Pfizer taps McKinsey executive to lead dealmaking efforts
Bio Pharma Dive
AUGUST 26, 2021
Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week.
Thu.Aug 26, 2021
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The Constitution and vaccinations
World of DTC Marketing
AUGUST 26, 2021
SUMMARY : Via Marci Hamilton is a professor at the University of Pennsylvania “the Constitution is not a suicide pact guaranteeing a right to harm others. The government has latitude to protect citizens from deadly conditions, especially when the science supporting vaccination is so clear” Prof Hamilton goes on to say, “One frequently heard pushback against vaccine mandates is that there is a “constitutional right” to choose whether to be vaccinated or not for adult
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Gilead wins reversal of $1.2B penalty in CAR-T patent case
Bio Pharma Dive
AUGUST 26, 2021
A federal appeals court overturned an earlier verdict that had ruled Gilead's Kite Pharma unit infringed on a patent held by Bristol Myers Squibb.
Digital mental health firms Headspace and Ginger in $3bn merger
pharmaphorum
AUGUST 26, 2021
A merger between two digital mental health companies – Headspace and Ginger – will create a $3 billion giant in a category that has been growing at breakneck speed as a result of the COVID-19 pandemic. The deal brings together Headspace’s meditation and mindfulness app – used by millions of people around the world – and Ginger’s platform which provides therapy and psychiatric support as an on-demand, video-based service.
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
AstraZeneca reports study success for rare disease drug acquired in Alexion deal
Bio Pharma Dive
AUGUST 26, 2021
With positive results from a Phase 3 trial in hand, the British pharma intends to soon seek regulatory approval for the Wilson disease treatment.
Humacyte Combines with Alpha Healthcare in Latest Biopharma SPAC
BioSpace
AUGUST 26, 2021
The combined company out of the Humacyte SPAC will be called Humacyte and is expected to trade shares of common stock and warrants on the Nasdaq Global Select Market.
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Aptamer Group and Bio-Works Technologies align for improved purification and scale up of gene therapy vectors
BioPharma Reporter
AUGUST 26, 2021
A new partnership promises improved biomanufacturing processes for gene therapies; the goal is to support the sector in scaling up through more efficient, cost-effective processes.
The Next Generation of Treatments for Advanced Cervical Cancer
BioSpace
AUGUST 26, 2021
Approximately 14,000 American women are expected to be diagnosed with invasive cervical cancer in 2021, and more than 4,000 are expected to succumb to the disease.
How COVID-19 Changed Food Sampling + Apeel’s Plant- Based Produce Coating – Xtalks Food Podcast Ep. 25
XTalks
AUGUST 26, 2021
How has the COVID-19 pandemic changed the way brands and retailers hand out food samples? In this episode of the Xtalks Food Podcast, Sydney discusses how food sampling has changed in retail settings and at home, with many companies shifting to e-commerce or online grocery orders as a means to send out samples. The team discusses whether in-store samples will return to their pre-pandemic state and why sample booths are crucial for small and emerging businesses.
UK Study: Blood Clot Risk Higher with COVID Infection than Vaccines
BioSpace
AUGUST 26, 2021
?Scientists from the U.K. conducted a massive study on the link between vaccinations and dropping platelet counts and found that the problem lies more on the virus itself than on the medications.
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
How the Approval of Aducanumab Will Change Alzheimer’s Trials — Xtalks Life Science Podcast Ep. 25
XTalks
AUGUST 26, 2021
In this episode, Sarah presents three ways that Alzheimer’s trials will change now that Biogen’s Aduhelm (aducanumab) has been approved by the FDA. The team discusses whether placebo-controlled trials are still ethical and how ongoing dementia studies can manage patient attrition. Can trials pivot to allow patients to aducanumab as a background therapy?
Proposed Medicare Overhaul Could Have Significant Impact on Drug Development
BioSpace
AUGUST 26, 2021
The bill may lead to a 15% to 25% reduction in expected returns for drugs in the top quintile of expected returns. Meaning a decrease in new medications entering the market in the following years.
Shape Therapeutics-Roche’s Deal; AllStripes Raises $50M; Datavant-Real Chemistry’s Partnership; BlueWillow’s Nasal Vaccine
Delveinsight
AUGUST 26, 2021
Shape Therapeutics inks gene therapy deal with Roche worth up to USD 3 Billion. Seattle biotech firm Shape Therapeutics has signed a deal potentially exceeding USD 3 billion with pharma giant Roche to bolster the development of gene therapies for Alzheimer’s and Parkinson’s disease. Shape’s RNA editing technologies can modify the RNA sequence, which makes the body’s protein building blocks.
FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal Conduct
FDA Law Blog
AUGUST 26, 2021
By JP Ellison — It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality. In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.
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.
Existing drug could offer hope as new therapy for ALL in children
Pharma Times
AUGUST 26, 2021
Early stage research found 5-azacytidine may be used to treat 'devastating' disease
Temperature control, track and trace, global distribution: Cryoport and Mitsubishi set up alliance for Japan and APAC region
BioPharma Reporter
AUGUST 26, 2021
cold chain logistics provider, Cryoport, has established a multi-year strategic partnership with Japanâs Mitsubishi Logistics Corporation (MLC).
Largest Study of Long COVID Points to an Alarming Prognosis
BioSpace
AUGUST 26, 2021
At the six-month mark, 68% of participants reported at least one persistent symptom, which fell to 49% after one year.
Eurofarma to manufacturer Pfizer-BioNTech COVID-19 shot for Latin American market: Production set to exceed 100 million doses annually
BioPharma Reporter
AUGUST 26, 2021
Brazilâs Eurofarma LaboratÃrios SA is to manufacture Pfizer and BioNTech's COVID-19 vaccine, Comirnaty, for distribution within Latin America.
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.
Home antibody tests for COVID-19 to be made available in UK
Pharma Times
AUGUST 26, 2021
Up to 8,000 people per day can access the tests
Research Roundup: Potential Eye Test for Alzheimer’s and More
BioSpace
AUGUST 26, 2021
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
MSD’s pneumococcal vaccine hits ‘key endpoints’ in Phase III
Pharma Times
AUGUST 26, 2021
Phase III trial evaluated use in infants 42-90 days old
Gilead Wins a Patent Battle in CAR-T War with BMS
BioSpace
AUGUST 26, 2021
Gilead won the most recent battle when a U.S. appeals court threw out a $1.2 billion ruling against the company.
Accelerating Clinical Supply Through Integrated Drug Development
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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.
Cara, Vifor receive FDA nod for pruritus treatment
Pharma Times
AUGUST 26, 2021
Korsuva injection will treat CKD patients undergoing haemodialysis
J&J Talc Spinoff Strategy Survives Legal Proceeding
BioSpace
AUGUST 26, 2021
An alleged plan by Johnson & Johnson to spin off a company solely responsible for its talc-based products in order to mitigate lawsuit damages is still on the table following a ruling by a federal judge.
J&J lung cancer initiative will use Optellum’s ‘digital biomarker’ tech
pharmaphorum
AUGUST 26, 2021
Three years ago, Johnson & Johnson set up a wide-ranging initiative with Boston University to try to improve lung cancer survival rates through prevention and early intervention. Now, its calling on artificial intelligence specialist Optellum to help with that effort. UK-based Optellum has developed an AI-powered clinical decision support – called Virtual Nodule Clinic – that it says acts as a “digital biomarker”, looking for signs of cancer in computed tomography (CT) scans.
Report reveals obstacles to implementing digital trial tech
Outsourcing Pharma
AUGUST 26, 2021
A study conducted by trial tech firms Curedatis and Climedo Health reveals what trial professionals view as challenges and opportunities in digitalization.
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.
BioSpace Movers & Shakers, Aug. 27
BioSpace
AUGUST 26, 2021
Biopharma companies and life sciences organizations strengthen their leadership teams and boards with these Movers & Shakers.
Chikungunya vaccine candidate enters Phase 2/3 trial
BioPharma Reporter
AUGUST 26, 2021
The International Vaccine Institute (IVI) and Bharat Biotech have started a Phase 2/3 clinical trial for a chikungunya vaccine candidate in Costa Rica.
New patent for Boehringer Ingelheim drug PRADAXA
Drug Patent Watch
AUGUST 26, 2021
Annual Drug Patent Expirations for PRADAXA Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are five patents…. The post New patent for Boehringer Ingelheim drug PRADAXA appeared first on DrugPatentWatch - Make Better Decisions.
EMA gives green light to additional mRNA COVID-19 vaccine manufacturing facilities
BioPharma Reporter
AUGUST 26, 2021
The European Medicines Agencyâs human medicines committee (EMA CHMP) has this week approved additional manufacturing capacity for Pfizer/BioNTech and Moderna COVID-19 vaccines.
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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