Sat.Jan 08, 2022 - Fri.Jan 14, 2022

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5 questions facing biotech M&A in 2022

Bio Pharma Dive

Analysts expect that deal engines are ready to start firing again following the recent quiet period. Still, uncertainty remains about how biopharma acquisitions could play out in the coming months.

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Pharma’s outdated hiring practices

World of DTC Marketing

One of the reasons it’s a job-seekers market because candidates today want more from their employers. They want a good work-life balance and want to be valued as a contributor to the success of their company. We live in an instant gratification world. Anything and everything we could ever want is at our fingertips, from the food we eat to the movies we watch.

HR 277
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PDUFA VII: More Changes Coming in the Latest Reauthorization

Camargo

As we noted in a separate blog post , the forthcoming reauthorization of the FDA’s Prescription Drug User Fee Act (PDUFA VII) includes several provisions that are expected to help advance cell and gene therapy products, as well as therapies designed to treat rare diseases. However, the anticipated impact of PDUFA VII will extend well beyond those industry segments.

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2022 will see pharma target nutraceutical products to tap into consumer spending on preventative health: CPhI Worldwide Report

Pharma Mirror

Amsterdam, CPhI Worldwide – the world’s largest pharma event, which will be hosted at the Frankfurt Messe (1-3 November, 2022) – releases the final part of its annual report with far reaching predictions for 2022 and beyond into 2025 for the nutraceuticals market. The findings explore the long-term trends underway in the global nutraceutical industry, with consumers predicted to increase spending on natural products and sustainable formulations that can offer ‘preventative or proactive’ health b

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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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Pfizer expands into gene editing with Beam research deal

Bio Pharma Dive

Pfizer's work with mRNA vaccines led it explore other applications of the technology, resulting in a multi-year partnership with the high-profile biotech Beam Therapeutics on gene editing treatments for rare diseases.

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HCPs are overwhelmed by promotional content in digital

World of DTC Marketing

As HCPs get more digitally savvy, pharma marketers should understand that engaging physicians through channels and time of their preference with content relevant to the individual customer. is no more an option but a critical factor to ensure success for any multichannel marketing initiatives. Key findings: 77% of HCPs use digital channels primarily for personal learning and development.

More Trending

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Oxford joins consortium to advance quantum drug discovery

Pharma Times

The partnership between Oxford University and SEEQC promises to accelerate the use of quantum computing within pharmaceutical research in order to reduce the development time required for drug production worldwide.

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Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

Bio Pharma Dive

A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

Trials 356
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Pharma spent $3.9B on TV ads in 2021

World of DTC Marketing

(Endpoints) Pharma TV advertising boomed in 2021 – to the tune of $3.91 billion across prescription meds, iSpot reports. That’s an increase of 4.8% year over year, which may not sound like much but marks pharma’s steady growth through the pandemic. And its continued growth of national TV ad spending while the rest of the industry is on the decline in the US.

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NervGen Pharma sets sights on trial for spinal-cord injury treatment

Outsourcing Pharma

The company plans to launch a Phase Ib/II study of its compound NVG-291 in collaboration with researchers at Northwestern Universityâs Shirley Ryan AbilityLab.

Trials 145
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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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New study finds AstraZeneca booster generates higher antibodies against Omicron

Pharma Times

AstraZeneca (AZ) has reported preliminary data from a trial it conducted on its COVID-19 booster shot, Vaxzevria.

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5 questions facing gene therapy in 2022

Bio Pharma Dive

As record levels of money pour into gene therapy research, biotechs are under increased pressure to address issues related to safety, delivery and overlapping pipelines.

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Pharma is in acquisition mode but small biotechs hurting for money

World of DTC Marketing

Pharma companies are flush with cash and looking to make deals, but there are still a lot of small biotech companies that don’t have enough money to launch their products entirely. It seems that pharma is only interested in drugs that have the potential to sell hundreds of millions as opposed to small products that may only sell to a limited audience.

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Protagen, BioAnalytix, and GeneWerk unveil combined CRO business: ProtaGene

BioPharma Reporter

Protagen, BioAnalytix, and GeneWerk this week announced their unified operations and re-brand as ProtaGene, a CRO partner for the biologics and cell and gene therapy developers, from discovery to commercialization.

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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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Pfizer, Moderna are prepping new vaccines for Omicron

pharmaphorum

With evidence growing that the current crop of COVID-19 vaccines are less protective against infection with Omicron, both Pfizer and Moderna have announced plans to develop new versions of their mRNA-based shots that are tailored to the new variant. Pfizer has said that a COVID-19 jab specifically targeting Omicron, as well as other existing variants, will begin human trials later this month and could be available as early as March.

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BioMarin plans return to FDA with updated data on hemophilia gene therapy

Bio Pharma Dive

Two-year results from a Phase 3 study of Roctavian show treatment prevented bleeding, potentially giving BioMarin the data it needs to resubmit an application for approval.

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Influencer marketing in pharma

World of DTC Marketing

The word influencer was added to the Merriam-Webster dictionary in 2019, but influencer marketing is nothing new. Scandals, fake followers, bot technologies, and the pandemic crisis converged have put a halt to influencer marketing growth and tarnished the public view of influencers as a whole. Can pharma leverage influencer marketing? Across the board, in­flu­encer mar­ket­ing was worth around $9.7 bil­lion in 2020, ac­cord­ing to In­flu­encer Mar­ket­ing Hub , which es­ti­mat­ed the mar­k

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Stand Up to Cancer research initiative targets pancreatic cancer

Outsourcing Pharma

Joining with a noted research foundation, the group is aiming for earlier detection and treatment of the disease, which hits nearly 500K people annually.

Research 136
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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.

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EMA sets out proposals to reform EU’s clinical trials framework

pharmaphorum

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research. The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.

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JPM22: M&A anxiety, Roche's comeback plan and Vir's omicron moment

Bio Pharma Dive

Pharma executives fielded many questions about their dealmaking intentions on the conference's second day, while Roche outlined its plan to compete against Merck and Bristol Myers in cancer immunotherapy.

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Korea’s Samsung Bio reveals massive capacity boost on the cards

BioPharma Reporter

Samsung Biologics flags further facility construction plans, with biologics, cell and gene therapies and next-generation vaccines to be the focus of those new sites.

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European Commission approves cystic fibrosis treatment for six to 11-year-olds

Pharma Times

There is currently no cure for cystic fibrosis (CF), a debilitating, progressive condition with over 10,830 people in the UK currently diagnosed with the disease.

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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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Roche debuts smart glucose monitor for hospital use

pharmaphorum

Roche has launched what it says is a first-of-its kind handheld glucose management device, backed up by a digital platform that aims to simplify the work of doctors and nurses as they deliver care to patients. The cobas pulse system is a point-of-care device that combines a glucose test strip reader with a touch screen that is used for displaying patient information and data, as well as analysing and sharing clinical results.

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5 questions facing the FDA in 2022

Bio Pharma Dive

If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.

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New study sheds light on origins of life on Earth

Scienmag

New Brunswick, N.J. (Jan. 14, 2022) – Addressing one of the most profoundly unanswered questions in biology, a Rutgers-led team has discovered the structures of proteins that may be responsible for the origins of life in the primordial soup of ancient Earth. Credit: Rutgers New Brunswick, N.J. (Jan. 14, 2022) – Addressing one of the […].

Protein 115
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UKHSA estimates one in seven still infectious after five day COVID-19 isolation

Pharma Times

Under current guidelines, individuals that test positive for COVID-19 may be able to leave self-isolation after 7 days if certain conditions are met.

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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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Otsuka backs GrayMatters’ digital wearable tech for mental disorders

pharmaphorum

Japanese pharma group Otsuka has led a $10 million first-round financing of GrayMatters Health, an Israeli company developing a digital health approach to the management of mental illness. Otsuka Medical Devices is also taking some rights to GrayMatters’ platform – called Prism – in Japan and some other Asian countries in connection with the financing, which was supported by Joy Ventures, J-Ventures, J-Impact, and existing backers Marius Nacht and Joyance Ventures.

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JPM22: Aftershocks for Lilly, CRISPR versus CRISPR and Bluebird's crucial year

Bio Pharma Dive

A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology.

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Pfizer to Increase Manufacturing of Paxlovid COVID-19 Treatment and Have Omicron-Specific Vaccine Ready by March

XTalks

Speaking at the JP Morgan Healthcare Conference, being held virtually this year, on Monday, Pfizer CEO Albert Bourla said the company has plans to boost manufacturing of its COVID-19 treatment Paxlovid by up to 50 percent this year. Bourla said the company would achieve the scale-up by expanding its manufacturing capacity. Paxlovid was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) late last month, making it the first authorized antiviral treatment for COV

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With $2 million grant, UTA scientist aims to create massive cancer database

Scienmag

University of Texas at Arlington computer scientist Jacob Luber has earned a five-year, $2 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to create a database that contains every publicly available cancer dataset from the National Cancer Institute (NCI). Credit: UT Arlington University of Texas at Arlington computer scientist Jacob Luber […].

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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.