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Pfizer issues global market withdrawal of sickle cell disease therapy Oxbryta

Fierce Pharma

Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to a $5.4 billion acquisition the New York pharma made two years ago. | Pfizer will voluntarily pull its sickle cell disease drug Oxbryta from all markets worldwide, a major blow to its $5.4 billion acquisition of Global Blood Therapeutics two years ago.

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Unpacking the Epic-Particle Health Dispute: When It Started, What’s Being Alleged & What It Means for the Industry

MedCity News

Following a months-long dispute, data platform Particle Health filed an antitrust lawsuit against Epic, alleging that the EHR giant is using its dominance in the market to prevent competition in the payer platform space. Particle believes the lawsuit is an “unprecedented challenge” to Epic’s market power, while Epic thinks the startup’s claims are “baseless.

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Ipsen crosses EU finish line with Alagille syndrome drug

pharmaphorum

After various twists and turns in the regulator path, Ipsen has secured EU approval for Kayfanda, its treatment for severe itching (pruritus) in patients with the rare liver disease Alagille syndrome (ALGS).Kayfanda (odevixibat) is labeled in the EU to treat cholestatic pruritus – itching caused by impaired bile formation or flow – in children aged six months and over with ALGS, a disease caused by a genetic mutation that leads to liver damage and jaundice.

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Considering Covering GLP-1s? Here’s What You Need to Know

MedCity News

Though chronic disease treatment is rapidly expanding, balancing the latest medication with proven initiatives can help employers manage rising healthcare costs wherever you fall on the GLP-1 coverage spectrum. The post Considering Covering GLP-1s? Here’s What You Need to Know appeared first on MedCity News.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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“PBMs favour high list prices”- Novo Nordisk CEO targets PBMs in US Senate hearing

Pharmaceutical Technology

Coverage for its long-acting insulin, Levamir, dropped from 90% to about 35% when the company dropped its list price by 65%.

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How to Make Your Sales Enablement Strategy Actually Work

Integrity Solutions

Sales enablement has become an integral component of the modern sales organization, yet there is still confusion around what sales enablement actually is and, crucially, how to really make it deliver results for your salespeople and your business. As sales leaders grapple with continual volatility and complexity in the selling ecosystem, they’ve increasingly turned to sales enablement strategies to help improve sales outcomes and drive growth more efficiently.

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Novo Nordisk CEO reticent on lowering semaglutide prices

pharmaphorum

Novo Nordisk chief executive Lars Fruergaard Jørgensen was taken to task by US lawmakers over the price of the company's semaglutide drugs for diabetes and obesity at a congressional hearing yesterday – but would not commit to reducing them. Jørgensen danced around the topic of price cuts, saying Novo Nordisk supported "anything that helps patients get access and affordability […] we will look into.

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EMA CHMP recommends AstraZeneca’s Fasenra to treat EGPA

Pharmaceutical Technology

The EMA CHMP has recommended granting approval for AstraZeneca’s Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA).

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Cell and Gene Therapy Production Facilities

PharmaTech

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.

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Novo Nordisk CEO prepares to defend Ozempic, Wegovy US pricing at Senate hearing

Fierce Pharma

After circling Novo Nordisk and its high GLP-1 drug prices for months, Sen. | Ahead of a hearing on Ozempic and Wegovy prices, prepared remarks from Novo CEO Lars Fruergaard Jørgensen shine a light on the larger U.S. healthcare system.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Pfizer pulls sickle cell med Oxbryta off market after deaths

pharmaphorum

Pfizer is voluntarily withdrawing its sickle cell drug Oxbryta after a review revealed an imbalance of deaths in clinical trials

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Qure.AI Snags $65M to Expand Its Presence in US Market

MedCity News

Qure.ai — which is headquartered in India — closed a $65 million Series D financing round. When asked whether the startup is thinking about a public exit anytime soon, CEO Prashant Warie said that for now, the company’s focusing is on continuing to build its market globally and “venturing deeper into meeting the healthcare challenges of the U.S.” The post Qure.AI Snags $65M to Expand Its Presence in US Market appeared first on MedCity News.

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EC authorises LEO Pharma Anzupgo cream for chronic hand eczema

Pharmaceutical Technology

The EC has granted marketing authorisation to LEO Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema.

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Drug Solutions Podcast: Alternative Drug Delivery Methods for Biologics: Where Are We At?

PharmaTech

In this podcast episode, we discuss both the challenges of and the progress made so far by the biopharma industry toward non-parenteral means of delivering biologic drugs.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Roche looks to grow Gazyva's reach with phase 3 lupus nephritis win

Fierce Pharma

After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis. | In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thur

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Obesity drug developer BioAge raises $198m in IPO

pharmaphorum

BioAge Labs has completed its upsized initial public offering (IPO), raising $198 million after increasing the number of shares on offer by 40%. The expansion of the listing reflects the massive investor appetite for companies with assets in the clinic for obesity and takes the on-paper value of the Richmond, California-based company above $600 million.

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Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds

MedCity News

Biohaven’s troriluzole, which initially failed a pivotal study in spinocerebellar ataxia, is now being readied for an FDA submission in this rare neurodegenerative disease. The turnabout is based on positive results from a new study that incorporated real-world evidence. The post Real-World Data Salvage Biohaven Drug, Paving Way for FDA Filing in Neuro Disease With No Approved Meds appeared first on MedCity News.

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Telix acquires RLS Radiopharmacies to expand US manufacturing presence

Pharmaceutical Technology

Telix has paid an upfront cost of $230m to acquire 31 licenced radiopharmacies from RLS located across the US.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Want better cancer treatments? Make biopharma more like Silicon Valley

PharmaVoice

Alicia Zhou brings startup bona fides to the nonprofit Cancer Research Institute to promote defragmentation of the cancer research effort.

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Bristol Myers Squibb axes 79 more in NJ as $1.5B cost-reduction program rolls on

Fierce Pharma

The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.

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AZ gets sought-after lung cancer approval for Tagrisso

pharmaphorum

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population that until now had no targeted treatments. The US regulator has cleared Tagrisso (osimertinib) for patients with stage 3 non-small cell lung cancer (NSCLC) expressing EGFR exon 19 or exon 21 (L858R) mutations that cannot be treated with surgery and has been previously treated with chemoradiotherapy.

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Carrot Fertility, Priority Health Strike Partnership for Reproductive Health Support

MedCity News

Carrot Fertility has partnered with Priority Health to offer two design solutions for fully-funded and self-funded employer groups. These solutions include support for fertility treatment, pregnancy, postpartum care, gestational surrogacy, adoption, menopause and low testosterone. The post Carrot Fertility, Priority Health Strike Partnership for Reproductive Health Support appeared first on MedCity News.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AI boom set to revolutionise healthcare in Europe

Pharmaceutical Technology

The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.

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FDA Approves Treatments for Niemann-Pick Disease, Type C

PharmaTech

Two drugs, Miplyffa (arimoclomol) and Aqneursa (levacetylleucine), have been approved by FDA to treat neurological symptoms associated with Niemann-Pick disease, type C in adults and children.

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Private equity firms bid on Sanofi's $16B+ consumer health business: Bloomberg

Fierce Pharma

As private equity firms reportedly place their bids, Sanofi may soon follow in the footsteps of GSK and Johnson & Johnson with the separation of its consumer health unit. | Sanofi has received two private equity offers for its consumer health business, which could be valued at 15 billion euros ($16.7 billion) or more, Bloomberg reported Tuesday, citing people close to the matter.

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Aurion launches eye disease cell therapy in its first market

pharmaphorum

Aurion Biotech has launched its cell therapy Vyznova for serious eye disorder bullous keratopathy in Japan, its debut market, becoming an alternative to corneal replacement using donor tissue.Vyznova (neltependocel, formerly AURN001) is the world's first allogeneic cell therapy for corneal endothelial disease, according to the Seattle, Washington-based company.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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How AI Humanizes Mental Healthcare

MedCity News

The integration of AI into mental healthcare is more advanced than many realize because it’s not always obvious; frequently, it’s providing support to free up clinicians to spend more time with their patients or to get more patients into treatment. The post How AI Humanizes Mental Healthcare appeared first on MedCity News.

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Active Pharmaceutical Ingredients and Intermediates for the Pharmaceutical Industry

Pharmaceutical Technology

Download our free, extensive list of the leading Active Pharmaceutical Ingredients and Intermediates companies and suppliers today.

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Bormioli Pharma Display at CPHI Milan to Include Low-Impact, Pharma-Grade Product Range

PharmaTech

The EcoPositive range, which comprises 50% of Bormioli Pharma’s current standard catalog and is composed of three distinct sustainability approaches, offers more than 3000 industrial solutions, in glass and plastic.

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Bluebird bio lays off 25% of workforce as gene therapy pioneer struggles to stay afloat

Fierce Pharma

After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%. | After bluebird bio acknowledged troubles keeping its business operational, the gene therapy biotech is launching a restructuring that will reduce the size of its workforce by about 25%, or nearly 100 employees.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.