STAT

MAY 31, 2024

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans. But a lack of visible progress from the initiative, called RECOVER, has drawn months of criticism from patient advocates, researchers, and lawmakers, including at a Senate hearing last week on the NIH’s budget.

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Documentation 364

PharmaVoice

MAY 31, 2024

The latest version of The Biosecure Act working its way through Congress could make waves in the U.S. biotech industry.

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STAT

MAY 31, 2024

There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2001, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either.

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pharmaphorum

MAY 31, 2024

Novartis’ Scemblix could be headed for first-line use in chronic myeloid leukaemia after outperforming TKI drugs in the ASC4FIRST study presented at ASCO.

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Communication

STAT

MAY 31, 2024

As the 77th World Health Assembly takes place this week, negotiations around the Pandemic Treaty are front and center of conversations. The treaty has been beset by delay and misinformation. The vested interests of pharmaceutical companies, lobbying groups, and conservative British broadcaster Nigel Farage bleating about “defending sovereignty” are threatening to derail the treaty process entirely.

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Pharmaceutical Companies Pharmaceutical Companies 337

pharmaphorum

MAY 31, 2024

Stay updated with the latest clinical trials news from 27th to 31st May, featuring companies like Arcturus Therapeutics, AZ, Vesper Bio, Ultragenyx, and Incannex. Get insights into their latest developments and advancements in the field.

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Pharmaceutical Technology

MAY 31, 2024

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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STAT

MAY 31, 2024

Ionis Pharmaceuticals, a California company that pioneered a whole class of RNA-targeted medicines, reported on Friday that a pair of late-stage trials showed that its experimental therapy for hereditary angioedema benefitted patients — including those taking drugs currently on the market. In one of the Phase 3 trials, dubbed OASIS, patients with hereditary angioedema, a rare disease characterized by severe bouts of swelling, were given injections of donidalorsen either monthly or every t

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Drug Development 238

Pharma Times

MAY 31, 2024

The CVLP platform will speed up access to BioNTech and Genentech’s mRNA personalised cancer vaccines

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Vaccines 119

European Pharmaceutical Review

MAY 31, 2024

The first treatment approved in the EU to target a genetic cause of amyotrophic lateral sclerosis (ALS), has been authorised by the European Commission (EC). QALSODY ® (tofersen) is indicated for adults with ALS associated with a mutation in the superoxide dismutase 1 gene ( SOD1 -ALS). The treatment is an antisense oligonucleotide (ASO) designed to bind to SOD1 mRNA to reduce SOD1 protein production, Biogen shared.

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Hospitals 91

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pharmaphorum

MAY 31, 2024

Moderna has secured FDA approval for its RSV vaccine, setting up a three-way market battle with GSK and Pfizer.

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Vaccines 119

The Pharmacist

MAY 31, 2024

A parliamentary committee has asked the government to set out what progress has been made on rolling out ‘the full digital product’ for the documentation of Pharmacy First consultations. In its report concluding its pharmacy inquiry earlier this week, the Health and Social Care Committee asked the government to share the percentage of community pharmacies […] The post MPs seek to hold government to account on Pharmacy First digital appeared first on The Pharmacist.

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Community Pharmacies Documentation 92

Pharma Times

MAY 31, 2024

The projects will focus on a range of research areas, including Down’s syndrome and ALS

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Drug Patent Watch

MAY 31, 2024

Brivaracetam is the generic ingredient in two branded drugs marketed by Ucb Inc, Aurobindo Pharma Ltd, Lupin Ltd, Sunshine, and Zydus Pharms and, and is included in seven NDAs.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

BioPharma Dive

MAY 31, 2024

Ahead of an advisory panel meeting, agency staff identified several sticking points in the clinical results backing Lykos’ ecstasy-based treatment for PTSD.

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Drug Patent Watch

MAY 31, 2024

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five… Source

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Express Pharma

MAY 31, 2024

The rise of India’s pharma sector: The Indian pharmaceutical sector has a significant influence on human well-being and continues to play a key role in supplying drugs and vaccines to millions around the world. The industry is poised for sustained growth and is expected to reach $65 billion in 2024 with forecasts pointing toward a remarkable growth of around $139 billion by 2024 and $450 billion by 2047.

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Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 82

pharmaphorum

MAY 31, 2024

Gilead's TROP2 ADC Trodelvy has missed the target in another clinical trial, this time in urothelial carcinoma.

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World Pharma News

MAY 31, 2024

Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

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Express Pharma

MAY 31, 2024

At this year’s European Renal Association, positive results were presented from Human Immunology Bioscience’s (HI-Bio) interim results of the Phase II IGNAZ clinical trial. According to the results, the use of MOR-202 (felzartamab) demonstrated a deep and durable reduction in proteinuria in patients with immunoglobulin A (IgA) nephropathy (IgAN). The drug potentially fills an unmet need in the IgAN space as it has an alternate mechanism of action to current marketed therapies, says GlobalData.

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BioPharma Dive

MAY 31, 2024

Regeneron and Sanofi now expect an FDA verdict in September. Elsewhere, Summit claimed victory over Keytruda and Neurocrine’s longtime CEO revealed plans to step down.

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The Pharmacist

MAY 31, 2024

The community pharmacy contract in Scotland will not be announced until after the election, although negotiations are ongoing, the Scottish Government has confirmed to The Pharmacist. 'Owing to the pre-election period we are unable to announce the financial settlement for community pharmacy,' a spokesperson said. But they added that 'negotiations are ongoing' and the Scottish […] The post Scottish Government 'unable' to announce community pharmacy contract before election appeare

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Community Pharmacies 72

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.

GMPSOP

MAY 31, 2024

Validation master plan (VMP) – when and how to create one? Pharmaceuticals quality assurance & validation procedures GMPSOP %title% Prev PREVIOUS POST Have you ever wondered why the regulatory inspectors are naturally keen to examine your validation master plan? That’s because a well-crafted validation master plan gives them a high-level view of your site validation activities (e.g., products, processes, systems, equipment, facility, utilities, etc.

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Documentation Method Validation Pharmaceutical Companies Pharmaceutical Companies 59

Pharmafile

MAY 31, 2024

AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Skyrizi (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to conventional or biologic therapy. […] The post AbbVie gains positive CHMP opinion for Skyrizi for treatment of UC appeared first on Pharmafile.

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Drug Patent Watch

MAY 31, 2024

Annual Drug Patent Expirations for ANGIOMAX+RTU Angiomax Rtu is a drug marketed by Maia Pharms Inc and is included in one NDA. It is available from three suppliers.

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Pharmaceutical Commerce

MAY 31, 2024

The latest news for pharma industry insiders.

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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.

Pharmacy Management

pharmaphorum

MAY 31, 2024

As AMR spreads globally, innovative startups are racing to develop solutions. Learn how Revagenix, LimmaTech and Lumen are using novel approaches to overcome AMR market failure.

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National Association of Boards of Pharmacy

MAY 31, 2024

RESOLUTION NO: 120-1-24 TITLE: Drug Shortages ACTION: PASS WHEREAS, in recent years, there have been many drug shortages resulting in pharmacies being unable to meet patient demand; and WHEREAS, many prescription drugs have been in critically short supply; and WHEREAS, these shortages have resulted in interruptions and changes to patient therapy, which may impact quality of life and cause notable strain in attempting to secure drugs in shortage at the pharmacy level; and WHEREAS, United States F

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PharmExec

MAY 31, 2024

In an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvoseltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company's VelociSuite technology.

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National Association of Boards of Pharmacy

MAY 31, 2024

RESOLUTION NO: 120-2-24 TITLE: Task Force to Assess Expanding Access to NABP Competency Assessment Examinations ACTION: PASS WHEREAS, the public at large relies on the professionals who the state boards of pharmacy license and regulate to provide critical health care services; and WHEREAS, state boards of pharmacy have a common duty to protect the public while ensuring a safe and streamlined process for pharmacist licensure; and WHEREAS, it is vital that appropriate measures are in place to ensu

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Communication 52

PharmExec

MAY 31, 2024

Results of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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