Thu.Feb 29, 2024

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In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials

Fierce Pharma

Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. | Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. But a new funding pact between Carlyle’s Abingworth and Gilead Sciences is somewhat unconventional.

Biopharma 244
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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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GSK avoids trial with another Zantac settlement in California

Fierce Pharma

For the second time in four weeks, GSK has settled a personal injury lawsuit in California sta | For the second time in four weeks, GSK has settled a personal injury lawsuit in California state court over the heartburn drug Zantac. The company revealed the dismissal of the case and the agreement in a release Thursday.

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The Future of Innovation Metastatic Breast Cancer: 2024 Outlook

MedCity News

While the past several decades have seen progress in early detection, recent innovations in metastatic breast cancer—or cancer that has spread to distant parts of the body, including the bone, brain, or lungs—continues to cause excitement.

Biopharma 110
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With J&J settlement, Biocon Biologics gets a license to challenge Stelara in the US

Fierce Pharma

As Johnson & Johnson's U.S. exclusivity period on its immunology blockbuster Stelara ticks away, another biosimilar player has lined up for the piece of the drug's sales pie. | As Johnson & Johnson's U.S. exclusivity period on Stelara ticks away, another biosimilar player has lined up for the piece of the blockbuster's sales pie.

Sales 235
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Healthcare Docket: A Near Doubling of Hospital System Cyberattacks Triggers Bipartisan Bill

MedCity News

Increasing costs and healthcare cybersecurity worries have sparked calls for new laws. The bipartisan “Strengthening Cybersecurity in Health Care Act” by four senators would require the HHS to perform routine evaluations of its systems and deliver biannual reports on practices and progress.

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Startup Orbis Medicines Launches With €26M for Next-Generation Peptide Drugs

MedCity News

Orbis Medicines is developing macrocyclic peptides that address a wider range of targets and can be taken as oral pills. Novo Holdings and Forbion are backing the startup, which is based on research from the scientific co-founder of peptide drug developer Bicycle Therapeutics.

Medicine 101
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After setting out on its own, Sandoz inks $265M deal to resolve 'legacy' price-fixing lawsuit

Fierce Pharma

Sandoz, after inking a new settlement in a price-fixing case inherited from its former parent Novartis, says it’s taken an encouraging step on its quest to leave “allegations of legacy conduct” in | Sandoz, after inking a new settlement in a price-fixing case inherited from its former parent Novartis, says it’s taken an encouraging step on its quest to leave “allegations of legacy conduct” in the past.

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Hims & Hers CMO: The Healthcare Industry’s Strengths and Weaknesses Regarding Telehealth

MedCity News

Telehealth is great at expanding access to care, but sometimes the quality isn’t there, according to Dr. Pat Carroll, chief medical officer of Hims & Hers.

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Endo agrees to $465M bankruptcy deal with federal government, inks 2 opioid settlements

Fierce Pharma

Editor's note: This story was updated to note that Endo's criminal and civil opioid settlement payments will be satisfied by the bankruptcy resolution, according to an Endo | As it looks to emerge from bankruptcy, Endo agreed to fork over up to $464.9 million to the federal government, which had been investigating the marketing of opioid Opana ER.

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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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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

FDA 105
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Sarepta details Elevidys launch progress while awaiting key FDA decision on label expansion

Fierce Pharma

Despite a restricted FDA label, Sarepta Therapeutics has seen early commercial success with its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. | The company is quickly moving through Elevidys' eligible patient population while awaiting the FDA's decision on a broader label. In the fourth quarter, the gene therapy pulled down $131 million in sales.

FDA 174
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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

Eligible individuals in England and Wales can access the first licensed treatment for amyloid light-chain (AL) amyloidosis on the NHS. The National Institute for Health and Care Excellence (NICE) recommended DARZALEX ® (daratumumab) plus VELCADE ® (bortezomib), cyclophosphamide and dexamethasone (DVCd) as an option for people newly diagnosed with the systemic form of the disease.

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Fierce Pharma Asia—BeiGene's 1,400 new hires; BMS' India innovation hub; Evrenzo's China growth

Fierce Pharma

BeiGene expanded its global workforce by 1,400 over the past 12 months amid fast revenue growth. | BeiGene expanded its global workforce by 1,400 over the past 12 months. Bristol Myers Squibb opened a large innovation hub in India. AstraZeneca has decided to hold onto Evrenzo in China and Korea while returning rights to FibroGen in the U.S.

Pharma 130
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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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Shifting the paradigm – novel approaches to amyotrophic lateral sclerosis therapy

Pharmaceutical Technology

Amyotrophic lateral sclerosis (ALS) is a swiftly advancing, fatal neurodegenerative condition marked by muscle weakness, atrophy, and spasticity.

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Clinigen educates on early access to rare disease therapies

pharmaphorum

On Rare Disease Day, Clinigen has launched a campaign to try to encourage doctors and patients to explore how they can get early access to investigational therapies.

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NHS expedites availability of Belumosudil for chronic GVHD

Pharmaceutical Technology

The NHS has expedited the availability of the new drug, Belumosudil for cancer patients with chronic graft versus host disease (GVHD).

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Short-Term Thinking Is Undermining Healthcare — Here’s What We Need Instead

MedCity News

Adopting an infinite mindset could be the antidote to the slow destruction of healthcare by short-term thinking.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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HHS advocates for health equity through sickle cell initiative

Pharmaceutical Technology

The US HHS Secretary called for state collaboration on a project to improve gene therapy access for sickle cell disease.

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Biogen partner NeuroSense seeks a role in the ALS revolution

PharmaVoice

Results from a mid-stage study for a new ALS drug have been strong, and NeuroSense is looking to join a small but sturdy wave of companies bringing new treatments to market.

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Healthcare Moves: A Monthly Summary of Hires and Layoffs

MedCity News

Here is a selection of recent executive hires, promotions and layoffs occurring across the healthcare industry.

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IPA, IFRRO, STM, IAF Oppose South Africa’s Copyright Bill

Copyright Clearance Center

A joint statement from major international publishing bodies appeals to South Africa's National Assembly to vote down its copyright bill…

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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.

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Palatin pummelled as dry eye therapy underwhelms in phase 3

pharmaphorum

Palatin Technologies’ therapy for dry eye disease (DED) missed its primary endpoints in a phase 3 trial, knocking investor confidence as it tries to chart a way forward.

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New digital iTalkBetter app significantly improves speech in stroke patients

PharmaTimes

Aphasia is a language disorder caused by some form of brain damage, including stroke

Patients 106
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Rare disease spotlight: first EU-approved treatment for Friedreich’s ataxia

European Pharmaceutical Review

Last year, in agreeing to acquire Reata Pharmaceuticals for $7.3 billion , Biogen gained rights to SKYCLARYS ® (omaveloxolone), the first approved treatment for the rare disease Friedreich’s ataxia. The Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of several therapies for rare diseases, including the first oral treatment against residual haemolytic anaemia in the rare blood disorder, paroxysmal nocturnal haemoglobinuria, as well as the first therapy to

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Ironwood felled by mixed data in short bowel syndrome trial

pharmaphorum

Ironwood Pharma says phase 3 trial of apraglutide in short bowel syndrome (SBS) hit it main endpoint, but missed secondary outcomes weigh on its share price

Pharma 77
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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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ProQuest®, part of Clarivate™, launches AI-powered research assistant

Clarivate

Around the world, college students are struggling post-pandemic. In the U.S. the national average score on the ACT college placement exam declined to its lowest point in 30 years. In the U.K., researchers are warning that higher ed students are facing increased pressures that significantly reduce their resilience. In the classroom, faculty are reporting high levels of absenteeism and low levels of engagement.

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In U-turn, NICE backs first drug for AL amyloidosis

pharmaphorum

Almost four years after it was approved in Europe to treat the incurable rare disease systemic amyloid light-chain (AL) amyloidosis, Johnson & Johnson’s Darzalex has been given the go-ahead for routine use by the NHS in England and Wales.

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Cencora's Corey Ford Discusses the Future of the Inflation Reduction Act

Pharmaceutical Commerce

In an interview with Pharma Commerce Associate Editor Don Tracy, Corey Ford, VP, Reimbursement & Policy Insights, Cencora, offers his thoughts on where the Inflation Reduction Act will be five to 10 years from now.

Pharma 59
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Sandoz will pay $265m to settle price fixing case in US

pharmaphorum

Generic and biosimilar drugmaker Sandoz has agreed to pay $265 million to settle allegations of price-fixing in a Pennsylvania lawsuit.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.