2021

New Merck study results raise questions about its COVID-19 pill

Bio Pharma Dive

Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday

Trials 281

Developmental and Reproductive Toxicology (DART) Studies: What Are They, and How Do They Fit into Your Program?

Camargo

Development and Reproductive Toxicology studies, or DART studies, are required for most non-oncology programs between IND and NDA filings.

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HCPs use of digital

World of DTC Marketing

SUMMARY: 62% of HCPs spend 3 hours per day accessing digtal resources. More HCPs chose to use smartphones to access digital resources as well and usage has increased when accessing a wide variety of professional content.

Cystic Fibrosis Market: A Rapidly Expanding Playing Field for Mid-Cap Pharma

Delveinsight

Cystic Fibrosis is a rare inherited disorder that causes loss of lung function and damages the digestive system. It has a higher prevalence in the Caucasian population.

RNA 52

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.

Drug Prices Are Up Again in 2021 and Canada’s PMPRB is On My Mind

Pharmacy Checkers

This week the prices of over 500 drugs went up in America, according to drug price transparency non-profit organization 46Brooklyn. This happens every year, usually coinciding with shouts of anger and disgust with the pharmaceutical industry’s greed.

Open Source “Wikipedia” for Drug Discovery

Pharma Mirror

By Kambiz Shekdar, Ph.D. Open source drug discovery was proposed in the past in connection with third-world diseases like tuberculosis and malaria, but it is in the context of first-world indications where it is needed most.

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Why natural language processing (NLP) is a critical part of your real world data strategy

Bio Pharma Dive

The barrier to knowledge can be eliminated when pharmaceutical companies use natural language processing to analyze unstructured content

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Is pharma hiring the right people?

World of DTC Marketing

SUMMARY: Older, more experienced employees are being shoved aside in favor of more inexperienced ones. The culture within pharma is driving people away, including new hires. More and more meetings are based on ROI, not the voice of the patient.

8 amlodipine alternative drugs for blood pressure

Druggist

Amlodipine is one of the most commonly prescribed drugs in the UK and the most prescribed high blood pressure ( BP ) medication. When patients are diagnosed with high blood pressure and a drug is recommended, amlodipine may be the first choice, but not always.

Drugs 87

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Bio Pharma Dive

Both companies are racing to prove their oral antivirals as treatments for COVID-19. Key clinical results could come later this year

Trials 285

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.

Pfizer taps McKinsey executive to lead dealmaking efforts

Bio Pharma Dive

Aamir Malik, a managing partner at the consulting firm, will replace longtime Pfizer executive John Young as chief business innovation officer next week

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Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Bio Pharma Dive

Marion Gruber and Phil Krause, two veteran vaccine reviewers, are unexpectedly leaving the agency at a critical time. The search for their replacements will begin "imminently," division head Peter Marks said in a letter

Moderna founder unveils new drug company focused on a different kind of RNA

Bio Pharma Dive

Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules

RNA 283

At FDA meeting, gene therapy experts wrestle with field's blindspots

Bio Pharma Dive

A panel convened by the regulator suggested ways to make gene therapy research safer, but struggled to propose broader recommendations for the field

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.

FDA halts tests of BioMarin drug amid heightened focus on gene therapy safety

Bio Pharma Dive

On the heels of a two-day FDA meeting in which experts debated the risks of gene therapy, the biotech said its early-stage PKU treatment was associated with cancer in mice

After talks with FDA, a biotech prepares to submit its closely watched ALS drug

Bio Pharma Dive

Executives at Amylyx Pharmaceuticals said that based on the agency's recent feedback, they will ask for approval of AMX0035 — likely within the next six months

Drugs 283

Celldex pins its hopes for a comeback on skin disease drug

Bio Pharma Dive

After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech

Relay's targeted cancer drug could be safer than its competitors. Is it more effective?

Bio Pharma Dive

Initial study results for Relay's experimental treatment offer some support for the biotech's protein motion technology, but raise some questions, too

Blaming the anti-vaxxers is not the answer

World of DTC Marketing

SUMMARY: Anti-vaxxers are vocal, and the media amplify their voices. There are many reasons why people aren’t getting vaccinated. We need more data to understand why. Republican extremism is part of the problem, but so is the lack of education.

Biotech M&A tracker: After hitting new heights, deals have slowed down. Here are the latest.

Bio Pharma Dive

Deals were few and far between last quarter. But the recent history of biopharma M&A suggests they'll return. Keep track of them as as they happen with BioPharma Dive's new database

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Intellia, with first results, delivers a 'landmark' for CRISPR gene editing

Bio Pharma Dive

Results published in The New England Journal of Medicine offer the first clinical evidence that CRISPR gene editing inside the body can be safe and effective, a culmination of years of scientific research

8 key clinical trials to watch for the rest of 2021

Bio Pharma Dive

The next six months could feature clinical milestones for CRISPR gene editing, the treatment of COVID-19, microbiome drugs and gene-targeted cancer therapy

Pfizer stocks cancer drug pipeline with $2.3B deal for Trillium

Bio Pharma Dive

The acquisition reflects growing industry interest in the cancer-linked protein targeted by Trillium's drugs, most notably shown by Gilead's acquisition of Forty Seven last year

Accelerating patient care through digital transformation and decentralized clinical trials

Bio Pharma Dive

The adoption of digital health technologies (DHTs) in the industry continues to pave the way to enable decentralized clinical trials (DCTs

How Bayer lured a biotech away from an IPO and into a buyout

Bio Pharma Dive

Vividion Therapeutics was headed toward an IPO earlier this year, but a company executive said Bayer’s $1.5B offer ended up being a more attractive option

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Two biotechs team up to bring CRISPR to 'natural killer' cell therapy

Bio Pharma Dive

A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy

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Fourth trial volunteer dies in Astellas gene therapy study

Bio Pharma Dive

The study, which was suspended following three deaths last year, had been restarted in February after Astellas lowered the treatment dose used

FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products

Social health: The future of healthcare marketing

Bio Pharma Dive

Approximately 79% of patients look to connect through social media to find answers to their health questions

Novo’s obesity drug has serious warnings and barriers to overcome

World of DTC Marketing

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings.

Positive data in hand, TG Therapeutics readies MS drug for FDA review

Bio Pharma Dive

If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies

Drugs 285

A three-decade monopoly: How Amgen built a patent thicket around its top-selling drug

Bio Pharma Dive

Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved

Drugs 279

After long wait, Editas reveals first data for CRISPR gene editing treatment

Bio Pharma Dive

Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions

In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective