharmacy inquiry this week, William Pett, the head of policy, public […] The post Government urged to ‘get a grip’ on prescription costs appeared first on The Pharmacist.

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pharmaphorum

JANUARY 19, 2024

AstraZeneca gets its first approval for oral Factor D inhibitor danicopan, in Japan, for treatment of paroxysmal nocturnal haemoglobinuria

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European Pharmaceutical Review

JANUARY 19, 2024

According to GlobalData, with demonstrated efficacy against carbapenem-resistant Acinetobacter Baumanni (CRAB), Roche’s zosurabalpin “has the potential to treat lethal hospital infection,” Anaelle Tannen, Infectious Disease Analyst at GlobalData explained. Currently in Phase I development , the antibiotic’s novel mechanism of action was showcased through its effectiveness against the pathogen in in vitro studies.

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Hospitals 92

pharmaphorum

JANUARY 19, 2024

Manufacturing problems have scuppered Satsuma Pharmaceuticals’ chances of a timely FDA approval for its intranasal migraine therapy STS101. The drug – a new dry powder intranasal formulation of the well-established migraine therapy dihydroergotamine mesylate (DHE) – was submitted for approval in the US last March as an easy-to-use, portable treatment option for acute migraine attacks, with or without aura, in adult patients.

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European Pharmaceutical Review

JANUARY 19, 2024

The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Pfizer’s TALZENNA ® (talazoparib) for HER2- negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations. An important advance in treating breast cancer The pharmaceutical company shared that its oral small molecule poly (ADP-ribose) polymerase (PARP) inhibitor is indicated in adults who have had an anthracycline or a taxane, or both, if suitable,

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Chemotherapy Labelling Pharmaceutical Companies Pharmaceutical Companies 85

pharmaphorum

JANUARY 19, 2024

CG Oncology joins the queue of US biotech companies hoping to complete an IPO, aiming to raise $181m for its late-stage bladder cancer therapy.

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Pharmaceutical Commerce

JANUARY 19, 2024

Experts explore ways in which the financial sector refined the healthcare landscape, including its evolutions throughout the years.

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Pharmaceutical Technology

JANUARY 19, 2024

BridgeBio Pharma has secured strategic financing of $1.25bn from Blue Owl Capital and CPP Investments for genetic therapies.

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World Pharma News

JANUARY 19, 2024

Most people infected with the SARS-CoV-2 virus recover after the acute illness. However, a significant proportion of infected individuals develop long-lasting symptoms with a wide range of manifestations. The causes and disease mechanisms of Long COVID are still unknown, and there are no diagnostic tests or targeted treatments.

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Pharma Times

JANUARY 19, 2024

New stroke therapy delivers electrical pulses to the brain

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Pharmaceutical Commerce

JANUARY 19, 2024

All healthcare stakeholders must participate to dismantle barriers and ensure access to medicines that save lives.

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Pharma Times

JANUARY 19, 2024

Company will present vital findings at SRI annual meeting

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Drug Patent Watch

JANUARY 19, 2024

Annual Drug Patent Expirations for RAVICTI Ravicti is a drug marketed by Horizon Therap Us and is included in one NDA. It is available from one supplier. There are sixteen… The post New patent for Horizon Therap drug RAVICTI appeared first on DrugPatentWatch - Make Better Decisions.

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National Association of Boards of Pharmacy

JANUARY 19, 2024

Recently, CPE Monitor , NABP’s continuing pharmacy education (CPE) tracking tool, was updated to provide a more modern interface that offers a better, more streamlined experience. And if you subscribe to the Plus plan, navigating your requirements for license renewal and staying compliant—whether you have 1 license or 15—is now even easier with the improved platform.

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Pharmacy Technician 59

Drug Patent Watch

JANUARY 19, 2024

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

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Pharmafile

JANUARY 19, 2024

Verastem Oncology has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s KRAS G12C inhibitor, Lumakras (sotorasib) for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC). Preliminary results from the phase 1/2 RAMP 2023 […] The post Verastem Oncology gains Fast Track Designation for combination NSCLC treatment appeared

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Drug Patent Watch

JANUARY 19, 2024

Annual Drug Patent Expirations for XYOSTED+%28AUTOINJECTOR%29 Xyosted (autoinjector) is a drug marketed by Antares Pharma Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Antares Pharma drug XYOSTED (AUTOINJECTOR) appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmafile

JANUARY 19, 2024

AstraZeneca has announced that Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), in combination for C5 inhibitor therapy when patients have had an insufficient response to C5 inhibitors alone. The drug is a first-in-class, oral, Factor D inhibitor, which has been developed as an add-on therapy to standard-of-care […] The post AstraZeneca’s Voydeya approved in Japan for PNH treatment appeared first on Pharmafile.

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Drug Patent Watch

JANUARY 19, 2024

Annual Drug Patent Expirations for HALAVEN Halaven is a drug marketed by Eisai Inc and is included in one NDA. It is available from two suppliers. There are two patents… The post New patent expiration for Eisai Inc drug HALAVEN appeared first on DrugPatentWatch - Make Better Decisions.

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BioPharma Dive

JANUARY 19, 2024

The Senate HELP committee, which is seeking testimony from J&J's Joaquin Duato and Merck's Robert Davis, hasn't issued a subpoena since 1981.

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Drug Pricing 62

Drug Patent Watch

JANUARY 19, 2024

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

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Pharmaceutical Technology

JANUARY 19, 2024

The layoffs will free cash resources that will extend financial runways and focus pipeline developmental efforts.

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