Fri.Jul 19, 2024

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Lilly alone in bidding for Morphic; Novartis won’t yet file MorphoSys drug

Bio Pharma Dive

Federal filings showed no companies other than Lilly made an offer to buy Morphic, while Novartis executives said they’re still waiting for more data on pelabresib.

Drugs 195
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Seventh patient ‘cured’ of HIV among highlights at AIDS 2024

Pharmaceutical Technology

New global projections and advances in HIV therapies are also on the agenda at the 25th International AIDS 2024 meeting.

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Global tech outage hits US hospitals

Bio Pharma Dive

At least 11 health systems were experiencing issues Friday after an update by cybersecurity firm CrowdStrike went awry.

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Glasgow scientists develop first bone marrow model to support human stem cells

Pharma Times

LT-HSCs replenish blood cells after treatment for blood cancers, such as leukaemia

Scientist 139
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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Tech leader’s $125m boosts Parker Institutes immunotherapy research

Pharmaceutical Technology

The Parker Institute for Cancer Immunotherapy was founded in 2016 by tech entrepreneur Sean Parker to bolster cancer research efforts.

Research 130
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Pharma companies report different impacts from IT outrage caused by CrowdStrike, Microsoft

Fierce Pharma

While the national IT outrage caused by cybersecurity specialist CrowdStrike—and subsequently Microsoft—has grounded airlines and forced cancelations at hospitals, the experience from the meltdown | While the national IT outrage caused by cybersecurity specialist CrowdStrike—and subsequently Microsoft—has grounded airlines and forced cancelations at hospitals, the experience from the meltdown appeared different among large pharma companies.

More Trending

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Study finds pain gene affects success of chronic pain medicine in women

Pharma Times

Chronic pelvic pain is a disabling condition that affects around one in four women worldwide

Medicine 122
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Exscientia acquires oral CDK7 inhibitor for $20m, plans breast cancer trial

Pharmaceutical Technology

Exscientia paid $20m in upfront cash and equity to buy its development partner GT Apeiron’s shares for the CDK7 inhibitor.

Trials 130
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Sounds great – HCA milestone for PharmaTimes Communications Awards

Pharma Times

Accreditation recognises 'continued professional development' opportunities

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Boehringer Ingelheim offers Humira biosimilar at 92% discount

Pharmaceutical Technology

Boehringer Ingelheim will sell an unbranded copycat of Humira through GoodRx for $550 in a two- pack form.

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

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FDA launches innovation hub to spur rare disease R&D

pharmaphorum

FDA will create a rare disease hub to speed the development of new treatments and build connections between developers and the rare disease community

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Rona Therapeutics gains Series A+ funds for siRNA pipeline expansion

Pharmaceutical Technology

Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic siRNA pipeline in clinical settings.

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Understanding PDURS: A new era for digital health and pharma

pharmaphorum

Explore the emerging era of digital health and pharmaceuticals with PDURS, featuring insights from industry experts Marty Culjat of EVERSANA and Edward Cox of Pfizer.

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EMA accepts Deciphera’s MAA cell tumour treatment for review

Pharmaceutical Technology

The EMA has accepted the MAA of Deciphera Pharmaceuticals' vimseltinib to treat tenosynovial giant cell tumours for review.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Chimeric antigen receptor T-cells: Emerging uses and future directions

pharmaphorum

Explore the emerging uses and future directions of chimeric antigen receptor T-cell therapy targeting mRNA, anti-EGFRvIII, and anti-NY-ESO-1 antigens in cancer treatments.

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Meitheal gains rights to CONTEPO from Nabriva in North America

Pharmaceutical Technology

Meitheal Pharmaceuticals has gained rights to CONTEPO (fosfomycin for injection) from Nabriva Therapeutics for the North American region.

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NICE backs first 'take at home' prostate cancer pill

pharmaphorum

NICE backs NHS use of Accord's Orgovyx, the first therapy for advanced hormone-sensitive prostate cancer that can be taken at home

Hormones 105
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Oticon Medical’s Sentio System Is FDA-Cleared

XTalks

Oticon Medical announced that the US Food and Drug Administration (FDA) cleared its first active transcutaneous bone conduction hearing system, the Sentio System. This innovative system offers the benefits of the Ponto System with a new transcutaneous option for patients. Bone conduction hearing aids amplify sound via vibrations through the bones of the skull, directly stimulating the cochlea without needing any part of the device in the ear canal.

Sales 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Cardurion heads crop of sizeable bio financings

pharmaphorum

While the pace of biotech private rounds seems to have slowed a little of late, this week saw four big financings for Cardurion Pharma, Scorpion Therapeutics, CatalYm, and NGM Bio.Burlington, Massachusetts-based Cardurion led the quartet with a $260 million Series B for its heart-focused drug pipeline, which features two candidates in phase 2 testing – PDE9 inhibitor CRD-750 for heart failure and CaMKII inhibitor CRD-4730 for rare genetic disease catecholaminergic polymorphic ventricular tachyca

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Susvimo Demonstrates Sustained Efficacy Over Two Years in Patients with Diabetic Macular Edema and Diabetic Retinopathy

Pharmaceutical Commerce

FDA to review one-year results for Susvimo showing non-inferior visual acuity gains in diabetic macular edema and in the Diabetic Retinopathy Severity Scale for Diabetic Retinopathy.

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GSK files Blenrep in EU, seeking return to market

pharmaphorum

Less than two years after pulling multiple myeloma therapy Blenrep off most markets around the world, GSK has filed for approval of the drug in the EU once again, hoping to restore its blockbuster credentials.The remarkable renaissance for the BCMA-directed antibody-drug conjugate is supported by a pair of phase 3 trials that could not only support its return but also make it an option for a much larger patient population than before.

Marketing 104
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LegitScript Finds 1200 Percent Increase in Problematic Ads for Compounded GLP-1 Meds

XTalks

According to a recent report from LegitScript, a leading provider of healthcare product verification and monitoring services, there has been a whopping 1200 percent increase in violative and misleading advertisements related to compounded GLP-1 medications. Compounded GLP-1 medications, created by specialized pharmacies under a special US Food and Drug Administration (FDA) allowance due to ongoing shortage, have become increasingly popular for weight loss.

Pharmacy 104
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Fierce Pharma Asia—Hengrui's FDA reprimands; Sanofi's India site expansion; Aslan's downfall

Fierce Pharma

A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind a recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. | A 10-observation Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind its recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India.

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Avista and Hamilton Lane Join Forces to Propel Growth and Innovation at Cosette Pharmaceuticals

Outsourcing Pharma

Avista, a New York-based private equity firm focused on healthcare, and Hamilton Lane, a global private markets investment management firm, have announced that funds managed by Hamilton Lane have acquired a significant equity interest in Cosette Pharmaceuticals from Avista and its co-investors.

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Former FTC director weighs in on Novo's $16.5B deal with Catalent

Fierce Pharma

Back in February, Novo Holdings laid out a $16.5 billion deal to snap up contract manufacturing giant Catalent. | In February, Novo Holdings announced a $16.5 billion deal to acquire Catalent, and this week on "The Top Line," we explore the current state and implications of the proposed buyout.

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Phathom Pharmaceuticals receives FDA approval for Voquenza to treat non-erosive GERD

Outsourcing Pharma

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquenza (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

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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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Which pharmaceutical companies have the most pellets dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most pellets dosed drugs. For a different perspective, see the most popular dosage types.

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Phathom Pharmaceuticals receives FDA approval for Voquezna to treat non-erosive GERD

Outsourcing Pharma

Phathom Pharmaceuticals, Inc.dedicated to developing and commercializing treatments for gastrointestinal (GI) diseases, announced today that the US Food and Drug Administration (FDA) has approved Voquezna (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease (non-erosive GERD) in adults.

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New tentative approval for Alembic drug dabigatran etexilate mesylate

Drug Patent Watch

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 NDAs.

Drugs 52
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FDA’s New Rare Disease Innovation Hub to Elevate Patient Care

XTalks

The US Food and Drug Administration (FDA) is stepping up to tackle the complexities of rare diseases, with the new Rare Disease Innovation Hub. This new initiative aims to speed up treatment and care for over 30 million Americans living with these conditions, focusing on enhancing outcomes and accelerating the approval of innovative therapies. Rare diseases affect approximately one in 10 Americans, with children making up nearly half of this demographic.

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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.