Fri.Jun 28, 2024

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Amylyx ventures into metabolic diseases market with $35.1m deal

Pharmaceutical Technology

On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.

Marketing 264
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Supreme Court overturns Chevron doctrine, limiting reach of federal agencies

Bio Pharma Dive

Federal courts will no longer have to defer to agency regulations for interpretation of ambiguous statutes, a ruling that could have significant impact on the FDA and CMS.

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Supreme Court votes against Purdue Pharma’s opioid settlement

Pharmaceutical Technology

The US Supreme Court blocked $6bn opioid crisis settlement that would have shielded the Sackler Family in a 5-4 decision.

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Rocket gene therapy rejected by FDA over manufacturing

Bio Pharma Dive

The complete response letter follows other recent manufacturing-related rejections, including one for a cell therapy from Abeona Therapeutics.

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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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AbbVie completes acquisition of Celsius Therapeutics for $250m

Pharmaceutical Technology

AbbVie has acquired Celsius Therapeutics, a company that focuses on developing new treatments for inflammatory diseases, for $250m in cash.

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PTC faces another Duchenne drug rejection; Coherus sells Humira biosimilar

Bio Pharma Dive

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

Drugs 173

More Trending

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Merck’s pneumococcal vaccine gets CDC panel backing

Bio Pharma Dive

Advisers to the agency unanimously recommended use of Capvaxive in older adults and in certain younger ones, putting it in the same tier as Pfizer's competing Prevnar shot.

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Eisai and Biogen launch LEQEMBI for Alzheimer’s in China

Pharmaceutical Technology

Eisai and Biogen have announced the introduction of LEQEMBI (lecanemab) for the treatment of Alzheimer's disease (AD) in China.

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Why progress on ovarian cancer treatments is slow

pharmaphorum

Progress on ovarian cancer treatments has been slow, despite promising drugs like Keytruda and Lynparza. Learn about the obstacles and challenges in developing effective treatments for this deadly disease.

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Coherus offloads Humira biosimilar Yusimry for $40m

Pharmaceutical Technology

Hong Kong King-Friend Industrial has acquired worldwide rights to Yusimry, and its subsidiary, Meitheal, will market the therapy in the US.

Marketing 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Merck's Capvaxive gears up to challenge Pfizer's dominant Prevnar with CDC panel backing

Fierce Pharma

After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.

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US Justice Dept cracks down on healthcare fraud schemes linked to $2.75bn loss

Pharmaceutical Technology

Nearly 200 people have been charged with participating in healthcare fraud schemes that resulted in $2.75bn in losses.

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Amazon bundles its telehealth services under one brand

pharmaphorum

Amazon’s strategy in telehealth has coalesced around a pay-per-visit and subscription-based model under a new brand – Amazon One Medical.

Branding 116
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Holoclara gains Series A financing for worm-derived therapies

Pharmaceutical Technology

Holoclara has secured $16m in a Series A financing to advance new worm-derived therapies targeting allergic and autoimmune diseases.

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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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EU's drug regulator again rejects Apellis' eye med and PTC's Translarna in busy week of up-and-down decisions

Fierce Pharma

For the second time in six months, Europe’s CHMP has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy.

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Alumis raises $250m in IPO as biotech stock stirs

Pharmaceutical Technology

Though downsized, Alumis still clocked one of the largest IPOs within the biotech sector this year.

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Without Pfizer appeal, Daiichi Sankyo closes long-running ADC patent arbitration with $47M win

Fierce Pharma

An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company. | An antibody-drug conjugate patent arbitration fight that Seagen waged against Daiichi Sankyo has officially ended in a win for the Japanese company.

Antibody 113
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Can routinely collected primary care data drive life sciences investment in the UK?

Pharmaceutical Technology

As the largest service provider in the NHS, primary care delivers over 300 million patient consultations annually. In the evolving landscape of clinical research, the data held in primary care Electronic Health Records (EHR) has been recognised for the significant potential it offers in uncovering insights, driving innovation, and enhancing patient care.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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House committee backs some Medicare cover for obesity drugs

pharmaphorum

The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.

Drugs 110
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Embracing digital solutions for enhanced patient care

Pharmaceutical Technology

In this article John McCormack, Executive Director of Research & Life Sciences, explores how unlocking the potential of healthcare technology can enable healthcare teams to work more safely and efficiently to drive improved patient outcomes.

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UK study reveals persistent challenges in heart health and cardiovascular diseases

Pharma Times

The study found an increase in incidence among young people and people from deprived areas

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Pharma Pulse 6/28/24: Pharmacy Closure Contributors, The Long-Term Consequences & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharmacy 105
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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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Healthcare IPOs of 2024: A Transformative Year for the Industry

XTalks

The healthcare industry has witnessed a surge of initial public offerings (IPOs) in 2024, signaling a dynamic shift toward innovation and expansion. These healthcare IPOs are reshaping the market landscape, bringing fresh capital and new solutions to the forefront. This year has been particularly notable for the range and impact of companies going public, from technology-driven startups to established service providers.

Marketing 102
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From data to action: Igniting the healthcare revolution

Pharmaceutical Technology

Dr Ian Wood, a GP and clinical director for EMIS, explores how technology could be implemented to drive proactive, preventative care within our healthcare system to reduce health inequalities and improve patient outcomes at a national scale.

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ASCO 2024 – Thanos Zomas

pharmaphorum

Stay updated on ASCO 2024 with Dr Thanos Zomas, a leading expert in oncology and a key figure at Takeda. Learn about the latest advancements in cancer treatment and research.

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Parkinson’s UK awards ICL £100,000 to develop small drugs for Parkinson’s disease

Pharma Times

The neurodegenerative condition currently affects around 153,000 people in the UK

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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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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 59
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Novo Nordisk Financially Commits $4.1 Billion Toward Growing US Manufacturing Capabilities

Pharmaceutical Commerce

The North Carolina project adds 1.4 million square feet of dedicated production space for aseptic manufacturing and finished production processes.

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New patent expiration for Valinor drug MOVANTIK

Drug Patent Watch

Annual Drug Patent Expirations for MOVANTIK Movantik is a drug marketed by Valinor and is included in one NDA. It is available from three suppliers.

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Breaking Down Medication Access and Affordability Barriers

Drug Channels

Today’s guest post comes from Kristina Crockett, VP of Product Management at CoverMyMeds. Kristina discusses challenges patients face accessing, affording, and adhering to prescribed medications. She goes on to describe how manufacturers can overcome these challenges to improve outcomes for both patients and brands. Click here to learn more about CoverMyMeds’ technology solutions.

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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.