May, 2022

BioMarin delays planned FDA filing for hemophilia gene therapy

Bio Pharma Dive

BioMarin now expects to resubmit its approval application to the FDA by the end of September, the latest regulatory setback for the company's closely watched treatment

Mental health apps and services may be doing more harm than good

World of DTC Marketing

Cerebral will stop writing prescriptions for Adderall, Ritalin, and other controlled substances to new ADHD patients as concerns grow about telehealth companies’ prescribing practices.

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Malaria parasites form vortices

Scienmag

The disease of malaria is triggered by single-celled parasites that accumulate in large groups in the salivary glands of mosquitoes before transmission to human beings.

Reaxys User Day 2022: Researcher secrets in the spotlight

Elsevier

In April, Elsevier hosted the first Reaxys User Day to learn from expert users and share best practices. Attendees were also updated on how the expert-curated chemistry database has dramatically upped its ability to streamline R&D.

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

How the Hospital Price Transparency Rule Helps You

Triage Cancer

Are you concerned about the cost of treatment at a hospital? Thanks to the Hospital Price Transparency Rule, you may have access to cost information on their website! What is the Hospital Price Transparency Rule? The Hospital Price Transparency Rule, created by the U.S.

Breakthroughs in Clinical Research

Riverside Clinical Research

Clinical research enables doctors and researchers to develop a better understanding of diseases.

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Pharma’s addiction to McKinsey

World of DTC Marketing

The top executive at McKinsey & Company appeared before Congress to answer for the consulting firm’s role in fanning the opioid crisis and came under intense criticism from lawmakers.

Experts call on governments to start including animal welfare in sustainable development governance

Scienmag

Scientists and other experts are calling on governments to start including animal welfare in sustainable development governance now in order to work towards a healthier, more resilient, and more sustainable world for all.

Responding to outbreak, Moderna starts early work on monkeypox vaccine

Bio Pharma Dive

One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus

Merck study results signal blood cancer potential for new type of immunotherapy

Bio Pharma Dive

Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor. But Merck is advancing its own and data to be presented at ASCO show it could help treat Hodgkin's lymphoma

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

GSK wagers $2.1B on Affinivax and its next-generation pneumonia vaccine

Bio Pharma Dive

The deal is the second acquisition for GSK since April and gives the company access to an experimental shot that’s meant to surpass new products from Pfizer and Merck & Co

Scientists home in on cause of Duchenne gene therapy side effect

Bio Pharma Dive

An unusual collaboration among gene therapy developers suggests certain mutations could be behind "peculiar" side effects experienced by several patients treated in clinical trials

Lilly has a new blockbuster

World of DTC Marketing

If You’re Short On Time: The U.S. Food and Drug Administration approved Eli Lilly’s novel treatment for diabetes. The drug led to impressive blood sugar and body weight drops in clinical trials.

“Growing end” of inflammation discovered

Scienmag

Redness, swelling, pain – these are signs of inflammation. It serves to protect the body from pathogens or foreign substances.

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Pfizer cleared to restart hemophilia gene therapy trial

Bio Pharma Dive

While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023

In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K.,

Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

Bio Pharma Dive

The rest of Biohaven's pipeline, which includes drugs for ALS and obsessive compulsive disorder, will be spun out into a new company led by the biotech's current CEO and retaining its name

Drugs 269

Biogen CEO to step down as company pulls back from Alzheimer's drug

Bio Pharma Dive

Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors

A new era of pharma marketing?

World of DTC Marketing

Just 13% of people trust the pharma companies they interact with. 68% say the interactions feel transactional. Only a third agree that organizations know their communication preferences.

Modifying the body’s immune system to help treat Type 1 diabetes

Scienmag

In a new study, a team of researchers from the University of Missouri, Georgia Tech and Harvard University has demonstrated the successful use of a novel Type 1 diabetes treatment in a large animal model.

Mirati matches Amgen with updated data for KRAS-blocking cancer drug

Bio Pharma Dive

Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however

Drugs 261

3 cancer drug studies to watch at next month's ASCO meeting

Bio Pharma Dive

Detailed results from important studies of AstraZeneca’s breast cancer drug Enhertu, Gilead’s Trodelvy and Roche’s TIGIT blocker are among the most anticipated late-breaking data set to be presented next month

Drugs 260

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily

Our healthcare system is really screwed up

World of DTC Marketing

A 2015 Commonwealth Fund brie f showed that — before the major provisions of the Affordable Care Act were introduced — the United States had worse outcomes and spent more on health care, primarily because of greater use of medical technology and higher prices, compared to other high-income countries.

Scripps Research scientists explain what makes COVID-19 antibody “J08” so potent

Scienmag

LA JOLLA, CA—Last year, scientists at Scripps Research and Toscana Life Sciences studied the blood of 14 COVID-19 survivors to find the most potent antibodies against the SARS-CoV-2 virus.

FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

Bio Pharma Dive

The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake

AbbVie asks FDA to approve Parkinson's treatment

Bio Pharma Dive

The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie

Clay Siegall, founding Seagen CEO, takes leave amid domestic violence accusation

Bio Pharma Dive

The company's board is investigating the allegation, which Siegall, who has led Seattle's largest biotech for 24 years, denied. Chief Medical Officer and former Merck executive Roger Dansey was named interim CEO

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Seagen CEO Siegall resigns amid domestic violence investigation

Bio Pharma Dive

The biotech company is searching for a permanent successor to Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO

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As pharma dives deeper into digital, ad fraud is getting worse

World of DTC Marketing

Short on Time? Adalytics r eported that for nine months, billions of ad auctions for space on Gannett’s USA Today website resulted in brands unknowingly getting stuck with their ads running on other Gannett sites — often remote community sites.

More than starting a company: The Art and Science of Entrepreneurship

Scienmag

Entrepreneurs who are ready to start companies often lack enough knowledge and skillsets to do it correctly. How can they gain these?

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J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

Bio Pharma Dive

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies

Roche SMA drug approved in youngest infants, challenging Novartis and Biogen

Bio Pharma Dive

Evrysdi, the only oral drug for the neurodegenerative disorder, can now be used to treat babies younger than 2 months who have been identified through newborn screening

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