Bristol Myers taps startup to boost CAR-T production
Bio Pharma Dive
APRIL 22, 2024
A partnership with Cellares, worth up to $380 million, is meant to help Bristol Myers speed and scale manufacture of the complex cellular treatments.
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BioMarin Pharmaceutical gets grant for treatment of adolescent PKU patients using AVPAL variant
Pharmaceutical Technology
APRIL 22, 2024
Discover how BioMarin Pharmaceutical's patent for PAL variants offers a groundbreaking method to treat PKU in adolescents. Administering AvPAL variants weekly over 50 weeks effectively reduces blood phenylalanine levels.
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Metsera, a well-funded obesity drug startup, sees chance to challenge Lilly, Novo
Bio Pharma Dive
APRIL 18, 2024
It’s “early innings” in the obesity drug race, said Metsera CEO Clive Meanwell, whose company has acquired a portfolio of medicines it aims to test in combination.
Outrun Therapeutics announces launch with $10m seed funding
Pharmaceutical Technology
APRIL 18, 2024
Outrun Therapeutics announced its launch with $10m seed funding to advance a protein stabilisation pipeline focused on E3 ligase inhibitors.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
April 23, 2024: Younger, Uninsured Patients Among Those at Greatest Risk for Missing Follow-up Assessments in Trauma Research
Rethinking Clinical Trials
APRIL 23, 2024
In an analysis of data from the TSOS study, younger patients and patients who were publicly insured or uninsured were among several subgroups of patients who were at significant risk of missing follow-up outcome assessments. The report was published this week in Injury. Successful studies of interventions for patients with posttraumatic stress disorder (PTSD) require engaging with injured patients in long-term follow-up.
NABH unveils plan for 2nd Edition of Accreditation Standards for Allopathic Clinics
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 23, 2024
In a significant development for healthcare quality assurance in India, the National Accreditation Board for Hospitals & Healthcare Providers (NABH) has announced the implementation plan for the 2nd Edition of NABH Accreditation Standards for Allopathic Clinics.
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Vertex begins bid for US approval of non-opioid painkiller
Bio Pharma Dive
APRIL 18, 2024
The start of a so-called rolling review formally begins an FDA evaluation of a closely watched drug that’s important to the biotech’s future, but faces questions about its sales potential.
Early Data Indicate Cell Therapies Could ‘Reset the Clock’ in Parkinson’s
BioSpace
APRIL 21, 2024
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
Innovative Strategies in Drug Repurposing
Drug Patent Watch
APRIL 23, 2024
Drug repurposing, or identifying new therapeutic uses for existing drugs, is gaining significant momentum as a promising approach to accelerate drug development and reduce costs.
Novo Nordisk attracts lawmakers' scrutiny after dropping discounted insulin product Levemir
Fierce Pharma
APRIL 18, 2024
Novo Nordisk is receiving pushback from a trio of lawmakers over its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year | Novo Nordisk is receiving pushback from a trio of lawmakers on its decision to discontinue its long-acting insulin product Levemir, which was due for a steep discount at the start of the new year.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Cerevel, in ‘major surprise,’ finds success in late-stage Parkinson’s study
Bio Pharma Dive
APRIL 18, 2024
Analysts had low expectations for Cerevel’s drug tavapadon, which was something of an afterthought in AbbVie’s proposed buyout of the biotech.
Health Canada approves Merck’s KEYTRUDA for gastric cancer treatment
Pharmaceutical Technology
APRIL 22, 2024
Health Canada has approved Merck’s KEYTRUDA (pembrolizumab), an anti-programmed cell death protein 1 (PD-1) therapy for use in combination with fluoropyrimidine- and platinum-containing-chemotherapy as a first-line treatment for adult gastric cancer patients.
FDA Rejects Abeona’s Epidermolysis Bullosa Cell Therapy, Asks for CMC Data
BioSpace
APRIL 22, 2024
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
What is health literacy? Definition and resources
Antidote
APRIL 23, 2024
Equitable access to medical care is valuable for everyone, and an important part of this equation is health literacy. Health literacy encompasses not just access to medical care, but also the ability to understand and use medical guidance. This can include anything from a doctor’s suggestions, to medication dosage information, and aftercare guidance.
How Machine Learning Drives Clinical Trial Efficiency
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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.
What pharma stands to gain from technological innovation
pharmaphorum
APRIL 22, 2024
Pharmaceutical companies stand to gain significant benefits from technological innovation in the form of improved data analytics, streamlined healthcare processes, and enhanced patient outcomes. Explore the potential advantages for the pharma industry.
Roche wins FDA OK for targeted drug in early lung cancer
Bio Pharma Dive
APRIL 19, 2024
The new label for Alecensa makes it the first targeted treatment available after surgery for people with ALK-positive lung tumors, who are at high risk for brain metastases.
GS-6212 by Gilead Sciences for Human Immunodeficiency Virus (HIV) Infections (AIDS): Likelihood of Approval
Pharmaceutical Technology
APRIL 22, 2024
GS-6212 is under clinical development by Gilead Sciences and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).
Opinion: Akero and Madrigal Face Off in the MASH Space
BioSpace
APRIL 21, 2024
While Madrigal Pharmaceuticals secured the first FDA drug approval for metabolic dysfunction–associated steatohepatitis, Akero Therapeutics is developing what may serve as a viable alternative treatment for precirrhotic disease.
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.
Sanofi, busy with cost-savings campaign, restructures US commercial vaccine group
Fierce Pharma
APRIL 18, 2024
During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. | During a busy period of overhaul at Sanofi, the company is restructuring its U.S. vaccine commercial group. A spokesperson said the company would offer affected employees a chance to apply for new roles, plus "outplacement services.
Novartis names ex-BMS CEO Caforio as chair amid strong Q1
pharmaphorum
APRIL 23, 2024
Novartis has proposed ex-BMS CEO Caforio as the successor to chair Joerg Reinhardt when he steps down next year, as it posts a strong set of Q1 results
AskBio’s AB-1002 gene therapy receives FDA fast-track status
Pharmaceutical Technology
APRIL 19, 2024
The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).
BMS Initiates First Round of Layoffs in New Jersey
BioSpace
APRIL 23, 2024
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Sanofi's Zantac settlement is worth $100M, or $25K per claimant: Bloomberg
Fierce Pharma
APRIL 22, 2024
Sanofi will pay $100 million—or approximately $25,000 each—to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (rani | Sanofi will pay approximately $25,000 per person to roughly 4,000 claimants who filed lawsuits saying that the French company failed to warn users that its heartburn medicine Zantac (ranitidine) can cause cancer, Bloomberg reported.
With $75m cash injection, SynOx plans ph3 rare tumour trial
pharmaphorum
APRIL 22, 2024
Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials. TGCT is a rare disease affecting the joints and tendons caused by overproduction of the protein CSF-1, which stimulates the proliferation of various cell types, inflammation, and destruction of the matrix of the joint.
Lilly to buy injectable drug plant in manufacturing ramp-up
Bio Pharma Dive
APRIL 22, 2024
The acquisition of a Nexus Pharmaceuticals facility in Wisconsin could help Lilly better meet demand for injectable medicines, like those it makes for diabetes and obesity.
Inflammation among current dementia research focus, says Alchemab CSO
Pharmaceutical Technology
APRIL 18, 2024
Inflammation, cell metabolism and neuronal health are current key areas of focus for dementia researchers, according to Jane Osbourn, chief scientific officer (CSO) at Alchemab.
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
CSL Vifor Offers Marketing Campaign to Reverse Alleged Anti-Competitive Practices
BioSpace
APRIL 21, 2024
Following an investigation regarding antitrust practices against Pharmacosmos’ Monofer, CSL Vifor has proposed a sweeping multi-channel communication campaign designed to reverse allegedly misleading messages about its rival.
Soon-Shiong's ImmunityBio bags FDA approval for Anktiva to challenge Merck in bladder cancer
Fierce Pharma
APRIL 22, 2024
After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. | After a merger and an FDA rejection, celebrity businessman and biotech entrepreneur Patrick Soon-Shiong’s ImmunityBio has landed the company’s first U.S. approval in the cancer immunotherapy Anktiva.
FDA clears ImmunityBio’s bladder cancer drug at 2nd attempt
pharmaphorum
APRIL 23, 2024
After rejecting ImmunityBio’s Anktiva last year, the FDA has now cleared the drug as a treatment for bladder cancer, making it the biotech's first commercial-stage product
Biogen: Don’t expect any big acquisitions this year
Bio Pharma Dive
APRIL 24, 2024
While the company is eager to diversify, CEO Chris Viehbacher said that in the near-term any dealmaking would likely focus on collaborations and early-stage assets.
The New Age of Decentralized Clinical Trials
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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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