Wed.Jul 17, 2024

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The US Biosecure Act threatens to destabilise the pharmaceutical industry 

Pharmaceutical Technology

In January, the US House Select Committee on the Strategic Competition between the US and the Chinese Communist Party introduced the Biosecure Act.

Marketing 246
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Obesity pill from Roche shows promising weight loss in small study

Bio Pharma Dive

Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.

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Scientists Identify a Speech Trait That Foreshadows Cognitive Decline

AuroBlog - Aurous Healthcare Clinical Trials blog

Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.

Scientist 240
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In strengthening Spravato sales, a positive sign for psychedelic drugs

Bio Pharma Dive

Jefferies analyst Andrew Tsai views growing sales for J&J’s depression treatment as evidence that psychedelics like it can be commercially viable.

Sales 294
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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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Delhi HC bans Zydus’ biosimilar Sigrima in a landmark injunction order

AuroBlog - Aurous Healthcare Clinical Trials blog

In a landmark injunction order, the Delhi High Court has banned Zydus’ biosimilar Sigrima. As per the Delhi HC order, Zydus and Dr Reddy’s launched ‘Sigrima/Womab,’ a biosimilar of Roche’s ‘Perjeta’ (pertuzumab), in a clear contempt of court.

Sales 189
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Gilead’s CMO to depart next year

Bio Pharma Dive

Merdad Parsey joined Gilead as its chief medical officer in 2019 and has helped lead the company’s expansion into oncology, with mixed success.

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More Trending

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Caribou lays off staff; Roche walks away from Relay

Bio Pharma Dive

Caribou is slashing its workforce by 12%. Elsewhere, a CDMO is investing in GLP-1 drug demand and Beam’s CFO is returning to J.P. Morgan.

Drugs 173
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Upperton gains MHRA approval for manufacturing in Nottingham

Pharmaceutical Technology

Upperton Pharma has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for its facility in Nottingham.

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NGM, now private, raises $122M for redrawn research plans

Bio Pharma Dive

The Series A round was led by healthcare investor The Column Group, which made the 17-year-old biotechnology company private earlier this year.

Research 173
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July 17, 2024: In This Week’s PCT Grand Rounds, Lessons From the PRECIDENTD Comparative Effectiveness Trial

Rethinking Clinical Trials

Dr. Brendan Everett and Dr. Deborah Wexler In this Friday’s PCT Grand Rounds, Brendan Everett and Deborah Wexler of Harvard Medical School will present “Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial.” The Grand Rounds session will be held on Friday, July 19, 2024, at 1:00 pm eastern. The PRECIDENTD study (Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes) is comparing SGLT2 inhibitors and a GLP-1 receptor agonist to treat type 2

Trials 147
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Medical device firms have cut more than 14,000 jobs in the past 18 months

Bio Pharma Dive

Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to an analysis by MedTech Dive.

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Drug development costs predicted to soar as BIOSECURE Act gains momentum

Pharmaceutical Technology

As US China trade relations are set to be impacted by the BIOSECURE Act, pharma companies exploring CDMOs outside China may need to contend with increased drug development and manufacturing costs.

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Bayer’s Nubeqa, en route to blockbusterland, clinches 2nd win in prostate cancer subtype

Fierce Pharma

Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC). | Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer.

Hormones 126
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FDA priority review advances Atara’s tabelecleucel for viral infection

Pharmaceutical Technology

Approval of tabelecleucel would mark the first available therapy for the treatment of EBV+PTLD in the US.

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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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US study reveals Co-STAR receptor cells show promise in treating cancers

Pharma Times

The most globally prevalent cancers include breast, lung, bowel and prostate cancers

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CatalYm secures $150m to advance GDF-15-targeting immune modulator   

Pharmaceutical Technology

The new funding is set to fund the expansion of the company’s Phase IIb studies into visugromab in combination with checkpoint inhibitors.

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Sanofi to more than double its workforce at Hyderabad site with $437M expansion: reports

Fierce Pharma

Sanofi is looking to bulk up its workforce at its global capacity center in Hyderabad, India, with a multi-year investment totaling 400 million euros ($437 million), according to reports. | The drugmaker plans to grow it its workforce at the site to 2,600, making it the largest of Sanofi's four global capacity centers, according to reports.

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AbbVie’s Humira loss of exclusivity has been a missed opportunity for competitors

Pharmaceutical Technology

AbbVie has maintained a strong position within the immunology space for the past few years, largely due to the success of its antitumour necrosis factor (TNF) agent, Humira (adalimumab).

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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J&J keeps growth projections afloat as it braces for IRA price negotiation impact

Fierce Pharma

As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations. | As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.

Drugs 114
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Finding the right solution and partner for your drug product’s commercial supply chain

Pharmaceutical Technology

Biomanufacturers must tread carefully when seeking the optimum solution for their drug product's commercial supply chain.

Drugs 130
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Roche reveals first data with Carmot-sourced oral GLP-1 drug

pharmaphorum

Roche has reported early-stage clinical data with an oral GLP-1 agonist acquired as part of its $3.

Drugs 111
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Gene therapy: How the CRO of Veristat cut trial database costs by 30%

Pharmaceutical Technology

Gene therapy trials can often be held back by cost and complexity. New database software is helping optimise the process.

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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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12 Questions with Dr James Burt

pharmaphorum

Get insights into Dr James Burt's leadership as CEO of Pharmanovia through a 12-question interview that covers his background, achievements, and vision for the company.

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Cardurion closes $260m in Series B to develop cardiovascular pipeline

Pharmaceutical Technology

The funds will finance late-stage trials of CRD-750, a PDE9 inhibitor for heart failure, and CRD-4730, a CaMKII inhibitor.

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Drug development and compliance: 4 Ways AI is impacting pharma

pharmaphorum

Discover how artificial intelligence is revolutionising drug development and compliance in the pharmaceutical industry with these four impactful ways.

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Scorpion Therapeutics secures $150m for oncology pipeline

Pharmaceutical Technology

Scorpion Therapeutics has secured $150m in a Series C financing round to progress the development of its clinical-stage oncology pipeline.

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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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At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

FDA Law Blog

By Sarah Wicks & James E. Valentine & Frank J. Sasinowski — On July 17, 2024, FDA announced the establishment of a Rare Disease Innovation Hub (the “Hub”) to enhance and improve outcomes for patients with rare diseases and conditions by focusing on rare disease drug and biological product development across the Agency’s Center for Drug Evaluation and Research (“CDER”) and Center for Biologics Evaluation and Research (“CBER”).

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China NMPA approves Zai Lab-argenx’s efgartigimod alfa for gMG

Pharmaceutical Technology

China’s NMPA has granted approval for Zai Lab and argenx's efgartigimod SC for the treatment of generalised myasthenia gravis (gMG).

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Winning Drug Patent Disputes: Proven Strategies for Pharmaceutical Companies

Drug Patent Watch

The High Stakes of Pharmaceutical Patent Litigation In the fiercely competitive pharmaceutical industry, patent disputes can make or break a […] Source

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Huma raises $80m, launches 'Shopify for digital health'

pharmaphorum

Huma raised $80m to support a cloud platform that can be used by digital health developers to create disease management tools

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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.