Thu.Sep 30, 2021

article thumbnail

Acceleron provides biggest biopharma deal this year, with $11.5B sale to Merck

Bio Pharma Dive

The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts.

Sales 345
article thumbnail

I Holland Celebrates 75 Years of Excellence

Pharma Mirror

As the longest established tablet compression tooling manufacturer in the world, I Holland is celebrating its 75th anniversary. The company has reached this remarkable milestone due to their commitment to research, development and investment which has established the company as the pre-eminent supplier of punches and dies to producers of tablets across the globe.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Otsuka partners with Sunovion, Sumitomo in neurology drug pact

Bio Pharma Dive

Sunovion will receive $270 million from Otsuka, and as much as $620 million more, in exchange for splitting rights to four experimental psychiatric drugs.

Drugs 269
article thumbnail

A*STAR and Local SME Work with Vaccination Centres to Deploy Automated Systems for Filling Syringes

Pharma Mirror

SINGAPORE; The Agency for Science, Technology and Research (A*STAR) has developed an Automated Vaccine Inoculation Dispenser (AVID) system, which replaces the manual step of filling injection syringes with vaccine liquid. AVID is customised for the vaccination centres which are set up by the Ministry of Health and operated by private healthcare providers AVID was designed to address the labour-intensive steps of the vaccination process to reduce the workload of healthcare providers, increase acc

article thumbnail

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

article thumbnail

Merck confirms $11.5bn Acceleron takeover deal

pharmaphorum

After days of speculation, Merck & Co confirmed today that it has agreed to acquire Acceleron Pharma $1.5 billion, setting up what could be one of the largest biopharma acquisitions of 2021 so far. The $180-per-share deal – if completed – will give Merck a pair of blockbuster drug candidates, one of which is already on the market, and help to reduce its reliance on $14.4 billion immuno-oncology blockbuster Keytruda (pembrolizumab).

Sales 117
article thumbnail

Merck COVID-19 Antiviral Cuts Death, Hospitalizations in Half

BioSpace

?The Phase III trial on a potential treatment for mild-to-moderate COVID-19 symptoms by Merck and Ridgeback Biotherapeutics showed promise in preventing hospitalizations and death.

Trials 102

More Trending

article thumbnail

Developing case-based content to engage HCPs

pharmaphorum

In this instalment of EPG Health’s HCP engagement series, Georga Cottle discusses how case-based learning connects medical theory to medical practice. Medical education doesn’t stand still. The acute demands on today’s healthcare systems require ever-more effective learning opportunities for healthcare professionals (HCPs) and offer pharma companies valuable chances to support evidence-based clinical practice.

article thumbnail

How QR Codes are Making a Comeback in the Foodservice Industry

XTalks

Of the many industries that have been negatively impacted by the COVID-19 pandemic, few have been hit harder than the foodservice industry. From labor shortages to lack of revenue, many restaurants were forced to lay off staff, adjust their operations or shut down entirely. But now, a decades-old technology is helping restaurants bounce back: quick response (QR) codes.

article thumbnail

The D.C. District Court Slaps Down on Procedural Grounds FDA’s 20-year Effort to Implement its Memorandum of Understanding to Address Interstate Shipments of Compounded Drug Products

FDA Law Blog

By Karla L. Palmer — The tale of “David versus Goliath” is never a dull skirmish. This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. And the “David” cast of characters has successfully challenged FDA’s promulgation of its final Memorandum of Understanding (“MOU”) intended to “address” shipments of compounded medications interstate.

article thumbnail

BioNTech Doses First Patient with Personalized mRNA Cancer Vaccine

BioSpace

First COVID-19, now cancer. BioNTech made history when its COVID-19 mRNA vaccine with partner Pfizer became the first ever approved.

article thumbnail

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.

article thumbnail

Glenmark to launch Ryaltris® in 13 UK and EU countries

Pharma Times

Glenmark Pharmaceuticals has announced that it has received marketing approval for its fixed-dose combination nasal spray, Ryaltris, in 13 countries across the UK and EU.

Marketing 101
article thumbnail

AACC Buzz: Noninvasive Blood or Saliva Tests for Cancer and COVID-19 Are Promising

BioSpace

Noninvasive tests for colorectal cancer, prostate cancer and COVID-19 were among the highlights of the American Association for Clinical Chemistry meeting September 26-30.

109
109
article thumbnail

Patients want to see more health industry collaboration: survey

Outsourcing Pharma

A study by Charles River finds patients believe the overall quality of healthcare would increase if stakeholders across the life sciences collaborated more.

article thumbnail

Moderna, Thermo Fisher Expand as Life Sciences Sector Continues to Prosper

BioSpace

Marked by recent announcements of new manufacturing sites, headquarters and job creations, the life science industry continues to thrive despite the COVID-19 pandemic.

article thumbnail

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.

article thumbnail

Virtual care with remote monitoring catches drug errors and reduces patient pain

Scienmag

Hamilton, ON (September 30, 2021) – Patients using take-home technology following non-elective surgery resulted in significantly greater detection and correction of drug errors, and reduction in patients’ pain, says a national study led by Hamilton researchers. Credit: McMaster University Hamilton, ON (September 30, 2021) – Patients using take-home technology following non-elective surgery resulted in significantly […].

Drugs 90
article thumbnail

FDA posts guidance on mining real-world data from health records

pharmaphorum

There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken. Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines.

article thumbnail

Critical groundwater supplies may never recover from drought

Scienmag

Along with hurricanes and wildfires, there’s another important, but seldom-discussed effect of climate change — toxic water and sinking land made worse by groundwater drought. Credit: USGS Along with hurricanes and wildfires, there’s another important, but seldom-discussed effect of climate change — toxic water and sinking land made worse by groundwater drought.

90
article thumbnail

GSK and Merck Break Up $4 Billion Oncology Collab After Multiple Failures

BioSpace

The deal's termination was announced Thursday, months after bintrafusp alfa failed to hit the mark in a Phase II clinical trial as a potential second-line treatment for metastatic biliary tract cancer.

article thumbnail

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.

article thumbnail

New research reveals that our choices may be making us more individualistic

Scienmag

According to research, an average American makes around 35,000 decisions each day. These decisions range from the mundane – what color shirt to wear – to the important – whether or not to be vaccinated. Credit: Virginia Tech According to research, an average American makes around 35,000 decisions each day. These decisions range from the […].

article thumbnail

Trio of Biopharmas Generates Over $500 Million for AI, Oncology Innovation

BioSpace

?This week, three global biopharmaceutical companies received over half a billion dollars to support research and development initiatives in the treatment of rare and deadly diseases.

article thumbnail

New treatment for inflammatory bowel disease: Opioids may cure that “bad gut feeling”

Scienmag

Opioids are a class of substances that control sensations such as pain and emotions in animals. While plant-derived opioid narcotics such as morphine are the most well-recognized, other opioid molecules like endorphins can also be synthesized by the body or artificially developed in laboratories. Opioids exert their actions by binding to opioid receptors present on […].

article thumbnail

Pharma CEO confidence tops pre-pandemic levels, companies look to nucleic-acid technology assets to fuel growth

BioPharma Reporter

CEOs at large pharma and biotech companies are upbeat when it comes to their outlook for both their own company and the industry at large; they also have a healthy appetite for M&A, found a KPMG survey.

article thumbnail

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.

article thumbnail

Brands can boost their own reputations and sales by praising rivals

Scienmag

Whether they’re beefing on billboards or sparring on social media, big brands are known for taking jabs at their competitors (see the famous “Get a Mac” ads or “the chicken sandwich wars”). Credit: Ryan Gaucher/Duke University’s Fuqua School of Business Whether they’re beefing on billboards or sparring on social media, big brands are known for […].

article thumbnail

Appeals Court Supports Catalyst’s Attempt to Overturn FDA Decision

BioSpace

Catalyst Pharmaceuticals received a positive decision from the 11th Circuit Court of Appeals over a suit against the U.S. FDA's approval of a competitor’s amifampridine product.

article thumbnail

Early accumulation of tau in the brain predicts memory decline in Alzheimer’s disease

Scienmag

Researchers at Karolinska Institutet in Sweden have compared how well different Alzheimer’s biomarkers predict the progression of the disease and its effect on the memory. They found that early accumulation of tau proteins in the brain as measured by PET scanner was more effective at predicting memory impairment than biomarkers in the cerebrospinal fluid or […].

Protein 88
article thumbnail

NICE recommends life-extending urothelial cancer treatment

Pharma Times

People with advanced or metastatic urothelial cancer will soon have access to a new treatment option following a NICE recommendation.

91
article thumbnail

The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

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.

article thumbnail

Satirical essay critiques power imbalances in global health research

Scienmag

When establishing partnerships with research counterparts in under-resourced countries, global health researchers often deploy discourse that claims to focus on sustainability and capacity building. But how is this viewed from the other side of the partnership? A satirical opinion article publishing September 30th in PLOS Biology by Iruka Okeke of University of Ibadan, Nigeria, highlights […].

article thumbnail

Large Acceleron Stakeholder Says Acquisition Price Undervalues Company

BioSpace

Investment firm Avoro Capital has raised concerns that the $180 per-share price Merck is paying Acceleron Pharma undervalues the rare-disease focused company.

97
article thumbnail

Bigleaf maple decline tied to hotter, drier summers in Washington state

Scienmag

As its name suggests, the bigleaf maple tree’s massive leaves are perhaps its most distinctive quality. A native to the Pacific Northwest’s wet westside forests, these towering trees can grow leaves up to 1.5 feet across — the largest of any maple. Credit: Jacob Betzen/University of Washington As its name suggests, the bigleaf maple tree’s […].

85
article thumbnail

Mobile technology facilitates decentralized skin and wound trials

Outsourcing Pharma

A leader from Swift Medical describes the companyâs skin and wound management technology, and how their tech empowers patient capture of vital information.

Trials 83
article thumbnail

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.